To join the online webinar, go to: Online Access Password: Webinar1 (case-sensitive) Welcome to the NQF Safe Practices for Better Healthcare Webinar: Updated 2010 CLABSI and SSI Practices: A New Standard of Care (Safe Practices 21-22) Hosted by NQF and TMIT

2 Charles Denham, MD Chairman, TMIT Co-chairman, NQF Safe Practices Consensus Committee Chairman, Leapfrog Safe Practices Program Safe Practices Webinar February 18, 2010 Welcome and Safe Practice Overview

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5 Panelists Charles Denham: Welcome and Safe Practices Overview Peter Angood: HAI Clinical and Financial Implications and Policy Future Rabih Darouiche: New Highlights in CLABSI and SSI Prevention Rabih DarouichePeter Angood Charles Denham

6 Panelists David Classen: Future Picture of Prevention of HAIs Mary Oden Challenges for Infection Preventionists Jennifer Dingman: The Role of the Patient Advocate Jennifer DingmanMary Oden David Classen

7 The Role of the Patient Advocate Jennifer Dingman Founder of Persons United Limiting Substandards and Errors in Healthcare (PULSE), Colorado Division Co-founder, PULSE American Division Safe Practices Webinar February 18, 2010

8 Harmonization – The Quality Choir

2010 NQF Safe Practices for Better Healthcare: A Consensus Report 34 Safe Practices Criteria for Inclusion Specificity Benefit Evidence of Effectiveness Generalization Readiness 9

10 Information Management and Continuity of Care Medication Management Healthcare-Associated Infections Condition- & Site-Specific Practices Consent & Disclosure Culture Workforce Consent and Disclosure

CHAPTER 7: Hospital-Associated Infections Hand Hygiene Influenza Prevention Central Venous Catheter-Related Blood Stream Infection Prevention Surgical-Site Infection Prevention Care of the Ventilated Patient and VAP MDRO Prevention UTI Prevention Information Management and Continuity of Care Medication Management Healthcare-Associated Infections Condition-, Site-, and Risk-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy VAP Prevention Central V. Cath. BSI Prevention Sx-Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Systems Leadership: High-Alert, Std. Labeling/Pkg., and Unit-Dose Med. Recon. Culture CPOE Read-Back & Abbrev. Discharge System Patient Care Info. Labeling Studies Culture Meas., FB., and Interv. Structures and Systems ID and Mitigation Risk and Hazards Team Training and Team Interv. Nursing Workforce ICU Care Direct Caregivers Workforce CHAPTER 4: Workforce Nursing Workforce Direct Caregivers ICU Care CHAPTER 2: Creating and Sustaining a Culture of Patient Safety (Separated into Practices]  Leadership Structures and Systems  Culture Measurement, Feedback, and Interventions  Teamwork Training and Team Interventions  Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management and Continuity of Care  Patient Care Information  Order Read-Back and Abbreviations  Labeling Studies  Discharge Systems  Safe Adoption of Integrated Clinical Systems including CPOE CHAPTER 6: Medication Management  Medication Reconciliation  Pharmacist Leadership Role Including: High-Alert Med. and Unit-Dose Standardized Medication Labeling and Packaging CHAPTER 8: Wrong-Site, Wrong-Procedure, Wrong-Person Surgery Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Organ Donation Glycemic Control Falls Prevention Pediatric Imaging Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Informed Consent and Disclosure Informed Consent Life-Sustaining Treatment Disclosure Care of the Caregiver Consent and Disclosure Care of Caregiver MDRO Prevention UTI Prevention Falls Prevention Organ Donation Glycemic Control Pediatric Imaging

