Bringing transparency to federal inspections
Tag No.: A0115
Based on record review, policy review, video review, document review, and interview, the Hospital failed to ensure Patient Rights requirements were met when the hospital failed to inform families of their rights to make decisions about patient care. Failure to inform families of the right to make and allow them to make decisions about the patients care has the potential to cause emotional pain, grief and mistrust.
Findings Include:
1. The hospital failed to ensure family was informed of their right to make decisions about the patients care or the option to decline organ donation. (Refer to Tag A-0131)
Tag No.: A0131
Based on record review, policy review, video review, document review, and interview, the Hospital failed to ensure the family was informed of their right to make decisions about the patients care or the option to decline organ donation for of 1 (Patient 1) of 10 potential organ donors reviewed. Failure of the hospital to inform the patient's family of their right to make informed decisions about the patients care and allow the family to decline organ donation places families at risk for emotional pain, grief and suffering during the loss of their loved one.
Findings Include:
Review of a hospital policy titled, Patient Rights and Responsibilities" effective date 03/17/22, documented, "PATIENT RIGHTS Overland Park Regional Medical Center respects the dignity and pride of each individual we serve. We comply with applicable Federal civil rights laws and do not discriminate on the basis of age, gender, disability, race, color, ancestry, citizenship, religion, pregnancy, sexual orientation, gender identity or expression, national origin, medical condition, marital status, veteran status, payment source or ability, or any other basis prohibited by federal, state, or local law. Each individual shall be informed of the patient's rights and responsibilities in advance of administering or discontinuing patient care. We adopt and affirm as policy the following rights of patient/clients who receive services from our facilities: ...Information regarding Health Status and Care o To be informed of his/her health status in terms that patient can reasonably be expected to understand, and to participate in the development and the implementation of his/her plan of care and treatment. ... Decision Making and Notification o To choose a person to be his/her healthcare representative and/or decision maker... o To request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. ... Ethical Decisions o To participate in ethical decisions that may arise in the course of care including issues of conflict resolution, withholding resuscitative services, foregoing or withdrawal of life sustaining treatment, and participation in investigational studies or clinical trials ... Protective Services o To access protective and advocacy services o To have upon request an impartial review of hazardous treatments or irreversible surgical treatments prior to implementation except in emergency procedures necessary to preserve one's life
Review of a hospital policy titled, "Organ and Tissue Donation and Retrieval" effective date 07/15/21 showed, "POLICY: In accordance with the Uniform Anatomical Gift Act, it is the policy of Overland Park Regional Medical Center to offer the option of organs, tissues and/or eyes donation for any deceased patient who meets donation criteria. The hospital provides full support to the patient and the patient's family during the decision-making and donation process ... ...NOTE: First Person Authorization is also known as Donor Designation = Legally Binding Decision for Donation. A donor may make an anatomical gift by a statement or symbol indicating that the donor has made an anatomical gift to be imprinted on the donor's driver's license or identification card and included on a donor database registry. Making an anatomical (organ, eye, tissue) gift upon death, is legally the same as designating a will or providing a testament of the decedent's wishes on how one wants their estate to be managed and personal property to be distributed. ...V. Care of Family A. All staff will provide the family the time and support as they acknowledge their loss. B. Nurse, social worker, house supervisor, and physician answer questions and address the concerns of the family, involving [OPO] staff as much as needed ..."
Review of the Kansas Statute Annotated (KSA) 65-3228. Who may make anatomical gift of decedent's body or part. (a) Subject to subsections (b) and (c) and unless barred by K.S.A. 65-3226 or 65-3227, and amendments thereto, an anatomical gift of a decedent's body or part for purpose of transplantation, therapy, research or education may be made by any member of the following classes of persons who is reasonably available, in the order of priority listed:
(1) An agent of the decedent at the time of death who could have made an anatomical gift under K.S.A. 65-3223(2), and amendments thereto, immediately before the decedent's death;
(2) the spouse of the decedent;
(3) adult children of the decedent;
(4) parents of the decedent;
(5) adult siblings of the decedent;
(6) adult grandchildren of the decedent;
(7) grandparents of the decedent;
(8) the persons who were acting as the guardians of the person of the decedent at the time of death;
(9) an adult who exhibited special care and concern for the decedent and who was familiar with the decedent's personal values; and
(10) any other person having the authority to dispose of the decedent's body.
(b) If there is more than one member of a class listed in subsection (a)(1), (3), (4), (6), (7), or (9) entitled to make an anatomical gift, an anatomical gift may be made by a member of the class unless that member or a person to which the gift may pass under K.S.A. 65-3230, and amendments thereto, knows of an objection by another member of the class. If an objection is known, the gift may be made only by a majority of the members of the class who are reasonably available. If both parents are living and available to decide, an anatomical gift may be made only if both parents agree.
(c) A person may not make an anatomical gift if, at the time of the decedent's death, a person in a prior class under subsection (a) is reasonably available to make or to object to the making of an anatomical gift.
65-3229. Manner of making, amending, or revoking anatomical gift of decedent's body or part. (a) A person authorized to make an anatomical gift under K.S.A. 65-3228, and amendments thereto, may make an anatomical gift by a document of gift signed by the person making the gift or by that person's oral communication that is electronically recorded or is contemporaneously reduced to a record and signed by the individual receiving the oral communication.
(b) Subject to subsection (d) [c], an anatomical gift by a person authorized under K.S.A. 65-3228, and amendments thereto, may be amended or revoked orally or in a record by any member of a prior class who is reasonably available. If more than one member of the prior class is reasonably available, the gift made by a person authorized under K.S.A. 65-3228, and amendments thereto, may be:
(1) Amended only if a majority of the reasonably available members agree to the amending of the gift; or
(2) revoked only if a majority of the reasonably available members agree to the revoking of the gift or if they are equally divided as to whether to revoke the gift.
(c) A revocation under subsection (b) is effective only if, before an incision has been made to remove a part from the donor's body or before invasive procedures have begun to prepare the recipient, the procurement organization, transplant hospital, or physician or technician knows of the revocation.
Review of hospital policy titled "Organ Donation After Cardiac Death" revised 7/2021 documented, " ...PROCEDURE: A. GENERAL CONSIDERATIONS AND ASSUMPTIONS ...4. If first person donor designation is opposed, refer to First Person Opposition Algorithm ... F. WITHDRAWAL OF SUPPORT AND PRONOUNCEMENT OF DEATH ... 6. Continuous care and support will be provided to the family during the withdrawal of care process ...G. CARE OF THE DONOR FAMILY 1. Designate a family support person from the hospital staff (nurse, social worker, chaplain) to partner with [OPO] personnel ..."
