abc’s of dcdd: the legal aspects of pursuing an authorized … · 2020. 11. 6. · abc’s of...

ABC’s of DCDD: The Legal Aspects of Pursuing an

Authorized Donor in DCDD Cases

June 18, 2020| 2-3pm ETSpeakers: Alexandra Glazier, JD, MPH| Brendan Parent, JD

CEPTC Information

§ 1.0 Category CEPTC credits are being offered for this webinar as well as a Certificate of Attendance

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Nursing Contact Hours

§ 1.0 Nursing contact hour is being offered for this webinar.

§ Participants desiring nursing contact hours must request their certificate within 30 days.

§ We highly encourage you to provide us with your evaluation electronically. Detailed instructions will be in the email which will be sent to you within the next 48 hours

§ You will receive a certificate via email upon completion of a certificate request or an evaluation.

§ Group leaders, please share the follow-up email.

Certificate of Attendance

§ Participants desiring CE’s that are not being offered, should complete a certificate of attendance.

§ Certificates should be claimed within 30 days of this webinar.

§ We highly encourage you to provide us with your feedback electronically. Detailed instructions will be emailed to you within the next 24 hours.

§ You will receive a certificate via email upon completion of a certificate request or an evaluation.

§ Group leaders, please share the follow-up email.

WEBINAR SPEAKERS

Moderator:

Jennifer SalmSenior Organ Procurement CoordinatorCenter for Donation and Transplant

Brendan Parent, JD Director, Transplant Ethics & Policy

ResearchDirector, Sports and Society

NYU Langone Health

Alexandra Glazier, JD, MPHChief Executive Officer

New England Donor Services

The Legal Frameworks of DCDAlexandra K. Glazier, Esq.

CEO, New England Donor Services

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US Deceased Donors: Growth in DCD

23% of total deceased donors in 2019

Legal Frameworks of Deceased Donation

•Laws governing organ donation in the U.S. are state based

•Uniform state laws create national legal frameworks for deceased donation

•Donation is conducted at a local level

•Facilitating transplant involves inter-state movement of resources subject to federal laws and regulations

Legal Frameworks of Deceased Donation

•Uniform Determination of Death Act (UDDA)

•Uniform Anatomical Gift Act (UAGA)

Legal Frameworks of DCD

What is different about DCD?

•Withdrawal of ventilator prior to death

•Death is declared based on circulatory cessation

Legal Frameworks of DCD

What is the impact of those differences under the law?

•Consent for withdrawal as well as authorization for donation

•Diagnosis of death based on absence of circulation versus absence of brain function

UAGA: Authorizing Deceased Donation

•UAGA is based on gift law principles◦ Authorization not Informed Consent

•The gift is conditional◦ Death◦ Clinical suitability

•The gift is limited by purpose◦ Transplant / therapy◦ Research◦ Education

UAGA:First Person Authorization

•Under the UAGA an anatomical gift can be made:◦By an adult prior to death◦By a surrogate decision-maker at death

•An adult making their own donation decision always occurs prior to death

First Person Authorization and DCD

•The UAGA governs donation after death

◦ Regardless of how death is declared

•Donor designation authorizes donation after death

◦ Regardless of how death is declared


•Authorizing donation does NOT also authorize withdrawal of support

•Surrogate consent for withdrawal required

•Withdrawal must be done in way that allows DCD to proceed

Legal Constructs in DCD

Anatomical

HealthCareDecision

Gift

Withdrawal of Support DonationDeath DeclaredAsystole

Timing of the Discussion and Authorization for DCD

• The dead donor rule does not preclude discussion of or consent to donation prior to death

• Separating out the withdrawal decision from the donation decision

Discussion and Authorizing DCD

• “Decoupling”o Institute of Medicine (IOM) reporto The decision to withdraw should be made independent of and

prior to donation discussion

• Ethical firewall

• Context of surrogate consent for both


•Effectively decouples the donation decision from the withdrawal decision

•Donation was authorized at a different time and in advance of withdrawal

•Separate surrogate consent for withdrawal and any pre-mortem procedures required

Declaring Death under the UDDA

•UDDA establishes 2 criteria for death declaration

◦ Irreversible cessation of circulatory function or

◦ Irreversible cessation of whole brain function

Legal Framework for Declaring Death in DCD

•“irreversible” is understood as “permanent”

◦ Circulation will not be restored (versus cannot)

◦ Brain function will not be restored (versus cannot)

Legal Framework for Declaring Death in DCD

•Legal premise for declaration under the UDDA

•The patient’s circulation has permanently ceased

◦ Will not auto-resuscitate◦ Waiting period (2-5min) after asystole prior to declaration

◦ Will not artificially be resuscitated◦ Context of planned withdrawal

Declaring Death in DCD

Adheres to the Dead Donor rule

•The patient is declared dead consistent with UDDA prior to the recovery of organs because circulation has permanently ceased (will not be restored)

