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COMPANY CONFIDENTIALISS Company Confidential
COMPLYING WITH CMS GUIDELINESJULY 2015
Barbara Maguire, CCE, MS, MBA
VP, Quality & Geisinger Clinical Engineering
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COMPANY CONFIDENTIAL
Background, Qualifications, and Capabilities Geisinger Health System
$4 billion, non-profit Healthcare Organization
Approximately 23,500 employees Headquarters in Danville, PA
ISS Solutions Geisinger Health System business Approximately 351 employees Headquarters in Langhorne, PA Clinical Technology Management
• Asset Lifecycle Management• Diagnostic Imaging• Specialty Medical Equipment• Biomedical Equipment
Information Tech Management• Contact Center Solutions• Integration and Support Services• Network Security Solutions• Managed Print Solutions
Clinical Engineering
Information Technology
COMPANY CONFIDENTIAL
ISS Solutions’ – Metrics
WHO WE ARE… 41 States throughout the United States
5 Operating Regions
386 Healthcare Clients
1333 Healthcare Clinics
Active Inventory Medical Devices
Geisinger Health System: 64,582
Non-Geisinger clients: 96,415
34 Clinical Engineers and Site Managers
138 Biomedical Techs and Imaging FSEs
COMPANY CONFIDENTIAL
ISS Solutions Corporate Parent – Geisinger Health SystemParent Corporate Entity: Geisinger Health System
Main Campus: Danville, Pennsylvania
Founded: 1915 by Abigail Geisinger
President and CEO: David T. Feinberg, M.D., M.B.A.
Revenue: $4 billion
Employees: Over 23,500
Market Served: Central and Northeastern Pennsylvania 3 Million Population 48 of Pennsylvania’s 67 Counties
Scope: Physician-led system 1,200-member multi-specialty group practice 9 hospital campuses 2 research centers +481,000-member health plan Estimated $7.7 billion positive impact on the
Pennsylvania economy
Patient Care Profile: Over 1.9 million Outpatient Visits per
Year Over 62,800 Admissions Over 49,900 Surgery Cases Over 1,700 Licensed Inpatient Beds 72% Average Occupancy Rate Over 185,700 Emergency Visits 2,195 Patient Air Transports
COMPANY CONFIDENTIAL
Independent and Objective Service Organization with Comprehensive Capabilities
40+ Years Delivering CE Services
64,500 Clinical Devices
1,740 Licensed Inpatient Beds
14 Clinical Engineers and Supervisors
59 Biomedical Technicians – AAMI Certifications, Military, and OEM Training
28 Imaging FSEs
State-of-the-Art Test Equipment
24 x 7 Coverage Capability
Robust On-line Maintenance and Program Management Documentation
Geisinger Clinical Engineering
COMPANY CONFIDENTIAL
Background• CMS Memo December 2013, Survey &
Certification Group :14-07, Hospital Maintenance Requirements
• Appendix A-Survey Protocol, Regs & Interpretive Guidelines
• TJC Revised Equipment Maintenance Standards EC.02.04.01 and EC.02.04.03, effective July 2014
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COMPANY CONFIDENTIAL
ISS Solutions PM Program-three tiers
• Equipment which must follow manufacturer guidelines.
• Identify high risk/critical equipment. May be on AEM, but surveyors will focus on this equipment.
• Chose to place all other equipment on an AEM (defined by existing Risk Assessment Policy)
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COMPANY CONFIDENTIAL
Must follow manufacturer’s recommendations for
Lasers Imaging/radiologic, including therapeutic
ultrasound Equipment types that are new to the
marketplace Must be able to identify this equipment in
your inventory-Risk Group
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COMPANY CONFIDENTIAL
ISS Response• Service contracts include language
requiring vendors to follow manufacturer guidelines
• You still must ask for documentation Contract/warranty T&M Third party or OEM
• Document in ISS AssetManager
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COMPANY CONFIDENTIAL
Maintenance Requirements
• All other equipment may be part of an AEM
• Hospitals must identify high/risk critical equipment
• Surveyors must focus their review on high risk/critical equipment
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COMPANY CONFIDENTIAL
ISS Response
• We have identified high risk(TJC)/critical(CMS) equipment
• We have chosen not to put this equipment on an AEM, but to follow the manufacturer guidelines.
