Surgical Outcome Reporting Requirements –

You ain’t seen nothing yet!Robin Blackstone, MD, FACS, FASMBS

Medical Director, Scottsdale Healthcare Bariatric Center

Disclosures

Enteromedics – multicenter trial of VBLOC device

Ethicon Endosurgery/Johnson and Johnson – consulting

National Institutes of Health Longitudinal Protocol of Bariatric Surgery Procedures- Intramural Study

Human Performance Institute – consulting

Scottsdale Healthcare Corporation – Employed Physician

Surgical Review Corporation - BSRC

Creating the climate for changeThe Leapfrog Project 1998

“To Err is Human” The Institute of Medicine Report 2000

The Leapfrog Group - 1998

Large employers How can the way we purchase health care influence quality and

affordability? Market was not functioning correctly – employers who pay billions of

dollars for health care had no way to compare health care providers or assess quality of care provided

1999 Institute of Medicine Report helped focus effort by Leapfrog to prevent medical mistakes

More deaths in hospital due to preventable medical mistakes than deaths from MVA, Breast cancer and Aids combined.

IOM recommended that large employers provide market reinforcement to improve quality and safety

Leapfrog – reward hospital that implement quality and safety improvements

Leapfrog launched in November 2000 with funding from the Business Roundtable Kohn LT, Corrigan JM, Donaldson MS, editors. To err is human:

building a safer health system. A report of the Committee on Quality of Health Care in America, Institute of Medicine. Washington, DC: National Academy Press; 2000.

Leapfrog Initiative – Four Targets

Computerized Physician Order Entry

Evidence-Based Hospital Referral – referral of patients based on survey results

ICU Physician Staffing

Leapfrog Safe Practices Score

Want to know how your hospital stacks up in bariatric surgery for the Leapfrog group? http://www.leapfroggroup.org/home

Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.

Leapfrog Initiative for 2011: Bariatric Surgery

Possible Outcome Reporting from Bariatric Surgery Databases

Explore use of risk-adjusted outcome data from ACS bariatric surgery database and ASMBS BOLD database

If reporting of hospital outcome data is validated

Facility outcomes will be compared to national standards

Hospitals that report complication rates better than the national average will receive credit for their outcome performance; hospitals with rates worse than the national average will not receive any credit for their outcome performance.

Institute of Medicine Report To Err is Human 1999/2000

44,000 operations at a large medical center 1977-1990

5.4 percent (2,400 patients) experienced complications

50% of the complications were attributed to error

Volume of operations annually in the US: 30 million operations

Issues driving Safety and Reporting

18 types of medical injurie accounted for 2.4 million additional hospital days and $9.3 billion in additional charges each year. Jama 2003

Post operative complications account for 22% of preventable deaths

Only 55% of US adults receive care consistent with current recommendations McGlynn EA, Asch SM, Adams J, et al. The quality of

healthcare delivered to adults in the United States. N Engl J Med. 2003;348(26):2635

Bariatric surgery cost of complications: a complication requiring readmission and reoperations cost roughly 3x more than a primary procedure

Public reporting

Public reporting on hospital process improvements linked to better patient outcomes. Werner RM, Bradlow ET.Health Aff (Millwood). 2010 Jul;29(7):1319-24.

Public reporting comes in many venues including some that are not transparent in the way they collect data (HealthGrades)

Critical for surgeons/programs to monitor the way they code the patients perioperative course

There is a tension between the facility coders (who always want to code everything they can for reimbursement) and outcomes reporting (where problems that aren’t clinically relevant can be used to make it look like you are having more serious complications than you are) Atelectasis often coded as pulmonary collapse Post op anemia coded as a “900” code

 ACCURACY IN PUBLIC REPORTING OF HEALTHCARE UTILIZATION AND ADVERSE EVENTS IN A COMMUNITY HOSPITAL

Inpatient and outpatient records in a community hospital system were retrospectively reviewed for utilization of post operative encounters during the 90 days after consecutive surgeries performed by ASMBS COE bariatric surgeons in 2009. 495 total surgeries were identified

Hospital publicly reported rates of utilization before and after reconciliation were respectively: readmissions (22.8% vs. 5.7%, p<0.0001), ER visits (6.2% vs. 5.1%, p<0.0001), and complications (10.3% vs. 9.7%, p=0.01).

