Surgical Site Infections: Meeting the Latest Standards & Assuring A SafeEnvironment for Prevention

1. Surgical Site Infections:Meeting the Latest Standards & Assuring A SafeEnvironment for Prevention Loretta Litz Fauerbach, MS, CIC Fauerbach & Associates – Global Infection Prevention Services March 7, 2013 Taking Quality to the Next Level Kentucky Hospital Association Annual Quality Conference and Hospital Engagement Network Convening Louisville, Kentucky

2. Objectives • To identify the components in the Surgical Care Improvement Project • To discuss CMS SSI reporting requirements to NHSN • To clarify NHSN methodology • To identify other quality initiatives related to SSI prevention • To identify key stake holders and reporting mechanisms for a strong surgical site infection prevention program. • To identify challenges with data collection and strategies to improve communications related to identifying surgical site infections • To discuss accrediting and licensing requirements related to SSI prevention LLF SSI Standards 2013

3. Impact of SSIs • Occur in 2%-5% of patients undergoing inpatient surgery in the United States. • Approximately 500,000 SSIs occur each year • 7-10 additional post operative hospital days • 2-11 times higher risk of death compared to patients who do not have an SSI • Patients with an SSI have a 2-11 times higher risk of death, compared with operative patients without an SSI. • 77% of deaths in patients who have an SSI are directly attributable to SSI • Attributable costs vary depending on procedure and organisms but range from $3000 to $29,000 • SSIs are believed to account for up to $10 billion annually in healthcare expenditures. LLF SSI Standards 2013

4. SSI Burden of Illness • Surgical Site Infections: • Represent 20 percent of all health care-associated infections reported to the National Nosocomial Infections Surveillance System (NNIS) in 2002. • Result in more than 8,000 deaths a year and occur in up to 25 percent of patients following major surgical procedures. • Extend average length of stay by 9.7 days while increasing cost by $20,842 per admission. • Are preventable in an estimated 40 to 60 percent of cases.

5. Surgical Site Infections (SSI’s)General Background • 2.6% of 30 million operations complicated by SSI’s • SSI’s Second most common healthcare associated • infection accounting for 17% of all hospital • acquired infections • SSI’s most common healthcare associated infection • in surgical patients (38%) • Consequences of SSI • Increased hospital stay by up to 10 days • Increased hospital costs • Increased readmission rates • Increased pain and suffering CDC, 2003 LLF SSI Standards 2013

6. National Patient Safety Goal NPSG.07.05.01 Implement best practices for preventing surgical site infections. • CDC Guideline for the Prevention of Surgical Site Infections • SHEA Compendium • IHI Bundle Care LLF SSI Standards 2013

7. Health & Human Services Infection Prevention Plan for Surgical Site Infections • SSI 1 • Deep incision and organ space infection rates using NHSN definitions (SCIP procedures) • Goal: CDC NHSN Median deep incision and organ space infection rate for each procedure/risk group will be at or below the current NHSN 25th percentile • Measure: Surgical site infection rate: Deep wound and organ space infections as a result of elective surgery to include coronary artery bypass graft (CABG) and cardiac surgery; hip or knee arthroplasty; colon surgery; hysterectomy (abdominal and vaginal); and vascular surgery. LLF SSI Standards 2013

8. Health & Human ServicesInfection Prevention Plan for Surgical Site Infections SSI 2 Adherence to SCIP/NQF infection process measures (perioperative antibiotics, hair removal, postoperative glucose control, normothermia) CMS SCIP Goal: 95% adherence rates to each SCIP/NQF infection process measure. Cardiac surgery patients with controlled postoperative serum glucose; Surgery patients with appropriate hair removal; Prophylactic antibiotics received; Prophylactic antibiotics selection; Prophylactic antibiotics discontinued Measure: Compliance with Centers for Medicare and Medicaid Services antimicrobial prophylaxis guidelines. LLF SSI Standards 2013

9. Evidence-Based Practice Guidelines for Surgical Site Infection Prevention Four components of care include: 1. Appropriate use of prophylactic antibiotics • Prophylactic antibiotic received within one hour prior to surgical incision • Prophylactic antibiotic selection for surgical patients consistent with national guidelines • Prophylactic antibiotics discontinued within 24 hours after surgery end time (48 hours for cardiac patients) 2. Appropriate hair removal (if deemed necessary, remove using clippers or depilatory)

