SCIP: Preventing Surgical Site Infections Gary Kanter, M.D. Betsy Lehman Center December 4, 2007

I would highlight our website once again I would highlight our website once again. You can learn a lot more about both projects at the MedQIC website. Information is available and will be updated as it becomes available on each of these websites.   It has certainly been my pleasure to give this presentation today, and I will be happy to answer questions by communicating through the websites, through the links that provide information on how to ask questions about the projects. Thank you. www.medqic.org/sip

Surgical Care Improvement Project National Quality Partnership CMS,CDC Reduce nationally the incidence of surgical complications by 25% by 2010 (13,027 deaths, 271,055 complications)/yr Focus on Surgical infection prevention Adverse cardiac events Prevention of DVT Post operative pneumonia Using evidence based medicine

How often do patients receive “scientifically indicated care” in this country? Near 100%- we are doing a great job 75%- not too shabby 55%- flip a coin What does science have to do with medicine? McGlynn, et al: The quality of health care delivered to adults in the United States. NEJM 2003; 348: 2635-2645 (June 26, 2003)

How often do patients receive “scientifically indicated care” in this country? Near 100%- we are doing a great job 75%- not too shabby 55%- flip a coin What does science have to do with medicine? McGlynn, et al: The quality of health care delivered to adults in the United States. NEJM 2003; 348: 2635-2645 (June 26, 2003)

Surgical Infection (SI): Epidemiology & Impact Account for 14-16 % of all Hospital Acquired Infections (HAI) 2-5% of operative patients will develop SI 0.8-2 million infections a year SI increase LOS Average 7.5 additional days Excess costs $130-$845 million per year Adds $2,734 - $26,019 per pt (average $3,000) Pain and suffering

SI: Epidemiology & Impact Patients who develop infection are: 60% more likely to spend time in an ICU 5 times as likely to be readmitted Have a mortality rate twice that of noninfected patients An estimated 40-60% of these infections are preventable

Business Case for SCIP APU increased to 2%

Business Case for SCIP

Baystate Medical Center 700 bed tertiary care referral center (population of ~1M) Flagship of Baystate Health 41 k admissions/year Annual surgical volume: 29,043 Western Campus of TUFTS Member CoTH, 9 residency programs, 244 residents 1200 member medical staff, 206 faculty MDs Level 1 Trauma Center IHI Mentor Hospital Surgical Infection Prevention

Use of antimicrobial prophylaxis for major surgery: baseline results from the National Surgical Infection Prevention Project Arch Surg. 2005 Feb;140(2):174-82.

Quality Improvement Process Benchmarking, measurement, and feedback Work with key physician champions Disseminate recommendations to educate Use physician order entry Enlist help of case managers as quality safety net Use PDSA cycles to test and improve

Prophylactic Antibiotics Antibiotics given for the purpose of preventing infection when infection is not present but the risk of post-operative infection is present

Prophylactic Antibiotics Questions Which cases benefit? When should you start? Which drug should you use? How much should you give? How long should antibiotics be continued?

Recently Updated Antibiotic Recommendations Surgery Type Antimicrobial 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 * 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).

Recently Updated Antibiotic Recommendations (continued) Surgery Type Antimicrobial 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 * 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.

Prophylactic Antibiotics Questions Which cases benefit? When should you start? Which drug should you use? How much should you give? How long should antibiotics be continued?

Timing of Antibiotic Prophylaxis GI Operations Stone HH et al. Ann Surg. 1976;184:443-452.

Perioperative Prophylactic Antibiotics Timing of Administration 14/369 15/441 1/41 1/47 Infections (%) 1/81 2/180 5/699 5/1009 Hours From Incision Classen. NEJM. 1992;328:281.

Antibiotic Timing Related to Incision Bratzler DW, Houck PM, et al. Arch Surg. 2005;140:174-182.0

Visual Prompt and data collection

Never Underestimate the Power of Competition BMC AB Timing by Anesthesiologist Never Underestimate the Power of Competition

Memorandum DIVISION OF HEALT H CARE QUALITY TO: , MD FROM: Associate Medical Director DATE: , 2006 SUBJECT: SCIP (Surgical Care Improvement Program) As part of the SCIP process, the medical record of PATIENT was reviewed. As eviden ced by the attached documentation , it appears that the patient’s prophylactic pre - operative antibiotic w as : _____ given greater than 1 hour prior to th e initial incision time not re dosed. _____given after the initial surgical incision. _ X __not g iven at all ( no time of administration was documented) Please remember that current standard of practice is · operative an tibiotic administration within 60 minutes p rior to the incision (Levaq uin and Vancomycin are within 120 minutes pri or to the incision ). Re dosing of antibiotics if the case extends beyond 3 hours when cefazolins are used Please contact me at 4 4326 if you have any questions. Thank you .

