Shannon Medical Center

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47893 Based on review of facility documentation, medical record review, and interview, the facility failed to: 1. ensure the patient’s authorized representative was provided information needed to make an informed decision regarding the patient’s care and the ability to refuse treatment, when a [third-party vendor] inserted a bronchoscope (used by physicians for bronchoscopy) into 1of 1 patitiens (Patient#1) receiving life-sustaining therapy, for whom palliative withdrawal of care (focuses on comfort, dignity, and symptom management while aligning with patient goals) was planned. The facility also failed to follow the hospital policy titled Patient Rights and Responsibilities, with effective date of 09/2025. Refer to Tag A0131 2. ensure a patient right to receive care in a safe setting when, a [third-party vendor] did not comply with physician/pulmonologist (Staff #7’s) requests to stop what he/she was doing for 1 of 1 patient (Patient 1) for whom palliative withdrawal of care was planned and withdrawal of life-sustaining therapy was pending. This failure to respond to hospital medical staff’s instructions, placed the donor patient/authorized representative at risk of discomfort and trauma; and risk to the organ suitability for transplant. The patient right to receive care in a safe setting is inconsistent with the provision of unauthorized procedures performed by unqualified person(s), without patient/patient/representative informed consent; without staff education to identify and communicate risk factors and manage process variation and staff roles; and to report and review safety events, investigate, and coordinate actions to prevent similar events from occurring. The facility also failed to follow the hospital policy titled Donation after Circulatory Death (DCD), with effective date 01/2025. Refer to Tag A0144”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able 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. This Standard is not met as evidenced by: 47893 Based on review of facility documents and interview, it was determined the facility failed to ensure the patient’s authorized representative was provided information needed to make an informed decision regarding the patient’s care and the ability to refuse treatment, when a [third-party vendor; technician] inserted a bronchoscope (used by physicians for bronchoscopies) into 1 of 1 patient (Patient#1) receiving life-sustaining therapy, for whom palliative withdrawal of care (focuses on comfort, dignity, and symptom management while aligning with patient goals) was planned. Findings were: A hospital policy, Patient Rights and Responsibilities, effective 9/2025 documented in part, “ ... PROCEDURES: PATIENT RIGHTS - To know the name and professional status of the physician(s) and all individuals responsible for the authorization and performance of medical procedures or treatments. - To be kept informed of health status and to participate in decisions regarding your care, including the right to request or refuse treatment in accordance with law and regulation ... - To allow the patient’s guardian, next of kin, or legal representative to exercise, to the extent permitted by law, these rights on the patient’s behalf. - To effective pain management ...” Clinical Notes dated 10/26/2025, attestation signed by DO/pulmonologist (Staff #7) at 10/26/25 10:31 AM, documented in part, “ ... Family notes she had a very poor quality of life and they have elected to transition to palliative measures. Organ donation evaluating for candidacy, pending disposition. Further optimization including bronchoscopy and labs ongoing for transplant process ... [OPO] team planning OR procurement 10/26 evening.” A PULMONARY & CRITICAL CARE MEDICINE BRONCHOSCOPY PROCEDURE NOTE, signed and dated by DO/pulmonologist (Staff #7) documented in part, “Date: 10/26/25 10:48 AM Procedure: Bronchoscopy with airway inspection and bronchoalveolar lavage Consent: Obtained from family Indication: airway surveillance, secretion clearance Monitoring: EKG, blood pressure, pulse oximetry Physician: [Staff #7, DO] Equipment: Reusable Glidescope bronchoscope Medications: 1. 