Baptist Health Richmond

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 43147 Based on record review and staff interview, the hospital failed to identify and implement a quality improvement assessment and improvement plan related to organ donations and ensure collaboration with the Organ Procurement Organization (OPO) for medical suitability for one (1) of 12 sampled patients (Patient #1). The findings include: Cross Refer A0283. Based on record review and staff interview, the hospital failed to identify performance improvement opportunities related to organ donations and ensure donor suitability for one (1) of twelve (12) patients reviewed (Patient #1). Specially, the hospital did not identify and put performance improvement measures in place after Patient #1’s medical suitability for organ donation was not appropriately determined and failed to identify that staff did not retain pertinent training on the donation after circulatory death (DCD) process.”

“ORGAN, TISSUE, EYE PROCUREMENT CFR(s): 482.45 Organ, Tissue and Eye Procurement This Condition is not met as evidenced by: 43147 Based on record review and staff interview, the hospital failed to ensure collaboration with the Organ Procurement Organization for determination of medical suitability occurred and staff comprehended the donation after circulatory death process for one (1) of 12 patients (Patient #1). The findings include: Cross Refer A0886. Based on record review, staff interviews, and review of the hospital’s policy titled “Organ and Tissue Donation” and the hospital’s “Memorandum of Understanding and Agreement,” the hospital failed to ensure that the medical suitability was determined in collaboration with the Organ Procurement Organization (OPO) for one (1) patient out of twelve (12) patients reviewed (Patient #1), regarding the potential for organ donation via donation after circulatory death (DCD). Cross Refer A0891. Based on record review, staff interviews, and review of the hospital’s policy titled “Organ and Tissue Donation” and the hospital’s “Memorandum of Understanding and Agreement,” the hospital failed to ensure that staff providing care to one (1) of 12 patients reviewed (Patient #1) comprehended the donation after circulatory death (DCD) process, even though education was provided on an annual basis.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 43147 Based on record review and staff interview, the hospital failed to identify performance improvement opportunities related to organ donations and ensure donor suitability for one (1) of twelve (12) patients reviewed (Patient #1). Specially, the hospital did not identify and put performance improvement measures in place after Patient #1’s medical suitability for organ donation was not appropriately determined and failed to identify that staff did not retain pertinent training on the donation after circulatory death (DCD) process. The findings include: Cross Refer A886. The hospital failed to ensure that the medical suitability was appropriately determined Patient #1, regarding the potential for organ donation via donation after circulatory death (DCD). Patient #1 was admitted to the hospital on 10/25/21 status post cardiac arrest requiring cardiopulmonary resuscitation (CPR), medications, and electrical cardioversion. Patient #1 had a history of abnormal electrocardiogram (ECG), arrhythmia, and hypertension. Review of the emergency medical services (EMS) on scene report dated 10/25/21 at 3:10 AM revealed that Patient #1 was pulseless and apneic, with periods of ventricular tachycardia until he had a return of spontaneous circulation (ROSC) on arrival to the emergency room at 3:35 AM. Review of the physician’s progress notes dated 10/26/21 through 10/29/21 revealed that the hospital physicians had discussions with the family regarding Patient #1’s prognosis and the family’s decision to proceed with terminal wean with organ donation. Review of the palliative care physician’s progress note dated 10/29/21 read “ ...family are well-informed regarding patient’s serious clinical condition following cardiac arrest which likely resulted in anoxic brain injury which is likely reversible. They were motivated to proceed with organ donation and are appreciative for staffs and the Organ Procumbent Organization’s (OPO) efforts to facilitate the same. As patient does not meet criteria for brain death, organ donation will follow the path of DCD. Family are aware that patient may not pass away post extubation. In such event, they wish to proceed with comfort measures. Based on patient’s previously expressed wishes, they wish to maintain Do Not Resuscitate Code Status in the event of cardiac arrest prior to proceeding with DCD ...” Review of Patient #1’s medical record did not reveal the medical