12 HAI Guidelines

Before insertion: Educate healthcare personnel involved in the insertion, care, and maintenance of central venous catheters (CVCs). At insertion: Use a catheter checklist at the time of CVC insertion. Perform hand hygiene prior to catheter insertion or manipulation. Avoid using the femoral vein for central venous access in adult patients. Use a catheter cart or kit with components for aseptic catheter insertion. Use maximal sterile barrier precautions. Use chlorhexidine gluconate 2% and isopropyl alcohol solution as skin antiseptic preparation in patients over two months of age and allow appropriate drying time per product guidelines. After insertion: Use a standardized protocol to disinfect catheter hubs, needleless connectors, and injection ports before accessing the ports. Remove nonessential catheters. Use a standardized protocol for non-tunneled CVCs in adults and adolescents for dressing care. Perform surveillance for CLABSI and report the data on a regular basis. NQF CLABSI Prevention Safe Practice Specifications: 2010 Update 13

Educate of healthcare professionals involved in surgical procedures. Educate the patient and his or her family as appropriate about SSI prevention. Conduct periodic risk assessments for SSI. Ensure that measurement strategies follow evidence-based guidelines. Provide SSI rate data and prevention outcome measures to key stakeholders. Administer antimicrobial agents for prophylaxis. When hair removal is necessary, use clippers or depilatories. Maintain normothermia immediately following colorectal surgery. Control blood glucose during the immediate postoperative period for cardiac surgery patients. Preoperatively, use chlorhexidine gluconate 2% and isopropyl alcohol solution as skin antiseptic preparation, and allow appropriate drying time per product guidelines. NQF SSI Prevention Safe Practice Specifications: 2010 Update 14

The Association for Professionals in Infection Control & Epidemiology Mission To improve health and patient safety by reducing the risks of infection and related adverse outcomes. The preeminent voice in infection prevention Over 13,000 members worldwide with responsibility for infection prevention, control and hospital epidemiology in a variety of healthcare settings.

APIC Targeting Zero Initiative Elimination Guides Evidence-based strategies to implement CDC guidelines, NQF Safe Practices and recommendations from the SHEA-APIC-IDSA Compendium –Guides to the elimination of SSIs, CR-BSIs, Mediastinitis, C. difficile, VAP and MRSA (hospital and long term care versions) help you bring science to the bedside –New guides in 2010 on A. baumannii, Hemodialysis and SSIs in orthopedics and oncology Research 2006 MRSA & 2007 C. difficile Prevalence Studies, 2010 MRSA II Study Education The most comprehensive program of live and online education to reduce infection, meet new and emerging regulatory requirements and understand the changing legal standard in acute, ambulatory and long term care settings Visit to learn more. Visit to learn more about the initiative and to access resources and practical toolswww.apic.org/targetingzero

17 HAI Clinical and Financial Implications and Policy Future Peter B. Angood, MD, FRCS(C), FACS, FCCM Senior Advisor, Patient Safety, National Quality Forum Member of Safe Practices Steering Committee Former Chief Patient Safety Officer and Vice President for The Joint Commission Safe Practices Webinar February 18, 2010

18 1 Stone PW, et al. AJIC 2005; 33:501-5 Background: Impact of HAIs 5%-10% of hospitalized patients develop an HAI 99,000 deaths per year $20 billion per year 1 Risk of serious HAI complications is highest for patients requiring intensive care Increasing number of HAIs Sicker patient population More complex procedures and equipment Increasing antimicrobial resistance

19 Klevens, Edwards, Richards, et al. Pub Health Rep 2007;122:160-6 Estimated Number of Healthcare-Associated Infections in U.S. Hospitals by Subpopulation and Major Site of Infection, United States, 2002

20 HRN = high-risk newborns; WBN = well-baby nurseries; ICU = intensive care unit; SSI = surgical-site infections; BSI = bloodstream infections; UTI = urinary infections; PNEU = pneumonia SSI 20% BSI 11% UTI 36% PNEU 11% Other 22% 133, , , , , , ,385 TOTAL HRN WBN Non-newborn ICU = SSI Klevens, Edwards, Richards, et al. Pub Health Rep 2007;122:160-6 Calculation of Estimates of Healthcare-Associated Infections in U.S. Hospitals Among Adults and Children Outside of Intensive Care Units, 2002

