HospitalInspections.org

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Based on medical record (MR) review, document review, and interview, the facility failed to ensure that the facility's policy for revocation of consent to donate was met.

Findings:

- The facility failed to ensure a statement of an anatomical gift revocation was made in the presence of a disinterested witness, as per facility policy and New York State (NYS) law.
(See Tag A-0885)

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Based on medical record (MR) review, document review, and interview, the facility failed to ensure a statement of an anatomical gift revocation was made in the presence of a disinterested witness, as per facility policy and New York State (NYS) Law.

Specifically, MR review found one (1) of 19 medical records with referrals to the OPO (Organ Procurement Organization) had concerns with donation revocation. This record was for the index case. All other records that were reviewed showed that the referrals resulted in donation evaluation per the policy.

This failure may have resulted in the loss of donor organs suitable for transplantation.

Findings:

The facility policy and procedure (P&P) titled, "Organ/Tissue Donation and Retrieval Following Death," last revised March 2023, stated the following: "Amendment or Revocation of an Anatomical Gift: ...Persons authorized to make an Anatomical Gift ...may revoke or amend such gift by ...an oral statement of revocation made in the presence of two persons, at least one of whom is a disinterested witness ...A "Disinterested Witness" means a witness other than the spouse, domestic partner, child, parent, sibling, grandchild of the individual who makes, amends, revokes or refuses to make an Anatomical Gift or a close friend or another adult who is related to the Decedent by blood, marriage or adoption ..."

This policy is consistent with NYS Public Health Law 4305 2. a (ii) that states, "An oral statement of revocation, subsequent to the creation of the gift, [must be] made by such individual in the presence of two persons, at least one of whom is a disinterested witness ..."

Review of Patient #1's MR identified the following: This 30-year-old presented to the Emergency Room (ER) on 6/26/2023 after being found unresponsive and not breathing by family at 7:50AM. Family initiated chest compressions and called 911. On arrival, Patient #1's pupils were fixed and dilated, and patient was without central reflexes. A CT scan of the head revealed diffuse cerebral edema and dysfunction [a life-threatening condition that causes fluid to develop in the brain, potentially reducing brain blood flow and decreasing the oxygen the brain receives]. The CT further showed uncal and tonsillar herniation [when rising intracranial pressure causes portions of the brain to move from one compartment to another and the cerebellar tonsils compress the brain stem, obstructing cerebrospinal fluid flow]. Patient #1 showed cerebral blood flow on transcranial dopplers, but alternative brain death examinations could not be performed due to Patient #1's poor clinical status. A decision was made by the family to withdraw care rather than pursue brain death testing when medically stabilized. Patient #1 was registered as an organ donor on the NYS Donor Registry, however, as per family members, Patient #1 had recently denied the desire to donate his organs. Life sustaining care was withdrawn from Patient #1 on 6/29/2023 at 6:26PM.

An Ethics Consult note, dated 6/29/2023 at 10:21AM, stated that an Ethics Consultant met with Patient #1's family. Present in the room were both parents, a fiancée, four (4) siblings, an aunt, an uncle, and another friend - ten (10) people total. Patient #1's mother shared that [Patient #1] had told her that he did not want to be a donor and had meant to change the information...the case has been escalated to senior leadership for procedural and legal input."

There was no documented evidence in the Ethics Consult note that a Disinterested Witness was included or agreed with the statement by the family that Patient #1 had declined to be an organ donor.

Per interview of Staff B (Medical Doctor) on 7/21/2023 at 12:31PM, Staff B stated there were only family members in the room when any discussion of organ donation was held.

There was no documented evidence found which demonstrated the facility ensured at least one disinterested witness had confirmed Patient 1's revocation of organ donation prior to the withdrawal of life sustaining care.