1. Izabella Gieras, MS, MBA, CCE Huntington Memorial Hospital, Pasadena, CA October 22, 2015

2. Courtesy of Huntington Hospital Huntington Hospital

3. 625 licensed beds Bariatric & Stroke Center Magnet Recognition 3 Davinci Robotic Systems 18 Operating Rooms (4 MIS suites) Skills Labs 5 Cath Labs & IR Suites 9000 medical devices 280 applications 450 servers with 200+ TB storage 1000+ wireless access points 4500+ end user computing devices 300+ hospital owned smart phones 60 Clinical & Information Technology employees Courtesy of Huntington Hospital

4. Agenda Healthcare Environment Building the Business Case – Capital Review Process Healthcare Technology Management (HTM) Role in Technology Management Cycle Benefits

6. Evolution of Healthcare - Past

7. Evolution of Healthcare - Present http://www.experimentalor.org/news.html

8. Evolution of Healthcare - Future http://w4.siemens.de/FuI/en/archiv/pof/heft2_01/artikel03/index.html

9. Regulatory Requirements Healthcare Environment Patient Environment

10. www.patientsafetyinstitute.ca Total lives lost per year How Hazardous is Healthcare? (Leape)

11. Medical Errors Estimated 8-12% of patients admitted to the hospital experience adverse events while receiving healthcare Adverse events include: Healthcare associated infections Medication related errors Surgical errors Medical device failures Errors in diagnosis Failure to act on results from tests 11 Frost and Sullivan Study

12. Medical Errors cont. Medical device failures account for 13% of all type of adverse events Device failure types: Product defects Design defect Manufacturing defect Misuse/abuse 12 Frost and Sullivan Study

13. Medical Errors cont. 100,000 medical device reports per year received by the FDA More than 1/3 involve use errors Use error often linked to design flaws 44% of medical device recalls due to design problems Reported by the FDA Recall Study

14. ECRI Top 10 Health Technology Hazards 1. Alarm hazards: Inadequate alarm configuration policies and practices 2. Data integrity: Incorrect or missing data in electronic health records and other health IT systems 3. Mix-up of IV lines leading to misadministration of drugs and solutions 4. Inadequate reprocessing of endoscopes and surgical instruments 5. Ventilator disconnections not caught because of mis-set or missed alarms 6. Patient-handling device use errors and device failures 7. “Dose creep”: Unnoticed variations in diagnostic radiation exposures 8. Robotic surgery: Complications due to insufficient training 9. Cybersecurity: Insufficient protections for medical devices and systems 10. Overwhelmed recall and safety alert management programs

17. Business Case Streamline the capital acquisition and assessment process CRC* and ORC* Develop a multidisciplinary capital medical equipment process The TJC compliance Evaluation process for safety and efficacy of medical equipment Control the capital equipment expenditure Routine capital projects Strategic capital projects Contingency allocations Cost effective expenditures *CRC: Capital Review Committee *ORC: Operational Review Committee

19. Capital Review Committee (CRC) Charter. CRC is responsible for reviewing the hospital’s Capital Acquisition Requests and for implementing Capital Acquisition Policy efforts throughout the organization. The Committee ensures that all elements of an effective Capital Acquisitions program are adhered to by all departments. Membership. Decision Support, Clinical Technology, Construction, Plant Operations, Information Services, Risk Management, Safety and Security and Purchasing Department. Courtesy of Huntington Hospital

20. Capital Review Committee (CRC) cont. Function. 1. Assist in the monitoring of the Capital Budget, 2. Provide oversight and supervision of the Capital Acquisition related policies and procedures, 3. Establish methods to improve the efficiency and quality of service, and to achieve savings through review and coordination of effort. Reporting Structure. CRC reports on a Monthly basis to the Operational Review Committee (ORC). http://content.wellspan.org

21. Budget Process Flow Courtesy of Huntington Hospital

22. Budget Planning & HTM Member of CRC and ORC committees Technology management cycle Short and long term replacement plans Budgetary quote request Submitting requests to the CRC database Review Maintenance, IT, Construction, Facilities needs Meeting with directors to prioritize requests Force ranking

23. CRC database Courtesy of Huntington Hospital

24. CRC database Courtesy of Huntington Hospital

25. CRC database Courtesy of Huntington Hospital

26. Force Ranking Process Strategic Operational Financial Clinical Regulatory

27. Force Ranking Process None = 0, Low =1, Medium=3, High=9

28. Force Ranking Process Criteria weight = Impact Value * Percentage of Importance Value. Total weight = all of the criteria weights for the request added together.

29. Force Ranking Process

30. CRC database report Courtesy of Huntington Hospital

31. Monthly Process Flow Courtesy of Huntington Hospital

33. Technology Assessment Technology Implementation Technology Acquisition Technology Planning Needs assessment ROI Cost benefit analysis Clinical & technical assessment HFE assessment RFP Negotiations Life cycle analysis Education Service delivery Technology Management Cycle

34. Technology Planning Perform needs assessment Consider utilities, cabling, and other infrastructure needs Consider labor resources needs and system integration EMR, IT applications, other medical equipment systems Consider any new regulatory changes/impact Consider medical equipment that is standard, well supported, reliable, not at the end of its life cycle Develop a multi year replacement plan - focus on major medical equipment categories Complete an ROI and cost benefit analysis Consider alternatives Technology Planning

35. Technology Assessment Request for Proposal (RFP) – projects over $20,000 ECRI RFP and RFI templates ECRI RFP assessment Vendor resources Internet Vendor presentations Clinical evaluations No charge PO, eval agreement, service reports, etc Human Factors evaluations – usability testing, simulations IT and Security assessments Site visits Review of recalls, hazard alerts (FDA MAUDE database) Confirm FDA clearance Check references Technology Assessment

36. Clinical Simulations Courtesy of Huntington Hospital & Mount Sinai Hospital

37. American Hospital Association http://www.ahaonlinestore.com U.S. Department of the Army Document TB MED 7, appendix B http://www.army.mil/usapa/med/ The manufacturer’s sales and service team Your own ideas Medical Assets Useful Life Resources

38. MAUDE Database www.fda.gov

39. Sample Evaluation Tool

40. Technology Acquisition Vendor selection Life cycle analysis – include all costs, supplies, maintenance, labor, testing equipment, training, etc Negotiations Clinical and technical training Testing equipment Pm during the warranty period Extended warranties/service contracts No cost delivery Payment upon clinical acceptance Latest technology delivered especially if delays on the project Operator and service manuals at no cost Technology Acquisition

41. Technology Implementation Assess physical space, structural, shielding, electrical, heating, cooling & plumbing After delivery and before installation, inspect for damage Confirm all components have been received Perform incoming inspections Installation/service documentation If manufacturer is performing the installation, monitor its progress and document any difficulties Coordinate clinical and technical training Final acceptance & final payment Technology Implementation

42. Risk Management and Quality Improvement Warranty period Downtime, failures, & problems may extend warranty or be cause for return Maintenance and mode of communication Primary/Secondary FSE assignments User acceptance and satisfaction Post-warranty Maintenance Vendor relations Patient outcomes Incident investigations Recalls and hazard alerts Strategic replacement

43. Benefits Cost-effective strategic technology planning and technology assessment Safe and efficacious patient and user environment Positive patient outcomes Patient and user satisfaction Maximized productivity of technology and staff Cost-efficient technology maintenance

44. Thank you!

45. Contact Information Izabella Gieras, MS, MBA, CCE Director, Clinical Technology Huntington Memorial Hospital Pasadena, California, USA E. izabella.gieras@huntingtonhospital.com