1. Innovative Practices to Increase Pediatric Organ Donation For the Donation and Transplantation Community of Practice June 12, 2014 Welcome to the Pediatric Webcast

2. Thomas Nakagawa, M.D., FAAP, FCCM Wake Forest Baptist Health, Brenner Children’s Hospital. Winston-Salem, NC LeAnn Swanson, MPH Executive Director, Organ Donation and Transplantation Alliance Teresa M. Beigay, DrPH Director of Special Donation Initiatives. Dept of Health and Human Services, HRSA, HSB. Division of Transplantation Roxane Cauwels, BSN, MBA DTCP Consultant, Organ Donation and Transplantation Alliance

3.  Lori West, MD, DPhil, FRCPC Professor of Pediatrics, Surgery and Immunology Canada Research Chair (Tier 1) in Cardiac Transplantation Director, Canadian National Transplant Research Program Interim Director and Research Director, Alberta Transplant Institute University of Alberta  Mudit Mathur, MD Associate Professor of Pediatrics Loma Linda University Children’s Hospital  Sarah Grays, RN-NIC, CPTC Donation Development Specialist, OneLegacy  Alexandra Glazier, JD, MPH Vice President and General Counsel, New England Organ Bank  Thomas Nakagawa, MD, FAAP, FCCM Professor, Anesthesiology and Pediatrics Section Head, Pediatric Critical Care Wake Forest Baptist Health, Brenner Children’s Hospital Director, Pediatric Critical Care and Respiratory Care Wake Forest University School of Medicine

4. To review the current need for pediatric organs To discuss innovative practices to increase organs from potential pediatric donors To examine ethical and legal perspectives on brain death

5. 1,946 children are waiting for a needed organ* Children make up 1.5 % of the total national waitlist Approximately 130 children die annually waiting for a needed organ and another 50- 60 children are removed from the national waiting list because their condition deteriorates making them ineligible for organ transplantation Children less than 1 year of age have the highest death rate waiting for an organ *OPTN data. Accessed June 9, 2014 www.OPTN.org

6. Data compiled from OPTN 2014 Pediatric patients: birth to 18 years of age

7. Data compiled from OPTN 2014

8. Pediatric patients: birth to 18 years of age Data compiled from OPTN 2014 Waitlist removals Too sick to transplant

9. Data from OPTN June 9, 2014

10. RESULTS Pediatric organ recipients increased from 1170-1475 Pediatric donors provided the majority of organs for pediatric recipients The number of recipients of pediatric donor organs was stable over the 10 years, however organs recovered from pediatric DNDD decreased by 13% Adults received the majority of pediatric donor organs. This decreased over the study period and children received an increasing percentage of donor organs (from 66% to 69%) from pediatric donors.

11. RESULTS DCDD organs were transplanted into pediatric recipients equally from both adult and pediatric donors Pediatric recipients of DCDD organs were infrequent, representing fewer than 10% of DCDD organ recipients. However, there was a steady increased from 1 to 31 over the 10 years studied Pediatric candidates dying waiting fro an organ decreased from 262 to 110. Pediatric candidates awaiting transplant has remained relatively stable over the study.

12. UNOS. OPTN data. 2014 Pediatrics patients < 18 years of age Adult DCDD donorsPediatric DCDD donors 645 DCD donors 2006 77 pediatric 793 DCD donors 200766 pediatric 847 DCD donors 2008 73 pediatric 747 DCD donors 200981 pediatric 939 DCD donors 2010 72 pediatric 1053 DCD donors2011 115 pediatric 1102 DCD donors 2012 124 pediatric 1205 DCD donors 2013 134 pediatric

13. UNOS. OPTN data. March 7, 2014 Pediatrics patients < 18 years of age Pediatric DCDD donors < 1 year of age Number of Donors 20062 20076 20081 200910 20109 201112 201233 201327

