Northshore University Healthsystem - Evanston Hospital

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 39802 Based on observation, document review, and interview, for 5 of 9 patients (Pts. #4, #6-#9) with 4 side rails in use, the Hospital failed to ensure that 4 side rails were used in accordance with a physician’s restraint order. Findings include: 1. A tour of the Medical Intensive Care Unit (MICU) was conducted on 06/01/2026, at approximately 9:46 AM. During the tour, one patient (Pt. #4) noted to be lying in bed, awake, and able to move, had all 4 side rails up. 2. A tour of the 3 South Medical-Surgical Unit was conducted on 06/01/2026, at approximately 11:15 AM. Three patients (Pts. #6-#8) noted to be lying in bed, awake, and able to move, had all 4 side rails up 3. The Hospital’s policy titled, “Restraints (Violent/Self-Destructive Behaviors and Non-violent/Non-Self-Destructive Behaviors)” (effective 03/2026) was reviewed and required “...Side rails: When using the bed’s 4 side rails to prevent a patient from voluntarily getting out of bed or attempting to exit the bed, the side rails are considered a restraint... Attachment Restraint Utilization Decision Tree:... Implement LEAST restrictive restraint type appropriate: Side rails x4... Secure a provider order as soon as possible...” 4. The clinical record of Pt. #4 was reviewed on 06/01/2026. Pt. #4 was admitted on 05/31/2026, with a diagnosis of pericardial effusion (build up of excess fluid in the sac around the heart). The record lacked documentation of use of 4 side rails (as observed during tour) and lacked restraint orders for 4 side rails. 5. The clinical record of Pt. #6 was reviewed on 06/01/2026. Pt. #6 was admitted on 05/31/2026 with a diagnosis of atrial fibrillation (abnormal heart rhythm). The record lacked documentation of use of 4 side rails (as observed during tour) and lacked restraint orders for 4 side rails. 6. The clinical record of Pt. #7 was reviewed on 06/01/2026. Pt. #7 was admitted on 05/30/2026 with a diagnosis of NSTEMI (type of heart attack caused by a partial blockage in a coronary artery). The record lacked documentation of use of 4 side rails (as observed during tour) and lacked restraint orders for 4 side rails. 7. The clinical record of Pt. #8 was reviewed on 06/01/2026. Pt. #8 was admitted on 05/30/2026 with a diagnosis of C. Difficile (bacteria) infection. The record lacked documentation of use of 4 side rails (as observed during tour) and lacked restraint orders for 4 side rails. 8. The clinical record of Pt. #9 was reviewed on 06/01/2026. Pt. #9 was admitted on 05/21/2026 with a diagnosis of somnolence. The record indicated that Pt. #9 was awake and confused, had some mobility, and had 4 side rails up from 05/25/2026 to 05/27/2026. The record lacked restraint orders for use of 4 side rails. 9. An interview was conducted with the MICU Clinical Coordinator/Charge Nurse (E#1) and MICU Staff Nurse (E#2) on 06/01/2026, at approximately 10:00 AM. E#1 stated that according to the policy, 4 side rails can be considered a restraint but they do not typically get orders for them. E#2 stated that for non-violent restraints, they must obtain an order and each order is good for 1 calendar day. 10. An interview was conducted with the 3 South Charge Nurse (E#3) on 06/01/2026, at approximately 11:40 AM. E#3 stated that if they use 4 side rails, they should obtain a physician’s order for restraint like they would if they were using other non-violent restraints such as soft wrist restraints.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 36774 Based on document review and interview, it was determined that the hospital failed to ensure compliance with 42 CFR 489.24. Findings include: 1. The hospital failed to provide appropriate observation and medical screening screening examination. See A-2406. The immediate jeopardy (IJ) began on 2/27/2025, due to the Hospital’s failure to appropriately examine Pt. #1’s medical condition while in the ED. Subsequently, Pt. #1 had a cardiac arrest and eventually died, and was identified on 3/19/2025. The IJ was announced on 3/19/2025 during a meeting with: President of the Hospital; Assistant Vice President of Accreditation; Chief Medical Officer; Chief Nursing Officer, Systems; Chief Nursing Officer, Evanston; Director of Emergency Services; Clinical Manager, ED, Evanston; Program Manager, Accreditation and Regulatory Compliance; and Program Manager, Accreditation and Regulatory Compliance, and was not removed by the survey exit date of 3/19/2025.