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Surgical Care Improvement Project

Dr. Philmore J. JosephMemorial Hermann NE

Humble, Texas

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"It may seem a strange principle to enunciate as the very first requirement in a hospital that it should do the sick no harm"

Florence Nightingale

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Nosocomial infection =

Any infection that is not present or incubating at the time the patient is admitted to the hospital

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History of infection control and hospital epidemiology Pre 1800: Early efforts at wound prophylaxis 1800-1940: Nightingale, Semmelweis, Lister, Pasteur 1940-1960: Antibiotic era begins, Staph. aureus nursery outbreaks,

hygiene focus 1960-1970’s: Documenting need for infection control programs,

surveillance begins 1980’s: focus on patient care practices, intensive care units, resistant

organisms, HIV 1990’s: Hospital Epidemiology = Infection control, quality improvement

and economics 2000’s: ??Healthcare system epidemiology

modified from McGowan, SHEA/CDC/AHA training course

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History of infection control and hospital epidemiology Pre 1800: Early efforts at wound prophylaxis 1800-1940: Nightingale, Semmelweis, Lister, Pasteur 1940-1960: Antibiotic era begins, Staph. aureus nursery outbreaks,

hygiene focus 1960-1970’s: Documenting need for infection control programs,

surveillance begins 1980’s: focus on patient care practices, intensive care units,

resistant organisms, HIV 1990’s: Hospital Epidemiology = Infection control, quality

improvement and economics 2000’s: ??Healthcare system epidemiology

modified from McGowan, SHEA/CDC/AHA training course

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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Surgical Infection PreventionPerformance Stratified by Risk Class

7%41%Readmission

$3,844$7,531Median direct cost

6 days11 daysLength of Stay

18%29%ICU admission

3.5%7.8%MortalityUn-infectedInfected

Kirkland. Infect Control Hosp Epidemiol. 1999;20:725.

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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

Surgical Care Improvement Project(SCIP)

Preventable Complication Modules– Surgical infection prevention– Cardiovascular complication prevention– Venous thromboembolism prevention– Respiratory complication prevention

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Surgical Care Improvement Project(Draft Global Outcome Measures)

Motality within 30 days of surgery Readmission within 30 days of surgery

Surgical Care Improvement ProjectPerformance measures

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 – <200 gm/dl at 6am postoperatively

• Proper hair removal• Normothermia in colorectal surgery patients

– Immediate postoperative• SSI rates during index hospitalization (test outcome)

0

1

2

3

4

≤-3 -2 -1 0 1 2 3 4 ≥5

Classen, et al. N Engl J Med. 1992;328:281.

Perioperative AntibioticsTiming of Administration

Hours From Incision

14/369

5/699 5/1009

2/1801/81

1/411/47

15/441

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!

Perioperative Glucose Control 1,000 cardiothoracic surgery patients Diabetics and non-diabetics with hyperglycemia

Patients with a blood sugar > 300 mg/dL during or within 48 hours of surgery had more than 3X the likelihood of a wound infection!

Latham R, et al. Infect Control Hosp Epidemiol. 2001.

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Perioperative Glucose Control

Carr J Thor Surg 2005

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

– Measure: Colorectal surgery patients with immediate postoperative normothermia

Kurz A, et al. N Engl J Med. 1996.

Also: Melling AC, et al. Lancet. 2001. (preop warming)

Surgical Care Improvement ProjectDraft performance measures

Perioperative cardiac events• Surgery patients on a beta-blocker prior to arrival that received a

beta-blocker during the perioperative period

Perioperative is defined as preoperatively on the day of surgery or intraoperatively prior to extubation.

24Leape et al. JAMA 2002

Mangano DT, et al. N Engl J Med. 1996;335:1713-20.

