1. VHA INNOVATION PROGRAM Innovation #104 Pre-Procedural Checklist Tool (PPCT) VHA ISB Business Case September 25, 2013

2. VETERANS HEALTH ADMINISTRATION Project Background Problem Statement – Healthcare requires coordination of multiple people and many pieces of information, completing a series of proscribed steps, over time, in preparation for procedural events, such as a major surgical operation or in the care of critical events such as a heart attack or stroke. – Healthcare requires coordination of multiple people and many pieces of information over time – Medical work ups consist of a series of essential steps that must be completed over time – VistA/CPRS records are limited to single author, are invisible to others prior to completion, and cannot be filled out over time, as a work up progresses – CPRS records document a single point in time and can not be used to follow a prolonged clinical workup or process over time Description of Solution - The Pre-Procedural Checklist Tool (PPCT) integrates and analyzes multiple different types of information from disparate sources over time. – PPCT allows the creation and editing of checklists for medical or surgical care – PPCT extracts data such as labs, tests, notes, medications, etc. from VistA/CPRS and writes back using the Class I Medical Domain Web Services (MDWS) interface – PPCT stores work up data so the checklist can be filled out as work-up progresses managing work flow – Single patient view is used to document and follow the work-up of a single patient – Multi-patient view which allows managing panels of patients, such as all patients scheduled for hip replacement – Logic editor identifies issues that are incomplete or out of range, identifying problems. 1

3. VETERANS HEALTH ADMINISTRATION Execution Status Fully developed and functional prototype successfully completed May 2013 in the Innovation Sandbox – Includes: Checklist Editor, Single-Patient View, Multi-Patient View, and Logic Editor Database for storage of work-ups in progress Uses Class I MDWS interface and can extract, analyze, and write data to and from VistA/CPRS Systems Based Medicine Resource Group (SBMRG) plan of validated checklists is complete Systems Based Medicine Resource Group (SBMRG) won first place for LVA 2012 Innovation Prize. PPCT has been presented to NCPS, MWM VERC, CAC, VA Quality Scholars, Kaiser Permanente, VA Anesthesia FAC, PACT, CHF QUERI, IHD QUERI, San Francisco VA Medical Center (VAMC) Performance Improvement for comments and suggested improvements Final code and documentation submitted to OSEHRA Approved for production environment by OI&T Region 1 On schedule for clinical testing in Region 1 starting with San Francisco VAMC High level, project specific, tasks required for enterprise deployment: – MDWS enhancements may be necessary for pharmacy data, order entry, etc. – Oracle database may need to be converted over to SQL if Oracle support not available – Refine functionality/improvements identified during prototype testing during pilot and C&A – Pilot at approximately twelve (12) and Class III to Class I verification prior to national release 2

4. VETERANS HEALTH ADMINISTRATION ISB Selection Criteria 3 CriteriaSee…Self-Assigned Score ComplianceSlide 41 Five-Year Net Operational Cost ChangeSlide 510 Implementation CostSlide 6-7 Clinical Impact (Broadness)Slide 710 Clinical Impact (Degree)Slide 810 Business Impact (Broadness)Slide 710 Business Impact (Degree)Slide 810 Patient SafetySlide 910 Patient ValueSlide 1015 Healthcare DisparitySlide 113 Summary Value = 1 * (23+48) = 71 Business Value = 10 + (-7) + 10 + 10 = 23 Clinical Value = 10 + 10 + 15 + 3 + 10 = 48

5. VETERANS HEALTH ADMINISTRATION Business Case – Compliance PPCT is compliant with regulations, including patient safety – A fundamental goal of the PPCT is to improve, monitor, and document compliance with approved standards of care.  Standards of care can be built into checklists.  Required tests, procedures, checks, notes, tests can be required elements in checklist.  Checklist elements that are not completed or are out of date or range are flagged red by the logic editor.  Overriding or checklist elements is allowed but all over ride decisions are documented to time, data, and author. – PPCT has been approved for production testing by OI&T Region 1 – Uses Class I MDWS interface for data exchange with VistA/CPRS – PPCT complies with patient safety requirements 4 Self Assigned Score: 1

6. VETERANS HEALTH ADMINISTRATION Business Case – 5 Year Net Operational Cost Change This innovation creates two major sources of benefit totaling more than $700 million in net savings over five years: – Cost savings associated with reductions in surgical cancellations: $41.6 million over the first five years of deployment and $30.25 million annually thereafter – Cost savings from reductions in surgical morbidity and mortality: $850 million over the first five years of deployment and $400 million annually thereafter 5 Data ElementAmount Approx. number of surgical cancellations in FY12 (national) 60,500 (13%) Cost of surgical cancellation $2,000-$10,000 Anticipated reduction in cancellation rate 25% Annual cost savings from reduced surgical cancellations $30.25 million Data ElementAmount Approx. number of morbidity or mortality events in FY12 (national) 41,140 (9%) Cost of morbidity or mortality event$28,00-$60,000 Anticipated reduction in rate of morbidity/mortality 35-50% Annual cost savings from reduced reductions in morbidity/mortality $400 million Self Assigned Score: 10 Cost Savings from Reduced Surgical Cancellations Cost Savings from Reduced Surgical Morbidity/Mortality