The hospital reported a higher incidence than the reconciled report due to duplication and inaccurate coding.

Unreconciled public reporting had an error rate of over reporting 19.3% of healthcare utilization rates.

Blackstone RP, Cortes MA Abstract accepted for Poster Presentation at ASMBS 2011

American Board of SurgeryMaintenance of Certification

American Board of Surgery :Maintenance of Certification MOC consists of four parts designed to assess physician competencies on a continuous basis:

Part 1 - Professional standing through maintenance of an unrestricted medical license, hospital privileges and satisfactory references.

Part 2 - Lifelong learning and self-assessment through continuing education and periodic self-assessment. 30 hours of Category I CME and 50 CME hours overall per year one-third of the Category I CME (i.e., 30 hours) must include a self-

assessment activity

Part 3 - Cognitive expertise based on performance on a secure examination.

Part 4 - Evaluation of performance in practice through tools such as outcome measures and quality improvement programs, and the evaluation of behaviors such as communication and professionalism. Bariatric surgery databases (ACS or ASMBS) are included in meeting this

requirement

Medicare Weighs In Surgical Care Improvement Program Patient Quality Reporting Initiative

Surgical Care Improvement Program(SCIP)

Infection

SCIP INF 1: Prophylactic antibiotic received within one hour prior to surgical incision

SCIP INF 2: Prophylactic antibiotic selection for surgical patients

SCIP INF 3: Prophylactic antibiotics discontinued within 24 hours after surgery end

SCIP INF 4: Cardiac surgery patients with controlled 6 a.m. postoperative blood glucose

SCIP INF 6: Surgery patients with appropriate hair removal

SCIP CARD 2: Surgery patients on beta-blocker therapy prior to arrival who received a beta-blocker during the perioperative period

VTE

SCIP VTE 1: Surgery patients with recommended venous thromboembolism prophylaxis ordered

SCIP VTE 2: Surgery patients who received appropriate venous thromboembolism prophylaxis within 24 hours prior to surgery to 24 hours after surgery

Core Competencies for delivery of high quality medical care

Six core competencies required of residents and physicians to deliver high quality medical care patient care medical knowledge practice-based learning and improvement interpersonal and communication skills professionalism systems-based practice.

Practice-based learning and improvement (PBLI)

Ziegelstein RC, Fiebach NH."The mirror" and "the village": a new method for teaching practice-based learning and improvement and systems-based practice. Acad Med. 2004 Jan;79(1):83-8.

Systems Based Practice

Care is never delivered in a vacuum

Patient safety is a good entry point into SBP because the concepts of safety, errors, and harm all place the individual, whether patient or provider, within the framework of a system.

Bariatric surgery is a example of a system based practice discipline – we are used to working with integrated health colleagues, it requires leadership which exhibits most the the core competencies, in response to our own crisis of poor outcomes ASMBS moved early to adopt a systems based care approach with the COE program

Donabedian Model for Patient Safety

Visionaries of Quality – Senior Leaders of ASMBS establish the ASMBS COE ProgramWalter Pories, Harvey Sugerman, Henry Buchwald, Alan Wittgrove, Ken Champion

Outcomes and Risk Adjustment

Every surgeon thinks his patients are sickest The lack of risk adjustment has delayed

implementation of outcomes in determining who can qualify for COE/BSN

Volume has been used as a surrogate for quality

Risk Adjusted Morbidity is a better predictor of quality than volume (83% vs 21%)

Dimick et al. Identifying High Quality Bariatric Surgery Centers: Hospital Volume or Risk-Adjusted Outcomes? J Am Coll Surg 2009 Dec 209(6):702-6.

Surgical Outcome Reporting – Risk Adjustment – Is it Still Relevant?

Early work used population with large numbers of open procedures and before the process was in place that came as a result of the COE environment (OS-MRS)

Identified Risk Factors for adjustment: Body mass index>or=50 kg/m2 male gender hypertension, known risk factors for pulmonary embolism (previous

thromboembolism, preoperative vena cava filter, hypoventilation, pulmonary hypertension)

age>or=45 years.

