1. The Surgical Infection Prevention and Surgical Care Improvement Projects Where we started and where we’re going… Dale W. Bratzler, DO, MPH QIOSC Medical Director Oklahoma Foundation for Medical Quality

2. Why focus on surgical quality? ~30 million major operations each year in the US Despite advances in surgical and anesthesia technique and improvements in perioperative care, variations in outcomes for patients having surgery are well known

3. Why focus on surgical quality Patients who experience a postoperative complication have dramatically increased hospital length of stay, hospital costs, and mortality On average, the length of stay for patients who have a postoperative complication is 3 to 11 days longer

4. Consequences of Surgical Complications Dimick and colleagues demonstrated increased costs: infectious complications was $1,398 cardiovascular complications $7,789 respiratory complications $52,466 thromboembolic complications $18,310. Dimick JB, et al. J Am Coll Surg 2004;199:531-7.

5. Impact of Complications on Survival Khuri SF, et al. Ann Surg 2005;242:326-41. Khuri and colleagues demonstrated that, independent of preoperative patient risk, the occurrence of a 30-day complication reduced median patient survival by 69%.

6. Who Pays for Surgical Complications? Hospital Reimbursement $ Costs of care $ Profit $ Profit margin % 14266 (uncomplicated) 10978328823.0 21911 (complicated) 211567553.4 Dimick JB, et al. Who pays for poor surgical quality? Building a business case for quality improvement. J Am Coll Surg. 2006;202:933-7. Complications were always associated with an increase in costs to healthcare payors: complications were associated with an average increase in payment of $7645 (54%) per patient.

7. Medicare Surgical Infection Prevention (SIP) Project Objective To decrease the morbidity and mortality associated with postoperative infection in the Medicare patient population

8. Quality Indicators National Surgical Infection Prevention Project Proportion of patients with antibiotic initiated within 1 hour before surgical incision Proportion of patients who receive prophylactic antibiotics consistent with current recommendations Proportion of patients whose prophylactic antibiotics were discontinued within 24 hours of surgery end time

9. Efficacy Of Prophylaxis Is Independent Of The Specific Antibiotic Age of Lesion at Antibiotic Injection (Hours) Lesion Size, mm (24 Hours) 0 510 Penicillin, 40,000 U Staph + Penicillin Control Chloramphenicol, 0.1 mg/Kg Erythromycin, 0.1 mg/Kg Tetracycline, 0.1 mg/Kg 0246-20246-2 0 510 0 510 0 510Control Control Control Staph + Erythromycin Staph + Tetracycline Staph + Chloramphenicol Burke JF. Surgery. 1961;50:161.

10. Clin Infect Dis. 2007; 44:921–7.

12. Discontinuation of Prophylaxis Numerous clinical trials have compared short-term to long-term antimicrobial prophylaxis Many compared single-dose prophylaxis to multiple dose prophylaxis Wide variety of operations using a wide variety of antimicrobial agents Infection rates are the same regardless of duration of prophylaxis Prolonged prophylaxis has been associated with higher rates of infections with resistant organisms (when infection occurs). Prolonged prophylaxis only changes the flora – it does not lower infection rates. Prolonged prophylaxis is a patient safety issue.

13. Conclusions: One-dose antibiotic prophylaxis did not lead to an increase in rates of surgical site infection and brought a monthly savings of $1980 considering cephazolin alone. High compliance to 1-dose prophylaxis was achieved through an educational intervention encouraged by the hospital director and administrative measures that reduced access to extra doses. Arch Surg. 2006;141:1109-1113.

14. Clin Infect Dis. 2007; 44:921–7. “Although it did not reach statistical significance, the timing of the administration of the first dose of an antibiotic after incision seems to be the most important prophylaxis parameter. Multiple postoperative dosing did not contribute to reduction of the incidence of SSI. We strongly recommend that intervention programs on surgical prophylaxis focus on timely administration of the prophylactic antibiotic.”

15. http://www.aaos.org/about/papers/advistmt/1027.asp Recommendation 3 Duration of prophylactic antibiotic administration should not exceed the 24-hour post-operative period. Prophylactic antibiotics should be discontinued within 24 hours of the end of surgery. Medical literature does not support the continuation of antibiotics until all drains or catheters are removed and provides no evidence of benefit when they are continued past 24 hours.

