ECMO Program Development

A successful ECMO program is a dynamic resource to a geological area. The medical center that appropriately provides ECLS adds life-saving value to the community. They have developed an ongoing program to maintain and sustain variations in patient flow, staffing capability and competency, along with evaluation of long term success for program implementation.

Careful evaluation and consideration is needed when adding an ECLS program to a hospital. A successful comprehensive program takes great effort, planning and resources to maintain a level of excellence needed to serve the community properly. The return on investment of an ECMO program for an institution can be complicated, thus taking a proactive and thoughtful approach to stepping into the ECMO world is essential.

Shadowing another ECMO center that will service similar patients is also beneficial in identifying how their program started, developed and is progressing to assist in the process of your program start. Review the suggested steps for creating and implementing a successful ECMO Program at your medical center below.

Service Identification

Perform a needs assessment that identifies patients who will utilize the service provided in the program. Program development should coincide with an associated program of service (examples include cardiac surgery, adult respiratory units, transplant programs, LVAD programs, pediatric cardiac surgery) or evaluation that an onside ECMO unit would benefit over transferring to an external center. Documentation of the cases for potential need is helpful to evaluate cost versus benefit. Putting together a plan that clearly displays this data is helpful when justifying implementation of a new program and can help administrative budgeting and planning. In addition to volume, processes and education also play important roles in consideration. According to ELSO, approximately 33% of current ECMO programs are low-volume centers that care for fewer than 6 cases annually. Achieving success with initial cases goes a long way to building confidence and buy in at the executive level.

Who is the Customer?

Identify who you will be servicing. Each medical center can answer this question differently based on the type of patients and specialties that they accommodate. One ECMO center may only service pediatric patients because they have a robust pediatric cardiac surgery department, while another center may only service adults who may potentially receive a heart or lung transplant. The ECMO program works in conjunction with other hospital services, so the need to identify this at the start is essential.

Build The Team

Create an ECLS steering committee to help identify key components of service and customer identification can help a program be successful. They can help identify how an ECLS program will best meet the needs of the organization and should include multidisciplinary members from all hospital departments that customers of the ECLS program will touch (nursing, pharmacy, physical therapy, physician, surgery, respiratory therapy, surgery, occupational therapy, hospital management, dietary,

education, management). As the program planning develops, it is helpful to identify a core team of people who will actually be taking care of the patient, meaning providing direct bedside care for the patient as well as the ECLS device. Their support, assistance in planning and buy-in is also important throughout the process. These individuals will help bring practical clarity to what is needed for successful program implementation and are an extra set of eyes and ears to help assist in the process. Engaging ECMO supporters and also skeptics addresses concerns head on in advance, rather than having a program derailed by those with disagreement about the project. Engage senior administration from the beginning by providing patient stories and hospital success programs is essential for support and buy-in.

A dedicated ECMO team needs to be created to support staff education, training and patient care. Team members include ECLS medical director, coordinator, specialists, medical team and primers. The “ELSO Guidelines for ECMO Centers” identifies all of the qualifications for these team members here.

Building the core ECMO Specialist team is best achieved prior to making the program operational. The ECLS program director is responsible for overall training and education, quality improvement, data verification and credentialing of physicians. The ECLS Coordinator should be a registered nurse or registered respiratory therapist with significant experience in critical care and is responsible for staff supervision, training, equipment maintenance and date collection. ELSO has created a guideline for, stating that the ECMO Specialist should have a strong critical care background with at least one year of experience. The ECMO Specialist needs to be trained and equipped to handle this new patient population and device. This takes time, education sessions, training with perfusion (if the program does not use a perfusionist for pump management), certification, wet labs and additional competency measures laid out in the education portion of this content to ensure excellent patient management. Identifying key leaders and people who are able to handle complex, difficult situations and think critically in emergency situations is essential when choosing an ECMO Specialist team.

In addition, a successful ECMO program requires a core group of ECMO trained physicians and surgeons. The approach of this may vary by institution, however understanding patient management while on ECLS is essential for successful outcomes and team morale.
In the event that your medical center has implemented an ECMO program without developing a core team, it is just as important to realign everyone into the process that will help achieve the best patient outcome outlined out in this section.

cardiohelp image.jpg — Equipment

Identify the type of equipment you will need. This will require collaboration from many disciplines to ensure all bases are covered. Equipment needs should match patient needs and connecting with the perfusion department of the medical center will help in the process. Policies and procedures for equipment management and maintenance must be made in conjunction with the biomedical engineering department. The purchasing department of the hospital must be involved from the start of program development to ensure appropriate equipment is readily available when needed.
A simplified list of equipment includes: cannula, oxygenator, blood pump, gas exchange devices (blender), heat exchanger, ECMO supply cart, backup equipment and pump.