Quality Indicators National Surgical Infection Prevention Project Proportion of patients who receive prophylactic antibiotics consistent with current recommendations The second performance measure is the proportion of patients who received prophylactic antimicrobials consistent with current recommendation. Basically, the expert panel reviewed all of the published guidelines for antimicrobial prophylaxis for patients having surgery and made the decision that, if the antibiotic was recommended in any of the published guidelines, it would be considered an appropriate antibiotic for prophylaxis. There are some antimicrobials that do have FDA approval for prophylaxis but are not currently recommended in any published guideline for prophylaxis, therefore, those antimicrobials are considered inappropriate. At this time, JCAHO and CMS have jointly agreed to suspend public reporting on this measure. Data collection will continue but the results will not be publicly reported.

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 2003 This is a list of guidelines that have been published for antimicrobial prophylaxis. They include the American Society of Health System Pharmacists, Infectious Disease Society of America, The Centers for Disease Control Hospital Infection Control Practices Advisory Committee, The Medical Letter guidelines (which are updated every other year), The Surgical Infection Society, and The Sanford Guide. In review of all of these guidelines, if any one guideline listed an antibiotic as approved or recommended for prophylaxis, the antimicrobial was considered acceptable for the procedure.

Antibiotic Selection - Successful Interventions Distribution of guidelines to perioperative staff (standardize practice) Antibiotic selection and ordering (standardize process, opt out for selection) Decision aids in the system (active prompt ) Use of cephalosporins and vancomycin/gentamicin in penicillin allergic patients Reviewed and revised AB selections in computer order sets (opt out, forcing function)

The Advisory Statement published in 2004 in Clinical Infectious Diseases. Clin Infect Dis. 2004;38:1706-1715.

Expanded pt populations

Quality Indicator #3 Proportion of patients whose prophylactic antibiotics were discontinued within 24 hours of surgery end time The third performance measure is the proportion of patients whose prophylactic antibiotics were discontinued within twenty-four hours after the end of surgery. Most of the national experts believe, based on published data, that giving a single preoperative dose of antibiotic is sufficient to prevent surgical site infections. Giving antibiotics after the incision is closed is of no value in reducing infection rates further. There was a very large opportunity for improvement if most of the country reduced any antimicrobial use to twenty-four hours after surgery, based on the review of many studies.

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.

Antibiotic Prophylaxis Duration Most studies have confirmed efficacy of  12 hours Many studies have shown efficacy of a single dose Whenever compared, the shorter course has been as effective as the longer course

Papers Comparing Duration of Peri-op Antibiotic Prophylaxis Colorectal 3 Mixed GI 4 Hysterectomy 3 Gyn & GI 1 Head & Neck 3 Orthopedic 4 Vascular 3 Cardiac __7__ Total 28 Papers supporting longer duration 1

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 http://www.aaos.org/wordhtml/papers/advistmt/1027.htm

Consequences of Prolonged AB Use Increased antibiotic and drug administration costs Increased antibiotic-associated complications Increased patterns of antibiotic resistance Clostridium difficile Enterocolitis Colonization with MRSA

Barriers – Antibiotic Use Timing Consistency Sustainability (constant monitor) Selection Resistance (surgeons and organism) Availability; national consensus issues Duration Knowledge gap If it’s not broke, don't change it

Surgical Infection Rate 1.13 % NNISS Benchmark = 2-11 %

Duration of Antibiotic Prophylaxis: What is Best for Our Patients? Antibiotic prophylaxis is one of many methods for reducing the incidence of SSI There is a lack of evidence that antibiotics given after the end of the operation prevent SSIs There is evidence that increased use of antibiotics promotes antibiotic resistance

Glycemic Control

Diabetes Complications Estimated 10 million Americans Poor glucose control is associated with: Increased risk of infection Delayed healing Increased mortality Blunts inflammatory response

Diabetes, Glucose, Control and SI Infections (%) Latham,ICHE 2001; 22:607-12

Glucose Control and Deep Sternal Wound Infections Historically, diabetics got q 4 hr sliding scale sqi to keep bg < 200.; after 1991, diabetics got insulin drip titrated to keep glucose levels between 150 and 200. Here there deep sternal infect rate declines. Furnary et al. Ann Thorac Surg 1999:67:352

Survival increased with intensive insulin therapy ( nondiabetic patients included ) targeting BG 80-110 mg/dL Van den Berghe et al. NEJM 2001; 345:1359-1367

Glycemic Control Established IV insulin protocol for cardiac surgery patients with known diabetes (Pre-op BG > 75 mg/dl) and all others (Pre-op BG >150 mg/dl) The protocol was developed by surgeons, anesthesiologists, endocrinologists, and nursing Insulin infusions to be initiated in OR Insulin infusion to be used for the duration of post-op period while the patient is in cardiac intensive care unit (CICU) Endocrine referral if insulin infusion is utilized Conversion protocol (IV infusion to sliding scale)