21 What Are the Costs of Healthcare- Associated Infections? U.S. Total excess costs $32 million to $825 million annually Most costs not reimbursed when DRGs are used or if costs are capitated Preventing 6% of nosocomial infections offsets cost of $60,000 I.C. program UK = cost £111 million/year and 950,000 lost bed days (1987) Decrease NI rate by 20%, saves $15 million - $16 million

NQF Safe Practices – 2010: Healthcare-Associated Infections 19. Hand Hygiene 20. Influenza Prevention 21. CLABSI Prevention 22. Surgical-Site Infection Prevention 23. Care of the Ventilated Patient 24. MDRO Prevention 25. Catheter-Associated UTI Prevention 22

23 New Highlights in Central Line- Associated Bloodstream Infection and Surgical-Site Infection Prevention Rabih O. Darouiche, MD VA Distinguished Service Professor Director, Center of Prostheses Infection at Baylor College of Medicine Safe Practices Webinar February 18, 2010

Co-invented antimicrobial-coated catheters that are licensed by Baylor College of Medicine to Cook Inc Received educational and research grants from CareFusion Do not plan to discuss off-label and investigational use of devices or drugs Disclosure Statement 24

Address similarities and differences between CLABSI and SSI Assess the impact of these two infections Analyze potentially protective approaches Overview of Presentation 25

Similarities Between CLABSI and SSI Both infections result primarily from breaking skin integrity Both infections are caused mostly by skin organisms Both infections occur at unacceptably high rates, can be difficult to manage, may require future intervention(s), and are expensive to treat 26

Differences Between CLABSI and SSI CLABSI manifests while the catheter is still in place, whereas SSI can manifest at any time after surgery, usually by 30 days post-op Microbiologic cause of CLABSI is almost always identified, whereas the microbiologic cause of SSI is unknown in many patients Occurrence of CLABSI can be attributed to various healthcare providers, whereas SSI is typically linked to the surgeon 27

Clinical Manifestations of infected CVC Exit site infection Tunnel infection Thrombophlebitis BSI

Impact of CLABSI Incidence: of the 6 million CVC inserted annually in the U.S., 250,000 result in BSI Management: cure often requires removal of the infected catheter and long antibiotic therapy Medical sequelae: attributable mortality 5%- 25% Economic burden: cost of treatment is $10K- $56K; annual cost in U.S., $3 billion–$16.8 billion 29

Annual Death Rates in the U.S. for Selected Infectious Diseases

Nosocomial Infections in the ICU National Nosocomial Infections Surveillance (NNIS) (97 hospitals) 87% central lines 86% Mechanical Ventilation 95% Urinary Catheters N= 14,177 < 55 = 33% 55 – 70 = 32% >70 = 35% 31

30% 70% 44% 56% 0% 10% 20% 30% 40% 50% 60% 70% 80% Non-CRBSICRBSINon-CRBSICRBSI Solid Tumor Malignancy Hematologic Malignancy % of Bacteremia with CVC as the source Gram-Positive Bacteremia in Cancer Patients: Role of the CVC 32

Difference between Surveillance Definition (by National Healthcare Safety Network: NHSN) and Clinical/Microbiologic Definition of CLABSI Surveillance definition: includes all cases of BSI in patients with CVC in whom other sites of infection are excluded ( catheter-associated BSI varies from from 1.3/1000 cath-days in medical surgical wards to 5.6/1000 cath-days in burn ICU) Clinical/microbiologic definition: includes only cases of BSI in patients with CVC in whom other sites of infection are excluded and microbiologic relationship of catheter to BSI exists ( catheter-related BSI ) 33

Relationship between Catheter Colonization and Bloodstream Infection Principle: catheter colonization is a prelude to catheter-related bloodstream infection Objective: to prevent infection by inhibiting catheter colonization 34

