Dale W. Bratzler, DO, MPH QIOSC Medical Director Oklahoma Foundation for Medical Quality
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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
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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
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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
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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.
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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%.
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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.
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Medicare Surgical Infection Prevention (SIP) Project Objective
To decrease the morbidity and mortality associated with postoperative infection in the Medicare patient population
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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
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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.
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Clin Infect Dis. 2007; 44:921–7.
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Clin Infect Dis. 2007; 44:921–7.
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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.
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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.
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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.”
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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.
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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.
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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
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Recent Guidelines
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Recent Guidelines
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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.
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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.
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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
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National SurveillanceAntimicrobial Prophylaxis
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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.
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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.
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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
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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).
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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
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Surgical Care Improvement ProjectNational Goal
To reduce preventable surgical morbidity and mortality by 25% by 2010
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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
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Surgical Care Improvement Project (SCIP)
• Preventable Complication Modules• Surgical infection prevention• Cardiovascular complication
prevention• Venous thromboembolism
prevention
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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
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Furnary et al. Ann Thorac Surg 1999:67:352
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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!
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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)
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Cardiovascular Complication Prevention
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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.
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Surgical Care Improvement ProjectPerformance measure - Process
• Perioperative cardiac events• Perioperative beta blockers in patients
who are on beta blockers prior to admission
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http://www.acc.org/clinical/guidelines/perio/periobetablocker.pdf
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Venous Thromboembolism Prevention
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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.
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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
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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….
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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)
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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
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Geerts WH, et al. CHEST. 2004;126:338S-400S.
ACCP Guidelines for VTE Prevention
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Public Accountability and SCIP
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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
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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
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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.
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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)
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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.
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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…
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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).
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Surgical Care Improvement Project: Why?
Medicare could prevent* up to:
13,027 perioperative deaths
271,055 surgical complications
* Major surgical cases
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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.
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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
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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
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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
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www.medqic.org/scip