Postoperative Survival 6-month survival 100% vs

92% (P<0.001)

2-yr survival 90% vs 79% (P=0.019)

Potential to Reduce Perioperative Complications in SCIP

3.35

2.28

0.72 0.58

2.49

0.490.29

0

0.5

1

1.5

2

2.5

3

3.5

4

SSI Pneumonia AMI VTE

Perc

ent

Current Complication Rate Potential Complication Rate25.7% relative

reduction

31.9% relative reduction 50.0% relative

reduction

Based on the goal of achieving near-complete guideline compliance to prevent each of these complications as compared to current national rates of guideline compliance

for each complication.

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Crossing the Quality Chasm “In its current form, habits, and environment, the health care system is incapable of giving Americans the health care they want and deserve….The current care systems cannot do the job. Trying harder will not work. Changing systems of care will.”

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Adopter Categories

EarlyAdopters

Innovators

EarlyMajority

LateMajority

Laggards

2.5% 13.5% 34% 34% 16%from E. Rogers, 1995

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A comprehensive and flexible program for achieving, sustaining and maximizing business success that:

– Is uniquely driven by a clear focus on the “Voice of the Customer”

– Is founded in a rigorous use of facts, data and statistical analysis

– Provides for diligent attention on managing, improving and reinventing business processes.

– Is an management methodology with three perspectives:• A Measure of Quality• A Process for Continuous Improvement• An Enabler for Cultural Change

What is Six Sigma?What is Six Sigma?

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Six Sigma is a statistical measure that expresses how close a service process comes to its quality goal

Six Sigma refers to a process that produces only 3.4 defects per million opportunities

Sigma DPMO Yield

2 308,537 69.1463%

3 66,807 93.3193%

4 6,210 99.3790%

5 233 99.9767%

6 3.4 99.9997%

A Measure of Quality:A Measure of Quality:

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Six Sigma provides a process based approach (DMAIC) to continuous improvement that can be used to improve any business process

Provides a data driven and evidence based format on which to base improvement decisions

Insists on statistical proof of improvement and process control

Provides a means to sustain and build upon proven improvements

A Process for Continuous A Process for Continuous Improvement:Improvement:

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Genuine Focus on the customer Data and Fact Driven Management Process focus, management and improvement Proactive management Boundaryless collaboration Drive for perfection; tolerance for failure

Six Sigma Themes:Six Sigma Themes:

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The Effectiveness (E) of the result is equal to the Quality (Q) of the solution times the Acceptance (A) of the idea.

Six Sigma Methodology

Change Acceleration

ProcessEffective Results

Work-OutTM

Q x A = EQ x A = E

Six Sigma Effectiveness:Six Sigma Effectiveness:

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You have to change the acceleration process

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Keys To Physician Acceptance

Credible evidence based literature Evidence should be compelling Presented by a credible, respected physician

(preferably their specialty) Explain that their peers endorse

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Hospital Process In Place To Educate Physicians

EBM education to medical staff Process to help physicians with indicators Concurrent review to catch missed indicators (early,

late) Retrospective review (educational) Physician profiles

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Rationale to Support Physician/Hospital Compliance

Right thing to do Quality issue Financial issue(P4P) Liability issue Public reporting issue Need to hold physician accountable (only if

hospital has process in place)

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SCIP 1 – Barriers(Antibiotic Within One Hour)

Never gets done in one hour Doesn’t make any difference No infections Never use antibiotics anyway

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SCIP 1 – Responses (Antibiotic Within One Hour)

Literature clear (EBM) Does make a difference Infections are related to timing of 1st dose Antibiotics are effective Hospital process (delegate individual/ team) Tourniquet issue Vancomycin issue

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SCIP 2 – Barriers(Evidence Based Antibiotic)

Who are these experts telling me (30 years experience) what to do?

Are they clinically involved, on the “battlefield” like me?

My patients don’t get infections. Don’t tell me how to practice medicine/surgery.

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SCIP 2 – Barriers, cont’d(Evidence Based Antibiotic)

Why can’t I use Vancomycin on all my patients? Why can’t I use antibiotic “x”

FDA approved Endorsed by manufacturer

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SCIP 2 – Responses (Evidence Based Antibiotic)

Experts are knowledgeable, credible, and in active practice.