7. VETERANS HEALTH ADMINISTRATION Business Case - Implementation Costs 6 Year 1Year 2Year 3Year 4Year 5 Pilot Phase$1,000,000 $0 Deployment Phase$0$1,000,000$3,000,000 Annual Total$1,000,000$2,000,000$3,000,000 Cumulative Costs$1,000,000$3,000,000$6,000,000$9,000,000$12,000,000 Self Assigned Score: -7

8. VETERANS HEALTH ADMINISTRATION Business Case – Clinical Impact Broadness: PPCT positively impacts many clinical performance metrics. PPCT is designed to improve compliance. 7 Self Assigned Score, Broadness: 10 Self Assigned Score, Degree: 10 Clinical Performance MetricDegree of Impact Surgery (SIP1a, SIP3an, SIP14, SIP8, SIP10a, SIP12, SIP25, SIP26, SIP13, SIP90) 25% improvement Diabetes (DMG90, 25hs, 23h, 31h, 32h, 27h, 34h, c9h) 25% improvement Clinical Practice Guideline Index (CPGI4) 25% improvement AMI (IHI90, 1, 6, 7, 9, 47, 61), HF (CHI70, 7, 10, 19,), HTN9h, 25% improvement Getting Care Quickly (OP) WTM53 25% improvement Access list 14 days- Specialty Care 25% improvement Degree: PPCT positively impacts these metrics in the following ways - Allows coordination of multiple team members, referring physicians, nurses, surgeons, internists - Standardizes surgical and medical works ups and follows standards of care - Reduces surgical mortality by 35 to 50% - Reduces surgical morbidity by 35 to 50% - Reduces cost from surgical cancellations, morbidity, mortality, and medical errors - Reduces surgical cancellations from inadequate or incomplete work ups - Reduces time for surgical work ups and prevents delays - Reduces inappropriate clinical testing - Identifies critical work up elements that are incomplete or abnormal or out of date

9. VETERANS HEALTH ADMINISTRATION Business Case – Business Impact Broadness: PPCT positively impacts six (6) business performance metrics 8 Self Assigned Score, Broadness: 10 Self Assigned Score, Degree: 10 Degree: PPCT positively impacts these metrics in the following ways - Allows coordination of multiple team members, referring physicians, nurses, surgeons, internists - Standardizes surgical and medical works ups and follows standards of care - Reduces surgical mortality by 35 to 50% - Reduces surgical morbidity by 35 to 50% - Reduces cost from surgical cancellations, morbidity, mortality, and medical errors - Reduces surgical cancellations from inadequate or incomplete work ups - Reduces time for surgical work ups and prevents delays - Reduces inappropriate clinical testing - Identifies critical work up elements that are incomplete or abnormal or out of date Business Performance MetricDegree of Impact Improved accuracy of decision making (quality of work) 25% improvement Standardization of best practices (quality of work) 25% improvement Enhanced data access, integrity, or aggregation (quality of work) 25% improvement Reduces program or organizational risk (quality of work) 25% improvement Reduces costs (VA staff efficiency or workflow) 25% improvement Improves the environment of care (Veteran/beneficiary’s experience) 25% improvement

10. VETERANS HEALTH ADMINISTRATION Business Case - Patient Safety PPCT demonstratively improves patient safety -Standardizes surgical and medical work ups reducing iatrogenic injury. -Identifies critical lab values and incomplete work ups. -Reminds staff of critical steps in processes. -Improves communication and coordination of staff during work ups. -Improves compliance with, and adoption of, standards of care. -Reduces surgical mortality by 35-50% -Reduces surgical morbidity by 35-50% Evaluation Criteria Scored -10 to 10 where -10 is severe decrease in patient safety, 0 is no change in patient safety and +10 is very strong impact in patient safety 1.Demonstratively reduces preventative harm in this population: 10 2.Reduces mortality and morbidity in this population: 10 3.Improves patient safety by demonstratively reducing the chance of human error: 10 9 Self Assigned Score: 10