Review of hospital document titled "Organ & Tissue Donation, First Person Authorization Opposition Algorithm" dated 12/22/17 documented steps to follow when there is opposition to first person organ donation. The algorithm path begins with verification of First-Person Authorization (FPA) by the OPO organization. If the patient is not an eligible donor, the donation process is stopped. If the patient is an eligible donor, then the OPO has a huddle, first meeting with the Family Support Coordinator (FSC), Registered Nurse (RN), and the family. If there is opposition to the donation, continue with donor management and retrieval process and provide family time, support and education. The algorithm path then leads to "Ethics Consult" branching to an OPO Huddle involving the FSC x 2, Hospital Services Coordinator (HSC), Administrator on call (AOC), and Uniform Anatomical Gift Act (UAGA) copy and a hospital huddle involving the ICU Director, Director of Risk Management, House supervisor/Director of Case Management, attending physician and intensivist. The algorithm path then leads to OPO huddle and family meeting #2. Following the second family meeting, if there is still opposition, the algorithm path leads to, continue with donor management and retrieval process and provide family time, support and education from there the path leads to OPO: OP director, HSC, AOC, Corporate Offices, the OPO Chief Executive Officer (CEO), Chief Operating Officer (COO) and legal counsel. The hospital huddle involves the Nurse Executive on-call, ICU Director, Director of Risk Management, Public Relations (PR), CEO, COO and legal counsel. This section of the algorithm then leads to the OPO final huddle, family meeting #3. The hospital huddle that involves CEO, COO and legal counsel then leads to the hospital supports donation in consideration to opposition, if the answer is no, the OPO leaves the facility and the hospital assumes care, if the hospital supports donation in consideration to opposition, then the path leads to organ application with plan to move to the operating room and continue family support.
Patient 1
Review of Patient 1's closed medical record showed a 21-year-old admitted on 10/04/21 with a diagnosis of Diffuse Traumatic Brain Injury (tearing of the brain long connecting nerve fibers when the brain is injured) from gunshot wound (GSW) with Loss of Consciousness (loss of awareness of oneself and one's surroundings) and death due to brain injury.
Review of "Neurosurgical Consultation" on 10/04/21 at 7:28 AM showed " ...Unfortunately [Patient 1] has suffered a devastating brain injury, the bullet has traveled through both hemispheres (sides) of his brain, he has poor neurological exam (an assessment of motor and sensory skills, balance and coordination, patient level of awareness and interaction with environment, reflexes and functioning of the nerves) ...At this time there is not a neurosurgical (brain surgery) procedure that would improve the likelihood of survival."
Review of Patient 1's medical record "HCM Support Services" dated 10/04/21 at 11:36 AM by Staff P, Licensed Master Social Worker (LMSW), prior to patient being declared brain dead showed, "Chart review. Pt [Patient] admitted to the ICU [intensive care unit] following a GSW (gunshot wound) to the head, not self-inflicted. He is unresponsive and, per notes, pt's current GCS (Glasgow Coma Scale a system to score how conscious you are) is 3 (score of 15 means you are awake and score of 3 most severe coma) and he is not likely to survive. OPO (Organ Procurement Organization) has already been contacted. SW (Social Work) remains available to family, who is at bedside."
During an interview on 11/01/23 at 1:15 PM Staff P, LMSW stated that she would only give support if needed but would not provide any support to organ donors once the patient is with the OPO. Staff P stated that she didn't remember anything about Patient 1.
Review of a document in Patient 1's medical record titled, "Examination Guidelines for Brain Death Determination" showed, "this patient meets the criteria for brain death: Date: 10/05/21 Time: 1810" (6:10 PM) and included a physician's signature.
Review of a document titled "Missouri Department of Health and Senior Services Division of Community and Public Health Organ and Tissue Donor Registry Enrollment Record" showed "Donor Profile: Active, Donor Name: [Patient 1], ...Donation Purpose: Transplant/Therapy Only, Gift Specifications: Any needed organs and tissues allowed by law, with the following restrictions; None, None, Enrollment Date: 5/22/2020, Permission Type: Consent, Date of Birth/Age: 1/21/2000 (21), Initial Enrollment Age: 15 ...Registration Type: DOR Driver License ..."
Review of Patient 1's "Missouri Driver License" issued on 05/04/2021, showed Patient 1's name; address, and additional demographics that included an expiration date of 01/21/24, and his date of birth as 01/21/2000.
Patient 1's driver's license did not have the donor symbol on the front of the license or the donor symbol sticker on the back of the license and did not have Patient 1's signature on the back of the license.
Review of document titled "Interoffice Memorandum" dated 10/21/21 showed "To: [Staff AA] From: [Staff BB]; Subject: Anatomical Gift (KS and MO Law) ... I have been asked to advise the hospital on whether its patient's family can revoke or refuse what was otherwise a properly executed anatomical gift. As I understand it, the current patient has what appears to be a properly executed symbol on his Missouri Driver's license indicating a desire to be an anatomical gift donor without restriction. He lives in MO and sustained (sic) the injury in MO, and is now at OPRMC in Kansas. I have researched and concluded that BOTH KS and Missouri recognize the Uniform Anatomical Gift Act. Both states' statutes state, in essence, that in the absence of an (sic) contrary indication by the donor, a person other than the donor is barred ro (sic) making, amending, or revoking an anatomical gift of a donor. There is no evidence to indicate that this license is fraudulent. The patient was 18 years or older as I understand it when he executed the license. A family member therefore cannot prevent his organ donation."
Review of a caselaw document, Frierson v. United States, 2016 U.S. Dist. LEXIS 21808, *16 documented "A decedent's placement on the [anatomical gift registry] does not necessarily provide a definitive conclusion as to [their] status as a donor, given the Gift Act's provisions for the subsequent revocation of an anatomical gift. Comments to UAGA support a family member's ability to revoke and/or refuse an anatomical gift donation. Specifically, the comments on page 46 of UAGA cite to 42 C.F.R. § 482.45 and state, "[I]f a valid refusal with respect to a prospective donor was made known to the procurement organization, for example, by a prospective donor's family, that refusal must be respected."
During an interview on 11/07/23 at 1:02 PM, Staff A, Director of Quality, stated "There is not a copy of [Patient 1]'s driver license in his medical record ..."
During an interview on 11/29/23 at 9:18 AM Staff F, RN, ICU Manager stated " ...I don't recall ever seeing a driver's license, we don't look at the driver's license or the donor registration only OPO (Organ Procurement Organization) does..."
During an interview on 11/29/23 at 9:15 AM, Staff A, Director of Quality, stated that she spoke with the attorney (Staff BB) he did not visualize the driver's license, he was only going off what the hospital said. She stated that the memo dated 10/21/21 was documentation for billing.
During an interview on 11/06/23 at 11:10 AM, Patient 1' Mother stated, "They never had a hard copy of his driver's license since it was in his phone and part of forensic evidence when I ask them to give me the driver's license, they couldn't give it. The only meetings were with nurse [Staff Y, RN, ICU Director], [Staff F, RN, Intensive Care Unit (ICU) Manager] and [OPO staff member], they wanted us to sign a consent on 10/05 we told them no, on 10/6 we told them no, on 10/07 we said no. On the 10/08/21, we thought we were clear in the meetings, sent kids to school. When we got there, they told us that you have 3 hours to say goodbye that they were harvesting him today. I was not given any rights. The last day I kept asking to speak to administration since they didn't have permission. I called the news and police trying to stop it. Right before the walk, [Staff C, MD (Doctor of Medicine), Chief Medical Officer (CMO)] came in the room, there was no meeting, he was very snub and told that the legal team and [Above Named hospital] had agreed to donation."