IA Recommendations in Upcoming CDC Guidelines for Prevention of CLABSI Staff education and training Insert CVC in subclavian catheters Place hemodialysis catheters in jugular or femoral veins Promptly remove CVC when no longer essential Hand wash with soap/water or alcohol-based hand rubs Utilize 2% chlorhexidine-based preparation for skin cleansing before inserting CVC, during dressing changes, and wiping access ports of needleless catheter systems Use sterile gauze or transparent semi-permeable dressings Use antimicrobial-impregnated CVC if expected duration of placement >5 days and CLABSI remains higher than goal set by institutions despite comprehensive strategy Guidelines for the Prevention of Intravascular Catheter-related Infections. Atlanta (GA): Centers for Disease Control and Prevention; [draft] 35

Before insertion: Educate healthcare personnel involved in the insertion, care, and maintenance of central venous catheters (CVCs). At insertion: Use a catheter checklist at the time of CVC insertion. Perform hand hygiene prior to catheter insertion or manipulation. Avoid using the femoral vein for central venous access in adult patients. Use a catheter cart or kit with components for aseptic catheter insertion. Use maximal sterile barrier precautions. Use chlorhexidine gluconate 2% and isopropyl alcohol solution as skin antiseptic preparation in patients over two months of age and allow appropriate drying time per product guidelines. After insertion: Use a standardized protocol to disinfect catheter hubs, needleless connectors, and injection ports before accessing the ports. Remove nonessential catheters. Use a standardized protocol for non-tunneled CVCs in adults and adolescents for dressing care. Perform surveillance for CLABSI and report the data on a regular basis. NQF CLABSI Prevention Safe Practice Specifications: 2010 Update 36

Comprehensive Protective Strategy Infection Control Bundle Hand washing Maximal barrier precautions 2% chlorhexidine-based skin antisepsis Avoiding femoral site if possible Removing unnecessary catheters 37

Although very essential, they: Are not easily enforceable Are not very durable Do not completely prevent infection Save some, but not enough, lives Potential Limitations of Traditional Infection Control Measures

Reasons to Optimize Prevention of SSI Unacceptably high incidence: the 30 million annual surgical procedures in the U.S. result in 300, ,000 cases of SSI Difficult management: may require repeated surgical interventions Serious medical consequences: tremendous morbidity and occasional mortality Soaring economic burden: annual cost of treatment in the U.S. is >$7 billion 39

Perioperative Approaches for Preventing SSI Non-antimicrobial approaches Normothermia Adequate oxygenation Tight glucose control Antimicrobial approaches Systemic antibiotic prophylaxis Nasal application of mupirocin Skin antisepsis 40

Impact of Timing of Systemic Antibiotic Prophylaxis on SSI 41

A Prospective Randomized Trial of Nasal Mupirocin Plus Chlorhexidine Wash Rapid identification of nasal carriage by S. aureus followed by a 5-day course of nasal mupirocin plus chlorhexidine wash: Reduces S. aureus infection (3.4% vs. 7.7%) Decreases S. aureus SSI by almost 60% Bode, et al. N Engl J Med 2010;362:

Importance of the Skin Largest bodily organ Protective barrier Skin flora most common cause of SSI (and CLABSI) 80% of bacteria reside in epidermis

Factors that Support the Need for Optimal Skin Antisepsis Most pathogens that cause SSI are skin flora At least 2/3 of cases of SSI are incisional Most SSI are considered preventable Other preventive measures reduce but do not eliminate SSI 44

Commonly used Preoperative Antiseptics Povidone-iodine (Iodophor) Chlorhexidine gluconate Alcohol Combination products: >2 active agents 45

Comparison of Antimicrobial Activity of Antiseptic Preparations Chlorhexidine-based preparations are better than alcohol or iodine-based products in: Reducing colonization of vascular catheters Preventing contamination of blood cultures Decreasing contamination of surgical tissues 46

