Clinical Engineers Can Make Healthcare Safer
An Efficient and Cost-Effective Approach to Medical Equipment
Assessments and AcquisitionsIzabella Gieras, MS, MBA, CCEHuntington
Memorial Hospital , Pasadena, CAOctober 22, 2015
Courtesy of Huntington Hospital
Huntington Hospital
2Huntington Hospital625 licensed bedsBariatric & Stroke
CenterMagnet Recognition3 Davinci Robotic Systems18 Operating Rooms
(4 MIS suites)Skills Labs5 Cath Labs & IR Suites9000 medical
devices
280 applications450 servers with 200+ TB storage1000+ wireless
access points4500+ end user computing devices300+ hospital owned
smart phones60 Clinical & Information Technology employees
Courtesy of Huntington Hospital3Agenda Healthcare Environment
Building the Business Case Capital Review Process Healthcare
Technology Management (HTM) Role in
Technology Management Cycle Benefits
4Healthcare EnvironmentEvolution of Healthcare - Past
Evolution of Healthcare - Present
http://www.experimentalor.org/news.html
Evolution of Healthcare - Future
http://w4.siemens.de/FuI/en/archiv/pof/heft2_01/artikel03/index.html
Regulatory Requirements
Healthcare Environment
Patient Environment
www.patientsafetyinstitute.caTotal lives lost per yearHow
Hazardous is Healthcare?(Leape)10Medical ErrorsEstimated 8-12% of
patients admitted to the hospital experience adverse events while
receiving healthcareAdverse events include:Healthcare associated
infectionsMedication related errorsSurgical errorsMedical device
failuresErrors in diagnosisFailure to act on results from tests
11 Frost and Sullivan Study
11Medical Errors cont. Medical device failures account for 13%
of all type of adverse eventsDevice failure types:Product
defectsDesign defectManufacturing defectMisuse/abuse
12 Frost and Sullivan Study
12 Medical Errors cont.100,000 medical device reports per year
received by the FDAMore than 1/3 involve use errorsUse error often
linked to design flaws
44% of medical device recalls due to design problemsReported by
the FDA Recall Study
ECRI Top 10 Health Technology Hazards1. Alarm hazards:
Inadequate alarm configuration policies and practices2. Data
integrity: Incorrect or missing data in electronic health records
and other health IT systems3. Mix-up of IV lines leading to
misadministration of drugs and solutions4. Inadequate reprocessing
of endoscopes and surgical instruments 5. Ventilator disconnections
not caught because of mis-set or missed alarms6. Patient-handling
device use errors and device failures7. Dose creep: Unnoticed
variations in diagnostic radiation exposures8. Robotic surgery:
Complications due to insufficient training9. Cybersecurity:
Insufficient protections for medical devices and systems10.
Overwhelmed recall and safety alert management programs
Building the Business Case
16Business CaseStreamline the capital acquisition and assessment
processCRC* and ORC* Develop a multidisciplinary capital medical
equipment processThe TJC compliance Evaluation process for safety
and efficacy of medical equipmentControl the capital equipment
expenditureRoutine capital projectsStrategic capital
projectsContingency allocationsCost effective expenditures
*CRC: Capital Review Committee*ORC: Operational Review
CommitteeCapital Review ProcessCapital Review Committee
(CRC)Charter. CRC is responsible for reviewing the hospitals
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 HospitalCapital 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
Budget Process FlowCourtesy of Huntington HospitalBudget
Planning & HTM Member of CRC and ORC committeesTechnology
management cycleShort and long term replacement plansBudgetary
quote requestSubmitting requests to the CRC databaseReview
Maintenance, IT, Construction, Facilities needsMeeting with
directors to prioritize requestsForce ranking
CRC databaseCourtesy of Huntington Hospital
CRC databaseCourtesy of Huntington Hospital
CRC databaseCourtesy of Huntington Hospital
Force Ranking ProcessStrategicOperationalFinancial
ClinicalRegulatory
Force Ranking Process
None = 0, Low =1, Medium=3, High=9Force 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 reportCourtesy of Huntington Hospital
SAMPLE
Monthly Process FlowCourtesy of Huntington Hospital Healthcare
Technology Management RoleTechnology AssessmentTechnology
ImplementationTechnology AcquisitionTechnology PlanningSafetyNeeds
assessmentROICost benefit analysisClinical & technical
assessmentHFE assessmentRFP
NegotiationsLife cycle analysis
EducationService delivery
Technology Management Cycle Technology PlanningPerform needs
assessmentConsider utilities, cabling, and other infrastructure
needsConsider labor resources needs and system integrationEMR, IT
applications, other medical equipment systemsConsider any new
regulatory changes/impactConsider medical equipment that is
standard, well supported, reliable, not at the end of its life
cycleDevelop a multi year replacement plan - focus on major medical