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 32741 Based on document review, observation, and interview, it was determined that for 1 of 1 Emergency Department (ED), the hospital failed to post signage related to the rights of the individual with respect to examination and treatment for emergency medical conditions and women in labor (EMTALA-Emergency Medical Treatment and Labor Act) that was visible to patients as they enter the hospital. This potentially affected all patients that enter the hospital through the ambulance bay. Findings include: 1. On 3/18/2025, the hospital’s policy titled, “EMTALA - Signage Policy” (dated 11/2021) was reviewed and required, “The Hospital will post appropriate signage notifying individuals of their right to a medical screening examination (MSE) and stabilization treatment as specified under EMTALA as well as information indicating whether or not the hospital participates in the Medicaid program. Signs will be posted in areas likely to be noticed by individuals entering the dedicated emergency department. 2. A tour of the ED was conducted on 3/18/2025 from 9:30 AM - 10:00 AM. There was EMTALA signage in both English and Spanish posted on the wall at the entrance door to the emergency department of the waiting room. The signs were not visible upon entrance to the ED. The ambulance bay lacked posting of the required EMTALA signage. 3. On 3/18/2025 at 9:45 AM, an interview was conducted with the Director of the ED (E #5). E #5 stated that EMTALA signage should be visible upon entering the ED and at the ambulance bay.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 36774 Based on document review, video surveillance review and interview, it was determined that for 1 of 10 patients’ (Pt. #1) clinical records reviewed with an ESI (emergency severity index/triage acuity) of 2 (patients with threatened vital functions), the hospital failed to provide appropriate monitoring and medical screening examination. Subsequently, Pt. #1 had a cardiac arrest and died. Findings include: 1. On 3/13/2025, the hospital’s document titled, “Triage Nurse Job Description/Responsibilities” (4/2021), was reviewed and indicated, “The Triage Nurse maintains a systematic flow of patients to expedite immediate care of patients upon their arrival to the emergency department ... Assessment ... determine the acuity level ... Emergency Severity Index (ESI) ... Acuity Level Two: Threatened vital functions with likely but not always obvious life or organ threat ... Continuous monitoring ... Procedure ... 7. During times of high acuity and high census ... Re-assessment of waiting patients will be done by the triage nurse during frequent rounding and as necessary ...” 2. On 3/13/2025, the incident report for Pt. #1, dated 2/28/2025, was reviewed and indicated, “ ... Summary of Findings: RCA (Root Cause Analysis) scheduled (on) 3/13/2025) (14 days after Pt. #1’s incident). Immediate action implemented before RCA is complete. 1. ER (Emergency Room) CNM (Clinical Nurse Manager) has implemented (every 2) hour vitals on patient in the waiting room. 2. ED (Emergency Department) quality is implementing a pilot ... to add MD (physician) to triage ... to ensure patients get medical screening ASAP (as soon as possible) when ED has high volume/wait times ... Brief Factual Description: Cardiac arrest while in ED waiting room ...” 3. On 3/13/2025, the clinical record for Pt. #1 was reviewed. The clinical record included: - On 2/27/2025, Pt. #1 had a physician’s office visit. At 10:12 AM, MD #3’s (Neurologist) note indicated, “ ... Accompanied by mother and caregiver ... Had Shingles (viral infection causing painful blisters) 3 weeks ago ... Now very weak ... Severe leg pain ... Severe general weakness. Cachectic (physical state characterized by significant weight loss, muscle wasting and emaciation) ... Impression: Significant worsening of general condition including worsened lower extremities weakness and severe disability ... instructed to go to the Emergency Room for admission ...” -At 10:48 AM, Pt. #1 arrived to the Hospital’s ED. - At 11:13 AM, E #6’s (ED Triage RN/Registered Nurse) note indicated, “(Pt. #1) brought by mother and caregiver for bilateral leg pain 7/10 (moderate pain) ... recently diagnosed (with) Shingles ... complaints of nausea, no vomiting ... (History of Multiple Sclerosis/Neurologic Condition).. (At 11:15 AM), (Temperature) 97.4-degree Fahrenheit (Normal 97 to 99), Pulse: 126 (Normal 60-100), (Respiration) 