**8.1 Team members for transport**

Per the 2015 ELSO guidelines, team members will vary depending on the need to cannulate the patient [19]. An ECMO specialist physician is required in either case, as is an ECMO specialist and a transport RN/RT. If cannulation is required, and the ECMO specialist physician is unable to perform this, there may be the need to add a cannulating physician and a surgical assistant to the team. Each team member has specific roles that should be delineated and understood prior to deployment to the outlying facility.

A checklist, should include all the needed equipment for the return trip with the patient, and should be verified prior to departure.

The equipment recommended by ELSO includes [20]:



#### **Table 2.**

*Decision-making for ECMO transport options.*

Additional equipment recommended by 2015 ELSO to improve safety includes:


Of note, the requirements for voltage, current, and power for all equipment should be verified for the transport vehicle prior to departure and monitored throughout transport. An adequate oxygen source must also be available with sufficient reserve to support high-flow 100% oxygen delivery for the duration of the transport. Provisions must be made to adequately secure the equipment during transport—brackets, holders, straps, etc. should be tested prior to first-time transport and should be compliance with appropriate regulatory guidelines (i.e., Federal Aviation Administration for the United States) (**Table 2**).

No patient should be transported without a means of manually providing circuit flow in the event of an electrical pump failure or malfunction.

#### **9. Quality and outcomes**

As with all areas of medicine, the optimization of patient outcomes must be a priority. This concept is especially important in the context of developing and maintaining an ECMO/ECLS program. Many other disease therapies have an infrastructure for monitoring clinical outcomes and benchmarking them against peer groups, national, and even international programs. These infrastructures typically are in the form of voluntary registries and databases (although some might argue that participation is becoming less and less voluntary and more and more a

**43**

*Clinical and Administrative Steps to the ECMO Program Development*

requirement—especially are payor sources are starting link payments to participation and eventually outcomes in such programs). Examples of these types of programs include the Society for Thoracic Surgeons (STS) Outcomes database (https:// www.sts.org/registries-research-center/sts-national-database) and the American College of Cardiology National Cardiovascular Data Registry (ACC NCDR: https:// cvquality.acc.org/NCDR-Home). Both organizations also for submission of patient characteristic data, comorbidities, therapies performed, and outcomes with the goal of providing program (and sometimes provider) specific outcome data—often risk adjusted, therapy specific, and benchmarked against other programs with provided

summaries that can allow for continuous quality improvement initiatives.

Currently, the Extracorporeal Life Support Organization (ELSO) provides a mechanism for tracking and benchmarking outcomes for ECMO programs (https://www.elso.org/Home.aspx). The organization was founded in 1989 and is headquartered in Ann Arbor, Michigan, USA. While the organization serves many roles to assist ECMO providers and programs—voluntary membership allows for the submission of clinical program outcome data and in return, summary data are provided. The organization also provides access to clinical guidelines, discussion forums, announcements for relevant meetings, links to key publications and references, and overall serves as a hub for ECMO/ECLS-related activities. Membership is strongly encouraged and the organization claims international membership and

In addition to submitting clinical patient and outcome data for benchmarking to ELSO, programs should also establish a formal case presentation and review process. Much like traditional surgical "morbidity and mortality" reviews, given the high-acuity and resource intensive nature of ECMO, similar periodic reviews of institutional ECMO outcomes should also be reviewed. While the focus should not be in individual practices or decision-making, ideally, each case should be reviewed by the team in a non-judgmental fashion to explore for potential areas of opportunity. Likewise, while good outcomes should be discussion in the context of "what went right"—such cases should also serve as team learning opportunity for growth and improvement. Depending on the number of cases performed, such meetings should be held in a timely manner (monthly, quarterly, etc.) so that real-time assessments can be performed and the nuances of each case might still be relatively fresh in the minds of the providers. While the structure of such meetings can be variable, many "quality" meetings typically will only involve key stakeholders—both providers (i.e. physicians, ECMO specialists, perfusionists, etc.) and appropriate administrators. The benefit of having meetings limited is that there is then the opportunity for open, honest, and transparent conversations—either on a case-by-case basis or from a programmatic standpoint—in a manner that can and should be protected from legal disclosure under the umbrella of a formal peer-review or quality improvement initiative. Appropriate protections of patient data and provider involvement

Likewise, summary data of program outcomes—such as the number of cases, types of cases, and overall outcomes should be actively tracked in real-time and made available to institutional leadership as a gauge of program growth and success. Institutional leadership/administration should also be able to provide financial data

*DOI: http://dx.doi.org/10.5772/intechopen.84838*

helps coordinate worldwide activities.

must be maintained and established from the onset.

**9.1 Role of ELSO**

**9.2 Interval reviews**

*Clinical and Administrative Steps to the ECMO Program Development DOI: http://dx.doi.org/10.5772/intechopen.84838*

requirement—especially are payor sources are starting link payments to participation and eventually outcomes in such programs). Examples of these types of programs include the Society for Thoracic Surgeons (STS) Outcomes database (https:// www.sts.org/registries-research-center/sts-national-database) and the American College of Cardiology National Cardiovascular Data Registry (ACC NCDR: https:// cvquality.acc.org/NCDR-Home). Both organizations also for submission of patient characteristic data, comorbidities, therapies performed, and outcomes with the goal of providing program (and sometimes provider) specific outcome data—often risk adjusted, therapy specific, and benchmarked against other programs with provided summaries that can allow for continuous quality improvement initiatives.