Review of an undated video showed what appears to be a patient room with glass doors, a person identified as Patient 1's Mother, stated, "We said no, ma'am please, can I get the director of, whoever is over ..." A person identified in the video as Staff Y, RN, ICU Director, stated, "Unfortunately your son signed his driver's license to be an organ donor and we appreciate the gifts he has given and that's all I have to say."
Further review of video showed, Staff Y, RN, ICU Director, and an unknown security guard standing outside of the room with the glass door open. Patient 1's Mother is heard stating "Can you go get whoever is in charge ... ma'am can you go get whoever is in charge I'm asking you please ma'am that is your job. I need to see who's in charge of [Above Named Hospital]. I need to speak to that person ma'am. That is my right. That is my son's right ma'am. We need to speak with them please. That is my son's right, that is [Patient 1's] right. [Patient 1's] family and him need to speak to whoever is in charge of this hospital and the attorneys who you say consent to this ma'am. Yes ma'am. You said they consented to this ma'am. The attorneys." Staff Y, RN, ICU Director is seen standing in doorway shaking her head, begins to speak, then takes off her glasses and shuts the door to room without speaking to family.
Review of video dated 10/08/21 at 11:12 AM showed Patient 1's Mother stating, "You forget that? You forget that for three days? For three days you forget to tell me that you're going to take him off life support this morning. Staff F, RN, ICU Manager stated, "I'm not going to have this discussion with you, ok" Staff F, RN ICU Manager starts to walk off then turns around to face Patient 1's Mother, Patient 1's Mother states "Because y'all wanted his organs that bad you forget to tell me. For three days you talk to me about organs, but you don't tell me you're going to take him off life support." Staff F, RN, ICU Manager, while left hand fingers tapping her right palm, states, "there is no life support to take him off of he is already dead." Patient 1's Mother states, "Ma'am, he's on life support, he's on life support! The video shows Patient 1 in hospital bed with multiple IV's and on a ventilator (machine that breaths for you). You have to tell me, no ma'am", Staff F, RN ICU Manager states "He is already dead, he is already dead."
Review of additional undated video, at 4 minutes and 8 seconds, showed Patient 1 on a hospital bed, in the hallway with intravenous lines (IV's), and multiple unidentified staff wearing masks in the hall, an unidentified security guard, and an unidentified police officer. Patient 1's Mother is heard saying, "We're doing a victory walk." An unknown person, stated "It's an honor walk." Patient 1's Mother stated, "An honor walk. And y'all just notify us three hours ago. The family only gets a three-hour notice. If this was y'all, wouldn't you want more than a three-hour notice of this? Don't we have a right to more than a three-hour notice? Three hours." [Staff Y, RN, ICU Director,] stated, "Please, take your time to say goodbye to [Patient 1], please. Give him a big hug." Patient 1's Mother making what sounds like crying stated, "[Patient 1] they lied to us. They never told us they were doing this, they never. They didn't give us time for emergency. They didn't give us time to get to the courts or anything. They just told us this three hours ago. Three hours. We've been going back and forth about organs for three days. And y'all didn't tell us this is the time y'all were going to be doing this. Then we got this [Staff C, MD, CMO] and he just want a whatever." Review of same video at 9 minutes and 27 seconds showed the unidentified Security Officer leading the family and is heard saying, "I don't want to make it look like I'm escorting y'all out. So, if there's anything I can do." Patient 1's Mother is then heard saying, "We know the way-out sir, thank you."
Review of Patient 1's "Surgical Case Record" dated 10/08/21 with a procedure start time of 1:39 PM and end time of 5:18 PM, showed, "Procedure: RETREIVAL (sic) DONATION AFTER CARDIAC DEATH, HEART, LUNGS BILATERALLY (both sides), LIVER, KIDNEY BILATERALLY." The medical record also showed pancreatectomy (removal of the pancreas).
During an interview on 11/02/23 at 10:16 AM, Staff C, MD, CMO, stated that the algorithm for opposition would not come into play because the patient was a first-person donor and they had two family member's consent, the father and another male individual. He stated that this never went to the ethics committee because they (Patient 1) had a first-person donor, there was a group of people there that had an ethical discussion on if mother should stay but they did not include family in on those discussions. He stated that if he were going to go through this again, they probably would have asked the mother to stay away and thinks there wouldn't have been a TikTok video if the mother was not present.
During an interview on 11/06/23 at 1:29 PM Patient 1's Father, stated that they told the hospital that the family did not want to do organ donation, they were hoping he would pull through this. Patient 1's Father stated that the family never got any support from any staff and were told that they didn't have any rights.
During an interview on 11/09/23 at 9:18 AM Staff F, RN, Intensive Care Unit Manager (ICU), stated, "We do not offer any donation rights to family ..."
During an interview on 11/09/23 at 9:52 AM Staff A, Director of Quality, stated " ...We do not have a donor right policy. The hospital does not give any information pertaining to donation rights to the family or first person opposition."
Patient 1's medical record failed to show documented evidence of communication or meetings with the family regarding the families right to oppose the organ donation, according to KSA 65-3228 ...If an objection is known, the gift may be made only by a majority of the members of the class who are reasonably available... , KSA 65-3229 ...(2) revoked only if a majority of the reasonably available members agree to the revoking of the gift and caselaw, Frierson v. United States ..."[I]f a valid refusal with respect to a prospective donor was made known to the procurement organization, for example, by a prospective donor's family, that refusal must be respected." There was no documentation in the medical record to show any of Patient 1's family (Mother, Father or Stepfather) consented to the donation. Failed to show evidence the Patient Rights were provided to the family. The record failed to show the family was informed of the "Organ & Tissue Donation, First Person Authorization Opposition Algorithm" and failed to show evidence the algorithm was initiated and followed. Review of Patient 1's medical record failed to show evidence of full support to the patient and the patient's family during the decision-making and donation process.
Tag No.: A0884
Based on record review, policy review, video review, document review, and interview, the Hospital failed to ensure the requirement for organ, tissue and eye procurement were met. Failure to ensure the requirements for organ, tissue and eye procurement are met places potential donor families at risk for not being fully informed of options or ability to decline a donation leading to misunderstandings, emotional pain, unmet emotional support, grief and a violation of patient rights.
Findings Include:
1. The Hospital failed to show evidence of collaboration with the Organ Procurement Organization (OPO). (Refer to Tag A-0888)
2. The Hospital failed to ensure discretion and sensitivity was provided to a patient's family. (Refer to Tag A-0890)
Tag No.: A0888
Based on record review, policy review, video review, document review, and interview, the Hospital failed to show evidence of collaboration with the Organ Procurement Organization (OPO) to ensure that the family of 1 (Patient 1) of 10 potential donors was informed of their option to decline donation of organs, tissues or eyes. Failure to collaborate with the OPO places the patient's family at risk for not being fully informed of the options or ability to decline the donation leading to misunderstandings, emotional pain, and grief for the family.