17 (normal 12-20), (Blood Pressure): 104/66 (low blood pressure is below 90/60, high blood pressure 130/80 and above) ... (Oxygen Level): 100% (Normal 92% to 100%) ... Pain Location: Leg (left) ... aching. Clinical Progression: Not Changed ... Pain Score: 7 (moderate). Patient’s Stated Pain Goal: 2 ... Patient Acuity: 2 ...” - From 11:16 AM through 8:54 PM (9 hours and 38 minutes), there was no documentation of reassessment/monitoring, e.g., vital signs of Pt. #1. - At 8:55 PM, E #8 (ED RN) documented Pt. #1’s blood glucose level was 55 (Normal 70 to 99). - At 9:28 PM, E #2’s (ED Charge RN) note indicated, “(Pt. #1) brought back immediately from ER (Emergency Room) waiting room after staff noticed (Pt. #1 was not) responding. (Pt. #1) rushed into ER room 15 and CPR (cardiopulmonary resuscitation/life-saving measure) initiated ...” - At 10:03 PM, MD #2’s (ED Attending Physician) progress note indicated, “ ...Physical Exam ... Upon arrival in ED room, (Pt. #1) in cardiac arrest ... Very thin cachectic ... pupils fixed and dilated (indicative of medical emergency) ... Impression/Plan: CPR started immediately in ER room ...prepping for intubation (artificial airway). Running code, ACLS (advanced cardiac life support/set of advanced medical procedure and protocol to treat life-threatening condition) ... Possible severe hypovolemia (low fluid volume) and hypoglycemia (low blood sugar) causing arrest ... Accepted to ICU (intensive care unit) ...” - On 2/28/2025 at 1:34 AM, the ICU RN’s progress note indicated, “(Pt. #1) received from Emergency Department ... Vital signs unstable on arrival ... Dependent lividity (bluish-purplish discoloration of the skin) noted ...” - On 2/28/2025 at 4:07 AM, the ICU physician’s note indicated, “ ... On arrival ... Minimal gag reflex but no other significant signs of life ... (Pt. #1) passed away at (3:51 AM) ...” 4. On 3/17/2025 at 1:05 PM, a video surveillance review was conducted with E #4 (Program Manager for Accreditation), E #5 (ED Director), and E #11 (Manager, Public Safety): - On 2/27/2025 at 10:49 AM, Pt. #1 was brought to the hospital’s ED via wheelchair by an unidentified transporter. At 11:12 AM, Pt. #1 was taken to Triage Room 1 by (E #6). At 11:19 AM, Pt. #1 was brought back to the waiting room by (E #6). At 8:54 PM, a staff took and wheeled Pt. #1 into Triage Room 2. - E #4 validated that there was no clinician observed taking/monitoring Pt. #1’s vital signs while Pt. #1 continued in the waiting room waiting awaiting to be seen. Pt. #1 was brought back to the waiting room by an RN at 8:54 PM. E #4 stated that Pt. #1 was taken to the main ED through Triage Room 2. 5. On 3/17/2025 at approximately 9:45 AM and 10:45 AM, telephone interviews were conducted with E #2 (ED Charge RN) and E #6 (ED Triage RN) respectively. Before Pt. #1’s incident, E #2 and E #6 stated that the usual practice of vital signs monitoring for patients waiting in the ED has been every two hours. After the incident, E #2 and E #6 stated that the ED has been enforcing that vital signs of patients are taken every two hours regardless of their ESI while waiting for a room. E #2 and E #6 also stated that either a PCT [Patient Care Technician] or nurse will be in the waiting room to monitor the patient at all times. E #6 stated E #6 did not know what happened with Pt. #1 after E #6’s triage because there were so many patients in the ED, and E #6 only worked for 4 hours (11 AM through 3 PM). 6. On 3/17/2025 at approximately 11:30 AM, a telephone interview was conducted with MD #2 (ED Attending Physician). MD #2 stated that the triage assessment and monitoring are part of the medical screening examination to determine if an emergency medical condition exists. For patient with an ESI of 2, MD #2 stated that patients are typically roomed right away. If a patient has high heart rate, the staff should let the provider know. MD #2 stated, “If I was in the triage that day, I would have seen (Pt. #1) right away. (Pt. #1) would have been high on the list to be roomed. Regarding ESI 2 patients waiting in the ED, there should be a repeat of vital signs.” 7. On 3/17/2025 at approximately 12:32 PM, a telephone interview was conducted with MD #3 (Neurologist). MD #3 stated that MD #3 contacted and talked to the ED charge nurse on 2/27/2025 after Pt. #1’s mom said that Pt. #1 has been sitting in the ED waiting room for a long time. MD #3 stated, “I told the charge nurse that the patient is not doing well and needs to be seen (by a physician) as soon as possible.” 