You have been lucky so far (won’t be able to defend SSI with unapproved antibiotic).

Vancomycin over utilized Increased infection rates Increased resistance

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SCIP 2 – Responses, cont’d (Evidence Based Antibiotic)

Many antibiotics approved by FDA, and manufacturer endorsed, not agreed by experts as good prophylaxis at this time (inadequate trials, time)

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SCIP 3 – Barriers(Why Physicians Don’t Stop ABX

at 24 Hours)

Most difficult Just because Fever Infection Tubes, drains, still in place

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SCIP 3 – Barriers, cont’d(Why Physicians Don’t Stop ABX

at 24 Hours)

No literature to support My patients are sicker Training program taught me this way I know what is best for my patient

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SCIP 3 – Responses(Why Physicians Don’t Stop ABX at 24 Hours)

Ample literature to support (many years). (one drug, one dose, one time, many procedures) Fever usually secondary to atelectasis. If infection on prophylactic ABX, no sense to continue

(?resistance). Contact surgical training program.

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SCIP 3 – Responses, cont’d(Why Physicians Don’t Stop ABX

at 24 Hours)

You may not know what is best for your patients (only your assumption).

Meet with ACS state chapters. Meet with medical school surgical programs. Society of Thoracic Surgery 48 Hours

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Successful Interventions SCIP 1-3

Establish prophylactic antibiotic administration accountability

Address antibiotic timing with surgeons via physician champion

Stock OR only with approved prophylactic antibiotics Develop pre-printed order sets with recommended

prophylactic antibiotics by procedure

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Shaving Barriers

Shave for years. No infection. Shaving doesn’t cause infection. Must shave (hair is “dirty”). Can’t see wound. Can’t apply bandage/tape.

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Shaving Excuse Response

Literature supports risk of infection. If patient becomes infected, after shaving,

difficult to defend. Options

Clip Depilatory Nothing

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Shaving Interventions

Physician, staff education (timeline for removal all razors)

Remove all razors from holding unit and OR Establish protocol for proper or no hair

removal Have adequate clippers available “No shave zone” posters in key areas Process to educate patients re no shaving

pre-op

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Hypothermia Issues:

Hypothermia contributes to• SSI• Cardiac irritability, cardiac arrhythmia• Bleeding

• Barriers: Surgeon wants “cold” OR CONFLICT- importance of temperature vs

comfort of surgeon and risk to patient

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Hypothermia Interventions

Education re risks to patients Process for warming devices (blankets,

solutions Need thermostatic control in OR, holding

units Designate responsibility and accountability Cooling vests for surgeons

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Hyperglycemic Issues Correlation – increased BS and SSI. Longer exposure - more frequent SSI. Increased BS paralyzes function of WBC. Response to high BS phone call – “just repeat”. No process to address high post-op BS. My patients “don’t have diabetes”.

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Hyperglycemic Responses

Data supports infection with increased BS. Not just CABG. Could apply to all procedures with

hyperglycemia. 1/3 of med-surg patients may have DM. Implement hyperglycemic protocol with a

trigger BS.

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Hyperglycemia Interventions

Education Process in place with trigger sugar Process in place for perioperative monitoring Process for “non diabetics”

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DVT/PE Prophylaxis Barriers

My patients don’t get DVT/PE. I ambulate patients quickly. No literature to support. ASA is good enough. Don’t believe any risk. Elastic stockings are just fine. My patient had a bleeding ulcer 10 years ago

– too risky to use anticoagulants.