14. Despite our successes, children and adults continue to die waiting for a life saving organ transplant The gap between donors and those waiting for a live saving transplant continues to increase The number of brain dead donors continues to decrease annually We continue to have missed opportunities for donation during withdrawal of life-sustaining medical therapies

15. Withdrawal of life-sustaining medical therapies should be viewed as a process and not an event During this process there are many times where the OPO could be engaged in discussions regarding end-of-life care with the family Donation should be included as a part of end-of- life care and the process of withdrawal of life- sustaining medical therapies Donation should not be the primary conversation about withdrawal of life-sustaining medical therapies and end-of-life care

16. Transplant outrage has a solution: more organ donors

17. Lori West, MD, DPhil, FRCPC Professor of Pediatrics, Surgery and Immunology Canada Research Chair (Tier 1) in Cardiac Transplantation Director, Canadian National Transplant Research Program Interim Director and Research Director, Alberta Transplant Institute University of Alberta

18. “Utilization of ABO Incompatible Neonatal Hearts” Lori J. West, MD, DPhil Departments of Pediatrics, Surgery and Immunology

19. The ABO blood group system as a barrier in organ transplantation Transplantation of ABO-incompatible organs: Binding of pre-formed antibodies to cognate antigens expressed on graft endothelium Activation of complement locally Recruitment of inflammatory mediators Rapid widespread thrombosis of graft vasculature ‘Hyperacute’ rejection

20. Widespread hemorrhage Occlusive intravascular thrombus Hyperacute rejection in setting of cardiac graft

21. Disproportionate competition for O donors disadvantages O recipients Kidney – mostly adult Heart – to date, infants/young children Liver – mixed Different reasons; different regimens; different tissues; different immunologic issues The need for donor organs intentional ABOi transplantation

22. ABO system in solid organ transplantation Recognition of risk of antibody-mediated rejection (hyperacute and/or delayed) in the setting of ABO-incompatible transplantation Avoidance or management of accidental ABO-incompatible transplantation Planning and management of intentional ABO-incompatible organ transplantation

23. ABO-incompatible heart transplantation? Risk:benefit decision-making differs substantially from kidney transplants Lack of effective ‘dialysis equivalent’ for rescue in case of graft failure due to HAR Susceptibility of heart graft to antibody- mediated damage Graft loss = patient death –thus higher risk of death gives rise to conservative approach in attempting to cross ‘historical’ barriers such as ABO

24. Historical reports of ABOi heart transplantation Cooper DKC Transplant. Proceedings 1990; 22:1457 –Global clinical survey of cardiac transplantation between ABO blood group-incompatible recipients and donors –8 reported cases, all adults, all accidental –Heavy morbidity, high mortality Additional rare case reports – mostly poor outcomes Likely exacerbated by passive administration of unrecognized anti-donor ABO antibodies in blood products

25. The special case of infants Factor #1: antibody responses Factor #2: relative risks of death Factor #3: immunologic malleability

26. The special case of infants Factor #1: antibody responses Antibody production to protein antigens –Reasonably predictable response in infancy –Polio, pertussis, diphtheria, HLA Antibody production to carbohydrate antigens –Generally poor before age 2 years –H. influenzae, pneumococcus, meningococcus, ABO Thus, infants lack the essential mediators of HAR that make ABOi transplantation risky

27. The special case of infants Factor #2: relative risks of death Especially compelling patient population due to high risk of death awaiting transplant

28. PEDIATRIC HEART TRANSPLANTATION Conditional Kaplan-Meier Survival (Transplants: 1/1982-6/2008) 2010 ISHLT J Heart Lung Transplant. 2010 Oct; 29 (10): 1083-1141

29. Wait list mortality Number of Transplants ISHLT Age at transplantation Almond et al. 2009, Circulation Heart Transplantation in Childhood

