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Pediatric donation after cardiac death

PART I: Policy and Practice

PART II: Background Reports

Donation after cardiac death

I. DCD Policy and Protocol

  1. Organ donation after Cardiac Death (DCD) from Boston Children’s Hospital patient-donors is guided by the “Foundation Conditions for DCD” established by the DCD Task Force and accepted by the Medical Staff Executive Committee.

  2. Boston Children's will implement theDCD Protocolfor donation of kidneys and any other organs that can be satisfactorily donated consistent with its terms. Donors may include Boston Children's patients of any age who have given informed consent, or for whom proxy consent has been given, as provided in the DCD Consent Form and who have met the consent requirements of the New England Organ Bank.  The DCD Protocol and the DCD Consent Form may be amended from time to time by the Hospital’s DCD Advisory Committee, subject to the approval of the SCLC.

  3. When Boston Children's surgeons procure organs at other institutions, and when organs are offered for transplantation in a recipient at Boston Children's Hospital, the donor hospital will be generally responsible for setting policy for the end of life care of the donor, including the criteria for declaration of death, subject to the approval of the relevant OPO. It is understood that these protocols may not be the same as the DCD protocols used at Boston Children's Hospital, and that at this stage in the development of DCD there can be reasonable differences of opinion as to the appropriate ethical standards within the range of conduct that is both legal and acceptable under national professional guidelines. The following special rules nonetheless apply:

    1. Boston Children's surgeons may not take part in the pre-mortem procedures or declaration of death of any patient whose organs they will procure.

    2. Boston Children's surgeons will not begin recovery of organs from patients until at least 2 minutes of acirculation have transpired. Boston Children's Hospital staff will not knowingly accept DCD organs recovered by surgeons from any other institution if the recovery took place after less than two minutes of acirculation. This minimum time may be altered if, in the judgment of the Senior Clinical Leadership Council, the change is supported by further scientific review regarding the time of death in children.

    3. When DCD organs are accepted for transplantation at Boston Children's Hospital, Boston Children's staff who would be involved directly in the procedure will be fully informed in advance of the fact that the organ is from a DCD donor, the known circumstances surrounding the donation, and the relevant policies of Boston Children's Hospital. Consistent with the Foundation Conditions, staff rights to avoid participation based on conscientious objection will be respected.

  4. Once a donor is dead, the Boston Children’s Hospital's primary aim is to benefit organ recipients. To this end, it is anticipated that innovative postmortem procedures could be developed to maintain or improve organ function. These shall be subject to appropriate policy review in the event they might reestablish cerebral perfusion or cause substantial offense to patient or public sensibilities.

II. Donations not Addressed by Current Policy 

  1. Any proposed DCD donations that do not fall within the terms of this policy and the approved protocol will be reviewed on a case by case basis by the DCD Advisory Committee described in section IV, until policies addressing the new circumstances have been adopted by Boston Children’s Hospital.

  2. In each case, the DCD Advisory Committee will consult with the Director of the Transplant Program, the attending physician and, in cases of ICU involvement, the chief of the pertinent ICU. Decisions will be consistent with the Foundation Conditions for DCD.  The committee may approve or disapprove the proposed DCD, subject to final review and decision by the Senior Clinical Leadership Council.

III. Implementation

  1. Operational responsibility for the successful implementation of the DCD protocols and policies of Boston Children’s Hospital will be held jointly by two DCD Co-Directors, who shall be advised by the DCD Advisory Committee and shall report directly to SCLC. The two Co-Directors will be (i) a designee of the President who is familiar with ICU practice and bioethical issues involved in DCD and (ii) the Director of the Transplant Program. Staff designated by the DCD Co-Directors will be responsible for initial and periodic staff education, ensuring that sufficient qualified personnel have freely indicated their willingness to participate in the DCD process, and training participants in the DCD Protocol.  

  2. With the advice of the DCD Advisory Committee, the Co-Directors will be responsible:

    1. to recommend adaptations of the DCD protocol for additional organs and patient populations, if appropriate.

    2. to formulate and implement strategies for improving the working relationship between Boston Children's ICU’s and NEOB.

    3. in conjunction with The Program for Patient Safety and Quality, to conduct a  confidential internal survey of ICU and OR staff at Children’s Hospital with respect to any concerns about participating in DCD, and to report the results to SCLC and the DCD Advisory Committee. The survey will be administered after staff education in the relevant units.

    4. with the assistance of the Senior Vice President for Patient Care Operations and other components of Boston Children's as necessary, to survey public opinion of DCD in the Boston Children's Hospital community, through focus groups or otherwise, and to report the results to SCLC and the DCD Advisory Committee.

