Izabella Gieras, MS, MBA, CCE
Huntington Memorial Hospital , Pasadena, CA
October 22, 2015
Huntington Hospital
Courtesy of Huntington Hospital
Huntington Hospital
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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
Courtesy of Huntington Hospital
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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
Agenda
 Healthcare Environment
 Building the Business Case – Capital
Review Process
 Healthcare Technology Management
(HTM) Role in

Technology Management Cycle
 Benefits
Evolution of Healthcare - Past
http://www.experimentalor.org/news.html
Evolution of Healthcare - Present
http://w4.siemens.de/FuI/en/archiv/pof/heft2_01/artikel03/index.html
Evolution of Healthcare - Future
Healthcare Environment
Regulatory Requirements
Patient Environment
Total lives lost per year
How Hazardous is Healthcare?
(Leape)
www.patientsafetyinstitute.ca
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
Frost and Sullivan Study
11
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

Frost and Sullivan Study
12
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
*CRC: Capital Review Committee
 Cost effective expenditures
*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).
http://content.wellspan.org
Manager and director
Identifies the Capital needs
of their Department
Meet With Primary Resource
Leads
Budget Process Flow
See Section On Preparation
Requirements
The Quote obtained at this point is for
Pricing estimate and a new current
quote will be required before the
request is sent in
a) Clinical technology
b) Information Systems
c) Construction
d) Plant Operations
Obtain information and
Price Quote from vendor
Review and Negotiate
Request List
with VP
Capital Request can be entered from
Jan-Sept for next years budget
The operational review committee
consist of EMT and Decision Support
Request are entered into the
Capital Request Database
all request for the following year are
reviewed by the
Operational Review committee
The Decision to Approve, Disapprove,
or move the request
to the following year is made
based on operational needs
Budget Finalized
October
Capital Improvement
Budget Approved
November
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
 Clinical
 Operational
 Regulatory
 Financial
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
Capital Request
Received in Decision
Support
Quote Attached
and Current
Obtain VP Signature Before Sending
Request in for Processing
Return Request to
Requestor asking
for Updated Quote
No
Monthly Process Flow
Yes
Update Database
that request was received
and send to purchasing for
ROI quote analysis
Purchasing Pre
Sub-Committee
Processing
To Make Sure we are getting the best
price, MD Buyline and ECRI analysis are
requested, This Process Takes
Approximately 30 Days
Request received back from
Purchasing are put on the
ORC Sub-committee Agenda
Request are returned back to before the
ORC Sub-Committee Meeting
The ORC Sub-Committee
Reviews the request and
verifies that all documents
and pre-work are complete
Yes
The requestor is
notified by the subcommittee member
that has the issue
Issue with request?
No
When the request passes
the sub-committee
it is sent to the
operational review
committee
Operational Review
Committee
Approved Request?
Issue
resolved?
Yes
No
Requestor Is
notified
Yes
Request sent to
CFO for Signature
Request
Approved?
Copies of Request are
sent to General
Accounting for CIP
assignment
No
Courtesy of Huntington Hospital
Requestor
Notified
General
Accounting
Process
Additional Copies
are sent to the
Requestor,
Information systems,
facilities and
construction
All original request
are sent to
purchasing
Purchasing
Post Approval
processing
Technology Management Cycle
Needs assessment
ROI
Cost benefit
analysis
Education
Service delivery
Technology
Planning
Technology
Assessment
Technology
Implementation
Technology
Acquisition
Clinical & technical
assessment
HFE assessment
RFP
Negotiations
Life cycle analysis
Technology Planning
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 Assessment
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
Clinical Simulations
Courtesy of Huntington Hospital & Mount Sinai Hospital
Medical Assets Useful Life Resources
 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
MAUDE Database
www.fda.gov
Sample Evaluation Tool
Technology Acquisition
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 Implementation
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
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. izabella.gieras@huntingtonhospital.com