Findings Include:
Review of a hospital policy titled, "Organ and Tissue Donation and Retrieval" effective date 07/15/21 showed, "POLICY: In accordance with the Uniform Anatomical Gift Act [UAGA], it is the policy of Overland Park Regional Medical Center to offer the option of organs, tissues and/or eyes donation for any deceased patient who meets donation criteria. The hospital provides full support to the patient and the patient's family during the decision-making and donation process ... ...NOTE: First Person Authorization is also known as Donor Designation = Legally Binding Decision for Donation. A donor may make an anatomical gift by a statement or symbol indicating that the donor has made an anatomical gift to be imprinted on the donor's driver's license or identification card and included on a donor database registry. Making an anatomical (organ, eye, tissue) gift upon death, is legally the same as designating a will or providing a testament of the decedent's wishes on how one wants their estate to be managed and personal property to be distributed. D. [OPO] Coordinator will provide the following information to the legal next of kin to insure informed authorization: ...10. If any conflict among next of kin or DPOA (Durable Power of Attorney), you must consult Risk Management or the Administrator-on-call to obtain legal advice ...V. Care of Family B. Nurse, social worker, house supervisor, and physician answer questions and address the concerns of the family, involving [OPO] staff as much as needed ..."
Review of a caselaw document, Frierson v. United States, 2016 U.S. Dist. LEXIS 21808, *16 stating "A decedent's placement on the [anatomical gift registry] does not necessarily provide a definitive conclusion as to [their] status as a donor, given the Gift Act's provisions for the subsequent revocation of an anatomical gift. Comments to UAGA support a family member's ability to revoke and/or refuse an anatomical gift donation. Specifically, the comments on page 46 of UAGA cite to 42 C.F.R. § 482.45 and state, "[I]f a valid refusal with respect to a prospective donor was made known to the procurement organization, for example, by a prospective donor's family, that refusal must be respected."
Review of hospital policy titled "Organ Donation After Cardiac Death" revised 7/2021 showed, " ...PROCEDURE: A. GENERAL CONSIDERATIONS AND ASSUMPTIONS ... ...D. AUTHOR 1. [OPO], in collaboration with the hospital care team will inform the patient's legal next of kin of their opportunity for organ donation, only after the family and medical staff have determined that life support will be discontinued. This process will be carried out with sensitivity and discretion at all times ...4. If first person donor designation is opposed, refer to First Person Opposition Algorithm ... F. WITHDRAWAL OF SUPPORT AND PRONOUNCEMENT OF DEATH ... 6. Continuous care and support will be provided to the family during the withdrawal of care process ...G. CARE OF THE DONOR FAMILY 1. Designate a family support person from the hospital staff (nurse, social worker, chaplain) to partner with [OPO] personnel ..."
Review of hospital document titled "Organ & Tissue Donation, First Person Authorization Opposition Algorithm" dated 12/22/17 documented steps to follow when there is opposition to first person organ donation. The algorithm path begins with verification of First-Person Authorization (FPA) by the OPO organization. If the patient is not an eligible donor, the donation process is stopped. If the patient is an eligible donor, then the OPO has a huddle, first meeting with the Family Support Coordinator (FSC), Registered Nurse (RN), and the family. If there is opposition to the donation, continue with donor management and retrieval process and provide family time, support and education. The algorithm path then leads to "Ethics Consult" branching to an OPO Huddle involving the FSC x 2, Hospital Services Coordinator (HSC), Administrator on call (AOC), and Uniform Anatomical Gift Act (UAGA) copy and a hospital huddle involving the ICU Director, Director of Risk Management, House supervisor/Director of Case Management, attending physician and intensivist. The algorithm path then leads to OPO huddle and family meeting #2. Following the second family meeting, if there is still opposition, the algorithm path leads to, continue with donor management and retrieval process and provide family time, support and education from there the path leads to OPO: OP director, HSC, AOC, Corporate Offices, the OPO Chief Executive Officer (CEO), Chief Operating Officer (COO) and legal counsel. The hospital huddle involves the Nurse Executive on-call, ICU Director, Director of Risk Management, Public Relations (PR), CEO, COO and legal counsel. This section of the algorithm then leads to the OPO final huddle, family meeting #3. The hospital huddle that involves CEO, COO and legal counsel then leads to the hospital supports donation in consideration to opposition, if the answer is no, the OPO leaves the facility and the hospital assumes care, if the hospital supports donation in consideration to opposition, then the path leads to organ application with plan to move to the operating room and continue family support.
Review of hospital document titled "Agreement Between [OPO] and Above Named Hospital" dated 01/10/18 showed " ...Whereas, the Hospital wishes to collaborate with [OPO] in facilitating the wishes of organ and tissue donors and families of patients who die at the Hospital along with mutual dedication to increasing the availability of organs and tissues for transplantation and research ... Create protocols between [OPO] and the Hospital which provide for cooperation by the Hospital with [OPO] to facilitate the donation of organs and tissues for transplantation, therapy, education or research as follows: a. if the patient is [a designated donor} first person authorized, the Hospital staff shall comply with the patient wishes and take all steps necessary and consistent with Hospital legal obligations, to give effect to those wishes ... IN the case of First Person Authorization, documentation is not limited to a donor card or donation registry, but includes any documentation signed by the individual that clearly states his/her wishes to donate organs, tissue and/or eyes, in compliance with state laws ...d. comply with the requirements of §42 U.S.C. 132ob-8(a), the state uniform anatomical gift act, and other legal requirements applicable to organ donation, Furthermore, the hospital will work with [OPO] to create a collaborative team approach to ensure that all families of potential donors are sensitively informed about gift of organs, tissues or eyes made by their family members valid document of gift as defined by the state anatomical gift act ..."
Patient 1
Review of Patient 1 closed medical record showed a 21-year-old admitted on 10/04/21 with a diagnosis of Diffuse Traumatic Brain Injury (tearing of the brain long connecting nerve fibers when the brain is injured) from gunshot wound with Loss of Consciousness (loss of awareness of oneself and one's surroundings) and death due to brain injury.
Review of "Neurosurgical Consultation" on 10/04/21 at 7:28 AM showed " ...Unfortunately [Patient 1] has suffered a devastating brain injury, the bullet has traveled through both hemispheres (sides) of his brain, he has poor neurological exam (an assessment of motor and sensory skills, balance and coordination, patient level of awareness and interaction with environment, reflexes and functioning of the nerves) ...At this time there is not a neurosurgical (brain surgery) procedure that would improve the likelihood of survival."
Review of a document in Patient 1's medical record titled, "Examination Guidelines for Brain Death Determination" showed, "this patient meets the criteria for brain death: Date: 10/05/21 Time: 1810" (6:10 PM) and included a physician's signature.
Review of document in Patient 1's medical record titled "Missouri Department of Health and Senior Services Division of Community and Public Health Organ and Tissue Donor Registry Enrollment Record" showed "Donor Profile: Active, Donor Name: [Patient 1], ...Donation Purpose: Transplant/Therapy Only, Gift Specifications: Any needed organs and tissues allowed by law, with the following restrictions; None, None, Enrollment Date: 5/22/2020, Permission Type: Consent, Date of Birth/Age: 1/21/2000 (21), Initial Enrollment Age: 15 ...Registration Type: DOR Driver License ..."