De Maria et al. Validation of Mortality Risk Score Ann Surg 2007Oct;246(4):578-82

Prospective Trials – Longitudinal Assessment of Bariatric Surgery (LABS)

Adverse event rate is very low – had to use a composite event rate

Adverse events occurred in a statistically random way An adverse event could not be predicted by any risk factors Only important variable was volume of the surgeon 3410 RYGB with 31 Surgeons 15 surgeons had volume of less than 50 cases annually

There was a continuous relationship between surgeon volume and risk of AE such that for every 10 cases/year increase in volume risk of a composite event decreased by 10%

Smith et al. Relationship between surgeon volume and adverse events after RYGB in LABSSOARD 2010 Mar 4;6(2): 118-25.

Large Data Base Risk Adjustment

ACS NSQIP 2005-2008 (includes laparoscopic, open and

revision bariatric cases) 32,426 patients Risk factors Identified

Age (to age 40 then levels off) BMI (minimum risk at 40) Serum Albumin Functional Status Other factors like HTN and Gender not significant

Turner P. et al Obes Surg 2010Dec 15 epub

Use Risk Factors to Manage Preoperative Risk rather than adjust outcomes

Identifying patients at risk and managing risk in advance of the procedure decreases adverse events ie manage antecedent conditions (Sleep Apnea, Asthma, DM, HTN, Cardiac Risk-others)(1)

Special Planning for Acuity 3 and 4 patients included planned decrease in risk(1)

Target for management of risk(2): Recent MI Stroke Dependent Functional Status Bleeding Disorder HTN BMI Type of Surgery

1. Blackstone RP et al. Metabolic Acuity ScoreSOARD 2010 May-June;6(3):267-73

2. Gupta PK et al. Development and Validation of a Bariatric Surgery Morbidity Risk Calculator J Am Coll Surg 2011 Jan 17. epub ahead of print

Summary – Risk Adjustment

Risk Adjustment may not be as relevant to outcomes, particularly in regards to judging “fitness” of a program to participate in COE/BSN

Bariatric surgeons who have implemented process measures may be able to operate within one standard deviation of benchmarks established by large databases

Volume may not be relevant if process is in place and monitored

Process measures are easier to measure/audit

Outcomes may be influenced by coding error

It may finally be time to change our quality paradigm

Donabedian Model for Patient Safety

Possible Targets - Moving bariatric safety to the next level

Use of current databases reporting to do quality improvement process and qualify for pay for performance

Patient Satisfaction Surveys – SQA has developed a surgeon specific survey (validated) for AHRQ: CAHPS Surgical Survey at: www.cahps.ahrq.gov

Implementation in all databases of process measurements rather than focus on outcomes Computerized order entry Use of EMR Written protocols for areas of critical importance:

VTE prophylaxis Sign Off of patients between providers Multidisciplinary rounds Patient and nurse satisfaction surveys Emergency Department protocol for patients with a history of bariatric surgery Surgical Pause Readmission for nausea/vomiting and rehydration

Possible process targets – Moving bariatric safety to the next level

Monitoring of SKIP compliance Audit for second generation informed consent

documents and process Identify key aspects of six core competencies

and monitor them for accreditation Maintain outcomes for programs within one

standard deviation of national benchmarks set by the committee

Establish a mentoring program to bring programs greater than one standard deviation from benchmark into compliance

Require MOC

Proposal of a new committee of ASMBS

The mission of the proposed Quality and Safety Committee is to: Provide a sound basis for evolution of the ASMBS COE program

administered by Surgical Review Corporation with regular reports to the Executive Committee of ASMBS and membership

Examine, update and support the development of new standards to keep pace with change in the quality environment

Address in the revised standards the issues of volume, risk adjustment, outcomes

Address the pathway to excellence in patient safety for rural and low volume centers and new centers

Prepare to expand quality patients programs to meet increased demand from BMI 30+ and success with national advocacy efforts

Develop pathways for long term data to be gathered with Patient and PCP portal access

Establish collaboration between the ASMBS Centers of Excellence Program and the ACS Bariatric Network

Prepare for approaching CMS about reopening the NCD

Thank you