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

Courtesy of Huntington Hospital Huntington Hospital

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 wireless access points end user computing devices 300+ hospital owned smart phones 60 Clinical & Information Technology employees Courtesy of Huntington Hospital

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

Evolution of Healthcare - Past

Evolution of Healthcare - Present

Evolution of Healthcare - Future

Regulatory Requirements Healthcare Environment Patient Environment

Total lives lost per year How Hazardous is Healthcare? (Leape)

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

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

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

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

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

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

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).

Budget Process Flow Courtesy of Huntington Hospital

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

CRC database Courtesy of Huntington Hospital

CRC database Courtesy of Huntington Hospital

CRC database Courtesy of Huntington Hospital

Force Ranking Process Strategic Operational Financial Clinical Regulatory

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

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

Force Ranking Process

CRC database report Courtesy of Huntington Hospital

Monthly Process Flow Courtesy of Huntington Hospital

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

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

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

Clinical Simulations Courtesy of Huntington Hospital & Mount Sinai Hospital

American Hospital Association U.S. Department of the Army Document TB MED 7, appendix B The manufacturer’s sales and service team Your own ideas Medical Assets Useful Life Resources

MAUDE Database

Sample Evaluation Tool

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

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

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

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

Thank you!

Contact Information Izabella Gieras, MS, MBA, CCE Director, Clinical Technology Huntington Memorial Hospital Pasadena, California, USA E.