Review of Patient 1's "Missouri Driver License" issued on 05/04/2021, showed Patient 1's name; address, and additional demographics that included an expiration date of 01/21/24, and his date of birth as 01/21/2000.
Patient 1's driver's license did not have the donor symbol on the front of the license or the donor symbol sticker on the back of the license and did not have Patient 1's signature on the back of the license.
Review of Patient 1's medical record failed to have a copy of Patient 1's driver's license.
During an interview on 11/07/23 at 1:02 PM, Staff A, Director of Quality, stated "There is not a copy of [Patient 1]'s driver license in his medical record ..."
During an interview on 11/29/23 at 9:18 AM Staff F, RN, ICU Manager stated " ...I don't recall ever seeing a driver's license, we don't look at the driver's license or the donor registration only OPO (Organ Procurement Organization) does..."
During an interview on 11/29/23 at 9:15 AM, Staff A, Director of Quality, stated that she spoke with the attorney (Staff BB) he did not visualize the driver's license, he was only going off what the hospital said. She stated that the memo dated 10/21/21 was documentation for billing.
Review of an undated video showed what appears to be a patient room with glass doors, a person identified as Patient 1's Mother, stated, "We said no, ma'am please, can I get the director of, whoever is over ..." A person identified in the video as Staff Y, RN, ICU Director, stated, "Unfortunately your son signed his driver's license to be an organ donor and we appreciate the gifts he has given and that's all I have to say."
Further review of video showed, Staff Y, RN, ICU Director, and an unknown security guard standing outside of the room with the glass door open. Patient 1's Mother is heard stating "Can you go get whoever is in charge ... ma'am can you go get whoever is in charge I'm asking you please ma'am that is your job. I need to see who's in charge of [Above Named Hospital]. I need to speak to that person ma'am. That is my right. That is my son's right ma'am. We need to speak with them please. That is my son's right, that is [Patient 1's] right. [Patient 1's] family and him need to speak to whoever is in charge of this hospital and the attorneys who you say consent to this ma'am. Yes ma'am. You said they consented to this ma'am. The attorneys." Staff Y, RN, ICU Director is seen standing in doorway shaking her head, tries to speak, then takes off her glasses and shuts the door to room without speaking to family.
Review of additional undated video, at 4 minutes and 8 seconds, showed Patient 1 on a hospital bed, in the hallway with intravenous lines (IV's), and multiple unidentified staff wearing masks in the hall, an unidentified security guard, and an unidentified police officer. Patient 1's Mother is heard saying, "We're doing a victory walk." An unknown person, stated "It's an honor walk." Patient 1's Mother stated, "An honor walk. And y'all just notify us three hours ago. The family only gets a three-hour notice. If this was y'all, wouldn't you want more than a three-hour notice of this? Don't we have a right to more than a three-hour notice? Three hours." [Staff Y, RN, ICU Director,] stated, "Please, take your time to say goodbye to [Patient 1], please. Give him a big hug." Patient 1's Mother making what sounds like crying stated, "[Patient 1] they lied to us. They never told us they were doing this, they never. They didn't give us time for emergency. They didn't give us time to get to the courts or anything. They just told us this three hours ago. Three hours. We've been going back and forth about organs for three days. And y'all didn't tell us this is the time y'all were going to be doing this. Then we got this [Staff C, MD, CMO] and he just want a whatever." Review of same video at 9 minutes and 27 seconds showed the unidentified Security Officer leading the family and is heard saying, "I don't want to make it look like I'm escorting y'all out. So, if there's anything I can do." Patient 1's Mother is then heard saying, "We know the way-out sir, thank you."
Review of Patient 1's "Surgical Case Record" dated 10/08/21 with a procedure start time of 1:39 PM and end time of 5:18 PM, showed, "Procedure: RETREIVAL (sic) DONATION AFTER CARDIAC DEATH, HEART, LUNGS BILATERALLY (both sides), LIVER, KIDNEY BILATERALLY." The medical record also showed pancreatectomy (removal of the pancreas).
During an interview on 10/30/23 at 4:30 PM, Staff A, Director of Quality, stated, "[OPO] transplant does not want to share their records, we told them that you were needing them."
During an interview on 10/31/23 at 12:03 PM, Staff C1, Attorney for the OPO, stated, "I will need a subpoena for any medical records since you do not regulate us."
During an interview on 10/31/23 at 3:15 PM, Staff C, MD, CMO, stated that Patient 1's Mother was objecting so hospital staff had a meeting the day before with legal to make sure the hospital was in the right of the things the hospital was doing. The family was not present for any meetings. On the last day before surgery, the mother asked to speak to him. Staff C stated that Patient 1's mother wasn't yelling but was tearful and angry. Staff C stated that he was trying to tell the mother what was going on and why the hospital couldn't stop. He stated that a first person consent is a binding contract. Staff C stated that when he first got involved and spoke to Patient 1's mother, Patient 1 had signed up twice for donation and it was a legal contract and the hospital had to follow a process. When asked how the process was identified, Staff C stated that he was at the 11th hour on how they validate the driver's license and the OPO would be able to speak to that. Staff C stated that he couldn't give the mother the answer that she wanted. He stated that the hospital went above and beyond. Staff C stated that the hospital staff just saw it as the mother being angry, and the hospital would not have been able to solve anything.
During an interview on 11/01/23 on 3:03 PM Staff T, CEO, stated "I was not part of meeting with family or speaking to the family directly. I was only in conversation with the lawyer."
During an interview on 11/02/23 at 10:16 AM, Staff C, MD, CMO, stated that the algorithm for opposition would not come into play because the patient was a first-person donor and they had two family member's consent. He stated that this never went to the ethics committee because they (Patient 1) had a first-person donor, there was a group of people there that had an ethical discussion on if mother should stay but they did not include family in on those discussions. He stated that if he were going to go through this again, they probably would have asked the mother to stay away and thinks there wouldn't have been a TikTok video if the mother was not present.
During an interview on 11/06/23 at 11:10 AM, Patient 1's Mother stated, "They never had a hard copy of his driver's license since it was in his phone and part of forensic evidence. When I ask them to give me the driver's license, they couldn't give it. The only meetings were with nurse [Staff Y, RN, ICU Director], [Staff F, RN, Intensive Care Unit (ICU) Manager] and [OPO staff member], they wanted us to sign a consent on 10/05 we told them no, on 10/6 we told them no, on 10/07 we said no. ...The last day I kept asking to speak to administration since they didn't have permission. I called the news and police trying to stop it. Right before the walk, [Staff C, MD (Doctor of Medicine), Chief Medical Officer (CMO)] came in the room there was no meeting, he was very snub and told that legal team and [the hospital] had agreed to donation."
During an interview on 11/06/23 at 1:29 PM Patient 1's Father, stated that they told the hospital that the family did not want to do organ donation, they were hoping he would pull through this. Patient 1's Father stated that the family never got any support from any staff and were told that they didn't have any rights.