#### **9.1 Role of ELSO**

*Advances in Extracorporeal Membrane Oxygenation - Volume 3*

3.Number of team embers 4.Ease of loading equipment 5.Unlimited weight

2.Ease of loading equipment

2.Number of team members

**Method of transport**

**Table 2.**

Ground 1.Lowest cost

Helicopter 1.Speed

Fixed wing 1.Speed

*Decision-making for ECMO transport options.*

2.Least noise

3.Limited weight

3.Limited weight

patient and blood return to the patient

Additional equipment recommended by 2015 ELSO to improve safety includes:

**Advantages Disadvantages Distance for** 

transport

members 2.Noise 3.Higher cost

1.Costly

1.Shortest ideal distance for

1.Least number of team

2.Can be difficult to load equipment 3.Noise

**transport**

Up to 300 miles

Up to 450 miles

Unlimited

1.System for servo-regulation of flow to balance venous drainage rate from the

2.Blood flow rate monitor (may be internal or external to the blood circuit)

hemoglobin (may be internal or external to the blood circuit)

5.Bubble detector with or without automatic pump regulation function

Of note, the requirements for voltage, current, and power for all equipment should be verified for the transport vehicle prior to departure and monitored throughout transport. An adequate oxygen source must also be available with sufficient reserve to support high-flow 100% oxygen delivery for the duration of the transport. Provisions must be made to adequately secure the equipment during transport—brackets, holders, straps, etc. should be tested prior to first-time transport and should be compliance with appropriate regulatory guidelines (i.e.,

No patient should be transported without a means of manually providing circuit

As with all areas of medicine, the optimization of patient outcomes must be a priority. This concept is especially important in the context of developing and maintaining an ECMO/ECLS program. Many other disease therapies have an infrastructure for monitoring clinical outcomes and benchmarking them against peer groups, national, and even international programs. These infrastructures typically are in the form of voluntary registries and databases (although some might argue that participation is becoming less and less voluntary and more and more a

4.Capacitance "bladder" incorporated into the circuit

Federal Aviation Administration for the United States) (**Table 2**).

flow in the event of an electrical pump failure or malfunction.

3.Monitor(s) for circuit blood temperature, blood gas, oxygen saturation, and

**42**

**9. Quality and outcomes**

Currently, the Extracorporeal Life Support Organization (ELSO) provides a mechanism for tracking and benchmarking outcomes for ECMO programs (https://www.elso.org/Home.aspx). The organization was founded in 1989 and is headquartered in Ann Arbor, Michigan, USA. While the organization serves many roles to assist ECMO providers and programs—voluntary membership allows for the submission of clinical program outcome data and in return, summary data are provided. The organization also provides access to clinical guidelines, discussion forums, announcements for relevant meetings, links to key publications and references, and overall serves as a hub for ECMO/ECLS-related activities. Membership is strongly encouraged and the organization claims international membership and helps coordinate worldwide activities.

#### **9.2 Interval reviews**

In addition to submitting clinical patient and outcome data for benchmarking to ELSO, programs should also establish a formal case presentation and review process. Much like traditional surgical "morbidity and mortality" reviews, given the high-acuity and resource intensive nature of ECMO, similar periodic reviews of institutional ECMO outcomes should also be reviewed. While the focus should not be in individual practices or decision-making, ideally, each case should be reviewed by the team in a non-judgmental fashion to explore for potential areas of opportunity. Likewise, while good outcomes should be discussion in the context of "what went right"—such cases should also serve as team learning opportunity for growth and improvement. Depending on the number of cases performed, such meetings should be held in a timely manner (monthly, quarterly, etc.) so that real-time assessments can be performed and the nuances of each case might still be relatively fresh in the minds of the providers. While the structure of such meetings can be variable, many "quality" meetings typically will only involve key stakeholders—both providers (i.e. physicians, ECMO specialists, perfusionists, etc.) and appropriate administrators. The benefit of having meetings limited is that there is then the opportunity for open, honest, and transparent conversations—either on a case-by-case basis or from a programmatic standpoint—in a manner that can and should be protected from legal disclosure under the umbrella of a formal peer-review or quality improvement initiative. Appropriate protections of patient data and provider involvement must be maintained and established from the onset.

Likewise, summary data of program outcomes—such as the number of cases, types of cases, and overall outcomes should be actively tracked in real-time and made available to institutional leadership as a gauge of program growth and success. Institutional leadership/administration should also be able to provide financial data

as profit/loss margins must be tracked in the context of program growth and success. Additional benchmarking information should also be considered and tracked in real-time to help monitor the evolution of a program—and should include, but not necessarily be limited to:

(1) Patient demographics (i.e., age, gender, and major comorbidities)

	- Successful weaning from support
	- Death on support
	- Death despite successful weaning
	- Major factors contributing to patient death (i.e., multi-organ failure, neurologic, etc.)

Such summary data should be in addition to the extensive amount of clinical and circuit data that is collected and tracked in the ELSO registry (see above).
