We Want an ECLS Program Where to Start? Regulations, Volumes, - PowerPoint PPT Presentation

We Want an ECLS Program –Where to Start? Regulations, Volumes, Staffing Needs Thomas Tribble, BA, CST Mechanical Circulatory Support Coordinator University of Kentucky

Faculty Disclosure • None

Educational Need/Practice Gap • A major practice gap exists in the availability of ECLS programs. There is an increase in presentation of patients with life- threatening conditions requiring ECLS. To ensure that a hospital is able to effectively treat these patients, it is important to be aware of the requirements necessary to start a program.

Objectives Upon completion of this educational activity, you will be able to: 1. Discuss the process of establishing an ECLS program. 2. Review staffing and training requirements for a new program.

Expected Outcome • What is the desired change/result in practice resulting from this educational intervention? • The desired change/result in practice is to be cognizant of the organization, staffing, training and regulations needed to start an operational ECLS program.

ECLS Program Expansion American Journal of Respiratory and Critical Care Medicine Vol. 190, No.5 2014

US ECLS Grow th Technological advancements Increased Expanded Awareness of Early applications ECMO Benefits

US ELSO Center Grow th 2017 – 206 Centers 6,000 reported cases 156% Increase in Cases Since 2010

ECMO Center Guidelines 2014

Strategic Planning – Steering Committee Hospital Administrator Nursing Physician Perfusionist Administrator Champion Financial Partner

Strategic Planning – Program Goal • ECLS Initiation Center • Stabilize and Transfer 1 • ECLS Center (Low Volume) • Limited infrastructure 2 • Short term Support • Regional Center (High Volume) • Advanced Therapy capabilities • Long Term Support 3 • Transport Team

Strategic Planning Evaluation Implementation Data Collection QAPI Staff Education Program Clinical reviews Didactic Development Measuring outcomes Staff training Reporting Data Wetlabs Staffing Model First Patient Protocol Development Steering Group Space allocation Physician Coverage Key Stakeholders Clinical Support Infrastructure Business Plan Equipment assessment

Strategic Planning: ECLS Volume Projections Utilizing this methodology an estimated 110 annual discharges would be projected as potential incremental ECMO patients. Assume 50% are an ECMO candidate. 55 Total Potential ECMO Patients

ECLS Core Leadership Team • Program oversight ECLS • Clinical Management Director • Protocol Development • Staff Education • Data Management ECLS Coordinator • Equipment Management • ECLS Clinical Support Perfusionist • Technical Consultation

Define Clinical Expectations • Patient Selection • Clear inclusion and exclusion Criteria • Consider • Age • Weight • Co-morbidities • ECLS Initiation locations • Surgery vs. Cathlab • ICU vs. Emergency Room

Multidisciplinary Support ADDITIONAL SUPPORT: Physician Radiology Nephrology Neurology Perfusion Nursing Nutrition Occupational Therapy Physical Therapy ECLS Pastoral Services Patient Palliative Care Surgery Infectious Disease Respiratory & Therapy Cathla b Pharmacy & Laboratory

Background: ECMO Resource Unit Impact FYTD 2016 February Resource Group Adult Peds Pharmacy IV Therapy 8,527 5,619 14,000 Pharmacy Labor 1,239 1,142 Laboratory 1,057 1,521 12,000 Med. Surg. Supplies 797 1,708 797 Respiratory 284 279 1,057 Physical Therapy 84 45 10,000 OR Services (incl Labor/Del) 59 20 1,239 1,708 Blood 39 49 8,000 Other Ancillary Services 39 32 1,521 Units X-Ray 36 39 1,142 6,000 Anesthesia 33 21 ICU 26 24 8,527 Other Accommodations 17 25 4,000 Other Spec Dx Svcs 13 19 5,619 Dialysis 11 14 2,000 Other Cardiac Services 7 20 Other Surgical Services 6 3 - Miscellaneous 5 60 Adult Peds EKG/Telemetry 5 4 Pharmacy IV Therapy Pharmacy Labor Laboratory Med. Surg. Supplies Respiratory Physical Therapy Routine Accommodations 4 5 OR Services (incl Labor/Del) Blood Other Ancillary Services CT/MRI 3 2 X-Ray Anesthesia ICU Other Accommodations Other Spec Dx Svcs Dialysis Nuclear Medicine 2 - Other Cardiac Services Other Surgical Services Miscellaneous Other Diagnostic Imaging 2 7 EKG/Telemetry Routine Accommodations CT/MRI Nuclear Medicine Other Diagnostic Imaging Transplantation Transplantation 1 1 10/25/2018 17

