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

• 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.

Educational Need/Practice Gap

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.

Objectives

• 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.

Expected Outcome

ECLS Program Expansion

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

Technological advancements

Increased Awareness of Early

ECMO Benefits Expanded

applications

US ECLS Growth

US ELSO Center Growth

2017 – 206 Centers

6,000 reported cases

156% Increase in Cases Since 2010

2014

ECMO Center Guidelines

Physician Champion

Hospital Administrator

Nursing Administrator

Financial Partner

Perfusionist

Strategic Planning – Steering Committee

1 • ECLS Initiation Center

• Stabilize and Transfer

2 • ECLS Center (Low Volume)

• Limited infrastructure • Short term Support

3

• Regional Center (High Volume) • Advanced Therapy capabilities • Long Term Support • Transport Team

Strategic Planning – Program Goal

Steering Group Key Stakeholders Infrastructure Business Plan

Program Development Staffing Model Protocol Development Space allocation Physician Coverage Clinical Support Equipment assessment

Implementation Staff Education Didactic Staff training Wetlabs First Patient

Strategic Planning

Evaluation Data Collection QAPI Clinical reviews Measuring outcomes Reporting Data

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 Director

ECLS Coordinator

Perfusionist

• Program oversight • Clinical Management • Protocol Development

• Staff Education • Data Management • Equipment Management

• ECLS Clinical Support • Technical Consultation

ECLS Core Leadership Team

• Patient Selection • Clear inclusion and exclusion Criteria • Consider

• Age • Weight • Co-morbidities

• ECLS Initiation locations • Surgery vs. Cathlab • ICU vs. Emergency Room

Define Clinical Expectations

ECLS Patient

Physician

Nursing

Respiratory Therapy

Pharmacy &

Laboratory

Surgery &

Cathlab

Perfusion

Multidisciplinary Support

ADDITIONAL SUPPORT: Radiology Nephrology Neurology Nutrition Occupational Therapy Physical Therapy Pastoral Services Palliative Care Infectious Disease

Background: ECMO Resource Unit Impact FYTD 2016 February

10/25/2018 17

8,527

5,619

1,239

1,142

1,057

1,521

797

1,708

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

Adult Peds

Uni

ts

Pharmacy IV Therapy Pharmacy Labor LaboratoryMed. Surg. Supplies Respiratory Physical TherapyOR Services (incl Labor/Del) Blood Other Ancillary ServicesX-Ray Anesthesia ICUOther Accommodations Other Spec Dx Svcs DialysisOther Cardiac Services Other Surgical Services MiscellaneousEKG/Telemetry Routine Accommodations CT/MRINuclear Medicine Other Diagnostic Imaging Transplantation

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

• Perfusion Equipment and Disposable Supplies

Equipment

ECLS Equipment Assessment

Maquet Cardiohelp

Abbott Centrimag

Maquet Rotoflow

Medtronic 560

Console & Motor $125,000 $28,000 $55,000 $36,700Blood Pump $13,275 $10,600 $360 $154Oxygenator n/a $1,250 $1,250 $1,250Tubing Pack n/a $340 $340 $340

Total Circuit Cost $13,275 $12,190 $1,950 $1,744Manufacturers' list Pricing 2018

Background: Current Inventory Manufacturer

Equipment Description Notes Purchase Life

Remaining Life (YY:MM)

Replace 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

Thoratec Centrimag 1st Generation 11/2013 8 05:10 2021

Thoratec Centrimag 2nd Generation 11/2013 8 05:10 2021

Thoratec Centrimag 2nd Generation 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 1st Generation 12/2007 8 Fully Depreciated 2015

Thoratec Centrimag 1st Generation 12/2007 8 Fully Depreciated 2015

Replaced by CardioHelp purchase from 11/2015

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

Equipment: Additional

Equipment: External System Monitors

CDI Blood Parameter Monitoring System Patient Monitor Systems

• Hemochron • POC Monitors ACTs

• Epoc • ABG, POC Chemistry Analyzer

• I-Stat (Abbott)

• ABG, POC Chemistry Analyzer

Equipment: Additional

• Roughly $ 110,000 for in house supplies (par level 4)

• Designated secure storage area for sterile inventory

• Surgery Suite • ICU • Cathlab

• Tubing Packs • HLS Kits • Custom Hospital Packs

• Cannula • Arterial • Venous • Double Lumen • Distal Perfusion

• Connectors • Appropriate sizes for circuit

assembly and cannula connection

Equipment: Disposables

Experienced Limited Resource

High monitoring

Fees

Requires extensive advanced ECLS

education

Moderate cost

Requires Extensive Cross

Training

Low cost

Staffing Service Models:

Staffing Model Comparisons

Option 1 Option 2 Option 3 Option 4

CostPerfusion

OnlyRN + Perfusion 2hr

RoundsRN/RT w Perfusion

Offsite RTAVG Salary $130,000 $67,000 $67,000 $60,000benefits N/A $18,765 $18,765 $18,765Training N/A $3,000 $3,000 $3,000FTE Contract 0.9 0.9 0.9Ext Hr charges N/A 1,265/Day N/A N/ATotal Cost $130,000 $88,765 $88,765 $81,765

ECMO Staffing Models

Roles and Responsibilities

ECLS Specialist • Maintain 24/7 Bedside Coverage • Document all circuit parameters • Circuit Prime • Titrate ECLS Sweep and Fio2 • Collection and interpret Patient Abgs • Collection Pre and Post Membrane

gases • Provide emergent troubleshooting

Interventions • Provide Intra-hospital transport

Perfusion Team • Maintain 24/7 Call for initiation and

emergent interventions • Daily a.m. rounds • Available for Circuit change-outs • Available for Surgical procedures • Inter-hospital Transports

Education and Training

Education

Physicians

ECLS Specialist

Nursing

Quality

Safety

PI

Research

Didactic lectures Simulation Training Wetlabs Competency Testing

ECLS Specialist Training Timeline

Initial

• External vs Internal Trainers

• Onsite vs Offsite • Didactic • Wetlabs

Continuing • Simulation Drills • Theoretical • Practical

assessments

Annual

• Cognitive Testing • Performance

Evaluation • National vs

Regional Conferences

Staff Training

Didactic • Management

Basics • 24 to 36 hrs

Wetlabs • Water Drill

Simulation • 8-12 hrs

Bedside • New

Specialist • 16 – 32 hrs

monitoring

Testing • Written Exam • Simulation

assessment

Staff Training

• Data Collection • Outcome Analysis • ELSO Registry • Case submissions

• Quality Initiatives • Benchmarking • Cost reductions

• Research • Case Studies

• Monthly Case reviews • Quarterly M&M reviews

• Abstract submissions • Collaborations • Publications

Quality Metrics

Benchmarking: • ELSO now provides

means to evaluate specific peer groups

• Mortality by Pt cohort • By Diagnoses • ECLS Modality • Run Times

Quality Assessment

ELSO Arbometrix Quality Reporting Platform

• Identify a Physician Champion • Create Core Steering Committee • Consider Institutional Mission Goals • Assess infrastructure limitations • Select Clinical team and Staffing model • Formalize and Standardize Protocols • Develop Quality and Benchmarking metrics • Keep Abreast of emerging ECLS developments

Conclusion

UK Medical Center MCS Department 859-323-3517