16. http://www.sts.org/sections/aboutthesociety/practiceguidelines/antibioticguideline/ Conclusions: The duration of antibiotic prophylaxis should not be dependent on indwelling catheters of any type. There is evidence indicating that antibiotic prophylaxis of 48 hours duration is effective. There is some evidence that single-dose prophylaxis or 24-hour prophylaxis may be as effective as 48-hour prophylaxis, but additional studies are necessary before confirming the effectiveness of prophylaxis lasting less than 48 hours. There is no evidence that prophylaxis administered for longer than 48 hours is more effective than a 48-hour regimen.

17. Antibiotic Recommendation Sources American Society of Health System Pharmacists Infectious Diseases Society of America The Hospital Infection Control Practices Advisory Committee Medical Letter Surgical Infection Society Sanford Guide to Antimicrobial Therapy The Johns Hopkins Guide Society of Thoracic Surgeons

18. Recent Guidelines

20. Recently Updated Antibiotic Recommendations Surgery TypeAntimicrobial recommendations Hip or knee arthroplasty Preferred: Cefazolin or cefuroxime If patient high risk for MRSA: Vancomycin* Beta-lactam allergy: Vancomycin or clindamycin Cardiac or vascular Preferred: Cefazolin or cefuroxime If patient high risk for MRSA: Vancomycin* Beta-lactam allergy: Vancomycin or clindamycin * For the purposes of national performance measurement a case will pass the antibiotic selection performance measure if vancomycin is used for prophylaxis (in the absence of a documented beta-lactam allergy) if there is physician documentation of the rationale for vancomycin use (effective for July 2006 discharges). Bratzler DW, Hunt DR. The Surgical Infection Prevention and Surgical Care Improvement Projects: national initiatives to improve outcomes for patients having surgery. Clin Infect Dis. 2006;43:322-30.

21. Recently Updated Antibiotic Recommendations (continued) Surgery TypeAntimicrobial recommendations Hysterectomy Cefotetan, cefazolin, cefoxitin, cefuroxime, or ampicillin-sulbactam Beta-lactam allergy: Clindamycin + gentamicin or fluoroquinolone* or aztreonam Metronidazole + gentamicin or fluoroquinolone* Clindamycin monotherapy Colorectal † Neomycin + erythromycin base; neomycin + metronidazole Cefotetan, cefoxitin, cefazolin + metronidazole, or ampicillin-sulbactam Beta-lactam allergy: Clindamycin + gentamicin or fluoroquinolone* or aztreonam Metronidazole + gentamicin or fluoroquinolone* * Ciprofloxacin, levofloxacin, gatifloxacin, or moxifloxacin (effective for July 2006 discharges). † For the purposes of national performance measurement, a case will pass the antibiotic selection indicator if the patient receives oral prophylaxis alone, parenteral prophylaxis alone, or oral prophylaxis combined with parenteral prophylaxis. Bratzler DW, Hunt DR. The Surgical Infection Prevention and Surgical Care Improvement Projects: national initiatives to improve outcomes for patients having surgery. Clin Infect Dis. 2006;43:322-30.

22. Antibiotics for Colorectal Surgery Ertapenem will be added to the acceptable antibiotics for October discharges Oral antibiotic prophylaxis alone will no longer pass the performance measure

23. National Surveillance Antimicrobial Prophylaxis

24. Antibiotic Timing Related to Incision Where we started in 2001 Bratzler DW, Houck PM, et al. Arch Surg. 2005;140:174-182.

25. Discontinuation of Antibiotics Patients were excluded from the denominator of this performance measure if there was any documentation of an infection during surgery or in the first 48 hours after surgery. Bratzler DW, Houck PM, et al. Arch Surg. 2005;140:174-182.

26. Reporting Hospitals (Voluntary) Surgical Infection Prevention Project

27. Based on medical record abstraction from the charts of patients discharged in the 1 st quarter of 2006. Benchmark rates were calculated for all HQA reporting hospitals in the US (N=3247) based on discharges during the 1 st quarter of 2006 using the Achievable Benchmarks of Care TM methodology (http://main.uab.edu/show.asp?durki=14527). Surgical Infection Prevention Hospital Voluntary Self-Reporting, Qtr. 1, 2006 243 Texas hospitals voluntarily reporting (Qtr 1, 2006).