Equipment • Perfusion Equipment and Disposable Supplies ECLS Equipment Maquet Abbott Maquet Medtronic Assessment Cardiohelp Centrimag Rotoflow 560 Console & Motor $125,000 $28,000 $55,000 $36,700 Blood Pump $13,275 $10,600 $360 $154 Oxygenator n/a $1,250 $1,250 $1,250 Tubing Pack n/a $340 $340 $340 Total Circuit Cost $13,275 $12,190 $1,950 $1,744 Manufacturers' list Pricing 2018

Background: Current Inventory Equipment Remaining Replace Manufacturer Description Notes Purchase Life Life (YY:MM) Year Maquet CardioHelp Peds Only 11/2015 8 07:10 2023 Maquet CardioHelp 11/2015 8 07:10 2023 Maquet CardioHelp 11/2015 8 07:10 2023 Maquet CardioHelp 1/2015 8 06:12 2023 Maquet CardioHelp 1/2015 8 06:12 2023 1 st Generation Thoratec Centrimag 11/2013 8 05:10 2021 2 nd Generation Thoratec Centrimag 11/2013 8 05:10 2021 2 nd Generation Thoratec Centrimag 11/2013 8 05:10 2021 Maquet RotorFlow 4/2010 8 02:03 2018 Maquet RotorFlow 4/2010 8 02:03 2018 Maquet RotorFlow 4/2010 8 02:03 2018 Stockhert S5 Roller Peds Only 5/2008 8 00:04 2016 Stockhert S5 Roller Peds Only 5/2008 8 00:04 2016 Thoratec Centrimag 1 st Generation 12/2007 8 Fully Depreciated 2015 1 st Generation Thoratec Centrimag 12/2007 8 Fully Depreciated 2015 Replaced by CardioHelp purchase from 11/2015

Equipment: Additional • Heater /Cooler Exchangers and Warmers • Capable of inflow temps up to 38 Celsius • Portable • Limited options for US market

Equipment: External System Monitors CDI Blood Parameter Monitoring Patient Monitor Systems System

Equipment: Additional • Hemochron • POC Monitors ACTs • Epoc • ABG, POC Chemistry Analyzer • I-Stat (Abbott) • ABG, POC Chemistry Analyzer

Equipment: Disposables • Tubing Packs • Roughly $ 110,000 for in • HLS Kits house supplies (par level 4) • Custom Hospital Packs • Cannula • Designated secure storage • Arterial area for sterile inventory • Venous • Surgery Suite • Double Lumen • Distal Perfusion • ICU • Cathlab • Connectors • Appropriate sizes for circuit assembly and cannula connection

Staffing Service Models: Experienced Requires extensive Requires advanced ECLS Extensive Cross Limited Resource education Training High monitoring Moderate cost Low cost Fees

Staffing Model Comparisons ECMO Staffing Models Option 1 Option 2 Option 3 Option 4 Perfusion RN + Perfusion 2hr RN/RT w Perfusion Cost Only Rounds Offsite RT AVG Salary $130,000 $67,000 $67,000 $60,000 benefits N/A $18,765 $18,765 $18,765 Training N/A $3,000 $3,000 $3,000 FTE Contract 0.9 0.9 0.9 Ext Hr charges N/A 1,265/Day N/A N/A Total Cost $130,000 $88,765 $88,765 $81,765

Roles and Responsibilities ECLS Specialist Perfusion Team • Maintain 24/7 Bedside Coverage • Maintain 24/7 Call for initiation and • Document all circuit parameters emergent interventions • Circuit Prime • Daily a.m. rounds • Titrate ECLS Sweep and Fio2 • Available for Circuit change-outs • Collection and interpret Patient Abgs • Available for Surgical procedures • Collection Pre and Post Membrane gases • Inter-hospital Transports • Provide emergent troubleshooting Interventions • Provide Intra-hospital transport

Education and Training Education Quality Safety Physicians Didactic lectures Simulation Training Wetlabs Competency Testing ECLS PI Specialist Research Nursing

ECLS Specialist Training Timeline

Staff Training Continuing Initial Annual • External vs Internal • Simulation Drills • Cognitive Testing Trainers • Theoretical • Performance • Onsite vs Offsite Evaluation • Practical • Didactic assessments • National vs Regional • Wetlabs Conferences

Staff Training Didactic Wetlabs Bedside Testing • Management • Written Exam • Water Drill • New Basics Simulation • Simulation Specialist • 24 to 36 hrs assessment • 8-12 hrs • 16 – 32 hrs monitoring

Quality Metrics • Data Collection • Research • Outcome Analysis • Case Studies • ELSO Registry • Monthly Case reviews • Case submissions • Quarterly M&M reviews • Quality Initiatives • Abstract submissions • Benchmarking • Collaborations • Cost reductions • Publications