1. Patient Safety and Health Care Associated Infections Infectious Disease Epidemiology Workgroup Jan. 4, 2008 Austin, Texas Gary Heseltine MD MPH Infectious Disease Control Unit “When speculation has done its worst, two and two still make four.” Samuel Johnson, The Idler

2. Outline Big picture – patient safety –Harm unintentional or not, preventable or not –The many players Health care-associated infections (HAI) –Surgical care improvement project (SCIP) –The burden of morbidity and mortality –What the evidence says SB 288 Public Reporting of HAI –Where are we and where are we going in Texas? Changing practices – adopting protocols –Barriers and incentives –Direction for the future

3. Patient Safety Hippocrates, Epidemics "Declare the past, diagnose the present, foretell the future; practice these acts. As to diseases, make a habit of two things — to help, or at least to do no harm." The Joint Commission defines patient safety solutions: "Any system design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the processes of health care.“ Institute for Healthcare Improvement defines medical harm: “Unintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment), that requires additional monitoring, treatment or hospitalization, or that results in death. Such injury is considered harm whether or not it is considered preventable, whether or not it resulted from a medical error, and whether or not it occurred within a hospital.” Safe - free from hurt, injury, danger or risk Harm – injury; damage; hurt Safety - state of being safe

5. Institute for Healthcare Improvement 37 Million Admissions X 40 Injuries per 100 Admissions = 15 Million Injuries per Year

6. Proportion of Adverse Events Most Frequent Categories Brennan. N Engl J Med. 1991;324 (6):377-384. Non-surgical Surgical 3.7% of patients experience serious adverse events related to medical management. 58% of these events were preventable mistakes – now called medical errors or patient safety failures Technical complication – e.g. injury to adjacent structures, gas emboli, anastomostic leak Non-technical complication – e.g. development of cardiac arrhythmias, vascular emboli

7. Burden of Healthcare-Associated Infections in the United States, 2002 1.7 million infections in hospitals –Most (1.3 million) were outside of ICUs –9.3 infections per 1,000 patient-days –4.5 per 100 admissions 99,000 deaths associated with infections –36,000 – pneumonia –31,000 – bloodstream infections Klevens, et al. Pub Health Rep 2007;122:160-6

8. Impact of Surgical Site Infections (SSI) InfectedUninfected Mortality (in- hospital) 7.8%3.5% ICU admission29%18% Readmission41%7% Median initial LOS11d6d Median total LOS18d7d Initial excess cost+$3,644 (median) Total excess cost+$5,038 (median) *Pairs matched for procedure, NNIS index, age *General inpatient surgical population; 22, 742 procedures included Kirkland. Infect Control Hosp Epidemiol. 1999;20:725. An estimated 40-60% of SSIs are preventable.

9. Centers for Medicare & Medicaid Services (CMS) Centers for Disease Control and Prevention (CDC) Department of Veteran’s Affairs Institute for Healthcare Improvement (IHI) Joint Commission on Accreditation of Healthcare Organizations (JCAHO) American College of Surgeons (ACS) American Hospital Association (AHA) American Society of Anesthesiologists (ASA) Association of peri- Operative Registered Nurses (AORN) Agency for Healthcare Research and Quality (AHRQ) Surgical Care Improvement Project (SCIP) 2010 National Goal Reduce preventable surgical morbidity and mortality by 25% Surgical Infection Prevention (SIP): previous CMS initiative focusing appropriate selection, administration and discontinuation of surgical antibiotic prophylaxis.

10. SCIP Has Four Modules Infection 7 Infection Prevention Process Measures Venous Thromboembolus (VTE) 2 VTE Prevention Process Measures Cardiac Prevention Module 1 Cardiovascular Prevention Measure Respiratory ( Post-operative ventilator associated pneumonia) Delayed implementation to use these measures in expanding the ICU Core Measure Set

11. SCIP Infection Module SCIP INF 1: – –Prophylactic antibiotic received within one hour prior to surgical incision SCIP INF 2: – –Prophylactic antibiotic selection for surgical patients SCIP INF 3: – –Prophylactic antibiotics discontinued within 24 hours after surgery end time (48 hours for cardiac patients) SCIP INF 4: – –Cardiac surgery patients with controlled 6 a.m. postoperative serum glucose SCIP INF 6: – –Surgery patients with appropriate hair removal SCIP INF 7: – –Colorectal surgery patients with immediate postoperative normothermia Effective with discharges beginning July 1, 2006

12. Classen. NEJM. 1992;328:281. Prophylactic Antibiotics Timing Administration of Pre-op Dose Infections (%) Hours From Incision Note: only 40% received antibiotics within two hours of incision 14/369 5/699 5/1009 2/180 1/81 1/41 1/47 15/441

13. Diabetes, Glucose Control, and SSIs After Median Sternotomy Increased risk: Diagnosed diabetes Undiagnosed diabetes Post-op glucose > 200 mg% within 48h Latham. Inf Contr Hosp Epidemiol. 2001;22:607. Dellinger. Inf Contr Hosp Epidemiol. 2001;22:604.

