2 Surgical Care Improvement Project Dr. Philmore J. Joseph Memorial Hermann NE Humble, Texas

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4 "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

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

6 History of infection control and hospital epidemiology l Pre 1800: Early efforts at wound prophylaxis l : Nightingale, Semmelweis, Lister, Pasteur l : Antibiotic era begins, Staph. aureus nursery outbreaks, hygiene focus l ’s: Documenting need for infection control programs, surveillance begins l 1980’s: focus on patient care practices, intensive care units, resistant organisms, HIV l 1990’s: Hospital Epidemiology = Infection control, quality improvement and economics l 2000’s: ??Healthcare system epidemiology modified from McGowan, SHEA/CDC/AHA training course

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8 History of infection control and hospital epidemiology l Pre 1800: Early efforts at wound prophylaxis l : Nightingale, Semmelweis, Lister, Pasteur l : Antibiotic era begins, Staph. aureus nursery outbreaks, hygiene focus l ’s: Documenting need for infection control programs, surveillance begins l 1980’s: focus on patient care practices, intensive care units, resistant organisms, HIV l 1990’s: Hospital Epidemiology = Infection control, quality improvement and economics l 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 Prevention Performance 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%Mortality Un-infectedInfected Kirkland. Infect Control Hosp Epidemiol. 1999;20:725.

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

Surgical Care Improvement Project (SCIP) l Preventable Complication Modules –Surgical infection prevention –Cardiovascular complication prevention –Venous thromboembolism prevention –Respiratory complication prevention

16 Surgical Care Improvement Project (Draft Global Outcome Measures) l Motality within 30 days of surgery l Readmission within 30 days of surgery

Surgical Care Improvement Project Performance measures l 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)

Classen, et al. N Engl J Med. 1992;328:281. Perioperative Antibiotics Timing of Administration Hours From Incision 14/369 5/699 5/1009 2/180 1/81 1/41 1/47 15/441

Pre-operative shaving l 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 l 1,000 cardiothoracic surgery patients l 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

21 Perioperative Glucose Control Carr J Thor Surg 2005

Temperature Control l 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) l 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 Also: Melling AC, et al. Lancet (preop warming)

Surgical Care Improvement Project Draft performance measures l 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.

24 Leape et al. JAMA 2002

Mangano DT, et al. N Engl J Med. 1996;335: Postoperative Survival l 6-month survival 100% vs 92% (P<0.001) l 2-yr survival 90% vs 79% (P=0.019)

Potential to Reduce Perioperative Complications in SCIP 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.

27 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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30 Adopter Categories Early Adopters Innovators Early Majority Late Majority Laggards 2.5%13.5%34% 16% from E. Rogers, 1995

31 l 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?

32 l Six Sigma is a statistical measure that expresses how close a service process comes to its quality goal l Six Sigma refers to a process that produces only 3.4 defects per million opportunities SigmaDPMOYield 2308, % 366, % 46, % % % A Measure of Quality:

33 l Six Sigma provides a process based approach (DMAIC) to continuous improvement that can be used to improve any business process l Provides a data driven and evidence based format on which to base improvement decisions l Insists on statistical proof of improvement and process control l Provides a means to sustain and build upon proven improvements A Process for Continuous Improvement:

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

36 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 Process Effective Results Work-Out TM Q x A = E Q x A = E Six Sigma Effectiveness:

37 You have to change the acceleration process

38 Keys To Physician Acceptance l Credible evidence based literature l Evidence should be compelling l Presented by a credible, respected physician (preferably their specialty) l Explain that their peers endorse

39 Hospital Process In Place To Educate Physicians l EBM education to medical staff l Process to help physicians with indicators l Concurrent review to catch missed indicators (early, late) l Retrospective review (educational) l Physician profiles

40 Rationale to Support Physician/Hospital Compliance l Right thing to do l Quality issue l Financial issue(P4P) l Liability issue l Public reporting issue l Need to hold physician accountable (only if hospital has process in place)

41 SCIP 1 – Barriers (Antibiotic Within One Hour) l Never gets done in one hour l Doesn’t make any difference l No infections l Never use antibiotics anyway

42 SCIP 1 – Responses (Antibiotic Within One Hour) l Literature clear (EBM) l Does make a difference l Infections are related to timing of 1 st dose l Antibiotics are effective l Hospital process (delegate individual/ team) l Tourniquet issue l Vancomycin issue

43 SCIP 2 – Barriers (Evidence Based Antibiotic) l Who are these experts telling me (30 years experience) what to do? l Are they clinically involved, on the “battlefield” like me? l My patients don’t get infections. l Don’t tell me how to practice medicine/surgery.