10. Evidence-Based Practice Guidelines for Surgical Site Infection Prevention 3. Controlled postoperative serum glucose in cardiac surgery • Glucose control is defined as serum glucose levels below 200 mg/dl, collected at or closest to 6:00 a.m. on each of the first two postoperative days • Tight glucose control (using an insulin drip) is often performed in an intensive care setting 4. Immediate postoperative normothermia in colorectal surgery LLF SSI Standards 2013

11. Evidence-Based Practice Guidelines for Surgical Site Infection Prevention Additional SCIP changes in care: • Beta blockade for patients on beta blockers prior to admission should be continued postoperatively • Venous thromboembolism prophylaxis • Ventilator-associated pneumonia prevention • Source: Institute for Healthcare Improvement, How-to Guide: Prevent Surgical Site Infections. (2012) http://www.ihi.org/explore/SSI/Pages/default.aspx Accessed 7/11/12. LLF SSI Standards 2013

12. The Florida Surgical Care Initiative (FSCI) • A partnership between the Florida Hospital Association (FHA) and the American College of Surgeons (ACS), and endorsed by the Florida Chapter of the ACS, • Focus initially on four outcome measures of the ACS National Surgical Quality Improvement Program (NSQIP) LLF SSI Standards 2013

13. FSCI Surgical Outcome Measures • Standard ACS NSQIP* measures that are followed from pre-op to 30 days post-discharge • surgical site infection (SSI), • urinary tract infection (UTI), • colorectal outcomes and • elderly surgery outcomes * ACS NSQIP - significantly decrease patient mortality and morbidity rates (Annals of Surgery, 250:363-376, September 2009) LLF SSI Standards 2013

14. LLF SSI Standards 2013

15. FSCI Unique Approach to Measurement • Uses medical chart data gathered by clinically trained personnel rather than insurance claims data derived from medical bills • Adjusts for risk so that the patient’s condition is taken into consideration when assessing the outcome • Evaluates how the patient is doing a month after his or her operation, since more than half of complications occur after discharge • Builds commitment and collaboration among surgeons, surgical teams and hospitals, because it is based on the highest quality data LLF SSI Standards 2013

16. FSCI Surgical Outcome Measures LLF SSI Standards 2013

17. Ambulatory Surgery Care Standards CMS State Operations Manual, Appendix L, Part I ASC Survey Protocol, and Part II General Conditions and Requirements • http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf • May also be accessed through the AAAHC.org website • Very Similar to CMSCDC/SHEA/TJC recommendations for hospitals LLF SSI Standards 2013

18. ASC • 416.51 Infection Control • The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases LLF SSI Standards 2013

19. ASC Key Elements of a Risk Assessment • Make it your own through a formal Risk Assessment • Collaborative effort • Regularly reviewed and updated • Governing body review • Forms the basis for your written Infection Prevention Plan including goals and measureable objectives LLF SSI Standards 2013

20. Risk Assessment for Facility’sUnique Practice Setting Identify Risks for Transmission • Populations • Procedures – general and specialty care procedures • Geographic Location/Weather • Size of Facility • Referral Patterns • Organisms and risks common to the community (endemic occurrences) • Surveillance data including HAIs and process monitoring • Construction • Cleaning, Disinfection Sterilization • Supply Chain • Staffing • Medical • ASC staff LLF SSI Standards 2013

21. Types of Infections • Surgical Site Infections • CA-UTI • Intravenous Catheters including CLA-BSIs • C. difficile or other GI pathogens • Respiratory Illness • Resistant Organisms LLF SSI Standards 2013

22. Collaboration is Key Part of IP Risk Assessment Interdisciplinary Input • Infection Prevention Team • Medical Staff • Nursing Staff • Administration • Other Leaders • Other potential participants • Patients • Public Relations • Public Health • 3rd Party Payors LLF SSI Standards 2013

23. Set Goals Based on Risk Assessment • High Risk - High Volume • Likelihood of event occurring • Key Risks • Determine top priority • Set Goals • Establish measurements to evaluate goals • Set protocols for obtaining the data for the measurements LLF SSI Standards 2013

24. Infection Prevention Program and QA/PI Program Linkage • 416.51(b) …”ongoing program designed to prevent, control, and investigate ..” • 416.51(b)(2) …”an integral part of the ASC’s quality assessment and performance improvement program..” LLF SSI Standards 2013

25. Basic Program Elements • SSI Prevention • Hand Hygiene • Cleaning, Disinfection and Sterilization • Safe Injection Practices LLF SSI Standards 2013