1% lidocaine without epinephrine topical, 20 ml 2. Continuous fentanyl infusion Procedure Summary: After consent was obtained and a time-out was performed, the patient was verified to be comfortable on continuous sedation and the bronchoscope was introduced through the endotracheal tube connector. Next, topical 1% lidocaine without epinephrine was used to anesthetize the tracheobronchial tree. A fiberoptic brochoscopic survey was performed revealing normal anatomy to the segmental level, without endobronchial lesions, mucus impaction, bleeding or other debris. The patient tolerated the procedure well without hypoxemia or hemodynamic instability ...” In interview on the morning of 2/11/26, Administrative Director of Critical Care (Staff #3) stated, “We [the hospital] carry out orders to meet their [the organ procurement organization’s (OPO)] criteria.” When asked to provide documentation of Patient #1/next of kin’s consent to bronchoscopy by third-party vendor, Staff #3 stated, “I did not see consent in patient’s chart.” In interview on the afternoon of 2/11/26, DO/pulmonologist (Staff #7) stated, “... [On 10/26/25], our [the hospital’s] operating room (OR) nurse prepped and sterile draped [Patient #1]... The [OPO] independent contractors left the [operating] room, as they were supposed to ... I noticed something going on behind curtain, commotion behind curtain. [Third-party vendor; technician] had a bronchoscope in Patient #1’s endotracheal tube and I could see only blood on the iPad screen; could not see bronchial tree (a branching system of airways in the lungs that transport air for gas exchange). [Third-party vendor; technician] was advancing the bronchoscope and holding [the scope] incorrectly. I asked [third-party vendor; technician] to stop what he was doing. The patient was hypertensive, tachypneic, coughing; in distress ... I told (third-party vendor; technician) I had already made a video for the lung transport team. Bronchoscopy on 10/26/25 AM videoed by [OPO] team on iPad. Micro [laboratory results] came back normal. [OPO] accepted the lungs and called the recipient ...” In reference to the bronchoscopy, performed by (Staff #7) on 10/26/25 at 10:48 AM, DO/pulmonologist (Staff #7) stated, “I had consent from [next of kin] ... I sedated [Patient #1], numbed with lidocaine. I made sure Patient #1 was comfortable. When asked if/how consent was obtained for the bronchoscopy provided by the [third-party vendor; technician], DO/pulmonologist (Staff #7) stated, “[Third-party vendor] had no right to touch my patient [Patient #1] ... If the [OPO] had wanted another bronchoscopy, I would have performed it.” Patient medical records show no consent was obtained prior to the (third-party vendor; technician) inserting the bronchoscope into Patient #1’s endotracheal tube [a flexible tube placed into the trachea (windpipe). Patient #1’s next of kin was not advised that a technician would perform the medical procedure [bronchoscopy]; was not informed that the medical procedure would be performed without sedation/medications to prevent pain and cough reflex, and was not given the opportunity to refuse.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 47893 Based on review of facility documentation and interview, the facility failed to ensure a patient’s right to receive care in a safe setting when, a [third-party vendor; technician] did not comply with physician/pulmonologist (Staff #7’s) requests to stop what he/she was doing, for 1 of 1 patients (Patient 1) for whom palliative withdrawal of care was planned and withdrawal of life-sustaining therapy was pending. This failure to respond to hospital medical staff’s instructions, placed the donor patient/authorized representative at risk of discomfort and trauma, and risk to the organ suitability for transplant. The patient right to receive care in a safe setting is inconsistent with the provision of unauthorized procedures performed by unqualified person(s), without patient/patient/representative informed consent; without staff education to identify and communicate risk factors and manage process variation and staff roles; and to report and review safety events, investigate, and coordinate actions to prevent similar events from occurring. Findings were: A hospital policy, Donation after Circulatory Death (DCD), effective 1/2025 documented in part, “ ... 10. Once in the Operating Room, while the donor is ventilator assisted and monitored, unconscious, and unresponsive to noxious or painful stimuli, the patient will be prepped and draped in the usual fashion for the recovery of organs. The Procurement OR team should leave the room at this point until the patient has been pronounced to ensure transplant procedures do not start until two (2) to five (5) minutes after death. 