14. Cleveland Regional Medical Center

15. Central Line Infections: Incidence & Risk 48% of ICU patients have central venous catheters, accounting for 15 million central venous catheter-days per year in ICUs. The case fatality rate for catheter-related blood stream infections approaches 20%. Attributable mortality ranges from 12-25% but was 3% in one meta-analysis. Mermel LA. Ann Int Med 2000;132: 391-402 Soufir L et al. Infect Control Hosp Epidemiol 1999 Jun;20(6):396-401.

16. Central Line Insertion Checklist Prevention of Central Line-Associated Bloodstream Infections Bundle: standard pack or cart for line insertion with all needed supplies

17. Do Central Line Bundles Work? 12 month Baseline average CA-BSI rate 2.84 12 month Project Average CA-BSI rate.73 = 74% Reduction 10 out of 12 months with zero CA-BSI Overlake Hospital Medical Center - SeattleIHI Collaborative

18. IOM Report 2002 “Disparities in the health care delivered to racial and ethnic minorities are real and are associated with worse outcomes in many cases, which is unacceptable.” Alan Nelson, committee chair Unequal Treatment: Confronting Racial and Disparities in Health Care Protocol driven interventions for HAIs are one step in addressing this larger issue.

19. SB 288 Mandatory Public Reporting of Healthcare-associated Infections 80 th Regular Legislative Session 2007 Hospitals, Ambulatory Surgical Centers (ASCs) to report specific HAIs to DSHS using CDC case definitions Must begin no later than 6/1/08 Minimum once per year, maximum each quarter Must contain sufficient patient ID data –avoid duplication –verify accuracy and completeness –allow for risk adjustment DSHS will review data for validity and “unusual data patterns or trends”

20. SB 288 Advisory Panel Two certified ICPs, one from a rural hospital Two ICP certified and licensed nurses Three MDs one with Pedi ID and Pedi epi, SHEA members with expertise in IC Two QA professionals-one ASC & one acute care One officer of a general hospital One officer of an ASC Three nonvoting DSHS members Two members representing the public as consumers No lobbyists or healthcare trade association representatives Reimbursement is allowed Sixteen member Advisory Panel– two year term

21. Adult Reportable SSI Infections colon surgeries hip and knee arthroplasties abdominal and vaginal hysterectomies CABG and vascular procedures Pediatric Reportable SSI Infections Cardiac procedures excluding thoracic cardiac VP shunt procedures Spinal surgery with instrumentation And (non-SSI) respiratory syncitial virus infection

22. Reportable Central Line Infections Lab confirmed from a patient in any “special care setting in the hospital” Alternative Reporting Report SSIs related to the 3 most frequently performed procedures from the National Healthcare Safety Network (NHSN) procedure list For facilities with an average < 50 procedures/monthly

23. Reporting Mechanism Plan A: Missouri Healthcare-Associated Infection Reporting System- large IT project Plan B: NHSN- complex and burdensome to ICP –CDC proposal: vendors send HL7 messages to NHSN Plan C: Use Texas Hospital Discharge Data Network –Already reaches statewide except rural hospitals and will be expanded to all ASCs under existing legislation –Claims file is called ANSI 837I, carries ICD9 claims data –ICP generated data attached to the ANSI 837 Common network carrying two data sets, claims and ICP-HAI. Both data sets can be used jointly to evaluate quality of care. Plan D – as needed Option for public to report suspected SSIs to DSHS –Poses significant challenges, particularly validation

24. HAI Report Public summary for each reporting facility Risk adjusted with a comparison of the risk- adjusted rates for each reporting facility Easy to read (consumer friendly) Concise facility comments on report will be allowed Posted on internet

25. Reporting Protections Confidential and privileged data May not be used in a civil action to establish standard of care Enforcement- general hospital under Health and Safety Code chapter 241, ASC under chapter 243 Potential Adverse Consequences of Reporting Diversion of resources from patient care to forms Creation of disincentives to treat higher risk patients Misleading stakeholders through data manipulation

26. SB 288 Funding For FY 2008 DSHS requested $4.5M, 36 FTEs LBB calculated $1.1M and 5 FTEs FY 2009 DSHS requested $3.7M LBB calculated $1.2M and 8 more FTEs Other scenarios presented Current status = not funded

27. Safe, nurturing place Place of sanctuary Place of healing Images of a Hospital

28. In one location Lots of colonized and/or infected persons Lots of vulnerable/susceptible persons Lots of traffic between infected and vulnerable persons Add in lots of antibiotic use Reality of a Hospital

29. Design a system to facilitate the spread of infection. What would it look like? –A Hospital Design a system to select for antimicrobial resistance. What would it look like? –A Hospital Reality of a Hospital

30. Adopting Change

31. Transformational Change Transformation (1) alters the culture of the institution by changing select underlying assumptions and institutional behaviors, processes and products; (2) is deep and pervasive, affecting the whole institution; (3) is intentional; and (4) occurs over time. Incremental improvement is not enough The pace of improvement is not fast enough

33. Resources Institute for Healthcare Improvement www.ihi.orgwww.ihi.org Texas legislature www.legis.state.tx.uswww.legis.state.tx.us Association of Professionals in Infection Control www.apic.org DSHS HAI website www.texasdisease.org