equipment categoriesComplete an ROI and cost benefit
analysisConsider alternatives
Technology PlanningTechnology AssessmentRequest for Proposal
(RFP) projects over $20,000ECRI RFP and RFI templatesECRI RFP
assessmentVendor resourcesInternetVendor presentationsClinical
evaluationsNo charge PO, eval agreement, service reports, etcHuman
Factors evaluations usability testing, simulationsIT and Security
assessmentsSite visitsReview of recalls, hazard alerts (FDA MAUDE
database)Confirm FDA clearanceCheck references
Technology Assessment
Clinical Simulations
Courtesy of Huntington Hospital & Mount Sinai
HospitalAmerican Hospital
Associationhttp://www.ahaonlinestore.com
U.S. Department of the ArmyDocument TB MED 7, appendix
Bhttp://www.army.mil/usapa/med/
The manufacturers sales and service team
Your own ideas
Medical Assets Useful Life Resources
Replacement life cycle document, make copies from the book MAUDE
Database
www.fda.gov Sample Evaluation Tool
Technology AcquisitionVendor selectionLife cycle analysis
include all costs, supplies, maintenance, labor, testing equipment,
training, etcNegotiationsClinical and technical trainingTesting
equipmentPm during the warranty periodExtended warranties/service
contractsNo cost deliveryPayment upon clinical acceptanceLatest
technology delivered especially if delays on the projectOperator
and service manuals at no cost
Technology AcquisitionTechnology ImplementationAssess physical
space, structural, shielding, electrical, heating, cooling &
plumbingAfter delivery and before installation, inspect for
damageConfirm all components have been receivedPerform incoming
inspectionsInstallation/service documentationIf manufacturer is
performing the installation, monitor its progress and document any
difficultiesCoordinate clinical and technical trainingFinal
acceptance & final payment
Technology ImplementationRisk Management and Quality
ImprovementWarranty periodDowntime, failures, & problems may
extend warranty or be cause for returnMaintenance and mode of
communicationPrimary/Secondary FSE assignmentsUser acceptance and
satisfactionPost-warrantyMaintenanceVendor relationsPatient
outcomes Incident investigationsRecalls and hazard alertsStrategic
replacement
At end of life, do it all over again!
42BenefitsCost-effective strategic technology planning and
technology assessmentSafe and efficacious patient and user
environmentPositive patient outcomesPatient and user
satisfactionMaximized productivity of technology and
staffCost-efficient technology maintenance
Thank you!Contact InformationIzabella Gieras, MS, MBA,
CCEDirector, Clinical TechnologyHuntington Memorial
HospitalPasadena, California, USAE.
[email protected]
Request are entered into the Capital Request DatabaseCapital
Request can be entered from Jan-Sept for next years budgetManager
and director Identifies the Capital needs of their DepartmentMeet
With Primary Resource Leads
a) Clinical technologyb) Information Systemsc) Constructiond)
Plant OperationsReview and Negotiate Request Listwith VP Obtain
information and Price Quote from vendor all request for the
following year are reviewed by the Operational Review committeeThe
operational review committee consist of EMT and Decision SupportThe
Decision to Approve, Disapprove, or move the requestto the
following year is madebased on operational needsBudget
FinalizedOctoberCapital Improvement Budget ApprovedNovemberSee
Section On Preparation RequirementsThe Quote obtained at this point
is forPricing estimate and a new current quote will be required
before the request is sent inCapital RequestReceived in Decision
SupportQuote Attached and CurrentUpdate Databasethat request was
received and send to purchasing for ROI quote analysisReturn
Request to Requestor asking for Updated QuotePurchasing Pre
Sub-Committee ProcessingRequest received back from Purchasing are
put on the ORC Sub-committee AgendaThe ORC Sub-Committee Reviews
the request and verifies that all documents and pre-work are
complete Issue with request?The requestor is notified by the
sub-committee member that has the issueIssue resolved?When the
request passes the sub-committee it is sent to the operational
review committeeNoYesYesNoYesOperational Review Committee Approved
Request?Request sent to CFO for SignatureRequestor Is
notifiedNoYesRequest Approved?Requestor NotifiedNoCopies of Request
are sent to General Accounting for CIP assignmentAdditional Copies
are sent to the Requestor, Information systems, facilities and
constructionAll original request are sent to purchasingGeneral
Accounting ProcessPurchasing Post Approval processingObtain VP
Signature Before Sending Request in for ProcessingTo Make Sure we
are getting the best price, MD Buyline and ECRI analysis are
requested, This Process Takes Approximately 30 Days Request are
returned back to before the ORC Sub-Committee Meeting