11. Not less than two (2) minutes following the pronouncement of death (pulselessness, no arterial blood pressure, no respirations), the recovery team will begin recovery of the organs deemed suitable in a regular fashion ...” A hospital policy, Protecting Patients from Abuse and Neglect, effective 1/2026 documented in part, “INVESTIGATION AND REPORTING OF POSSIBLE ABUSE & NEGLECT Any potential abuse or neglect will be investigated by the organization and reported to the appropriate State authorities in accordance with hospital policy. Upon initial new hire orientation, [the hospital] team members are given information on the appropriate process including a contact number (1-800-458-9858) for reporting allegations/suspicions of patient abuse/neglect ...” During an interview on the afternoon of 2/11/26, pulmonologist (Staff #7) stated, [On 10/26/25,] “I optimized patient #1 from a respiratory standpoint ... [The hospital’s] operating room (OR) nurse prepped and sterile draped the patient ... The [OPO’s - Organ Procurement Organization’s] independent contractors left the room, as they were supposed to. I noticed something going on behind curtain ... A [third-party vendor; technician] had a bronchoscope in the patient’s endotracheal tube, and I could see only blood on the iPad screen; could not see bronchial tree [a branching system of airways in the lungs that transport air for gas exchange]. The [third-party vendor; technician] was advancing the bronchoscope and holding [the scope] incorrectly. I asked [third-party vendor; technician] to stop what he/she was doing. The patient [Patient #1] was in distress ... I identified myself and said that [third-party vendor; technician] was causing the patient discomfort. I had already made a video [of the bronchoscopy I performed on the patient, earlier the same day [on 10/26/25] for the lung transport team. [Bronchoscopy] during procurement is standard procedure, but one had already been done. The [third-party vendor; technician] had no right to touch my patient until 5 minutes after death ... If the OPO had wanted another bronchoscopy, I would be responsible for performing it.” During an interview on the afternoon of 2/11/26, Staff #8 stated, “ ... [Third-party vendor] fairly aggressive, struggling with bronchoscope. [Third-party] was abrasive ... continued with the bronchoscope and did not respond to physician (Staff #7). Staff #7 had performed a bronchoscope earlier in the day for the patient (Patient #1) ... I am assuming they [OPO] does the bronchoscopy as part of the procurement.” During an interview on the morning of 2/11/26, Administrative Director of Critical Care (Staff #3) stated, “ ...We [the hospital] supports [OPO] ... we carry out orders to meet their criteria. [On 10/27/25,] pulmonologist (Staff #7) brought to my attention behavior that she felt inappropriate. I verbally escalated concern to CNO (Staff #6) and COO (Staff #5) ... We discussed what happened during the case, pulmonologist (Staff #7) experience with donations after circulatory death (DCD), and what to do in situations where there might be inappropriate care ... “ When asked to provide documentation of patient #1/next of kin’s consent to bronchoscopy by [third-party vendor; technician], Staff #3 stated, “I did not see consent in patient’s chart ... and did not follow up to escalate concerns further. Just recently, the hospital has reviewed processes for organ donation and working with [OPO] liaison to firm up weekend cases and communication, including staff availability and readiness...” Patient medical records show no consent was obtained prior to the (third-party vendor; technician) inserting the bronchoscope into patient #1’s endotracheal tube [a flexible tube placed into the trachea (windpipe). Patient #1’s next of kin was not advised that a technician would perform the medical procedure [bronchoscopy]; was not informed that the medical procedure would be performed without sedation/medications to prevent pain and cough reflex; and was not given the opportunity to refuse. During an interview on the afternoon of 2/10/26, Intensive Care Unit (ICU) Director (Staff #4), when asked about the circumstances surrounding the event, responded, “ ... (Patient #1) was a lung donor. I would imagine they needed to look at lung fields one more time). Pulmonologist reported concerns to [OPO]. Staff #3 and I spoke with [OPO] coordinator. [Third-party vendor] will not return to the facility ... We had internal discussion. I pass on report that [OPO] gives me in committee meetings. Staff #3 spoke to Chief Operating Officer - COO (Staff #5) and Chief Nursing Officer - CNO (Staff #6) after the incident/event.” During an interview on the morning of 2/11/26, COO (Staff #5) stated, “... End of life, we make referral and [OPO] comes in to speak with family. [OPO] drives donation conversation. They [OPO] have protocols we have to follow ... We [the hospital] deliver direct care under the direction of [OPO]. One of our pulmonologists (Staff #7) reported she was