Pressing Need to Compare Clinical Efficacy of Antiseptic Preparations in Preventing SSI CDC guidelines for prevention of infections related to vascular catheters recommend antiseptic cleansing of the skin with 2% chlorhexidine-containing products O’Grady, et al. Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep 2002;51(RR-10):1-29 CDC has not previously issued a preference as to type of preoperative skin antiseptics 47

Prospective, Randomized, 6-Center Clinical Trial of 849 Patients Population: adult patients scheduled for abdominal or non-abdominal clean-contaminated surgery Randomization: hospital-stratified Intervention: preoperative skin cleansing with: ChloraPrep® (2% chlorhexidine gluconate-70% isopropyl alcohol = CA) 26-ml applicators; OR 10% povidone-iodine (PI) scrub and paint Evaluation: SSI was assessed by blinded evaluators Darouiche, et al. N Engl J Med 2010;362:

Proportion of Patients with Surgical-Site Infection, According to Type of Infection (Intention-to-Treat Population). Type of Infection Chlorhexidine- Alcohol (N=409) no. (%) Povidone- Iodine (N=440) no. (%) Relative Risk (95% CI)P-Value Any surgical-site infection 39 (9.5)71 (16.1)0.59 ( ) Superficial incisional infection 17 (4.2)38 (8.6)0.48 ( ) Deep incisional infection 4 (1.0)13 (3.0)0.33 ( ) 0.05 Organ-space infection 18 (4.4)20 (4.6)0.97 ( ) >0.99 Sepsis from surgical-site infection 11 (2.7)19 (4.3)0.62 ( )

Kaplan-Meier Curves for Freedom from Surgical-Site Infection (Intention-to-Treat Population)

Proportion of Patients with Surgical-Site Infection, According to Type of Surgery (Intention-to-Treat Population). Chlorhexidine-AlcoholPovidone-Iodine Type of Surgery N no. Infected (%) InfectedN no. Infected (%) Infected Abdominal (12.5)30863 (20.5) Colorectal (15.1)19142 (22.0) Biliary 442 (4.6)545 (9.3) Small intestinal 414 (9.8)3410 (29.4) Gastroesophageal 263 (11.5)296 (20.7) Non-abdominal 1122 (1.8)1328 (6.1) Thoracic 442 (4.5)574 (7.0) Gynecologic 420 (0.0)401 (2.5) Urologic 260 (0.0)353 (8.6) 51

Chlorhexidine-Alcohol (CA) vs. Povidone- Iodine (PI) for Prevention of SSI CA significantly reduces SSI Number of patients needed to receive CA instead of PI to prevent one case of SSI: 17 Delays onset of SSI CA and PI have similar rates of adverse events (including events related to study medication in 0.7% in each group) and serious adverse events 52

New CMS Regulations (effective 10/08) Changes to Inpatient Prospective Payment System 10 non-reimbursable conditions met these criteria: High cost High volume Triggers a high-paying MS-DRG May be considered reasonably preventable through application of evidence-based guidelines Federal Register, Volume 73, No. 161; 08/19/08 53

Non-reimbursable Infectious Conditions Catheter-associated urinary tract infection Vascular catheter-associated infection Surgical-site infection-mediastinitis after CABG Surgery on various joints, including shoulder, elbow, and spine 54

Perspective Optimal prevention of CLABSI and SSI can: Improve patient care Incur cost-savings Enhance infection control measures 55

56 Future Picture of Prevention of Healthcare-Associated Infections David Classen, MD, MS Chief Medical Officer at CSC Associate Professor of Medicine at the University of Utah Infectious Diseases Consultant, University of Utah School of Medicine Safe Practices Webinar February 18, 2010

57 Challenges for Infection Preventionists Mary A. Oden, RN, BSN, MHS, CIC Senior Director, Cleveland Clinic Health System Infection Prevention Program Safe Practices Webinar February 18, 2010

58 The Role of the Patient Advocate Jennifer Dingman Founder of Persons United Limiting Substandards and Errors in Healthcare (PULSE), Colorado Division Co-founder, PULSE American Division Safe Practices Webinar February 18, 2010

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