11. VETERANS HEALTH ADMINISTRATION Business Case – Patient Value This solution significantly increases patient satisfaction and it is anticipated VA would be contacted with written accolades -Decreases surgical cancellation rates -Reduces time for surgical work ups and prevents delays -Decreases waiting time for surgery by better management of pre surgical work ups -Reduces unnecessary preoperative testing and iatrogenic injury -Improves compliance with, and adoption of, standards of care. -Reduces disparity in VHA healthcare by standardizes work ups throughout VHA -Reduces surgical mortality by 35-50% -Reduces surgical morbidity by 35-50% 10 Self Assigned Score: 15

12. VETERANS HEALTH ADMINISTRATION Business Case – Healthcare Disparity PPCT addresses a healthcare disparity with regard to standardization of care –PPCT is designed to standardize medical and surgical pre-procedural work ups –Patients will receive standardized care driven by checklists thus reducing the disparity in healthcare –Best practice checklists from each VAMC will be shared across the VHA system reducing healthcare disparity between VAMCs –VAMCs with special expertise will develop checklists that can then be used by all VAMCs thus reducing system-wide disparities in specialty healthcare –Increased adoption of and compliance with standards of care across VHA system will reduce the disparity in healthcare –Care will be uniform and the best care possible regardless of the VAMC location 11 Self Assigned Score: 3

13. VETERANS HEALTH ADMINISTRATION Back Up Slides 12

14. VETERANS HEALTH ADMINISTRATION Other Considerations – Data Sources Used to Estimate Cost Savings Resulting from PPCT 13 Number of surgical cancellations in FY12: VASQIP 2012 Cost associated with surgical morbidity and mortality: VASQIP 2012, NSQIP 2004, Costs associated with surgical cancellation: – Data pulled from SF VAMC; costs associated with surgical cancellation include cost of un-used OR time, wasted equipment, contract employees, etc. Anticipated reduction in cancellation rate: – Observed reduction in cancellation rate with simple checklist was 75%. Model used 25% reduction to increase aplicability. Approximate number of morbidity and mortality events in FY12: VASQIP 2012 – Mortality 4,571 – Morbidity 36,569 Costs associated with morbidity or mortality event: – $28,000 Veterans Affairs Surgical Quality Improvement Program (NSQIP) 2004 data – $37,000 - $45,000: Veterans Affairs Surgical Quality Improvement Program (VASQIP) 2012 data. Wakefield H, Vaughan-Sarrazin M, Cullen JJ. Am J Surg. 2012 Oct;204(4):434-40.Wakefield HVaughan-Sarrazin MCullen JJAm J Surg. Anticipated reduction in rate of morbidity/mortality: – 35% Reduction in mortality.: Wallace, AW, Selwyn Au, S. Cason, BA. Association of the Pattern of Use of Perioperative b- Blockade and Postoperative Mortality. Anesthesiology 2010 113:794-805. – 50% Reduction in mortality: Mangano D.T., Layug E.L., Wallace A., Tateo I., and the Multicenter Study of Perioperative Ischemia (McSPI) Research Group. – 50% Reduction: Effect of Atenolol on Mortality and Cardiovascular Morbidity after Noncardiac Surgery. N. Engl. J. Med. 335(23): 1713-1720, 1996. – 50% Reduction Weisner et al Effect of a 19-item surgical safety checklist during urgent operations in a global patient population. Ann Surg. 2010 May;251(5):976-80.Ann Surg.

15. VETERANS HEALTH ADMINISTRATION Other Considerations – Calculating the Annual Cost Savings of Pre-Procedural Checklist Tool 14 PPCT Yearly Cost Savings PPCT Reduction in Surgical Mortality SF VAMCVISN 21Nationally Number of Scheduled Cases/Year444521957457113 VASQIP 30-Day Surgical Mortality1% VASQIP 30-Day Surgical Morbidity8% Cost of Morbid or Mortal Event $ 28,000 Percent Reduction in Morbidity and Mortality35% Expected Number of 30-Day Deaths442204571 Expected Number of 30-Day Morbidity356175736569 Expected Total 30-Day Morbidity and Mortality400197641140 Cost of 30-Day Mortality $ 1,244,600 $ 6,147,960 $ 127,991,640 Cost of 30-Day Morbidity $ 9,956,800 $ 49,183,680 $ 1,023,933,120 Cost of Total 30-Day Morbidity and Mortality $ 11,201,400 $ 55,331,640 $ 1,151,924,760 Cost Reduction of 30-Day Mortality $ 435,610 $ 2,151,786 $ 44,797,074 Cost Reduction of 30-Day Morbidity $ 3,484,880 $ 17,214,288 $ 358,376,592 Cost Reduction of 30-Day Morbidity and Mortality $ 3,920,490 $ 19,366,074 $ 403,173,666 Size Ratio for Local Calculations1%5%100% PPCT Reduction in Cost of Medical Admissions Number of Medical Admissions6,72933,240 692,000 Cost of Medical Care $ 442,652,423 $ 2,186,573,508 $ 45,521,299,625 Number of Unique Patients54,119267,3305,565,427 Cost of Medical Care per unique patient $ 8,179 Estimated Cost of Medical Admission$5,000 $ 33,645,291 $ 166,197,899 $ 3,460,000,000 Percent Reduction in Cost of Medical Admission10% $ 3,364,529.1 $ 16,619,789.9 $ 346,000,000.0 Total Yearly Cost Savings for Reduction in Surigcal and Medical Morbidity and Mortality $ 7,285,019 $ 35,985,864 $ 749,173,666