very concerned with interaction with [third-party vendor; technician]. [Third-party vendor; technician]] not respectful to patient [Patient #1] or [hospital] staff. Pulmonologist (Staff #7) asked to meet with CNO (Staff #6), Administrative Director of Clinical Care (Staff #3), Chief Medical Officer - CMO (Staff #12), and I. Pulmonologist (Staff #7) shared what happened; [third-party vendor; technician] behaved inappropriately. Pulmonologist (Staff #7) asked that we address [OPO]. ...We [the hospital] reached out to [OPO] and said that [third-party vendor] cannot come back. Our contract with [OPO] says that they will only send credentialed people. We provide our staff to support [OPO]. I would assume our [hospital] consent policies are followed. Working on assumption that [bronchoscopy] on [OPO] guidance. When we became aware [of the event] we took that and we addressed [the third-party vendor]. We [the hospital] are attempting to address, contractually, the concerns that came up to us.” During an interview on the morning of 2/11/26, CNO, (Staff #6) stated, “... After the weekend event, COO (Staff #5) and I were notified of event with donor, DCD case, and pulmonologist (Staff #7). Pulmonologist (Staff #7) reported to [OPO]; saw patient get in distress. I was told that [pulmonologist] stopped it. We scheduled a meeting with pulmonologist (Staff #7) in which Administrative Director of Clinical Care, ICU Director, COO, CMO, and I participated. Pulmonologist (Staff #7) was concerned with DCD cases. Difference in donor brain death [OPO] takes over. [OPO] does everything from ICU to OR. Our [the hospital’s] ICU nurses don’t go to OR with brain death donors. For DCD patients, these patients have not been declared dead ... our nurse(s) stay with that patient until the patient is declared dead/deceased. [OPO] nurses are advising. There is a gray area as to who is in charge. To address concerns, we met with [OPO]; we do not want this [third-party vendor] back in the facility. To my knowledge, the event was not reported.” When asked what (Staff #6) would do if had concerns regarding care without consent or inappropriate care, Staff #6 responded they would report to Quality. “CMO, Assistant Vice President (AVP) Quality, Quality Director, and I look at cases to see if something that reportable.” During an interview on the afternoon of 2/11/26, AVP Surgical Services (Staff #13) reported he/she had just been made aware of the event and planned to follow up to educate involved hospital personnel.”

“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: 47893 Based on interview and review of facility documentation, the governing body failed to ensure that there was an effective, ongoing, facility-wide, data-driven quality assurance program to evaluate the provision of patient care by tracking adverse patient events. Event reporting procedures were not implemented, and a report was not created to reflect and elevate concerns when a third-party vendor/technician performed bronchoscopy without consent, for 1 of 1 inpatient (Patient #1) pending withdrawal of life sustaining therapy for organ donation. The procedure was performed in an unsafe manner. The patient showed signs of discomfort during the procedure and had evidence of trauma from the procedure. The failure to report potential adverse events hinder identification of hazards/vulnerabilities and the facility’s ability to address/resolve issues before harm can occur. Findings were: In interview on the afternoon of 2/10/26, regarding patients with pending withdrawal of life sustaining thrapy for organ donation, Quality Director (Staff #2) stated, “Patient #1 was discharged out of acute care status. Our [the hospital] medical team was providing care, but directives were received through the organ procument organization [OPO]. We do not have any reports on that patient (Patient #1).” In interview on the morning of 2/11/26, Chief Operating Officer (Staff # 5) stated, “ ... [OPO] has protocols we have to follow ... We [the hospital] deliver direct care under the direction of [OPO] ... Our contract with OPO says that they will only send credentialed people. We provide our staff to support [the OPO]. I would assume our hospital consent policies are followed. Working on assumption that [bronchoscopy] on [OPO] guidance ...” In interview on the morning of 2/11/26, Chief Nursing Officer (Staff #6) stated, “ ... the event ... was reported to [the OPO].” When Staff #6 was asked what they would do if had concerns regarding a procedure provided without consent, or quality of care issues, Staff #6 stated, “I would report to Quality. The Chief Medical Office, Assistant Vice President, Quality, Quality