8. On 3/18/2025 at approximately 10:20 AM and at 11:16 AM, interviews were conducted with E #5 (ED Director) and E #1 (ED Manager) respectively. Since Pt. #1’s incident, E #1 clarified that what has been implemented every two hour vital signs monitoring of patients. E #1 stated that the process for having a clinician assigned in the waiting room to monitor patients has not been fully developed and implemented. E #5 stated that continuous monitoring means that the patient is attached to a monitor and in the presence of a clinician at all times. Regarding staff’s compliance with vital signs monitoring every two hours, E #5 stated that there was about 30% (sample size of 10) non-compliance from March 10, 2025, and 20% (sample size of 10) non-compliance as of March 16, 2025. E #5 stated that the hospital is currently working on developing guidelines, policies, and procedures to facilitate consistent workflow in the ED so that processes can be replicated when educating staff.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 32741 Based on document review and interview, it was determined that for 3 of 3 emergency room clinical records (Pt #7, Pt. #8 and Pt. #13) reviewed for transfers, the hospital failed to ensure the transfer forms were completed, as required. Findings include: 1. On 3/18/2025, the hospital’s policy titled, “Transfer of Patients to Other Acute Care Facilities -COBRA/EMTALA” (dated 9/2024) was reviewed and required, “...If the patient is unstable the risks and benefits of the transfer will be explained and consent obtained. The completed form will be kept as part of the medical record, and a copy of the form will accompany the patient...” 2. On 3/18/2025, the Emergency Department (ED) clinical record for Pt #7 (dated 1/27/2025) was reviewed. Pt. #7 was seen in Hospital A’s ED (transferring hospital) on 1/27/2025 with a diagnosis of RSV (respiratory syncytial virus). Pt. #7 was transferred to Hospital B (receiving hospital) for inpatient care. Pt.#7’s ED clinical record from the Hospital A lacked the required physician certification that notes whether Pt. #7’s emergency condition stabilized or unstable prior to transfer. 3. On 3/18, 2025, the ED clinical record for Pt. #8 (dated 1/28/2025) was reviewed. Pt. #8 was seen in Hospital A’s ED on 1/28/2025 with a diagnosis of moderate persistent asthma, hypoxic respiratory failure, influenza A and pneumonia. Pt. #8 was transferred to Hospital B for inpatient care. Pt. #8’s ED clinical record from Hospital A lacked a transfer form, as required. 4. On 3/18/2025, the ED clinical record for Pt.#13 (dated 2/26/2025) was reviewed. Pt.#13 was seen in Hospital A’s emergency department on 2/26/2025 with a diagnosis of acute constipation and acute kidney injury. Pt.#13 was transferred to Hospital B for inpatient psychiatric treatment. Pt.#13’s ED clinical record from Hospital A lacked the required physician certification that notes whether Pt. #13’s emergency condition stabilized or unstable prior to transfer. 5. On 3/18/2025 at 12:15 PM, an interview was conducted with the ED Nurse Educator (E #10). E #10 stated that each ED clinical record should have a completed transfer form.”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 51457 A. Based on document review and interview, it was determined that for 2 of 5 patients’ (Pts. #1 and #3) clinical records reviewed for blood transfusions, the hospital failed to ensure that assessments for vital signs were documented in accordance with approved policies and procedures. Findings include: 1. On 03/09/2025, the hospital’s policy titled, “ Routine Administration of Blood and Blood Components” (effective 07/2024) was reviewed and included, “...J. Check the blood pressure, pulse, respirations, oxygen saturation (pulse oximeter) and temperature pre-transfusion, 15-20 minutes after initiating the infusion and at one, two, three hours, and post-transfusion” 2. The clinical record of Pt. #1 was reviewed on 03/10/2025. Pt. #1 was admitted on 04/01/2024 with diagnoses of hepatic (liver) abscess and septic shock. The clinical record indicated that Pt. #1 received the following blood products: - On 4/1/2024, a unit of FFP (fresh frozen plasma) was administered at 8:00 PM. There were no vital signs (i.e., temperature, respiratory rate, pulse rate, blood pressure, and oxygen saturation) taken 15 minutes after initiation of the transfusion. - Multiple additional units of FFP were administered on 4/2/2024, where vitals were not taken before and/or 15 minutes after initiation of the transfusion. - On 4/2/2024, a unit of RBC (red blood cells) was administered at 10:25 PM. There was no temperature taken before initiation of the transfusion. There were also no vital signs taken 15 minutes after initiation of the blood transfusion. - On 4/3/2024, a unit of RBC was administered at 4:57 AM. There were no vital signs taken 15 minutes after initiation of the transfusion. - On 4/3/2024, a unit of RBC was administered at 10:28 AM. There were no vital signs taken 15 minutes - On 4/3/2024, another unit of FFP was administered at 12:27 PM. There were no vital signs taken 15 minutes after initiation of the transfusion. 