16. VETERANS HEALTH ADMINISTRATION Other Considerations – Calculating the Annual Cost of Pre- Procedural Checklist Tool 15 Pre-Procedural Checklist Tool Development PhaseOperational Phase Operational Life Cycle*Year 1 (SF)Year 2 (SF&PA)Year 3 (VISN 21)Year 4 (VISN 21&22)Year 5 (National) Locations12612150 Surgical Patients 4,000 8,000 20,000 40,000 457,000 Medical Patients 6,729 13,458 33,240 66,479 692,000 Physicians30601803604500 Specialty Nurses20401202403000 % Deployed End of Period1% 4%8%100% * Numbers are end of period where relevant Cost ProfileYear 1Year 2Year 3Year 4Year 5 Pilot Phase1,000,000 000 Deployment01,000,000 Operation001,000,000 Protocol Development, Testing, Maintenance001,000,000 Annual Total$1,000,000$2,000,000$3,000,000 Cummulative Costs$1,000,000$3,000,000$6,000,000$9,000,000$12,000,000 Benefit ProfileYear 1Year 2Year 3Year 4Year 5 Preventable 30-Day Surgical Morbidity $ 3,484,880$6,969,760 $ 17,214,288 $ 34,428,576 $ 358,376,592 Preventable 30-Day Surgical Mortality$435,610$871,220$2,151,786$4,303,572$44,797,074 Reduction in Surgical Cancellations$312,000$624,000$1,852,500$3,705,000$30,289,000 Reduction in Cost of Medical Admissions$3,364,529$6,729,058$16,619,790$33,239,580$346,000,000 Annual Total Surgical and Medical Care$7,597,019$15,194,038$37,838,364$75,676,728$779,462,666 Cummulative Benefit$7,597,019$22,791,057$60,629,421$136,306,149$915,768,815 Annual PerformanceYear 1Year 2Year 3Year 4Year 5 Annual Cost$1,000,000$2,000,000$3,000,000 Annual Benefit$7,597,019$15,194,038$37,838,364$75,676,728$779,462,666 Annual Net Benefit$6,597,019$13,194,038$34,838,364$72,676,728$776,462,666

17. VETERANS HEALTH ADMINISTRATION PPCT: Multi-Patient View allows review of all patients scheduled for a procedure, or all patients with a common problem such as diabetes. 16

18. VETERANS HEALTH ADMINISTRATION PPCT: Single Patient View 17

19. VETERANS HEALTH ADMINISTRATION Enter Checklist Data as work flow progresses 18

20. VETERANS HEALTH ADMINISTRATION PPCT: Review checklist data for completeness and problems. 19

21. VETERANS HEALTH ADMINISTRATION PPCT: Checklist work up stored in CPRS as a text note and in database for analysis. 20

22. VETERANS HEALTH ADMINISTRATION PPCT: Can extract data from Vista/CPRS, analyze, and write notes back to CPRS. Lab data example. 21

23. VETERANS HEALTH ADMINISTRATION PPCT: Lab Data extracted from Vista/CPRS 22

24. VETERANS HEALTH ADMINISTRATION PPCT: Editor allows creation and editing of checklist – Add items 23

25. VETERANS HEALTH ADMINISTRATION PPCT: Checklists can have questions for completion. Checklist editor is flexible to allow many different types of checklists. 24

26. VETERANS HEALTH ADMINISTRATION PPCT: Follows standard rules for assigning clinician roles. 25

27. VETERANS HEALTH ADMINISTRATION PPCT: Logic editor allows validation of data and identification of problems. 26

28. VETERANS HEALTH ADMINISTRATION PPCT: Possibilities for using Checklist for Quality Improvement Presurgical workup guidance (like SQWM) Preoperative briefing-timeout-debriefing Guidelines for acute MI, congestive heart failure Discharge planning Managing panels of patients PACT 27

29. VETERANS HEALTH ADMINISTRATION PPCT: Where do the checklists come from? Systems Based Medicine Resource Group (SBMRG) 28