30. Isohemagglutinin ontogeny in normal human infants (blood type O)

31. International ABOi ‘Infant’ Heart Transplant Activity (1996-2012)

32. American Journal of Transplant 2010

33. Clinical conclusions to date ABOi heart transplantation can be performed without aggressive maneuvers in young children Antibody-removal strategies have been used successfully to allow ABOi heart tx in older children and rare adult pts; upper ‘threshold’ of safe antibody titres is unclear AMR has been reported only rarely, of varying severity and responsiveness to treatment, but prediction is still unclear Comparable clinical outcomes to ABOc transplants have been reported in the ‘mid to long-term’ Waiting list mortality for infants has dropped; organ wastage has decreased

34. Kaplan-Meier survival after ABOi transplantation

35. The special case of infants Factor #3: immunologic malleability Introduction of foreign antigens during immunologic immaturity may prevent subsequent development of immune response (‘neonatal tolerance’)

36. Isohemagglutinin ontogeny after ABO- incompatible heart transplantation (‘A into O’) Fan et al., Nat Med, 2004 Donor-specific B-cell tolerance after ABO-incompatible infant heart transplantation 6 months1 year Age Isohemagglutinin titre Birth Anti-A Anti-B A

37. Isohemagglutinin ontogeny after ABO- incompatible heart transplantation (‘B into O’) Fan et al., Nat Med, 2004 Donor-specific B-cell tolerance after ABO-incompatible infant heart transplantation 6 months1 year Age Isohemagglutinin titre Birth Anti-A Anti-B A

38. Tolerance was defined (ie, measured) by: Absence or deficiency with time after transplant of antibody production to donor blood group as measured in agglutination assays Absence of intragraft complement components and other evidence of AMR Supported by studies of cultured PBMC showing donor- specific hyporesponsiveness in vitro (ab production by ELISA and ASC by ELISPOT) Persistence of donor antigen expression in graft Absence of donor-specific B cells in PBC Fan et al., Nat Med, 2004, Donor-specific B-cell tolerance after ABO-incompatible infant heart transplantation

39. Plate 1 Patient Samples

40. Caleb, age 16 Summer 2012

42. Potential Organ Donors in Newborns Undergoing Circulatory Determination of Death Mudit Mathur, MD Associate Professor, Pediatric Critical Care, Loma Linda University Pediatric Intensivist, Huntington Hospital

43. Objectives Review newborn organ donation potential DCDD kidney donation and outcomes – Adult recipients – Pediatric recipients Hepatocyte transfusion as a bridge to transplantation (experimental)

44. Brain death- rarity in NICU Mechanisms-non trauma, focal bleeds-maybe less edema? Open fontanelle, non-fused sutures: lower ICP? Withdrawal before progression? Brain death criteria limitations-not any more – 2011 update (Nakagawa et al, Crit Care Med 2011) – Defines gestational age (>37 weeks) – Defines inter-examination interval (24 hours)-may be shortened if ancillary study consistent with BD – Clarifies ancillary study preferred (CBF)

45. Modes of death: Brain death, DNR, Death despite CPR, elective withdrawal Withdrawal of life support most common (40- 60% of all deaths) Withdrawal Potential DCDD Donor Neonatal Organ Donor Potential

46. NICU DCDD Donor Potential similar to PICU data (5.5-8.7%) Featured Articles

47. Kidney transplantation Can’t we just continue dialysis? >95,000 wait-listed for kidney transplant (>80% of the >120, 000 waitlist!) 35,000 added to the list annually (about 17,000 cadaveric and living donor transplants per year) 5% mortality for each year on dialysis 5,000 kidney waitlist deaths/year

48. Bhayana et al. Transplantation 2010; 90 (3): 248-54 Pediatric En Bloc Kidney Transplantation to Adult Recipients: More Than Suboptimal?

49. Butani et al. Outcomes of children receiving en bloc renal transplants from small pediatric donors. Pediatr Transpl 2013; 17: 55-58 Small en bloc kidneys into 8 pediatric recipients Donors 4-22 kg One kidney lost to intraoperative thrombosis, other remained viable All grafts increased in size Median eGFR was 130 mL/min/1.73 m2 size How about pediatric recipients?