    5. to seek review and approval of the Task Force’s DCD protocol for kidney donation, and any adaptations of this protocol that are approved by SCLC, through other governance committees in the institution, including the Operating Room Governance Committee, ICU Governance Committee, and the Cardiovascular and Critical Care Policy and Practice Review Committee.

    6. to make minor clarifications and refinements of any Boston Children's Hospital DCD protocol and implement the same pending SCLC approval.

IV. DCD Advisory Committee

  1. There shall be a DCD Advisory Committee, which will be co-chaired by the Co-Directors. The Senior Vice President for Patient Services or her designee, the co-chairs of the DCD Task Force, and the General Counsel or his designee will also serve. The President in his sole discretion may also appoint other members of the Children’s staff, and family or lay representatives.

  2. When appropriate, the DCD Advisory Committee shall:

    1. Reconvene the “Time of Death” Committee from the Task Force (Tamara Vesel, David Urion and Martha Curley), with such additional staff as are appropriate, to evaluate whether the period of waiting after acirculation should remain fixed at five minutes or reduced to a shorter time as considered necessary for donation of other organs, and report the results with comment and recommendations to SCLC.

    2. Consider proposed protocols for the DCD of other organs, including liver, heart, and lung, with specific recommendations as to pre-mortem interventions and the waiting period of acirculation before declaration of death.

    3. Consider proposed protocols, as appropriate, for the DCD of patients not included within section I.B above.

  3. The DCD Advisory Committee shall report to SCLC after each of the first 3 DCD cases, and then semi-annually concerning the DCD program in practice, and the fulfillment of the requirements of this policy.

Foundation Conditions for Pediatric DCD

In July 2005, a summary of the Phase I deliberations from the Task Force on Donation after Cardiac Death was presented to the Medical Staff Executive Committee (MSEC) at Boston Children’s Hospital. This report stated that a protocol for DCD could be consistent with the mission of Boston Children’s Hospital, provided the following eight foundational criteria were met:

Each child will be an appropriate candidate for withdrawal of life support under circumstances not involving the prospect of organ donation.

The withdrawal of life support process will be consistent with established practices at Boston Children's Hospital, and there will be no physical harm, suffering or hastening of death to the child by the DCD process / protocol. The withdrawal of life support will be conducted in a compassionate and sensitive fashion that respects and preserves the human dignity of the patient.

There will be rigorous oversight of protocol development and the subsequent implementation. Resources will be made available to ensure independent oversight and monitoring of the DCD process and outcomes, with controls and authority established to prevent conflicts of interest, variance from the established protocol, and violations of any of these eight foundational criteria.

Boston Children's will work with the NEOB to find mutually agreeable ways of proceeding with DCD, but the implementation of the protocol will not alter the quality of care in the ICU or the trust of families that the welfare of their child is their and the staff's paramount concern. DCD will be an option for some families, but none will be pressured to see organ donation as an obligation or expectation.

Participating families will give genuine informed consent that includes a statement that parents can change their mind at any time in the process. They will be informed of (i) the differences between the orchestration and experience of death, for both their child and themselves, if their child is going to be a DCD donor or not, and (ii) other facts likely to make a difference in their decision (e.g., the likelihood of the organs going to another child).

The child will clearly be dead, which implies no potential for cognition before organ removal takes place, and our criteria for declaring death, including our concept of “irreversibility,” will be ethically and medically justifiable.

Diversity in religious, cultural and personal values will be respected. Staff who object to DCD may avoid participation.

There will be no extra financial costs to the family from DCD participation.

Sixteen of the seventeen members of the Task Force supported this recommendation. The remaining member felt that the requirements of the procedure itself (the need to take steps that are not for the patient’s direct benefit, the need to retrieve the organs within a fixed amount of time and the limitations placed on parental contact) compromises the human dignity of the patient and therefore causes harm; however, this member determined that these reservations, based on personal spiritual beliefs and values, should not prevent the Task Force as a whole from proceeding as outlined here.

In all areas of clinical care and research, children are identified as a unique and vulnerable population, in need of special protections and safeguards. Policies and procedures developed for the care of adults frequently require modification before they can be adapted for use in children. The Task Force recommended that these considerations should guide the process of adopting aspects of existing protocols into an approach to be used at Boston Children’s.

Motion presented to the Medical Staff Executive Committee:

“That MSEC approve the Phase I Report & Recommendation of the Task Force on Donation after Cardiac Death, and support the protocol-development proposed by the Task Force for its second phase, with the understanding and intent that a DCD protocol should be adopted at Boston Children's only if it meets the conditions established by the Task Force."

Passed unanimously by MSEC 7-12/2005

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