44 SCIP 2 – Barriers, cont’d (Evidence Based Antibiotic) l Why can’t I use Vancomycin on all my patients? l Why can’t I use antibiotic “x”  FDA approved  Endorsed by manufacturer

45 SCIP 2 – Responses (Evidence Based Antibiotic) l Experts are knowledgeable, credible, and in active practice. l You have been lucky so far (won’t be able to defend SSI with unapproved antibiotic). l Vancomycin over utilized  Increased infection rates  Increased resistance

46 SCIP 2 – Responses, cont’d (Evidence Based Antibiotic) l Many antibiotics approved by FDA, and manufacturer endorsed, not agreed by experts as good prophylaxis at this time (inadequate trials, time)

47 SCIP 3 – Barriers (Why Physicians Don’t Stop ABX at 24 Hours) l Most difficult l Just because l Fever l Infection l Tubes, drains, still in place

48 SCIP 3 – Barriers, cont’d (Why Physicians Don’t Stop ABX at 24 Hours) l No literature to support l My patients are sicker l Training program taught me this way l I know what is best for my patient

49 SCIP 3 – Responses (Why Physicians Don’t Stop ABX at 24 Hours) l Ample literature to support (many years). (one drug, one dose, one time, many procedures) l Fever usually secondary to atelectasis. l If infection on prophylactic ABX, no sense to continue (?resistance). l Contact surgical training program.

50 SCIP 3 – Responses, cont’d (Why Physicians Don’t Stop ABX at 24 Hours) l You may not know what is best for your patients (only your assumption). l Meet with ACS state chapters. l Meet with medical school surgical programs. l Society of Thoracic Surgery 48 Hours

51 Successful Interventions SCIP 1-3 l Establish prophylactic antibiotic administration accountability l Address antibiotic timing with surgeons via physician champion l Stock OR only with approved prophylactic antibiotics l Develop pre-printed order sets with recommended prophylactic antibiotics by procedure

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

53 Shaving Excuse Response l Literature supports risk of infection. l If patient becomes infected, after shaving, difficult to defend. l Options  Clip  Depilatory  Nothing

54 Shaving Interventions l Physician, staff education (timeline for removal all razors) l Remove all razors from holding unit and OR l Establish protocol for proper or no hair removal l Have adequate clippers available l “No shave zone” posters in key areas l Process to educate patients re no shaving pre-op

55 Hypothermia l 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

56 Hypothermia Interventions l Education re risks to patients l Process for warming devices (blankets, solutions l Need thermostatic control in OR, holding units l Designate responsibility and accountability l Cooling vests for surgeons

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

58 Hyperglycemic Responses l Data supports infection with increased BS. l Not just CABG. l Could apply to all procedures with hyperglycemia. l 1/3 of med-surg patients may have DM. l Implement hyperglycemic protocol with a trigger BS.

59 Hyperglycemia Interventions l Education l Process in place with trigger sugar l Process in place for perioperative monitoring l Process for “non diabetics”

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

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

62 DVT/PE Solution, cont’d l NB issue regarding counter pulsation pressure devices l NB chemoprophylaxis vs pressure devices l Age >40, general anesthesia > 30 minutes l Bleeding too remote l Geerts - Chest.2004, 126:

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

64 Beta Blocker Barriers l Don’t believe literature. l Patient has asthma, COPD. l Patient has bradycardia. l Patient has diabetes. l Patient has hypotension.

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

66 VAP Barriers l I elevate bed. l Nurses lower bed. l I see no difference. l Patient more comfortable. l I don’t believe peptic ulcer prophylaxis necessary. l Don’t believe weaning protocol necessary.

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

68 Dealing with Non-Compliant Physicians l Carrot vs stick l Education l Physician profile (bubble graph) l Counseling  Chief of service, Chief of Staff  Physician advisor  VPMA/CMO

69 Dealing with Non-Compliant Physicians, cont’d Letter to support action (evidence based) Meet with MEC Peer Review Credentialing Track and trend

70 MEC Action l Additional counseling. l Letter of reprimand. l Mandate CME. l Mandate second opinion. l Possible corrective action (possible suspension).

71 Risk for Hospital (Allowing Physicians to be Non-Compliant with Quality Indicators) l Poor outcome data. l Public reporting implications (state, CMS, national, ? impact referral pattern). l Financial implications (P4P). l Legal implications  Physician was non-compliant.  Hospital “no oversight”.

72 Physician Quality Reporting Initiative (PQRI) l 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

73 Physician Quality Reporting Initiative (PQRI) l 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

74 Physician Quality Reporting Initiative (PQRI) l 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

75 Physician Quality Reporting Initiative (PQRI) l Eligible Professionals –Therapists Physical Therapist Occupational Therapist Qualified Speech-Language Pathologist

76 Physician Quality Reporting Initiative (PQRI) l 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.

77 Physician Quality Reporting Initiative (PQRI) l 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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79 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. FL20051c A. Questions ?