50. American Academy of Pediatrics

51. Exploring Neonatal Donor Potential Discharges from our 84 bed NICU over 10 years (November 2002-October 2012) All deaths categorized into four modes: 1. Brain death 2. Death despite CPR 3. Death with DNR order in place 4. Withdrawal of life support Examined patients undergoing withdrawal for cause of death and criteria for kidney donation

52. Inclusion Criteria > 1.8 kg DCD warm ischemia ≤ 120 min Acute kidney injury okay unless donor is anuric

53. Exclusion Criteria Presence of tumor, systemic infection, or HIV Renal replacement therapy Urine output < 0.5 mL/kg/h Creatinine ≥ 1.5 mg/dL Death >120 minutes after withdrawal

54. Results Total NICU discharges: 11,201 Deaths: 609 Weight ≥ 1.8 kg at the time of death: 359 Mode of Death – Brain deaths: 0 – Death despite CPR: 55 (15.1%) – DNR: 145 (40.6%) – Withdrawal: 159 (44.3%)

55. Mode of Death (n=359)

56. Results 159/359 (44%) patients withdrawn from life support Age: 1 day to 214 days Weight 1800 to 9845 grams at the time of death

57. Potential Newborn DCDD Ventilator withdrawn in all 159, also inotropes in 57, ECMO in 7 patients 100 patients had at least one exclusion criteria, time of withdrawal not recorded in 2 patients leaving 57 DCDD eligibles WIT <60 min in 42 babies WIT 60-120 min in 15 babies

58. Cause of Death

59. Newborn Donor Potential No brain deaths 42-57 newborns (26-36% after withdrawal were potential DCDD kidney donors) A NICU DCDD program would provide about 1.7-4 additional paired kidneys per year for transplantation at our center (based on 40% DCDD and 70 % PICU brain death consent rate)

60. The true potential-DCDD Brain death is rare in NICU-very few donors now, in the future?? In California alone there are 89 Level IIIB and C NICUs with a total of 2726 NICU beds: 55-120 additional paired DCDD kidneys available for transplant each year Nationally: 677 Level III B and C NICUs with 24,043 beds: 487 to 1145 paired donor kidneys

61. Personal Communication with Dr. Richard V. Perez, UC Davis Over 200 kidney transplants from donors < 20 kg About 40% DCDD Over 20 newborn donors (Results to be presented at ATC conference, July 2014) Clinical Experience at UC Davis

62. Neonatal Donation-Challenges Many NICUs No BD, few potential DCDD donors/year Donation not considered an option by most NICU staff Few accepting transplant centers-outcomes, surgical technique Answer: Education, Education, Education

63. Hepatocyte Transplantation Challenges: – Quantity, Quality – Duration of clinical effect – Viability/Interaction with native hepatocytes? – Immune suppression needed? Duration? Advantages: – Lower cost and morbidity, repeatability, OLT option preserved

64. Hepatocyte Donor Selection Brain Dead, DCDD Neonatal Donors Non-transplantable livers Consent for research Neonatal – Birth (32 weeks) to 28 days > 2000 gms DCD WIT – Neonate – 180 Minutes

65. Hepatocyte Processing Cannulated, flushed free of transport solutions Enzymatically digested, capsule removed Cells concentrated, washed through a series of spins on the centrifuge Pooled into a single cell suspension Cryopreserved and stored for testing and release

66. Hepatocyte Transplantation Studies Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders (SELICA III), NCT01195753 Hepatocyte Transplantation for Acute Decompensated Liver Failure: NCT01345565

67. Case series-hepatocyte transplant Ribes-Koninckx C et al. Cell Transplant. 2012;21(10):2267-82: Clinical outcome in four infants with inherited metabolic diseases. Beck et al. Nephrol Dial Transplant. 2012 Jul;27(7):2984-9.Liver cell transplantation in severe infantile oxalosis- bridge to OLT?