Diabetes, Glucose Control, & SIs ICHE 2001; 22: 607-12 Summary Peri-operative hyperglycemia and diabetes are associated with increased risk of SIs Early diagnosis of diabetes among high-risk patients may have short and long-term benefits

Hair Removal 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! Shaving the surgical site with a razor induces small skin lacerations and causes potential sites for infection. When the skin is shaved, particularly the area where the surgery will be performed, the hair follicles are disturbed, and most of the studies have demonstrated that it increases the risk of surgical site infections. This is particularly great when the shaving is done the night before surgery. Patient education needs to be done to make sure patients don’t do the surgical team a “favor” by shaving the surgical site the day before they come into the hospital. It can result in a higher infection rate.

Shaving, Clipping & SI Infections (%) Alexander. Arch Surg 1983; 118:347

Hair Removal Preoperative shaving of the surgical site the night before an operation is associated with a significantly higher SI risk than either the use of depilatory agents or no hair removal Do not remove hair preoperatively unless the hair at or around the incision site will interfere with the operation (Category IA) If hair is removed, remove immediately before the operation, preferably with electric clippers (Category IA)

Cochrane Database Syst Rev. 2006 Apr 19;(2) Three trials involving 3193 patients Compared shaving with clipping Statistically significantly more SSIs when people were shaved rather than clipped (RR 2.02, 95%CI 1.21 to 3.36)

Interventions Razors removed from OR’s Razors removed from most clinical areas Patients may use razors for personal hygiene

HYPOTHERMIA Increased myocardial ischemia & VT Bleeding and increased transfusion requirements Surgical wound infections & prolonged hospitalizations Lower pain threshold Drug metabolism decreased

Temperature and SSI Following Colectomy Normo (N=104) Hypo (N=96) P SSI 6 18 .009 Collagen dep 328 254 .04 Time to eat 5.6d 6.5d <.006 Kurz. NEJM 1996;334:1209

Normothermia Standardization Review by patient populations Pre warm Removed “random number generators” One device and one measure (first PACU temp) Review by patient populations Education/communication Room set point pre-op Increased temperature upon pt arrival to room until draped Staff comfort balanced against patient centered care Products Forced hot air Warm fluids Cooling vests Temporal thermometers

Barriers - Normothermia Staff comfort Expense Knowledge gap Impact Importance Consistent application

Apparently Unavoidable Potentially Preventable This complication may not have occurred with the application of every indicated prevention measure Apparently Unavoidable Despite the application of every indicated prevention measure the complication occurred anyway A mystery………

Surveillance List of patients sent to each surgeon, 30 days post procedure 97% return rate (SASE, interoffice mailing) Self report: any post operative infection/ comments Daily admissions with wound infection Review for surgical date and s/s infection Daily microbiology reports of all + cultures reviewed for wound, fluid cultures, e.g joint aspirates Charts reviewed for NNIS criteria, surgical date and s/s infection

Investigation NNIS criteria: ASA, Wound Class, Length of Procedure Presence of interventions Antibiotic use Surgical prep and skin condition Implants Cluster evaluation Specific conditions of the patient Surgical environment Organism Surgical team

Potentially Preventable Review All infections reviewed for potential preventability using SCIP guidelines Reviewed using other criteria as well Review done by IC dept and fed back to multiple cmts (COI, SCIP, SPIT, SAQI) System level changes made when applicable Consistently, 50% of infections have a SCIP miss!!

Where Do Things Fall Through the Cracks? System – information, tests, diagnoses Communication Hand offs Failure to recognize Failure to activate Failure to rescue

Improvement Tools Systems Populations Cycles of Change PDSA, Six Sigma, LEAN Process Analysis Failure Mode Identification BH PI Tool Kit

Make The Right Thing The Easy Thing Keys to Success Persistence and reinforcement/high visibility Senior leader support Multidisciplinary cooperation & collaboration Accurate, timely and relevant data Right people Willing to try changes and take a risk Develop reliable systems (strive for 10-2 > 90%) Incorporate into workflow Make changes easy and transparent Stress importance of impact on patient and practitioner Make The Right Thing The Easy Thing

Lessons Learned Involve all stakeholders Leave your stripes at the door Must have physician champions- credible Be humble Take more blame and give more credit BROAD shoulders Must work as team Small tests of change with frequent tempo Small pilot population Work within your culture Steal shamelessly Make the right thing the easy thing

Medicine used to be simple, ineffective, and relatively safe……. Now it is complex, effective, and potentially dangerous. Sir Cyril Chantler 1999 Hollister Lecture at Northwestern University, Illinois James, B. 16th IHI Conference

Department of Anesthesiology Baystate Medical Center For More Information: Gary Kanter, M.D. gary.kanter@bhs.org Department of Anesthesiology Baystate Medical Center Springfield MA 01199 413 794 3520