There was no documented evidence in Patient 1's medical record, of communication or collaboration with the OPO regarding Patient 1's family's opposition to the organ donation, there was no evidence of collaborative meetings between the hospital and OPO with Patient 1's family. There was no documented evidence in the medical record to show a nurse, social worker, house supervisor, or physician answered questions, addressed the concerns of the family or involved the OPO staff regarding the family's opposition of the organ donation. There was no documented evidence in the medical record of a hospital staff designated as the family support person (nurse, social worker, chaplain) to partner with OPO personnel. There was no documentation in the medical record to show any of Patient 1's family (Mother, Father or Stepfather) consented to the donation. There was no evidence in the medical record to show that the "Organ & Tissue Donation, First Person Authorization Opposition Algorithm" was initiated or followed by the hospital regarding the family's opposition of Patient 1's first person donor designation in violation of the hospitals own policies and procedures.
Tag No.: A0890
Based on record review, policy review, video review, document review, and interview, the Hospital failed to ensure discretion and sensitivity was provided to the family of 1 (Patient 1) of 10 potential donors. Failure to ensure discretion and sensitivity with respect to the circumstances, views, and beliefs of the family places the family at risk for emotional pain and heightened grief during the loss of their loved one.
Findings Include:
Review of hospital document titled "Agreement Between [OPO] and Above Named Hospital" dated 01/10/2018 documented, ... Furthermore, the hospital will work with [OPO] to create a collaborative team approach to ensure that all families of potential donors are sensitively informed about gift of organs, tissues or eyes made by their family members valid document of gift as defined by the state anatomical gift act ..."
Review of a hospital policy titled, "Organ and Tissue Donation and Retrieval" effective date 07/15/21 documented, " ...The hospital provides full support to the patient and the patient's family during the decision-making and donation process ... ...NOTE: First Person Authorization is also known as Donor Designation = Legally Binding Decision for Donation. A donor may make an anatomical gift by a statement or symbol indicating that the donor has made an anatomical gift to be imprinted on the donor's driver's license or identification card and included on a donor database registry. Making an anatomical (organ, eye, tissue) gift upon death, is legally the same as designating a will or providing a testament of the decedent's wishes on how one wants their estate to be managed and personal property to be distributed. D. [OPO] Coordinator will provide the following information to the legal next of kin to insure informed authorization: ...10. If any conflict among next of kin or DPOA (Durable Power of Attorney), you must consult Risk Management or the Administrator-on-call to obtain legal advice ...V. Care of Family B. Nurse, social worker, house supervisor, and physician answer questions and address the concerns of the family, involving [OPO] staff as much as needed.
Review of hospital policy titled "Organ Donation After Cardiac Death" revised 7/2021 documented, " ...PROCEDURE: A. GENERAL CONSIDERATIONS AND ASSUMPTIONS ... ...D. AUTHOR 1. [OPO], in collaboration with the hospital care team will inform the patient's legal next of kin of their opportunity for organ donation, only after the family and medical staff have determined that life support will be discontinued. This process will be carried out with sensitivity and discretion at all times ...4. If first person donor designation is opposed, refer to First Person Opposition Algorithm ... F. WITHDRAWAL OF SUPPORT AND PRONOUNCEMENT OF DEATH ... 6. Continuous care and support will be provided to the family during the withdrawal of care process ...G. CARE OF THE DONOR FAMILY 1. Designate a family support person from the hospital staff (nurse, social worker, chaplain) to partner with [OPO] personnel. 2. Offer spiritual support, if appropriate. 3. Be flexible in determining how the family want to say "goodbye" to their loved one. Options my include, but are not limited to the following: The family can say goodbye in the ICU, and follow-up communication will be facilitated by the [Organ Procurement Organization] coordinator; or The patient will be transferred to a designated area in close proximity to the OR suite (such as the cath lab, minor room, or PACU), where the withdrawal of care and family support can be carried out; or after the recovery of organs, in a private area post-op."
Review of hospital document titled "Organ & Tissue Donation, First Person Authorization Opposition Algorithm" dated 12/22/17 documented steps to follow when there is opposition to first person organ donation. The algorithm path begins with verification of First-Person Authorization (FPA) by the OPO organization. If the patient is not an eligible donor, the donation process is stopped. If the patient is an eligible donor, then the OPO has a huddle, first meeting with the Family Support Coordinator (FSC), Registered Nurse (RN), and the family. If there is opposition to the donation, continue with donor management and retrieval process and provide family time, support and education. The algorithm path then leads to "Ethics Consult" branching to an OPO Huddle involving the FSC x 2, Hospital Services Coordinator (HSC), Administrator on call (AOC), and Uniform Anatomical Gift Act (UAGA) copy and a hospital huddle involving the ICU Director, Director of Risk Management, House supervisor/Director of Case Management, attending physician and intensivist. The algorithm path then leads to OPO huddle and family meeting #2. Following the second family meeting, if there is still opposition, the algorithm path leads to, continue with donor management and retrieval process and provide family time, support and education from there the path leads to OPO: OP director, HSC, AOC, Corporate Offices, the OPO Chief Executive Officer (CEO), Chief Operating Officer (COO) and legal counsel. The hospital huddle involves the Nurse Executive on-call, ICU Director, Director of Risk Management, Public Relations (PR), CEO, COO and legal counsel. This section of the algorithm then leads to the OPO final huddle, family meeting #3. The hospital huddle that involves CEO, COO and legal counsel then leads to the hospital supports donation in consideration to opposition, if the answer is no, the OPO leaves the facility and the hospital assumes care, if the hospital supports donation in consideration to opposition, then the path leads to organ application with plan to move to the operating room and continue family support.
Patient 1
Review of Patient 1 closed medical record showed a 21-year-old admitted on 10/04/21 with a diagnosis of Diffuse Traumatic Brain Injury (tearing of the brain long connecting nerve fibers when the brain is injured) from gunshot wound with Loss of Consciousness (loss of awareness of oneself and one's surroundings) and death due to brain injury.
Review of "Neurosurgical Consultation" on 10/04/21 at 7:28 AM showed " ...Unfortunately [Patient 1] has suffered a devastating brain injury, the bullet has traveled through both hemispheres (sides) of his brain, he has poor neurological exam (an assessment of motor and sensory skills, balance and coordination, patient level of awareness and interaction with environment, reflexes and functioning of the nerves) ...At this time there is not a neurosurgical (brain surgery) procedure that would improve the likelihood of survival."
Review of Patient 1's medical record "HCM Support Services" dated 10/04/21 at 11:36 AM by Staff P, Licensed Master Social Worker (LMSW), prior to patient being declared brain dead showed, "Chart review. Pt [Patient] admitted to the ICU [intensive care unit] following a GSW (gunshot wound) to the head, not self-inflicted. He is unresponsive and, per notes, pt's current GCS (Glasgow Coma Scale a system to score how conscious you are) is 3 (score of 15 means you are awake and score of 3 most severe coma) and he is not likely to survive. OPO (Organ Procurement Organization) has already been contacted. SW (Social Work) remains available to family, who is at bedside."
During an interview on 11/01/23 at 1:15 PM Staff P, LMSW stated that she would only give support if needed but would not provide any support to organ donors once the patient is with the OPO. Staff P stated that she didn't remember anything about Patient 1.