•The UAGA prohibits a member of the transplant team from declaring deathoPotential conflict of interest avoided

Declaring Death in DCD

Evolving Medical Standards

◦ UDDA - “in accordance with accepted medical standards”

◦ The diagnosis of irreversible cessation may change over time

◦ The protocol must support the medical determination that circulatory cessation has ceased permanently or irreversibly

Understanding the Legal StandardsSupports Ethical Practices

• Precision as to when death occurs and how it is declared

•Transparency

•Public Trust

Ethical Issues in controlled Heart Donation after Circulatory DeathJune 18, 2020Brendan Parent, JDAsst Professor, Division of Medical Ethics, NYU Grossman School of Medicine

Disclosure

• Salary support from gift from United Therapeutics• NIH Grants under review to study Ethical/Logistical Concerns of Heart

cDCD using NRP; lung uDCD

Division Name or Footer2

Direct Procurement (Rapid Recovery) cDCD

• Co-locate donor and recipient, or cold transport

• Limits functional reassessment after circulatory death

• Ischemic time

3 NYU Grossman School of Medicine, Division of Medical Ethics

Ethical Concerns Regarding cDCD (Not Specific to Heart)

TIMING: withdrawal of life sustaining treatment vs. donation conversation

Acceptable “Hands Off” period

NYU Grossman School of Medicine, Division of Medical Ethics4

Acceptable pre-death donation prep/assessment measures

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Using heart to declare death, then restarting heart in new recipient…

Does this undermine death determination?

Ethical Concern Regarding Heart cDCD

NYU Grossman School of Medicine, Division of Medical Ethics

Uniform Determination of Death Act (1980)

• [relevant part]: Irreversible cessation of circulatory and respiratory functions

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We replace “Irreversible” with “Permanent” in practice


High Bar means few are legally dead unless:

Alternative Definition of Death?

Alternative Definition:“Irreversible loss of the functioning of the organism as a whole”

Sure. How to implement this in practice?

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Heart works in Recipient does not mean heart works in Donor.


Direct Procurement Followed By Ex-Situ NRP cDCD

• Transmedics Organ Care System

• Limits ischemic time

• Cost

• Limits evaluation under physiologic conditions


In Situ NRP cDCD

• Ligate internal carotid and vertebral vessels

• Reinstitute in situ circulatory support after circulatory death

• Co-locate donor/recipient


• Might mitigate initial ischemic impact (to all organs) compared to ex situ • Allows more time for organ evaluation and under physiologic conditions

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In Situ NRP cDCD – Compliance with UDDA?

• Death does not meet Irreversible Standard

• Does death meet Permanent Standard?


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In Situ NRP cDCD - Compliance with Dead Donor Rule?

Organ removal process must not cause death

• Does In Situ NRP cDCD cause death? • NO. Pt was already dead. Everything after is organ donation• YES. Docs prevent blood-flow to brain, thereby complicit in donor’s

death

• Should we abandon the dead donor rule?


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In Situ NRP cDCD – Authorization

Informed authorization of donation = ?

Would YOU agree to cDCD-NRP as a donor? - How much information would you want?- How much information are we obligated to give?

Back to Permanence: wLST is warranted because there is no chance of meaningful life/recovery


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References

Bernat JL. Controversies in defining and determining death in critical care. Nat Rev Neurol. 2013;9(3):164-173.Uniform Law Commission. 1980 Determination of Death Act. 2019.https ://www.unifo rmlaws.org/commi ttees/ commu nity-home?CommunityK ey=155fa f5d-03c2-4027-99ba-ee4c9 9019d6c.Overby K, Weinstein MS, Fiester A. Addressing consent issues in donation after circulatory determination of death. Am J Bioeth. 2015;15(8):3-9. Bastami S, Krones T, Biller-Andorno N. Whose consent matters? Controlled donation after cardiac death and premortem organ-preserving measures. Transplantation. 2012;93(10):965-969.Dalle Ave AL, Shaw DM, Bernat JL. Ethical issues in the use of extracorporeal membrane oxygenation in controlled donationafter circulatory determination of death. Am J Transplant. 2016;16(8):2293-2299.Truog RD, Miller FG, Halpern SD. The dead-donor rule and the future of organ donation. N Engl J Med. 2013;369(14):1287-1289.Parent B, Moazami N, Wall S, et al. Ethical and logistical concerns for establishing NRP-cDCD heart transplantation in the United States. Am J Transplant. 2020;20:1508–1512.McGregor, Joan, Joseph L. Verheijde, and Mohamed Y. Rady. "Do donation after cardiac death protocols violate criminal homicide statutes." Med. & L. 27 (2008): 241.


abc’s of dcdd: the legal aspects of pursuing an authorized … · 2020. 11. 6. · abc’s of...

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