68. Preliminary Results Liver cell therapy in 16 children with urea cycle defects vs. 63 historical controls Nine completed the trial per protocol Time to first moderate (NH3 250-500) or severe (>500) hyperammonemic events was delayed Incidence of moderate and severe hyperammonemic events lowered Opladen et al, Molecular Genetics and Metabolism 2014,

69. Neonatal Donation: The Potential Many NICUs Unrecognized opportunities for DCDD (>2500 grams?, WIT 120 min) Evaluate donor kidneys with Pulsatile Pump Preservation Consider liver donation-hepatocytes (>2000 grams, WIT 180 min) Societal benefits Potential psychological benefits for the family

70. Sarah Grays, RN-NIC, CPTC Donation Development Specialist OneLegacy, Los Angeles, CA

71. Learning from OneLegacy’s Angel Babies Sarah Grays, RNC-NIC, CPTC Becky Hill, CPTC The Littlest Donors

72. Covers the 7 county greater Los Angeles area Serves over 200 hospitals, 11 transplant centers, community of 19M people Approached by 8 families of infants with anencephaly over 18 months OneLegacy

73. Medical Advancements Able to meet families desire to donate The Internet Families have new access to information and peer support Giving Meaning to Life Possibility gives added meaning to baby’s life Every organ, every donor, every time. Why Re-Examine Now?

74. to assist OPO’s, donor hospitals, and donor families Challenges Faced & Tools Developed

75. Remain within scope of policy/procedure. Enable all OPO Coordinators to facilitate. Provide guidance to hospital staff. Challenges accepted! Goal: Facilitate Case as Standard DCD

76. Baby born, ventilation occurs as requested by family/clinically indicated Tissue (heart valves) evaluated for transplant Family time with baby Intra Uterine Fetal Demise Donation Scenarios MD intubates, UAC placed; withdrawal time set Family time with baby Ventilation withdrawn and comfort care instituted per hospital policy Baby expires ≤ 2 hrs Recovery of enbloc kidneys, liver for Cytonet, tissues for transplant Baby expires > 2 hrs and ≤ 3 hrs Recovery of liver for Cytonet, tissues for transplant Baby expires > 3 hrs No recovery of organs, evaluation of tissues for transplant and liver for Cytonet Baby born, does not require ventilation Family time with baby and follow to determine if ventilation needed Ventilation needed; determine if donation is still an option No plans to ventilate, hospital provides comfort care per policy Family time with baby until baby expires Evaluation of tissues for transplant and liver for Cytonet

77. Unfamiliar with donation/DCD in general  Great opportunity for education  Each hospital took ownership in the process (administration, Ethics engaged)  Staff requested to be involved in these cases Unique atmosphere  Closed environment/increased sensitivity  Vocabulary unique to NICU Challenge: L&D/NICU New Territory

78. Challenge: Assessing a Donor in Utero

80. Challenge: Wide Variability After Birth

82. Challenge: Limited Blood & Access

83. Questions  Withdrawal in NICU v. OR?  How far away is the OR?  Is there an L&D OR that could be utilized?  Will the parents be holding the infant after extubation?  Who will be monitoring the saturations?  How will the patient be transported in the 5 minute wait time?  Is this an outlying hospital? Pediatric instrumentation Surgeon/staff activation to hospital Hospital staff preparation and emotional support Challenge: Readiness for Recovery

84. Checklist Examples

87. 9 infants 5 prepared for donation but did not meet criteria  3 born alive but did not meet weight and/or gestational age criteria  2 stillborn 2 started as DCD/intubated, became unstable  1 liver recovered, patient died on vent, taken to OR after CTOD  1 liver recovered, family wished no pressors, taken to OR after CTOD 2 heart valves for transplant recovered Outcomes