Process Development

The complex processes of ECMO care require a high level of standardization to elevate the quality and safety level of individual providers to help facilitate positive patient outcomes. Every ECMO center needs a center-specific policy and procedure manual. This manual includes everything from who meets criteria for ECMO to directions for changing the oxygenator. The development of this is critical for the training and education of the new ECMO team. Standardized policies and procedures effectively prevent human error when caring for complex patients. New ECMO team members need to be fluent in center-specific

policies and practice ECMO procedures in simulations before caring for an ECMO patient. This helps prevent human error. The Institute of Medicine published a report on medical errors and patient safety. It highlighted the costly effects errors have on patient survival and approximately 70% of medical errors are associated with caregiver responsibility in the event. Quality improvement techniques can help a new ECLS program transform their processes by using proven techniques to design, test, and implement changes to improve human responses and decrease patient errors. Work standardization, visual aids, and checklists are helpful aids to assist caregivers in this environment.

Create the following to help the development of the program and team:

Policies and Procedures
Education Requirements
Competency and Validation Requirements
ECMO Specialist preceptor guide (view example here)
Pump setup checklist
Safety equipment checklist (view example here)
Cannulation and decannulation checklist
Pump/oxygenator system exchange checklist
Order sets for common procedures
Bedside shift report example (view example here)
Job descriptions for each position and role

Review and creation of scenerios with the steering committee during the initial phase of program development to identify potential strengths, weaknesses and competencies that will benefit or expand once the program is operational. A new center should benchmark with other ECMO centers and incorporate best practices into guidelines and policies during program development. Joining ELSO, reviewing the resources available through ECMO Resource and contributing data to the registry are helpful opportunities to benchmark their outcomes and complications with more experienced centers.

Registry

Creating a registry with ELSO for the medical center at the start of planning and development is beneficial. The quality reporting registry allows you to track your center’s performance across time and compare it to peer centers using metrics such as survival, major complications, minor complications and length of stay. It gives you the opportunity to identify areas of your performance where you excel and areas you may want to monitor your performance more closely. Data is risk adjusted to account for variations in patient populations and case complexity. Powered by ArborMetrix, you will receive real-time analytics and report that are HIPPA-compliant. This gives further opportunity to perform research and walk the path toward becoming a center of excellence.
View additional information and begin the ELSO Quality Reporting here.

Education

ECMO education can be challenging due to the complexities in an organization. It is nevertheless, essential to an ECMO Program and required for the care team to achieve before they can be considered qualified to deliver ECMO care. The ECMO team includes clinicians with responsibilities to the patient and/or the ECMO circuit. This includes the physician, surgeon, nurse, respiratory therapist, perfusionist and anyone else who will have any kind of involvement or responsibility for the patient undergoing ECLS therapy. Establishing an education program and maintaining competency is an in-depth process. It is recommended that each center develop its own training program based on their patient population, equipment, and assigned responsibilities of team members.
A comprehensive guide to training and education requirements is extensive and can be found here - locate “Center and Training Guidelines” and link to “ELSO Guidelines for Training and Continuing Education”.

The program should include an extensive didactic course that covers an comprehensive list of topics necessary to understand the entirety of ECMO management, training labs, water drills, high fidelity simulation. The ECMO Program education session should include verification of competency of all ECMO team members with a written test that includes critical thinking about decision making, prioritizing, trouble shooting, and responding to actual or potential events. Competency is additionally verified by assessing cognitive, technical and behavioral skills. Institutional certification of ECMO team members is achieved when performance criteria for clinical competency are fulfilled.

Curriculum to introduce critical care nurses to extracorporeal membrane oxygenation is a topic studied by Vanderbilt University Medical Center. Read the full article here.

Education resources for team members can be found on the Education page within this site here. Classes and coaching packages are also tailored to your organization that include ELSO standards and guidelines. Connect with our team to receive more information.