28. Antibiotic practices that have been shown to reduce the risk of SSI. Administration of the antibiotic dose just before incision Antibiotic selection for the common organisms to be encountered Appropriate dose adjustment based on patient weight Redosing the patient in the operating room for long cases

30. Surgical Care Improvement Project National Goal To reduce preventable surgical morbidity and mortality by 25% by 2010

31. SCIP Steering Committee American College of Surgeons American Hospital Association American Society of Anesthesiologists Association of peri- Operative Registered Nurses Agency for Healthcare Research and Quality Centers for Medicare & Medicaid Services Centers for Disease Control and Prevention Department of Veteran’s Affairs Institute for Healthcare Improvement Joint Commission on Accreditation of Healthcare Organizations

32. Surgical Care Improvement Project (SCIP) Preventable Complication Modules Surgical infection prevention Cardiovascular complication prevention Venous thromboembolism prevention

33. Surgical Care Improvement Project Performance measures - Process Surgical infection prevention Antibiotics Administration within one hour before incision Use of antimicrobial recommended in guideline Discontinuation within 24 hours of surgery end Glucose control in cardiac surgery patients Proper hair removal Normothermia in colorectal surgery patients

35. Furnary et al. Ann Thorac Surg 1999:67:352

36. Pre-operative shaving Shaving the surgical site with a razor induces small skin lacerations potential sites for infection disturbs hair follicles which are often colonized with S. aureus Risk greatest when done the night before Patient education be sure patients know that they should not do you a favor and shave before they come to the hospital!

37. Temperature Control 200 colorectal surgery patients control - routine intraoperative thermal care (mean temp 34.7°C) treatment - active warming (mean temp on arrival to recovery 36.6°C) Results control - 19% SSI (18/96) treatment - 6% SSI (6/104), P=0.009 Kurz A, et al. N Engl J Med. 1996. Also: Melling AC, et al. Lancet. 2001. (preop warming)

38. Cardiovascular Complication Prevention

39. Prevention of Cardiac Events Introduction As many as 7 to 8 million Americans that undergo major noncardiac surgery have multiple cardiac risk factors or established coronary artery disease More than 1 million cardiac events annually Myocardial ischemia either clinically occult or overt confers a 9 - fold increase in risk of unstable angina, nonfatal myocardial infarction, and cardiac death Schmidt M, et al. Arch Intern Med. 2002;162:63-69. Mangano DT, et al. N Engl J Med. 1996;335:1713-1720. Selzman CH, et al. Arch Surg. 2001;136:286-290.

40. Surgical Care Improvement Project Performance measure - Process Perioperative cardiac events Perioperative beta blockers in patients who are on beta blockers prior to admission

42. http://www.acc.org/clinical/guidelines/perio/periobetablocker.pdf

43. Venous Thromboembolism Prevention

44. Prevention of Venous Thromboembolism Recent estimates show that more than 900,000 Americans suffer VTE each year about 400,000 of these being DVT About 500,000 being manifest as PE In about 300,000 cases, PE proves fatal; it is the third most common cause of hospital-related deaths in the United States. Heit JA, Cohen AT, Anderson FA on behalf of the VTE Impact Assessment Group. [Abstract] American Society of Hematology Annual Meeting, 2005.

45. National Body Position Statements Leapfrog 1 : PE is “the most common preventable cause of hospital death in the United States” Agency for Healthcare Research and Quality (AHRQ) 2 : Thromboprophylaxis is the number 1 patient safety practice American Public Health Association (APHA) 3 : “The disconnect between evidence and execution as it relates to DVT prevention amounts to a public health crisis.” 1.The Leapfrog Group Hospital Quality and Safety Survey. Available at: www.leapfrog.medstat.com/pdf/Final/doc 2.Shojania KG, et al. Making Healthcare Safer: A Critical Analysis of Patient Safety Practices. AHRQ, 2001. Available at: www.ahrq.gov/clinic/ptsafety/ 3.White Paper. Deep-vein thrombosis: Advancing awareness to protect patient lives. 2003. Available at: www.alpha.org/ppp/DVT_White_Paper.pdf

46. Acquired Risk Factors Risk FactorAttributable Risk Hospitalization/Nursing home61.2 Active malignant neoplasm19.8 Trauma12.5 CHF11.8 CV catheter10.5 Neurologic disease with paresis8.2 Superficial vein thrombosis4.3 Varicose veins/stripping6 Many others….