88. OneLegacy’s Angel Babies

89. Prepared for liver pathway Mom’s blood drawn for serologies Labor induced per schedule Organ & Tissue Outcome: Rule Out: stillborn, for liver, too small for heart valves Website: Carrying Colin Inspiration: Colin & the Perry Family

90. Prepared for DCD pathway Emergent C-section done at 36 1/7 weeks Born at 2046 grams Intubated at birth, lines placed Passed away on vent as teams rapidly mobilized Family spent time with baby Organ Outcome: Liver recovered for Cytonet; used for research Baby Arriana

91. Prepared for DCD pathway Born 41 weeks NVD, 3210 grams Intubated 4 hours later after respiratory distress Rapidly declined; no pressors per family, died on vent and went to OR after death Organ & Tissue Outcome: Liver recovered for Cytonet Heart Valves recovered for transplant Baby Samuel

92. Prepared for DCD pathway Induced at EGA 37 weeks Dubowitz at birth 33-34 weeks Intubated to extend time with family Organ & Tissue Outcome: Rule Out: weight/actual gestational age Same dedicated hospital team delivered his baby sister in May Baby Ezekiel

93. In early prep for DCD pathway Mom went into early labor at EGA 34 2/7 Organ & Tissue Outcome: Rule Out: stillborn/size/age Donate Life Flag raised in baby’s honor Baby Nova

94. Prepared for DCD pathway Scheduled C-section at EGA 38 weeks Born at 2195 grams Dubowitz to 36 weeks Organ/Tissue Outcome: Rule Out for kidneys, gestational age at birth Baby Lennox

95. Staff of Riverside County L&D and NICU join OneLegacy staff after Baby Samuel’s liver and heart valve donation. Hospital & OneLegacy Staff learned from parents of Arriana and Colin at OneLegacy 2013 Donation and Transplantation Symposium. Hospital Partner Participation and Support

96. Angel Baby families meeting to place roses 2014 Donate Life Colin’s parents placing his rose on 2013 Donate Life Rose Parade Float Carrying Colin has over 13,000 followers ; documentary coming soon. Community Awareness

97. Share best practices amongst OPO’s/Donor hospitals More doctors to recover or transplant tiny kidneys. Raise awareness of all donation potential in the NICU. “Imagine a love so strong that saying hello and goodbye at the same time is worth the sorrow.” - Colin’s Parents, 2013 Donor Remembrance Ceremony Moving Forward

98. Alexandra Glazier, JD, MPH Vice President and General Counsel New England Organ Bank Thomas A. Nakagawa, MD, FAAP, FCCM Professor, Anesthesiology and Pediatrics Section Head, Pediatric Critical Care Wake Forest University School of Medicine Director, Pediatric Critical Care and Respiratory Care Wake Forest Baptist Health, Brenner Children’s Hospital

99. Ethical and Legal Perspectives on Brain Death Alexandra K Glazier, JD MPH VP & General Counsel, New England Organ Bank Faculty, Boston University School of Law Chair, OPTN/UNOS Ethics

100. Defining Death

101. Defining Death – Legal perspective Uniform Determination of Death Act (UDDA)  State law  Establishes legal standard Death = irreversible cessation of  circulatory and respiratory functions  all functions of the entire brain, including brain stem In accordance with accepted medical standards  Medical diagnosis of absence of neurological function

102. Defining Death – Legal perspective Irreversible: Lost function cannot possibly be restored Permanent: Lost function will not be restored  No spontaneous recovery possible  No medical attempts will be made to restore Death based on neurologic criteria (brain death) Death based on circulatory criteria (asystole)

103. Legal Consequences to Death Declaration Rights and Duties  Organ Donation  Burial  Criminal charges  Inheritance  Social Security  Pensions No legal duty to continue to provide medical care to a deceased patient

104. Legal Consequences to Death Declaration Continuation of support for purposes of organ donation Legal obligation to preserve the opportunity of donation  Uniform Anatomical Gift Act  CMS