suitability of organ donation for a patient with an anoxic brain injury from a suspected drug overdose. During an interview with the Director of Patient Safety and Risk Management on 12/02/24 at 2:20 PM, she indicated the hospital did not identify Patient #1’s case as adverse and did not put a plan in place to improve DCD donations. The hospital did make some changes regarding the DCD process over the years, such as not conducting an honor walk for DCD patients, but did not identify that the suitability for donation was an issue for Patient #1 and therefore no quality assurance activity took place. There was no documentation the hospital identified possible quality improvement opportunities related to DCD donation or that quality improvement plans were put in place to ensure both physician’s and the OPO determined medical suitability of DCD donors prior to proceeding with organ donation. Cross Refer A891. The hospital failed to ensure that staff providing care for Patient #1 comprehended the donation after circulatory death (DCD) process training. Review of Patient #1’s medical record revealed a cardiac catheterization with consent dated 10/29/21 as “ ...Indication: Complete invasive cardiac evaluation as part of organ donation protocol ...Impression: Angiographically minor coronary atherosclerosis affecting LAD (Left Anterior Descending Artery). Normal left ventricular systolic function, globally and regionally. Normal right ventricular filling pressures Normal left ventricular filling pressures. Normal cardiac output Normal pulmonary artery pressures No evidence of intracardiac shunt Elevated LVEDP (left ventricular end-diastolic pressure) due to severe hypertension ...” During an interview with the cardiologist on 12/04/24 at 12:30 PM, he stated he was unaware of the DCD donation process. He was “alarmed” upon seeing Patient #1 prior to performing his cardiac catheterization as he expected a “deeply comatose patient” based on past experience with brain death being the only criteria for organ donation. The cardiologist stated he did address his concern to the OPO representative as he did not think Patient #1 was brain dead and stated, “I guess you realize this guy is nowhere near brain dead.” The OPO representative responded to the cardiologist with “you don’t have to be brain dead to be an organ donor” and did not provide any additional explanation or information. The cardiologist was unable to recall if he received any training on organ donation or the DCD process. Review of the cardiologist’s employee file revealed training on organ donation on 05/04/2016. Even though training had been provided, the cardiologist was not provided any additonal information or education regarding Patient #1 to ensure a understanding of the DCD process. During an interview on 12/05/24 at 9:32 AM with the respiratory therapist, he stated he provided care to Patient #1 on 10/29/21 as the assigned respiratory therapist who would assist with the terminal weaning from the ventilator in preparation for organ donation. The respiratory therapist stated that he thought it was “strange” that the OPO would ask for a respiratory therapist to be present for an organ donation case as in the past he would assist the patients to the operating room and leave for “brain dead” donations. He stated he did not know what DCD was and had never heard of that phrase or the process. He stated he could not recall receiving any organ donation training regarding DCD. Review of the respiratory therapist’s employee file revealed annual training on organ donation from 2020-2023. Although training had been provided, the hospital failed to identify staff did not understand the DCD process and failed to develop a quality improvement plan and/or study to ensure a complete understanding of the DCD process. Review of the training manual titled “RIC- {OPO): Annual Training for {Name of OPO} “revealed a section titled “2 Types of Organ Donation: Donation after Brain Death-DBD and Donation after Circulatory Death-DCD ...patient still has neurological functions or can not be declared brain dead. The family has decided to terminally extubate the patient for comfort care measure only. Hospital maintains medical management of patient ...” During an interview on 12/05/24 at 3:45 PM with the Director of Regulatory Affairs and Emergency Preparedness, she stated that all staff including contractors, are required to have new employee orientation training on the organ donation process and that the cardiologist was a contractor. She stated that staff employed by the hospital are additionally required to have annual training on the organ donation process. She stated that all training included information on DCD and brain death donation and was prepared in collaboration with the OPO.”