26. Qualified IP Required • 416.51 Condition for Coverage – Infection Control: “The ASC’s infection control program must be directed by a designated health care professional with training in infection control.” • ICSW Item #17 – “Does the ASC have a licensed health care professional qualified through training in IC and designated to direct the ASC’s IC program?” LLF SSI Standards 2013

27. Impact of ICSW Item #17: • “If the ASC cannot document it has designated a qualified professional with training in IC to direct its IC program, a deficiency must be cited. • Lack of a designated professional responsible for IC should be considered .. for a Condition level deficiency related to 416.51.” LLF SSI Standards 2013

28. Common Citations Written materials are needed, yet are absent, incomplete, or insufficient to meet the standards Cleaning, disinfection, and sterilization of instruments, equipment and supplies, environmental cleaning • Governing body formal meeting minutes • Policies & procedures • Required recordkeeping such as logs • Evidence of delegation of responsibilities • Evidence of compliance with policies • Manufacturer’s Recommendations • Follow AAMI, AORN, CDC LLF SSI Standards 2013

29. Common Citations Safe Injection Practices One Needle, One Syringe, One Patient, One Time • Outbreaks due to improper use of single dose vials, syringes and needles • Single patient use vials are single patient use, unless drawn up under a certified pharmacy hood, no exceptions! • Nationally recognized guidelines adopted by your organization’s Governing Body as evidenced in formal meeting minutes • Most current version • Adherence • Education • Surveillance LLF SSI Standards 2013

30. Common Citations Procedures to minimize risk of Infection including Surveillance NHSN • CDC Guidelines • Patient Safety Goals • AORN • Process Monitoring • Outcome Monitoring • Targeted activities- high risk /high volume • Legislative Mandates • Definitions • Methodology • Comparisons LLF SSI Standards 2013

31. Tips for Success for Accreditation Survey • Present the most current standards book upfront. • Prepare for the challenging aspects • Set up a space for the surveyor to work • Document quality and infection prevention initiatives • Prepare a list of physicians and staff • Make sure credentials are in order • Have evaluations and education/orientation records readily available LLF SSI Standards 2013

32. Key Resources • Accreditation Association for Ambulatory Health Care • www.aaahc.org • info@aaahc.org for general questions • Association for Professionals in Infection Control • www.apic.org • Safe Injection Practices • www.oneandonlycampaign.org • Center for Disease Control • www.cdc.gov LLF SSI Standards 2013

33. Basic practices for prevention and monitoring of SSI: 1. Perform surveillance for SSI (A-II). 2. Provide ongoing feedback on SSI surveillance and process measures to surgical and perioperative personnel and leadership (A-II). 3. Increase the efficiency of surveillance through the use of automated data (A-II). LLF SSI Standards 2013 CDC SSI Guideline 1999

34. SSI Surveillance Methods • Daily Direct Observation by trained person starting 24-48 hours after surgery • Considered to be the most accurate method of surveillance, but rarely used due to resource limitation • Indirect SSI surveillanceusing a combination of sources • Microbiology and Patient Records • Survey of surgeons and patients • Re-admission tracking • Other information including coded dx, or op reports • Efficacy of Indirect Surveillance • Less time consuming, IP can perform during surveillance rounds • Reliable (sensitivity, 84%-89%) and specific (specificity, 99.8%) when compared to “gold standard” of direct surveillance. LLF SSI Standards 2013 CDC SSI Guideline 1999

35. Automated Surveillance • Expanded by using hospital databases • data on administrative claims, • days of antimicrobial use, • readmission to the hospital, • return to the operating room • Automatically import data • microbiologic culture data, • surgical procedure data, and • general demographic information • Improve the sensitivity of indirect surveillance for detection of SSI • Improve IP efficiency in data collection LLF SSI Standards 2013 CDC SSI Guideline 1999

36. Perform Surveillance • High Risk - High Volume • Identify, collect, store, and analyze data needed for the surveillance program. • Implement a system for collecting data needed to identify SSIs. • Develop a database for storing, managing, and accessing collected data on SSIs. • Prepare periodic SSI reports (the time frame will depend on hospital needs and volume of targeted procedures). LLF SSI Standards 2013 CDC SSI Guideline 1999

37. Perform Surveillance • Collect denominator data on all patients undergoing targeted procedures, to calculate SSI rates for each type of procedure • Identify trends (eg, in rates of SSI and pathogens causing SSIs). • Use CDC and NHSN definitions of SSI • Perform indirect surveillance for targeted procedures. • Perform postoperative surveillance for 30 days; if prosthetic material is implanted during surgery then follow for 12 months LLF SSI Standards 2013 CDC SSI Guideline 1999