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DVT/PE Solution

Ample evidence based medicine in literature BRP daily – inadequate ambulation Patients end up in hospital with DVT/PE ASA not effective ES not effective

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DVT/PE Solution, cont’d

NB issue regarding counter pulsation pressure devices

NB chemoprophylaxis vs pressure devices Age >40, general anesthesia > 30 minutes Bleeding too remote Geerts - Chest.2004, 126:3385-4005

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DVT/PE Interventions

Education DVT/PE Awareness programs Process to assess patients at risk Pre-printed order sets with guidelines by

procedures

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Beta Blocker Barriers

Don’t believe literature. Patient has asthma, COPD. Patient has bradycardia. Patient has diabetes. Patient has hypotension.

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Beta Blocker Responses Evidence based literature (recent controversy) Only relative contraindications

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VAP Barriers

I elevate bed. Nurses lower bed. I see no difference. Patient more comfortable. I don’t believe peptic ulcer prophylaxis

necessary. Don’t believe weaning protocol necessary.

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VAP Responses

Data supports (recent controversy) No difference regarding patient comfort Weaning protocols effects Show physician profile

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Dealing with Non-Compliant Physicians

Carrot vs stick Education Physician profile (bubble graph) Counseling

Chief of service, Chief of Staff Physician advisor VPMA/CMO

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Dealing with Non-Compliant Physicians, cont’d

• Letter to support action (evidence based)• Meet with MEC• Peer Review• Credentialing• Track and trend

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MEC Action

Additional counseling. Letter of reprimand. Mandate CME. Mandate second opinion. Possible corrective action (possible

suspension).

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Risk for Hospital (Allowing Physicians to be Non-Compliant with Quality

Indicators)

Poor outcome data. Public reporting implications (state, CMS, national, ?

impact referral pattern). Financial implications (P4P). Legal implications

Physician was non-compliant. Hospital “no oversight”.

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Physician Quality Reporting Initiative (PQRI)

Tax Relief and Healthcare Act (TRHCA) Section 101 Implementation– Eligible Professionals– Quality Measures– Form and Manner of Reporting– Determination of Successful Reporting– Bonus Payment– Validation– Appeals– Confidential Feedback Reports– 2008 Considerations– Outreach and Education

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Physician Quality Reporting Initiative (PQRI)

Eligible Professionals– Medicare physician, as defined in Social Security Act

(SSA) Section 1861(r):• Doctor of Medicine• Doctor of Osteopathy• Doctor of Podiatric Medicine• Doctor of Optometry• Doctor of Oral Surgery• Doctor of Dental Medicine• Chiropractor

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Physician Quality Reporting Initiative (PQRI)

Eligible Professionals– Practitioners described in Social Security Act (SSA)

Section 1842(b)(18)(C)• Physician Assistant• Nurse Practitioner• Clinical Nurse Specialist• Certified Registered Nurse Anesthetist • Certified Nurse-Midwife • Clinical Social Worker• Clinical Psychologist• Registered Dietitian• Nutrition Professional

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Physician Quality Reporting Initiative (PQRI)

Eligible Professionals

– Therapists• Physical Therapist• Occupational Therapist• Qualified Speech-Language Pathologist

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Physician Quality Reporting Initiative (PQRI)

Eligible Professionals

– All Medicare-enrolled eligible professionals may participate, regardless of whether they have signed a Medicare participation agreement to accept assignment on all claims

– No registration is required to participate in PQRI.

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Physician Quality Reporting Initiative (PQRI)

Bonus Payment– Participating eligible professionals who successfully report

may earn a 1.5% bonus, subject to cap• 1.5% bonus calculation based on total allowed

charges during the reporting period for professional services billed under the Physician Fee Schedule

• Claims must reach the National Claims History (NCH) file by February 29, 2008

– Bonus payments will be made in a lump sum in mid-2008 – Bonus payments will be made to the holder of record of the

Taxpayer Identification Number (TIN)– No beneficiary coinsurance

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Improvement Never Ends…

Thank You

This material was prepared by Florida Medical Quality Assurance, Inc., under contract with the Centers for Medicare & Medicaid Services (CMS). The contents presented do not necessarily reflect CMS policy. FL20051c151027440A.

Questions ?