Dale W. Bratzler, DO, MPH QIOSC Medical Director Oklahoma Foundation for Medical Quality

The Surgical Infection Preventionand 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

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

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

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.

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%.

Who Pays for Surgical Complications?

Hospital

Reimbursement

$

Costs of care

$

Profit

$

Profit margin

%14266

(uncomplicated)10978 3288 23.0

21911

(complicated)21156 755 3.4

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.

Medicare Surgical Infection Prevention (SIP) Project Objective

To decrease the morbidity and mortality associated with postoperative infection in the Medicare patient population

Quality IndicatorsNational 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

Efficacy Of Prophylaxis Is Independent Of The Specific Antibiotic

Age of Lesion at Antibiotic Injection (Hours)Age of Lesion at Antibiotic Injection (Hours)

Les

ion

Siz

e, m

m (

24 H

ou

rs)

Les

ion

Siz

e, m

m (

24 H

ou

rs)

00

55

1010

Penicillin, 40,000 UPenicillin, 40,000 U

Staph + PenicillinStaph + Penicillin

ControlControl

Chloramphenicol, 0.1 mg/KgChloramphenicol, 0.1 mg/Kg

Erythromycin, 0.1 mg/KgErythromycin, 0.1 mg/Kg

Tetracycline, 0.1 mg/KgTetracycline, 0.1 mg/Kg

00 22 44 66-2-2 00 22 44 66-2-2

00

55

1010

00

55

1010

00

55

1010

ControlControl ControlControl

ControlControl

Staph + ErythromycinStaph + Erythromycin

Staph + TetracyclineStaph + TetracyclineStaph + ChloramphenicolStaph + Chloramphenicol

Burke JF. Surgery. 1961;50:161.

Clin Infect Dis. 2007; 44:921–7.

Clin Infect Dis. 2007; 44:921–7.

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.

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.

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.”

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.

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.

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

Recent Guidelines

Recent Guidelines

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

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.

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

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.

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

National SurveillanceAntimicrobial Prophylaxis

2.7 1.24.3

20.3

56

2.8 1.4 0.9 0.9

9.6

0

10

20

30

40

50

60

Minutes Before or After Incision

Per

cen

t

Inc

isio

n

Antibiotic Timing Related to Incision

Where we started in 2001

Bratzler DW, Houck PM, et al. Arch Surg. 2005;140:174-182.

26.2

10

22.6

6.2 6.32.2 2.7

9.3

14.5

40.7

50.7

73.3

79.5

85.888

90.7

0

20

40

60

80

100

Hours After Surgery End Time

Pe

rce

nt

0

20

40

60

80

100

Cu

mu

lati

ve

Pe

rce

nt

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.

Reporting Hospitals (Voluntary)Surgical Infection Prevention Project

30 42

237 265 271 337470 450

808894

1297

14921623

1718

3247

0

500

1000

1500

2000

2500

3000

3500

# H

os

pit

als

86

66

82.3

90.5

74

97.2 99.195.7

75.3

0

20

40

60

80

100

Antibiotics w/in 1 hour Correct Antibiotic Antibiotic DCed w/in 24hours

Pe

rce

nt

Texas National Average* Benchmark

Based on medical record abstraction from the charts of patients discharged in the 1st quarter of 2006. Benchmark rates were calculated for all HQA reporting hospitals in the US (N=3247) based on discharges during the 1st quarter of 2006 using the Achievable Benchmarks of CareTM methodology (http://main.uab.edu/show.asp?durki=14527).

Surgical Infection PreventionHospital Voluntary Self-Reporting, Qtr. 1, 2006

243 Texas hospitals voluntarily reporting (Qtr 1, 2006).

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

Surgical Care Improvement ProjectNational Goal

To reduce preventable surgical morbidity and mortality by 25% by 2010

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

Surgical Care Improvement Project (SCIP)

• Preventable Complication Modules• Surgical infection prevention• Cardiovascular complication

prevention• Venous thromboembolism

prevention

Surgical Care Improvement ProjectPerformance 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

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

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!

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)

Cardiovascular Complication Prevention

Prevention of Cardiac EventsIntroduction

• 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.

Surgical Care Improvement ProjectPerformance measure - Process

• Perioperative cardiac events• Perioperative beta blockers in patients

who are on beta blockers prior to admission

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

Venous Thromboembolism Prevention

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.

National Body Position Statements

• Leapfrog1:

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

Acquired Risk Factors

Risk Factor Attributable RiskHospitalization/Nursing home 61.2

Active malignant neoplasm 19.8

Trauma 12.5

CHF 11.8

CV catheter 10.5

Neurologic disease with paresis 8.2

Superficial vein thrombosis 4.3

Varicose veins/stripping 6

Many others….

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)

Surgical Care Improvement ProjectPerformance 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

Geerts WH, et al. CHEST. 2004;126:338S-400S.

ACCP Guidelines for VTE Prevention

Public Accountability and SCIP

Hospital Public Reporting – “P4R”

434

1407

1952

4043 4192

August, 2003 February,2004

May, 2004 October, 2004 March, 2005

Number of Reporting Hospitals

98.3% of PPS hospitals now reporting

0.4% Incentive

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

Deficit Reduction Act – 2005Final 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.

OPPS RuleFinal 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)

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.

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…

Deficit Reduction Act – 2005Pay 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).

Surgical Care Improvement Project: Why?

Medicare could prevent* up to:

13,027 perioperative deaths

271,055 surgical complications

* Major surgical cases

Preliminary SCIP DataQtr. 1, 2005

59.9

78

49.5

69

85.4

66.2

72.56967.4

83.5

57.6

81.4

89.2

6771.9 69.7

0

10

20

30

40

50

60

70

80

90

100

Abx 1

hr

Abx S

elec

t

Abx D

Ced 2

4 hr

Glu c

ontro

l

Hair R

emova

l

Norm

other

mia

VTE o

rder

ed

VTE g

iven

Per

cen

t

Texas National Average

National sample of 19, 497 Medicare patients. The charts were independently abstracted by the CMS CDAC.

SCIP Baseline – AntibioticsPreliminary National Data

Abx 1 hour Guideline AbxAbx stopped <

24 hours

All operations 67.8 88.0 55.2

Cardiac 67.1 89.8 50.6

Vascular 63.1 85.8 58.1

Hip and knee 70.3 94.7 55.2

General colon 56.7 61.5 47.0

Hysterectomy 72.6 71.7 79.4

SCIP Baseline – VTE ProphylaxisPreliminary National Data

Appropriate Prophylaxis Ordered

Appropriate Prophylaxis Received

All operations 78.3 76.1

Neurosurgery 93.9 92.8

Spinal surgery 96.6 96.5

General surgery 53.7 51.0

Gyn surgery 72.2 70.9

Urologic surgery 84.1 83.5

Hip replacement 91.0 89.4

Knee replacement 93.7 90.9

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

www.medqic.org/scip