“OPO AGREEMENT CFR(s): 482.45(a)(1) Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose; This Standard is not met as evidenced by: 43147 Based on record review, staff interviews, and review of the hospital’s policy titled “Organ and Tissue Donation” and the hospital’s “Memorandum of Understanding and Agreement,” the hospital failed to ensure that the medical suitability was determined in collaboration with the Organ Procurement Organization (OPO) for one (1) patient out of twelve (12) patients reviewed (Patient #1), regarding the potential for organ donation via donation after circulatory death (DCD). The findings include: Patient #1 was admitted to the hospital on 10/25/21 status post cardiac arrest requiring cardiopulmonary resuscitation (CPR), medications, and electrical cardioversion. Patient #1 had a history of abnormal electrocardiogram (ECG), arrhythmia, and hypertension. Review of the emergency medical services (EMS) on scene report dated 10/25/21 at 3:10 AM revealed that Patient #1 was pulseless and apneic, with periods of ventricular tachycardia until he had a return of spontaneous circulation (ROSC) on arrival to the emergency room at 3:35 AM. Review of Patient #1’s medical record revealed that on 10/25/21 a CT (computed tomography) of the head without contrast determined that Patient #1 had “mild asymmetric low-density changes in the right caudate head and basal ganglia compatible with anoxic event resulting in infarctions. Probably mild diffuse cerebral edema from global anoxic event mildly effacing the lateral ventricles” and on 10/26/21 an electroencephalogram (EEG) showed “evidence for diffuse cerebral dysfunction of at least mild degree.” The family made the decision on 10/26/21 to change Patient #1’s code status to do not resuscitate (DNR). Review of the physician’s progress notes dated 10/26/21 through 10/29/21 revealed that Patient #1 was unresponsive, on mechanical ventilation without sedation, did not awaken or follow commands, and had no purposeful movements with his gag reflex intact and pupillary reflex intact. Review of the physician’s progress notes dated 10/26/21 through 10/29/21 revealed that the hospital physicians had discussions with the family regarding Patient #1’s prognosis and the family’s decision to proceed with terminal wean with organ donation. Review of the palliative care physician’s progress note dated 10/29/21 read “ ...family are well-informed regarding patient’s serious clinical condition following cardiac arrest which likely resulted in anoxic brain injury which is likely reversible. They were motivated to proceed with organ donation and are appreciative for staffs and {Name of Organ Procurement Organization (OPO)}efforts to facilitate the same. As patient does not meet criteria for brain death, organ donation will follow the path of DCD. Family are aware that patient may not pass away post extubation. In such event, they wish to proceed with comfort measures. Based on patient’s previously expressed wishes, they wish to maintain Do Not Resuscitate Code Status in the event of cardiac arrest prior to proceeding with DCD ...” Even though the palliative care physician thought Patient #1 would not expire after extubation, the donation continued and there was no documented collaboration between the hospital and OPO staff to ensure medical suitability was determined. Further review of Patient #1’s medical record revealed no documentation of the medical suitability of organ donation for a patient with an anoxic brain injury from a suspected drug overdose. During an interview with the palliative care physician on 12/04/24 at 11:37 AM, she stated that she did not think that Patient #1 would expire within the timeframe for organ donation after the withdrawal of treatment, but the hospital and the organ procurement organization (OPO) wanted to honor the patient’s and family’s wishes regarding organ donation. She stated, “My prognostic opinion was based on assessment prior to the operating room (OR); is this patient expected to survive? likely no. Prognostication is an inaccurate science based on clinical assessment; he had a surprising acute change, that was not proceeded by signs this was going to happen. In the ICU (intensive care unit) he was unresponsive, was unresponsive during honor walk and after the OR staff cleaned and shaved his abdomen, it appeared he miraculously woke up and became more alert with purposeful movements.” Review of the hospital’s policy titled “Organ and Tissue Donation,” revised and effective 09/01/2021 read “ ...{OPO} will organize and carry out the following duties related to organ and tissue donation: Review the patient’s medical record for suitability of donation ...III. Organ Donation After Circulatory Death ...2. Discussion with Family- {OPO} personnel will assist in confirmation of the family’s understanding of DCD, consultation with the provider, nursing, and pastoral staff on the best approach process, and inform the family regarding the option of organ and tissue donation, if no contraindications exist. {OPO} personnel will discuss donation options with the family and document the family’s decision in the {OPO} medical record ....3. Continued Mechanical Support- If the patient meets the criteria for DCD and the next of kin has provided authorization for donation, {OPO} personnel will discuss with the staff the timing of the withdrawal of care and steps that are necessary for the donation. 4. Evaluation of Organs for Donation- The physician will continue the mechanical support of a Donor’s cardiopulmonary functions until necessary lab tests can be performed. The physician will order tests necessary to evaluate donated organs, under the direction of the physician in consultation with {OPO} personnel ...” Review of the hospital’s “Memorandum of Understanding and Agreement” entered into on June 10, 2019, read “ ...r. if applicable, will provide direction and guidance based on Hospital DCD policy or {OPO} protocol to hospital staff in donation after circulatory death donors. Will collaborate closely with Hospital staff to ensure optimum care for the donor ...””