• Implemented means to document this
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COMPANY CONFIDENTIAL
High Risk/Critical• Anesthesia units• Blood Pump/Perfusion Systems• Chest Compression system• Defibrillators (including AEDs)• Heart Lung by-pass (including Heater/cooler systems, blood
pumps, tubing clamps)• Ventilators• Ventricular Support Device• Robotic surgery device (new)• IABP (new)
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COMPANY CONFIDENTIAL
Identified High Risk Critical
• Identified using Risk Group• Create new reports to easily produce
inventory if requested
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COMPANY CONFIDENTIAL
Inventory-Maintenance Strategies
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Control Device Category Manuf Model : Model Desc Risk Group Serial # In Date Dept NameMaintenance Strategy
050075133 Anesthesia Unit Datex Ohmeda Aestiva 3000 High Risk/Critical AMRD00543 04/07/00 Anesthesia Units High Risk/Critical
050075563 Anesthesia Unit Datex Ohmeda Aestiva / 5 High Risk/Critical AMRL00108 02/21/07 Anesthesia Units High Risk/Critical
050075981 Anesthesia Unit Datex Ohmeda Aestiva / 5 High Risk/Critical AMRL00105 02/21/07 Anesthesia Units High Risk/Critical
050075999 Anesthesia Unit Datex Ohmeda Aestiva / 5 High Risk/Critical AMRL00107 02/21/07 Anesthesia Units High Risk/Critical
050166465 Anesthesia Unit Datex Ohmeda Aestiva / 5 High Risk/Critical AMRL00104 02/21/07 Anesthesia Units High Risk/Critical
050166546 Anesthesia Unit Datex Ohmeda Aestiva / 5 High Risk/Critical AMRL00106 02/21/07 Anesthesia Units High Risk/Critical
050166594 Anesthesia Unit Datex Ohmeda Aestiva / 5 High Risk/Critical AMRL00121 02/21/07 Anesthesia Units High Risk/Critical
050168549 Anesthesia Unit Datex Ohmeda Aespire High Risk/Critical APHS00265 04/01/13 Anesthesia Units High Risk/Critical
050168557 Anesthesia Unit Datex Ohmeda Aespire High Risk/Critical APH800266 04/01/13 Anesthesia Units High Risk/Critical
050204988 Anesthesia Unit Datex Ohmeda Aespire S/5 High Risk/Critical AMXJ00519 04/20/05 Anesthesia Units High Risk/Critical
050204989 Anesthesia Unit Datex Ohmeda Aespire S/5 High Risk/Critical AMXJ00520 04/20/05 Anesthesia Units High Risk/Critical
050204990 Anesthesia Unit Datex Ohmeda Aespire S/5 High Risk/Critical AMXJ00521 04/20/05 Anesthesia Units High Risk/Critical
050204999 Anesthesia Unit Datex Ohmeda Aespire S/5 High Risk/Critical AMXJ00518 04/20/05 Anesthesia Units High Risk/Critical
050205000 Anesthesia Unit Datex Ohmeda Aespire S/5 High Risk/Critical AMXJ00517 04/20/05 Anesthesia Units High Risk/Critical
050051462 Blood Pump Stockert/Cobe 10-65-00 : SIII High Risk/Critical 10S8313 08/01/12 Perfusion High Risk/Critical
050051463 Blood Pump Cobe 10-60-00 : SIII High Risk/Critical 10S5653 08/01/12 Perfusion High Risk/Critical
050051467 Blood Pump Stockert/Cobe 10-60-00 : SIII High Risk/Critical 10S4942 11/01/12 Perfusion High Risk/Critical
050051469 Blood Pump Stockert/Cobe 10-60-00 : SIII High Risk/Critical 10S5081 11/01/12 Perfusion High Risk/Critical
050051478 Blood Pump Stockert/Cobe 10-60-00 : SIII High Risk/Critical 10S4852 11/01/12 Perfusion High Risk/Critical
050051479 Blood Pump Cobe 10-60-00 : SIII High Risk/Critical 10S5082 08/01/12 Perfusion High Risk/Critical
GCMC GCMC
COMPANY CONFIDENTIAL
Documenting PMs follow Mfr Guidelines• To standardize documentation, PM Procedures for all
Life Support/Critical Equipment, lasers and imaging will include a PM Checklist.
• There is a required Pass/Fail question “PM was performed per manufacturers specifications”.
• The technician must follow the manufacturer recommended procedure for maintenance and document it in the work order by attaching the completed checklist or pasting the steps into the work order notes.
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COMPANY CONFIDENTIAL
Access to Manufacturer Procedures
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• Manufacturers service manuals should be available at the facility which owns the device.
• Manufacturers service documentation will also be attached to the model record by ISS AssetManager Team.
• This can be viewed/printed/downloaded from ISS AssetManager.
COMPANY CONFIDENTIAL
Manufacturer Procedures in ISS AssetManager
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• Manufacturers PM Procedures attached to the Model record.
COMPANY CONFIDENTIAL
Manufacturer Procedures in ISS AssetManager
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• Manufacturers PM Procedures can be viewed/printed/saved.
COMPANY CONFIDENTIAL
Justification for Defibs• Reviewed extensive steps required by Defib
manufacturers.• Analyzed 479 repairs over three year period. Used
ISS AssetManager to export data on all repairs, had to review Notes.
• None of the repairs could have been prevented by manufacturer PM
• Concluded ISS PM Procedure in place was effective
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COMPANY CONFIDENTIAL
Scoring with Repair Data
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Global Data Facility Interval Data Risk Assessment Data
Device CategoryTotal
Device
Global Dev
Inventory Total
Global Work Order
Total over 3 year period
Global Repair
Rate Per Year
Average Global Repair
Rate
Total Devices
with Repair Component
Work Order Total
Repair Rate FCT USE EXP
Total Score
Recommended Interval
Defibrillator/Monitor 55 883 1678 0.6334 0.2655 129 46 0.3566 5 5 1 11 SemiannualCapnograph 3 93 32 0.1147 0.2655 3 1 0.1147 3 3 1 7 AnnualPatient Warmer 73 869 383 0.1469 0.2655 206 42 0.2039 2 2 5 9 AnnualPulse Oximeter 38 1774 931 0.1749 0.2655 157 43 0.2739 2 2 5 9 AnnualScale, Patient 6 385 132 0.1143 0.2655 35 5 0.1429 3 3 5 11 SemiannualScalpel, Harmonic 2 61 51 0.2787 0.2655 8 0 0.0000 4 4 1 9 AnnualSpirometer 1 62 15 0.0806 0.2655 2 3 0.0806 3 3 1 7 Annual
Equipment Data
COMPANY CONFIDENTIAL
Annual Review of MEMP
• Include review of effectiveness of PM Program
• Added Repair Fault Code ‘P-PM Preventable’
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COMPANY CONFIDENTIAL
Next Steps• Verify you have access to manufacturer guidelines for
all devices, especially high risk/critical• Confirming Techs are folllowing mfr guidelines for all
imaging, lasers and high risk/critical devices• Conduct self-audits• Follow-up with all vendors (OEM and third party) that
they are performing PMs according to mfr guidelines and get documentation from them.
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