47. Thromboprophylaxis Use in Practice 1992-2002 Prophylaxis Patient Group Studies Patients Use (any) Orthopedic surgery 4 20,216 90 % (57-98) General surgery 7 2,473 73 % (38-98) Critical care 14 3,654 69 % (33-100) Gynecology 1 456 66 % Medical patients 5 1,010 23 % (14-62)

48. Surgical Care Improvement Project Performance measures - Process Prevention of venous thromboembolism Proportion who have recommended VTE prophylaxis ordered Proportion who receive appropriate form of VTE prophylaxis (based on ACCP Consensus Recommendations) within 24 hours before or after surgery

50. Geerts WH, et al. CHEST. 2004;126:338S-400S. ACCP Guidelines for VTE Prevention

51. Public Accountability and SCIP

52. Hospital Public Reporting – “P4R” 98.3% of PPS hospitals now reporting 0.4% Incentive

53. For purposes of clause (i) for fiscal year 2007 and each subsequent fiscal year, in the case of a subsection (d) hospital that does not submit, to the Secretary in accordance with this clause, data required to be submitted on measures selected under this clause with respect to such a fiscal year, the applicable percentage increase under clause (i) for such fiscal year shall be reduced by 2.0 percentage points. The Secretary shall expand, beyond the measures specified under clause (vii)(II) and consistent with the succeeding subclauses, the set of measures that the Secretary determines to be appropriate for the measurement of the quality of care furnished by hospitals in inpatient settings. The Secretary shall report quality measures of process, structure, outcome, patients' perspectives on care, efficiency, and costs of care that relate to services furnished in inpatient settings in hospitals on the Internet website of the Centers for Medicare & Medicaid Services. Deficit Reduction Act of 2005

54. Deficit Reduction Act – 2005 Final Inpatient Prospective Payment System Rule Rules increase requirements: 21 measures (8-AMI, 7-Pneumonia, 4- Heart failure, 2-Surgical Infection) Though reporting is voluntary, failure to report results in loss of 2% of the Medicare Annual Payment Update Federal Register. August 18, 2006.

55. OPPS Rule Final Rule Posted on November 1, 2006 Expands required measures for hospital public reporting: 21 current measures Adds SCIP Infect 2 (antibiotic selection) SCIP VTE 1 and 2 HCAHPS (consumer satisfaction) Three new CMS 30-day mortality measures for AMI, HF, and Pneumonia (based on CMS analysis of Medicare fee-for-service claims data)

56. Hospital Acquired Infections (provisions of the Deficit Reduction Act) In order to manage the costs associated with Hospital Acquired Infections, the DRA requires the Secretary to identify, by October 1, 2007, at least two conditions that are: o High cost or high volume or both o Result in a DRG that has a higher payment when present as a secondary diagnosis o Could have been reasonably prevented through the application of evidence based guidelines The IPPS proposed that for discharges on or after October 1, 2008, that have one of the two selected conditions as a secondary diagnosis that was not present at admission will be paid as if the secondary diagnosis was not present. Therefore any charges associated with the infection would not be paid.

57. Deficit Reduction Act - 2005 … the Secretary is directed to begin phasing out payment increases associated with complications of care Remember who pays for surgical complications…

58. Deficit Reduction Act – 2005 Pay for performance …. the Secretary is directed to develop a plan to implement a value-based purchasing program based on the expanded measure set for which hospitals will submit data starting in FY 2007. The program will begin implementation in FY 2009 (2008).

59. Surgical Care Improvement Project: Why? Medicare could prevent* up to: 13,027 perioperative deaths 271,055 surgical complications * Major surgical cases

60. Preliminary SCIP Data Qtr. 1, 2005 National sample of 19, 497 Medicare patients. The charts were independently abstracted by the CMS CDAC.

61. SCIP Baseline – Antibiotics Preliminary National Data Abx 1 hourGuideline Abx Abx stopped < 24 hours All operations67.888.055.2 Cardiac67.189.850.6 Vascular63.185.858.1 Hip and knee70.394.755.2 General colon56.761.547.0 Hysterectomy72.671.779.4

62. SCIP Baseline – VTE Prophylaxis Preliminary National Data Appropriate Prophylaxis Ordered Appropriate Prophylaxis Received All operations78.376.1 Neurosurgery93.992.8 Spinal surgery96.696.5 General surgery53.751.0 Gyn surgery72.270.9 Urologic surgery84.183.5 Hip replacement91.089.4 Knee replacement93.790.9

63. Summary As the SIP project is expanded into the new Surgical Care Improvement Project we need to find ways to make evidence- based processes of care routine We have to quit relying on memory to ensure high quality care Recognize that there is now a national commitment to improving outcomes for surgical patients

64. www.medqic.org/scip