Review of a document in Patient 1's medical record titled, "Examination Guidelines for Brain Death Determination" showed, "this patient meets the criteria for brain death: Date: 10/05/21 Time: 1810" (6:10 PM) and included a physician's signature.
Review of document in Patient 1's medical record titled "Missouri Department of Health and Senior Services Division of Community and Public Health Organ and Tissue Donor Registry Enrollment Record" showed "Donor Profile: Active, Donor Name: [Patient 1], ...Donation Purpose: Transplant/Therapy Only, Gift Specifications: Any needed organs and tissues allowed by law, with the following restrictions; None, None, Enrollment Date: 5/22/2020, Permission Type: Consent, Date of Birth/Age: 1/21/2000 (21), Initial Enrollment Age: 15 ...Registration Type: DOR Driver License ..."
Review of Patient 1's "Missouri Driver License" issued on 05/04/2021, showed Patient 1's name; address, and additional demographics that included an expiration date of 01/21/24, and his date of birth as 01/21/2000.
Patient 1's driver's license did not have the donor symbol on the front of the license or the donor symbol sticker on the back of the license and did not have Patient 1's signature on the back of the license.
Review of Patient 1's medical record failed to have a copy of Patient 1's driver's license.
Review of a document in Patient 1's medical record titled "Kansas Registry Removal/Revocation Form" showed, " ...Participant name; [Patient 1]; ...Initial The Appropriate Category; I am the parent/guardian of the child being removed from the registry. My relationship to the child is: Mother; Please remove my name from the Kansas Organ and Tissue Donor Registry. This is not a refusal to be a donor.; Signature (Parent/Guardian if removing a child) [Patient 1 Mother]; Date 10/07/21 ..."
During an interview on 11/28/23 at 5:05 PM Patient 1's Mother stated "I filled out the Kansas registry removal revocation after a news anchor told me to look up his name on the Kansas registry, and I knew he was not on the registry, it was precautionary. I submitted it anyway to Kansas and showed them as well. [Patient 1] never lived in Kansas or had a driver's license in Kansas ..."
Review of document titled "[Patient 1]- NOTES" showed "Grievance/Complaint Date: 10/07/21; Case, [Patient 1] ...Date of Discharge 10/06/21; date of event 10/05/21; Complainant: [Patient 1's Mother]- Her husband- Pt Father; Type: Organ donation; Summary of issue 10/07/21 about 1600 (4:00 PM) [Staff Y, RN, ICU Director] and [Staff F, RN, ICU Manager] came to my office. Patient was determined brain dead on Tuesday (10/05/21). (GSW victim on Missouri side -4 people in the car. One other dead and another injured. Pt also lives in MO (Missouri) Pt signed back of driver's license to be an organ donor (signed originally at 15.5 years old and again about 1 year ago when license was update.) [OPO], and ICU (intensive care unit) have been working with parents to understand he is organ donor. Father agrees. Mother is not in agreement. Contacted [Staff CC Attorney]- she brought [Staff BB Attorney] into case. [Staff C, MD, CMO] and [Staff T, CEO]- updated on case. [Staff BB Attorney] gave okay to procedure with organ retrieval-relayed to [Staff C, MD, CMO] who talked to [Staff T, CEO]- also agreed to organ retrieval. Comments/Resolution; Organ retrieval for the next day 10/08/2021. Mother very upset and talked to [Staff C, MD, CMO] and then to me. Organ retrieval proceeded. Did honor walk- mother recorded and yelled out threats along the way. Father of patient and mother's husband in all conversations and at honor walk."
During an interview on 10/31/23 at 3:15 PM, Staff C, MD, CMO, stated that Patient 1's Mother was objecting so hospital staff had a meeting the day before with legal to make sure the hospital was in the right of the things the hospital was doing. The family was not present for any meetings. On the last day before surgery, the mother asked to speak to him. Staff C stated that Patient 1's mother wasn't yelling but was tearful and angry. Staff C stated that he was trying to tell the mother what was going on and why the hospital couldn't stop. He stated that a first person consent is a binding contract. Staff C stated that when he first got involved and spoke to Patient 1's mother, Patient 1 had signed up twice for donation and it was a legal contract and the hospital had to follow a process. When asked how the process is identified, Staff C stated that he was at the 11th hour on how they validate the driver's license and the OPO would be able to speak to that. Staff C stated that he couldn't give the mother the answer that she wanted. He stated that the hospital went above and beyond. Staff C stated that the hospital staff just saw it as the mother being angry, and the hospital would not have been able to solve anything.
Review of document titled "Interoffice Memorandum" dated 10/21/21 showed "To: [Staff AA] From: [Staff BB]; Subject: Anatomical Gift (KS and MO Law) ... I have been asked to advise the hospital on whether its patient's family can revoke or refuse what was otherwise a properly executed anatomical gift. As I understand it, the current patient has what appears to be a properly executed symbol on his Missouri Driver's license indicating a desire to be an anatomical gift donor without restriction. He lives in MO and sustained (sic) the injury in MO, and is now at OPRMC in Kansas. I have researched and concluded that BOTH KS and Missouri recognize the Uniform Anatomical Gift Act. Both states' statutes state, in essence, that in the absence of an (sic) contrary indication by the donor, a person other than the donor is barred ro (sic) making, amending, or revoking an anatomical gift of a donor. There is no evidence to indicate that this license is fraudulent. The patient was 18 years or older as I understand it when he executed the license. A family member therefore cannot prevent his organ donation."
Review of a caselaw document, Frierson v. United States, 2016 U.S. Dist. LEXIS 21808, *16 documented "A decedent's placement on the [anatomical gift registry] does not necessarily provide a definitive conclusion as to [their] status as a donor, given the Gift Act's provisions for the subsequent revocation of an anatomical gift. Comments to UAGA support a family member's ability to revoke and/or refuse an anatomical gift donation. Specifically, the comments on page 46 of UAGA cite to 42 C.F.R. § 482.45 and state, "[I]f a valid refusal with respect to a prospective donor was made known to the procurement organization, for example, by a prospective donor's family, that refusal must be respected."
During an interview on 11/06/23 at 11:10 AM Patient 1's mother stated "They never had a hard copy of his driver license since it was in his phone and part of forensic evidence.
During an interview on 11/07/23 at 1:02 PM, Staff A, Director of Quality, stated "There is not a copy of [Patient 1]'s driver license in his medical record ..."
During an interview on 11/29/23 at 9:18 AM Staff F, RN, ICU Manager stated " ...I don't recall ever seeing a driver's license, we don't look at the driver's license or the donor registration only OPO (Organ Procurement Organization) does..."
During an interview on 11/29/23 at 9:15 AM, Staff A, Director of Quality, stated that she spoke with the attorney (Staff BB) he did not visualize the driver's license, he was only going off what the hospital said. She stated that the memo dated 10/21/21 was documentation for billing.