38. Special Approaches for SSI Prevention Perform an SSI Risk Assessment Perform Expanded SSI Surveillance • Identify areas that surveillance data suggest lack of effective control. • Elements to Consider • High Risk -High Volume • Surveillance Data • Rates • Processes • Organisms • Strategies • Determine the source, extent of the problem, and to identify potential interventions • Case finding • Observational Studies • Check adherence rates to best practices LLF SSI Standards 2013 CDC SSI Guideline 1999

39. Post Discharge SSI Surveillance • More Procedures are being done in outpatient setting • Shorter Post OP stays for Inpatients • No standard method for Post OP SSI surveillance • Questionnaires to patients, surgeons, or clinics • Shown to have poor sensitivity and specificity • Rates do increase after Post Op Surveillance implemented • Superficial incisional infections usually managed as outpatient • Deep incisional and organ/space infections typically require readmission to the hospital for management. LLF SSI Standards 2013 CDC SSI Guideline 1999

40. LLF SSI Standards 2013

41. Infrastructure Requirements Trained personnel • Infection prevention and control personnel • SSI surveillance, • Able to apply CDC definitions of SSI, • Basic computer and mathematical skills, and • Good communication skills and adept at providing feedback and education to healthcare personnel when appropriate • NSQIP – surveillance nurse LLF SSI Standards 2013 CDC SSI Guideline 1999

42. Computer Assisted Decision SupportCreating automatic reminders • Use computer support to improve pre-op administration of antimicrobial prophylaxis • Initial and repeat doses • Stop orders • Utilization of automated data • Tracking • Monitoring LLF SSI Standards 2013

43. Feedback Provide ongoing feedback on SSI surveillance and process measures to surgical and perioperative personnel and leadership (A-II). • Routinely provide feedback on SSI rates and process measures to individual surgeons and hospital leadership. • For each type of procedure performed, provide risk adjusted rates of SSI. • Anonymously benchmark procedure-specific risk adjusted rates of SSI among peer surgeons. • Confidentially provide data to individual surgeons, the surgical division, and/or department chiefs. LLF SSI Standards 2013

44. Will automation and reminders help? 30% of SSI are preventable with appropriate use of preoperative antibiotics* LLF SSI Standards 2013 *Dellinger EP 2005

45. Prevention of SSI: Process • MD to treat any existing infection at remote site • (urine, bloodstream, etc.) • Remove hair only when necessary • Do not shave • When necessary, use clippers or depilatories • Control hyperglycemia • Implement preoperative showers--CHG preferred • Administer surgical prophylaxis according to • guidelines • Maintain appropriate oxygenation control • Maintain normothermia/control of hypothermia CDC SSI Guideline 1999 LLF SSI Standards 2013

46. SSI Complexity • Microbial characteristics (eg, degree of contamination and virulence of pathogen) • Patient characteristics (eg, immune status and comorbid conditions) • Surgical characteristics (eg, type of procedure, introduction of foreign material, and amount of damage to tissues) LLF SSI Standards 2013

47. Extrinsic Procedure Related Perioperative: Patient Preparation Hair Removal Pre-Operative Infections • Do not remove hair unless hair will interfere with the operation • If hair removal is necessary remove by clipping. • Do not use razor. A I • Identify and treat remote infections prior to elective surgical procedures. A II CDC SSI Guideline 1999 LLF SSI Standards 2013

48. SSI Prevention GuidelinesPreparation of Patient • Do Not Remove Hair at the incision site, unless it will interfere with surgery itself. • If the hair must be removed, do it directly beforehand, • preferably with electric clippers. (1A) • Pre-surgical patients should perform an antiseptic shower at least the night before and preferably also the morning of the scheduled surgery. Wash and clean the incision site area, scrubbing lightly to remove any gross skin contamination prior to antiseptic surgical preparation. (1B) • CDC, 1999 LLF SSI Standards 2013

49. Hair Removal MethodShaving versus Clipping Cruce and Forde, 1981 The increased risk with shaving prior to the operation is associated with microscopic cuts and shaving immediately before seriously reduces the SSI risk ( 20% risk if shaved > 24hrs--CDC, 1999). LLF SSI Standards 2013

50. Implement evidence based standards (A-II) • Policies and practices should include but are not limited to the following: • Reducing modifiable patient risk factors • Optimal cleaning and disinfection of equipment and the environment • Optimal preparation and disinfection of the operative site and the hands of the surgical team members • Adherence to hand hygiene • Traffic control in operating rooms LLF SSI Standards 2013 CDC SSI Guideline 1999