105. Defining Death – Ethical Perspective Dead Donor Rule  Recovery of donated organs cannot cause the death of the donor  Public trust  Ethical debate regarding the necessity of the DDR Futility  Medical resources should not be expended on the deceased

106. Defining Death – Ethical Perspective Allowing families to define death? Death is a diagnosis not a treatment option Public policy

107. Hard Cases Make Bad Law McMath Case: Family rejected death declaration based on neurological criteria The law is clear Its application is hard

108. Hard Cases Make Bad Law Tools for handling escalating conflict over a brain death declaration  Confirmatory tests  Second opinion  Death certificate issued  State law defining death Communication  Family  Staff  Court  Public

109. Thomas A. Nakagawa, MD, FAAP, FCCM Professor, Anesthesiology and Pediatrics Section Head, Pediatric Critical Care Wake Forest University School of Medicine Director, Pediatric Critical Care and Respiratory Care Wake Forest Baptist Health, Brenner Children’s Hospital

110.  Conversations with families about death and dying are difficult but necessary so parents can understand and begin preparing for the loss of their child Conversations should be open and honest We must work to improve our communication to prepare families for a devastating outcome We have a responsibility to care not only for the child, but also the family and guide them through this process This process starts when the critically ill child is first admitted to the PICU

112. Allow families to be present during the clinical examination and apnea test Communication should be in simple terminology allowing parents and family members to understand their loved one has died

113. Brain death – Medical term – Describes the death of an organ Utilize terminology that describes the death of the individual: – More appropriate communication “Your loved one has suffered a severe injury to the brain that is not recoverable. Your loved one has died.”

114. Life support – When used in the context of brain death, we are not supporting life since death has been declared Avoid providing options for termination of mechanical support and medical therapies following declaration of death “Your loved has died. We need to withdraw life support”

115. More appropriate communication – “Your loved one has died. Medical therapies used to help your loved one get better are no longer indicated since death has occurred. These medical therapies will be stopped” It should be made clear that once death has been declared no further treatment options exist and all medical therapies stop, unless organ donation is planned

116. Physicians have no obligation to treat a patient declared dead Families no longer have options about continuing medical therapies Appropriate emotional support for the family should continue to be provided

118. Review current institutional brain death guidelines and ensure they reflect the most recent SCCM/AAP/CNS guidelines for the determination of brain death in infants and children Ensure that there is language that specifically states that, “once death has been declared using currently accepted guidelines, the family will be given appropriate time to grieve with their child before mechanical support is discontinued.” Policies and guidelines should reflect a specific time period, ie 4 hours

119. Continued communication is vital Continued support for the family should be provided Development of an escalation plan – Multidisciplinary involvement Critical care specialists Nursing Respiratory care Hospital administration Risk management Hospital legal counsel Public relations

120. Minimum Level: – Concerns raised by the family or barriers to communication exist about the medical process Ongoing communication with the family Third independent examination to confirm brain death Ensure appropriate documentation of brain death in accordance with hospital policy Risk management and hospital legal staff are made aware of an escalating situation Maximum level: – Family is in direct opposition to the plan of care Plans are established about ongoing mechanical support and medical staff involvement with the patient Hospital administration, risk management and hospital legal staff intervene with the family Work to ensure physicians and the healthcare team are removed from the middle of this dispute

121. Emotional distress and conflict for medical team – Continue ventilator support and treatment for person who has been declared dead Daily rounds Charting vital signs Providing fluids, medication, and nutrition Resource utilization – Other critically ill patients may be denied life- sustaining medical therapies Delays the grieving process for the family Potential loss of organs recovered for donation

122. We can never forget that a family has suffered the loss of their child Conversations and interactions with the family must be done with compassion and respect We must do our best and continue to emotionally support the family during their time of crisis

123. To ask a question, please follow the prompts on your screen.

124. Organ Donation Toolbox http://www.organdonationalliance.org/educational- resources/toolbox