Eligible Deaths Definitions ASMHTP Annual Meeting September 24, 2010

1. Eligible Deaths DefinitionsASMHTP Annual MeetingSeptember 24, 2010 Teresa M. Beigay, DrPH, Director, Special Donation Initiatives John Rosendale, Biostatistician, OPTN/UNOS Health Resources and Services Administration Department of Health and Human Services Healthcare Systems Bureau Division of Transplantation

2. Controversy Between HRSA & UNOS What controversy?

3. Reminder: “Eligible deaths” is different from “eligible donors”

4. Development of Definitions Outgrowth of AOPO Death Record Review Study Effort to instill consistency in data reporting Brought brain death into the equation

5. Eligible Death Definition Eligible Death: Although it is recognized that this definition does not include all potential donors, for reporting purposes for DSA performance assessment, an eligible death for organ donation is defined as the death of a patient 70 years old or younger who ultimately is legally declared brain dead according to hospital policy independent of family decision regarding donation or availability of next-of-kin, independent of medical examiner or coroner involvement in the case, and independent of local acceptance criteria or transplant center practice, who exhibits none of the following:

6. Exclusionary Conditions: Active infections (specific diagnoses) [Exclusions to the Definition of Eligible] Bacterial: Tuberculosis, Gangrenous bowel or perforated bowel and/or intra-abdominal sepsis, See "sepsis" below under “General” Viral: HIV infection by serologic or molecular detection, Rabies, Reactive Hepatitis B Surface Antigen, Retroviral infections including HTLV I/II, Viral Encephalitis or Meningitis, Active Herpes simplex, varicella zoster, or cytomegalovirus viremia or pneumonia, Acute Epstein Barr Virus (mononucleosis), West Nile Virus infection, SARS Fungal: Active infection with Cryptococcus, Aspergillus, Histoplasma, Coccidioides, Active candidemia or invasive yeast infection Parasites: Active infection with Trypanosoma cruzi (Chagas'), Leishmania, Strongyloides, or Malaria (Plasmodium sp.) Prion: Creutzfeldt-Jacob Disease General [Exclusions to the Definition of Eligible]: Aplastic Anemia, Agranulocytosis

7. Exclusionary Conditions (cont.): Extreme Immaturity (<500 grams or gestational age of <32 weeks) Current malignant neoplasms except non-melanoma skin cancers such as basal cell and squamous cell cancer and primary CNS tumors without evident metastatic disease Previous malignant neoplasms with current evident metastatic disease A history of melanoma Hematologic malignancies: Leukemia, Hodgkin's Disease, Lymphoma, Multiple Myeloma Multi-system organ failure (MSOF) due to overwhelming sepsis or MSOF without sepsis defined as 3 or more systems in simultaneous failure for a period of 24 hours or more without response to treatment or resuscitation Active Fungal, Parasitic, Viral, or Bacterial Meningitis or Encephalitis

8. Eligible Death Criteria: Brain dead 70 years old and younger No medical exclusions noted in policy Thus, excludes: Patients over the age of 70 years DCD donors Any donor that meets one of the exclusions

9. Conversion Rates & Eligible Criteria Traditional conversion rate = (donors recovered that meet the eligible death criteria ÷ number of reported eligible deaths) *100 Collaborative conversion rate = DCD and brain dead over 71 added to both numerator and denominator

10. Goal – 75% Conversion Rate

11. Imminent Neurological Death Imminent Neurological Death: Imminent Neurological Death is defined as a patient who is 70 years old or younger with severe neurological injury and requiring ventilator support who, upon clinical evaluation documented in the OPO record or donor hospital chart, has an absence of at least three brain stem reflexes but does not yet meet the OPTN definition of an eligible death, specifically that the patient has not yet been legally declared brain dead according to hospital policy. Persons with any condition which would exclude them from being reported as an eligible death would also be excluded from consideration for reporting as an imminent death. For the purposes of submitting data to the OPTN, the OPO shall apply the definition of imminent neurological death at the time when the OPO certifies the final disposition of the organ donation referral.

12. Imminent Neurological Death (cont.) Brain stem reflexes: Pupils reactive to light Response to iced caloric Gag Reflex Cough Reflex Corneal Reflex Doll's eyes reflex Response to painful stimuli Spontaneous breathing

13. Comparison of Eligible and Imminent Neurological Deaths

14. Data Submitted to the OPTN by OPOs Referral, Eligible Death, and Imminent Death Data - Reported differently pre-2008 and post-2008 Pre-2008 Number of referrals and number of eligible deaths reported monthly in aggregate by donor hospital Post-2008 Number of referrals reported monthly in aggregate by donor hospital Eligible and Imminent Deaths reported on the Death Notification Registration (DNR) form Limited data reported on an individual patient basis Eligible death data used in conversion rate calculations

15. Old System (Pre-2008)(aggregate)

16. New System (Post-2008)

17. Donors Meeting Eligible Death Definition Changed in 2008 because of the way the data were collected – from aggregate to deaths linked to donors Pre-2008: An actual brain dead donor age 0-70 Post-2008: Any donor that is linked to a reported eligible death (DNR) This is done by entering the Donor ID in the DNR record of the eligible death

18. The DCD Exception - Rare Legally declared brain dead Meets age & medical criteria for ‘eligible’ Recovered under a DCD protocol Reported as DCD donor Counted as: “Donor meeting eligible death criteria” for conversion rate calculations DCD for Percent DCD calculations

19. The Brain Death Challenge Patients who are physically brain dead but have not been pronounced may be “eligible” in reality, but are not counted in rates Inconsistent picture of true potential

20. Conversion of Eligible DeathsJanuary 2008 – June 2010Data as of August 28, 2010

21. Validated Eligible DeathsConversion Rates

29. Considerations for the Future Better addressing the impact of imminent death definitions into rates Factoring out multi-system organ failure (OPO Committee working on this) Evaluate changing age criterion (70?75? OPO Committee working on this)

30. Contact Information Teresa Beigay, DrPH Director, Special Donation Initiatives 301-443-5464 tbeigay@hrsa.gov John Rosendale Biostatistician, UNOS 804-782-4656 rosendjd@unos.org