During an interview on 11/06/23 at 11:10 AM, Patient 1's mother stated "The only meetings were with nurse [Staff Y, RN, ICU Director], [Staff F, RN, Intensive Care Unit (ICU) Manager] and [OPO staff member], they wanted us to sign a consent on 10/05 we told them no, on 10/6 we told them no, on 10/07 we said no. On the 10/08/21, we thought we were clear in the meetings, sent kids to school. When we got there, they told us that you have 3 hours to say goodbye that they were harvesting him today. I was not given any rights. The last day I kept asking to speak to administration since they didn't have permission. I called the news and police trying to stop it. Right before the walk, Staff C, MD (Doctor of Medicine), Chief Medical Officer (CMO) came in the room there was no meeting, he was very snub and told that legal team and [the hospital] had agreed to donation."
Review of an undated video showed "what appears to be a patient room with glass doors, a person identified as Patient 1's Mother, stated, "We said no, ma'am please, can I get the director of whoever is over ..." A person identified in the video as Staff Y, RN, ICU Director, stated, "Unfortunately your son signed his driver's license to be an organ donor and we appreciate the gifts he has given and that's all I have to say."
Further review of the video showed, Staff Y, RN, ICU Director, and an unknown security guard standing outside of the room with the glass door open. Patient 1's Mother is heard stating "Can you go get whoever is in charge ... ma'am can you go get whoever is in charge I'm asking you please ma'am that is your job. I need to see who's in charge of [Above Named Hospital]. I need to speak to that person ma'am. That is my right. That is my son's right ma'am. We need to speak with them please. That is my son's right, that is [Patient 1's] right. [Patient 1's] family and him need to speak to whoever is in charge of this hospital and the attorneys who you say consent to this ma'am. Yes ma'am. You said they consented to this ma'am. The attorneys." Staff Y, RN, ICU Director is seen standing in doorway shaking her head, tries to speak, then takes off her glasses and shuts the door to room without speaking to family.
During an interview on 10/31/23 at 3:15 PM, Staff C, MD, CMO, stated that Patient 1's Mother was objecting so we had a meeting the day before with legal to make sure we were in the right of the things we were doing. The family was not present for any meetings. On the last day before surgery, she asked to speak to me. She wasn't yelling but was tearful and angry. I was trying to tell her what was going on and why we couldn't stop."
During an interview on 11/02/23 at 10:16 AM, Staff C, MD, CMO, stated that the algorithm for opposition would not come into play because the patient was a first-person donor and they had two family member's consent. He stated that this never went to the ethics committee because they (Patient 1) had a first-person donor, there was a group of people there that had an ethical discussion on if mother should stay but they did not include family in on those discussions. He stated that if he were going to go through this again, they probably would have asked the mother to stay away and thinks there wouldn't have been a TikTok video if the mother was not present.
Review of video dated 10/08/21 at 11:12 AM showed Patient 1's Mother stating, "You forget that? You forget that for three days? For three days you forget to tell me that you're going to take him off life support this morning. Staff F, RN, ICU Manager stated, "I'm not going to have this discussion with you, ok" Staff F, RN ICU Manager starts to walk off then turns around to face Patient 1's Mother, Patient 1's Mother states "Because y'all wanted his organs that bad you forget to tell me. For three days you talk to me about organs, but you don't tell me you're going to take him off life support." Staff F, RN, ICU Manager, while left hand fingers tapping her right palm, states, "there is no life support to take him off of he is already dead." Patient 1's Mother states, "Ma'am, he's on life support, he's on life support! The video shows Patient 1 in hospital bed with multiple IV's and on a ventilator (machine that breaths for you). You have to tell me, no ma'am", Staff F, RN ICU Manager states "He is already dead, he is already dead."
During an interview on 11/06/23 at 1:29 PM, Patient 1's Father, stated that they told the hospital that the family did not want to do organ donation, they were hoping he would pull through this. Patient 1's Father stated that the family never got any support from any staff and were told that they didn't have any rights. They never even said they were sorry about us losing our son.
During an interview on 11/09/23 at 9:18 AM, Staff F, RN, ICU Manager stated, "I remember the mother being upset, she wasn't threatening she just kept saying "[Patient 1] would not consent, it's not what he wanted. She was never physical with anybody, the father and stepfather they never said yes or no to donation they were very cordial."
Review of additional undated video, at 4 minutes and 8 seconds, showed Patient 1 on a hospital bed, in the hallway with IV's, and multiple unidentified staff wearing masks in the hall, an unidentified security guard, and an unidentified police officer. Patient 1's Mother is heard saying, "We're doing a victory walk." An unknown person, stated "It's an honor walk." Patient 1's Mother stated, "An honor walk. And y'all just notify us three hours ago. The family only gets a three-hour notice. If this was y'all, wouldn't you want more than a three-hour notice of this? Don't we have a right to more than a three-hour notice? Three hours." [Staff Y, RN, ICU Director,] stated, "Please, take your time to say goodbye to [Patient 1], please. Give him a big hug." Patient 1's Mother making what sounds like crying stated, "[Patient 1] they lied to us. They never told us they were doing this, they never. They didn't give us time for emergency. They didn't give us time to get to the courts or anything. They just told us this three hours ago. Three hours. We've been going back and forth about organs for three days. And y'all didn't tell us this is the time y'all were going to be doing this. Then we got this [Staff C, MD, CMO] and he just want a whatever." Review of same video at 9 minutes and 27 seconds showed the unidentified Security Officer leading the family and is heard saying, "I don't want to make it look like I'm escorting y'all out. So, if there's anything I can do." Patient 1's Mother is then heard saying, "We know the way-out sir, thank you."
Review of hospital document titled "Report: 2021 -1126398" dated 10/08/21 at 11:50 AM showed " ...At around 1150 (11:50 AM) hours ... responded an Honor walk for patient [1] down to the OR. Prior to this Security called [Police Department] to stand by in case the [Patient 1's mother] got physical with staff. Security responded multiple times to ICU 17 today due to her getting verbally combative with staff. Security stood by both times. [Police Department] Officers ... responded and stood by. Before the walk had started security stood by outside of ICU 17 while [Patient 1's mother] argued with staff about taking the patient downstairs. After a few minutes staff was able to start moving the patient down. The [Patient 1's Mother] was yelling but not in a combative way while we escorted the patient down. Her other family members held her back from getting physical. The patient was taken down to the OR with no issues. Shortly afterwards the [Patient 1's mother] spoke with the [Police Department] and then left. Security cleared at around 1230 (12:30 PM) hours ...."
Review of Patient 1's "Surgical Case Record" dated 10/08/21 with a procedure start time of 1:39 PM and end time of 5:18 PM, showed, "Procedure: RETREIVAL (sic) DONATION AFTER CARDIAC DEATH, HEART, LUNGS BILATERALLY (both sides), LIVER, KIDNEY BILATERALLY." The medical record also showed pancreatectomy (removal of the pancreas).
The hospital failed to show documented evidence in Patient 1's medical record of discretion and sensitivity with respect to the circumstances, views, and beliefs of the family, there was no evidence of any meetings with the family, and there was no documented Social Work notes showing family support following the Support Services chart review dated 10/04/21 at 11:36 AM. There was no documentation in the medical record to show any of Patient 1's family (Mother, Father or Stepfather) consented to the donation. There was no documented evidence of communication or collaboration with the OPO regarding the mother's feelings and opposition of the donation, and the hospital failed to initiate and follow the "Organ & Tissue Donation, First Person Authorization Opposition Algorithm."