3. On 03/10/2025, the clinical record for Pt. #3 was reviewed. Pt. #3 was admitted on 2/25/2025 due to cardiac arrest. The clinical record indicated that Pt. #3 had a blood transfusion on 3/9/2025 at 08:59 AM. Pt. #3’s clinical record lacked the initial temperature in the flowsheet at 08:59 AM. 4. An interview was conducted on 03/10/2025, at approximately 1:30 PM, with the Clinical Nurse Educator (E#8). E #8 stated that there should be documentation of Pt. #3’s initial vital signs including temperature, pulse, respirations, oxygen saturation, and blood pressure. 5. On 3/10/2024 from 1:00 PM through 3:00 PM, clinical record review of administration of blood products was conducted with E #3 (Clinical Nurse Manager). Findings of the review was also discussed with E #3. E #3 stated a complete set of vital signs, i.e., temperature, blood pressure, respiratory rate, pulse rate, and oxygen saturation should be taken before and 15 minutes after initiation of transfusion. B. Based on document review and interview, it was determined that for 2 of 5 patients’ (Pts.#1 and #3) clinical records reviewed for blood transfusion, the hospital failed to ensure that stop time, infusion rate, and blood volume were documented in accordance with approved policies and procedures. Findings include: 1. On 03/09/2025 the hospital’s policies titled, “ Routine Administration of Blood and Blood Components” (revised 06/2021 and 07/2024) were reviewed and included”... The date transfused and the transfusion start and stop times must be completed in the appropriate electronic medical record (EPIC) Blood Product Administration Module...1. Set the infusion rate so that transfusion will be completed within the physician order time... Record the volume infused...” 2. On 3/10/2025, the clinical record of Pt. #1 was reviewed. Pt. #1 was admitted on 04/01/2024 with diagnoses of hepatic (liver) abscess and septic shock. The clinical record indicated that on 04/01/2024, Pt. #1 was administered a unit of FFP (fresh frozen plasma) at 8:00 PM. The record lacked documentation of the time the transfusion was completed. 3. On 03/10/2025, the clinical record for Pt. #3 was reviewed. Pt.#3 was admitted on 02/25/2025 due to cardiac arrest. The clinical record indicated that Pt. #3 had a blood transfusion on 3/9/2025 at 08:59 AM. Pt. #3’s clinical record lacked documentation of the stop time, infusion rate, and blood volume administered during the transfusion. 4. An interview was conducted on 03/10/2025 at approximately 1:30 PM with the Clinical Nurse Educator (E#8). E #8 stated that there should be documentation of the transfusion infusion rate, blood volume, and stop time in EPIC. C. Based on document review and interview, it was determined that for 2 of 5 patients’ (Pts. #1 and #8) clinical records reviewed for blood transfusions, the hospital failed to ensure that potential signs and symptoms of a blood transfusion reaction were reported immediately to the physician and blood bank. Findings include: 1. On 03/10/2025, the hospital’s policy titled, “Routine Administration of Blood and Blood Components” (effective 07/2024) was reviewed and included, “...Observe the patient frequently during the entire infusion. Be alert for any adverse events possibly due to transfusion reaction...” 2. On 03/10/2025, the hospital’s policy titled, “Transfusion Reaction Management” (effective 12/2023) was reviewed and included, “...All adverse consequences of transfusion (‘Transfusion Reaction’) will be reported to the blood bank as soon as recognized. Transfusion reaction evaluation is ordered and reaction manifestations are documented in EPIC [electronic medical record]. Transfusion Reaction: includes any adverse consequences of transfusion, immediate or delayed...Symptoms of a transfusion reaction include but are not limited to: ...hypoxemia [low oxygen saturation]... blood pressure changes, usually acute, either hypertension [high blood pressure] or hypotension [low blood pressure]...Notify the patient’s physician of any possible transfusion reaction... Initiate and order a transfusion reaction work-up [notifies the blood bank of potential reaction]...” 