“STAFF EDUCATION CFR(s): 482.45(a)(5) Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues; This Standard is not met as evidenced by: 43147 Based on record review, staff interviews, and review of the hospital’s policy titled “Organ and Tissue Donation” and the hospital’s “Memorandum of Understanding and Agreement,” the hospital failed to ensure that staff providing care to one (1) of 12 patients reviewed (Patient #1) comprehended the donation after circulatory death (DCD) process, even though education was provided on an annual basis. The findings include: Patient #1 was admitted to the hospital on 10/25/21 status post cardiac arrest requiring cardiopulmonary resuscitation (CPR), medications, and electrical cardioversion. Patient #1 had a history of abnormal electrocardiogram (ECG), arrhythmia, and hypertension. Review of Patient #1’s medical record revealed that on 10/26/21, his family made the decision to chane his code status to do not resuscitate (DNR). Review of the physician’s progress notes dated 10/26/21 through 10/29/21 revealed that Patient #1 was unresponsive, on mechanical ventilation without sedation, did not awaken or follow commands, and had no purposeful movements with his gag reflex intact and pupillary reflex intact. Review of Patient #1’s medical record revealed a cardiac catheterization with consent dated 10/29/21 as “ ...Indication: Complete invasive cardiac evaluation as part of organ donation protocol ...Impression: Angiographically minor coronary atherosclerosis affecting LAD (Left Anterior Descending Artery). Normal left ventricular systolic function, globally and regionally. Normal right ventricular filling pressures Normal left ventricular filling pressures. Normal cardiac output Normal pulmonary artery pressures No evidence of intracardiac shunt Elevated LVEDP (left ventricular end-diastolic pressure) due to severe hypertension ...” During an interview with the cardiologist on 12/04/24 at 12:30 PM, he stated he was unaware of the DCD donation process. He was “alarmed” upon seeing Patient #1 prior to performing his cardiac catheterization as he expected a “deeply comatose patient” based on past experience with brain death being the only criteria for organ donation. The cardiologist stated he did address his concern to the OPO (Organ Procurement Organization) representative as he did not think Patient #1 was brain dead and stated, “I guess you realize this guy is nowhere near brain dead.” The OPO representative responded to the cardiologist, “You don’t have to be brain dead to be an organ donor” and did not provide any additional explanation or information. The cardiologist was unable to recall if he received any training on organ donation or the DCD process. Review of the cardiologist’s employee file revealed training on organ donation on 05/04/2016. There was no documenation the cardiologist received any addition training regarding the DCD process, even though he did not have an understanding of DCD process and documented in the medical reocord his lack of understanding. During an interview on 12/05/24 at 9:32 AM with the respiratory therapist, he stated he provided care to Patient #1 on 10/29/21 as the assigned respiratory therapist who would assist with the terminal weaning from the ventilator in preparation for organ donation. The respiratory therapist stated that he thought it was “strange” that the OPO would ask for a respiratory therapist to be present for an organ donation case as in the past he would assist the patients to the operating room and leave for “brain dead” donations. He stated he did not know what DCD was and had never heard of that phrase or the process. He stated he could not recall receiving any organ donation training regarding DCD. Review of the respiratory therapist’s employee file revealed annual training on organ donation from 2020-2023. There was no documenation the hospital and the OPO collaborated to provide training of the DCD donation process that was understood and retained by staff. Review of the training manual titled “RIC- {OPO): Annual Training for {Name of OPO} “revealed a section titled “2 Types of Organ Donation: Donation after Brain Death-DBD and Donation after Circulatory Death-DCD ...patient still has neurological functions or can not be declared brain dead. The family has decided to terminally extubate the patient for comfort care measure only. Hospital maintains medical management of patient ...” During an interview on 12/05/24 at 3:45 PM with the Director of Regulatory Affairs and Emergency Preparedness, she stated that all staff including contractors, are required to have new employee orientation training on the organ donation process and that the cardiologist was a contractor. She stated that staff employed by the hospital are additionally required to have annual training on the organ donation process. She stated that all training included information on DCD and brain death donation and was prepared in collaboration with the OPO. Review of the hospital’s “Memorandum of Understanding and Agreement” entered into on June 10, 2019, read “ ...Responsibilities of the hospital ...i. Work collaboratively with {OPO and eye bank} in educating all appropriate Hospital staff and physicians on donation issues. including the authorization process, the importance of discretion and sensitivity, the role of the Designated Requester (if applicable), the transplantation and donation process, ensuring that staff understands their roles for management of donor viability, quality improvement activities, and how to work with the {OPO and eye bank} ...””