Director and I look at cases to see if something is reportable. To my knowledge, the case was not reported.” In interview on the morning of 2/11/26, Administrative Director of Critical Care (Staff #3) stated, “ ... We carry out ordert to meet the {OPO]’s criteria .. [On 10/27/25,] pulmonologist (Staff #7) brought to my attention behavior that she felt inappropriate. I verbally escalated concern to CNO (Staff #6) and COO (Staff #5) ... We discussed what happened during the case, pulmonologist (Staff #7) experience with donations after circulatory death (DCD), and what to do in situations where there might be inappropriate care ... “ When asked to provide documentation of patient #1/next of kin’s consent to bronchoscopy by third-party vendor, Staff #3 stated, “I did not see consent in patient’s chart ... and did not follow up to escalate concerns further.” In continued interview on the morning of 2/11/26, Quality Director (Staff #2) stated, “Anyone can enter a report into the facility’s [software for event reporting] system. Reports are reviewed twice weekly ...we would be looking at quality for any case involving provider concerns.” In interview on the afternoon of 2/11/26, Assistant Vice President, Quality (Staff #1) confirmed no event report was recieved involving Patient #1.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 47893 Based on interview and review of documentation, the facility failed to promote safety, and detect adverse safety events and circumstances when pulmonologist (Staff #7) expressed concerns involving the inappropriate and unsafe actions of a third-party participant and 1 of 1 patients (Patient #1) reviewed for pending withdrawal of life-sustaining therapy for organ donation. The facility did not complete an incident report.The potential adversere event was reported to hospital administrative officials; however, investigation of circumstances surrounding the event was not undertaken by the facility; clear expectations for safety were not established. The facility failed to identify, communicate and report a safety event for Patient #1. Findings were: During an interview on the afternoon of 2/11/26, pulmonologit (Staff #7) stated, “I have had multiple conversations with Admininstrative Director of Critical Care (Staff #3); Intensive Care Unit (ICU) Director (Staff #4); Chiief Medical Officer (Staff #12); Chief Nursing Officer (Staff #6) ...we’ve talked about how we [the hospital] can change our protocols to protect our patients.” A hospital policy, Patient-Visitor Adverse Events and Near Misses Reporting Process, effective 10/2022 documented in part, “ PURPOSE: [The hospital] encourages the reporting of errors, adverse drug events, and near misses or potential adverse events as a means to assess and provide a safe environment to ensure safe patient care ... POLICY: All incidents, particularly clinical errors, need to be reported as soon as possible ... Definitions of Events: ... Adverse Event - An unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome ... All associates will participate in the organizational-wide reporting process. Individuals involved in the event or with knowledge related to an event will document the details in [the hospital’s software system for reporting events/incidents] ... The reporting of an Event ... 2. ... Describe in detail the chain of events and any actions taken as a result of the event and include any harm or injury to the patient or visitor. 3. Implement any adjustments in patient’s treatment as indicated or as ordered, and notify the immediate supervisor. In the case of a significant event or Adverse event, notification of the clinical supervisor, manager, director, administrator, etc. will be completed as detailed in the Adverse event policy ... 5. When [the hospital’s software system for reporting events/incidents] is completed, it is automatically forwarded to the worklists of the manager/director of the initiating department/nursing unit and the Risk Manager ... Review of the Safety Learning Events 1. The manager/director of the involved department(s) will review the event, complete a timely investigation of the circumstances surrounding the event ... Documentation should include details of what happened, treatment, patient/visitor status and actions taken as a result of the event ... 2. Events that involve more than one department will be discussed by the involved department’s managers/supervisors with coordinated actions taken to prevent recurrences. 3. The severity level may be assigned as appropriate by the Risk Manager, depending on the final outcome. Once the investigation is completed, the Risk Manager will close the event ... “”