3. On 03/11/2025, the hospital’s policy titled, “ Routine Care, Assessment and Vital Signs Guidelines” (effective 10/2023) was reviewed and included,”Blood Administration, abnormal vital signs are reported to the physician by the RN [registered nurse] promptly and notification documented...” 4. The clinical record of Pt. #1 was reviewed on 03/10/2025. Pt. #1 was admitted on 04/01/2024 with diagnoses of hepatic (liver) abscess and septic shock. The clinical record indicated that on 04/02/2024, Pt. #1 was administered a unit of FFP (fresh frozen plasma) between 3:30 PM and 4:00 PM. At 4:00 PM, Pt. #1’s oxygen saturation went down to 88% (normal level above 92%). There was no documentation that the physician and/or blood bank were notified regarding changes in Pt. #1’s clinical condition following administration of blood product. 5. On 03/10/2025, the clinical record for Pt. #8 was reviewed. Pt. #8 was admitted on 2/4/2025 due to shock. The clinical record indicated that Pt. #8 had a blood transfusion on 2/9/2025 at 12:15 PM. The physician’s order on 2/9/2025 at 11:46 AM to transfuse blood includes, “Notify physician if signs of transfusion reaction (e.g. temp increase greater than 2F [Fahrenheit] or 1 centigrade, other significant change in vital signs, rash or pain. If patient reacts, stop transfusion, document reaction in document flowsheet, and place transfusion reaction evaluation order). The record indicated that Pt. #8’s blood pressure on 2/9/2025 at 12:30 PM (during transfusion) was 92/54. The next vitals at 12:45 PM indicated that the blood pressure rose to 142/71 (indicates hypertension if greater than 120/90). The record lacked documentation that the increase in blood pressure was noticed and that the physician and blood bank were notified. 6. An interview was conducted on 03/10/2025 at approximately 1:30 PM with the Clinical Nurse Educator (E#8). E#8 stated that if the vitals change and/or are out of range, the expectation would be to retake the vitals to see if there was an error. E#8 stated that if the vitals remained out of range or concerning, then the physician should be notified immediately. 7. On 3/10/2024 from 1:00 PM through 3:00 PM, the clinical record review of administration of blood products was conducted with E #3 (Clinical Nurse Manager). E #3 stated that there should be documentation when a physician was notified regarding change in patient’s clinical condition. 39802 D. Based on document review and interview, it was determined that for 1 of 5 (Pt. #3) clinical records reviewed for blood transfusions, the hospital failed to ensure that verification of the blood product to recipient was completed by two qualified individuals prior to starting the transfusion. Findings include: 1. The hospital’s policy titled, “Routine Administration of Blood and Blood Components” (revised 07/2024), was reviewed and required, “...The identity of the recipient must be established at his or her bedside prior to transfusion by two individuals, who are qualified to participate in this process (i.e. registered nurse(s)..) ...This includes comparison of both the patient’s full name and date of birth or medical record number on the ‘compatibility tag’ and the patient’s identification band... This check must be documented in [the electronic medical record]...” 2. The clinical record of Pt. #3 was reviewed on 03/10/2025. Pt. #3 was admitted on 02/25/2025 due to cardiac arrest. The record indicated that Pt. #3 had a blood transfusion initiated on 03/09/2025 at 8:59 AM. The record lacked documentation that identity of the recipient was completed by two individuals prior to starting the transfusion. 3. An interview was conducted with the Clinical Nurse Educator (E#8) on 03/10/2025 at approximately 1:30 PM. E#8 stated that the verification screen pops-up when the nurse enters a new bag for transfusion. E#8 stated that the computer will then prompt for another nurse to sign in and verify the patient and blood product. E#8 stated that E#8 was unsure how the nurse entered a start time for the transfusion but did not complete the next steps to verify. E#8 stated that two nurses are required to verify the correct patient and blood product before every transfusion.”