Providence Saint Joseph Medical Ctr

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 45774 Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Nursing Services as evidenced by: A. For one of 30 sampled patients (Patient 24) that a label on a feeding tube container (a way to provide nutrition for patients who are unable to eat or drink by mouth) did not indicate the date, time, type of feeding, and the initials of the person who initiated the tube feeding required to indicate the need for a tube feeding replacement after 24 hours of use per facility ’ s policy and procedure. This deficient practice had the potential for risk of contamination (growing microorganisms, such as bacteria or parasites, or toxic substances making the feeding unit for consumption) from growth of microorganisms from prolonged use of the feeding tube, which may result in gastrointestinal (digestive pathway from the mouth to the anus) problems for Patient 24 such as diarrhea, abdominal pain, vomiting, etc. (Refer to A-398). B. For one of 30 sampled patients (Patient 24), Patient 24 ’ s two peripherally (pertaining to the outer parts of the body, such as the arms and legs) inserted intravenous (IV, access directly into the blood stream) lines were not labeled in accordance with the facility ’ s policy and procedure regarding comprehensive vascular (having to do with blood vessels and circulation) access management. The deficient practice had the potential to result in complications such as growth of bacteria (organisms which may cause an infection) or other germs entering Patient 24 ’ s blood stream that may lead to a deterioration in Patient 24 ’ s medical condition and a prolonged hospital stay. (Refer to A-398) C. For one of 30 sampled patients (Patient 7), who reported bilateral (both) arm and back pain was not given pain medicatiion in accordance with the facility ’ s policy and procedure. This deficient practice resulted iPatient 7 ’ s delay of pain relief and had the potential for Patient 7 to suffer from unresolved pain and may cause deterioration of Patient 7 ’ s medical condition. (Refer to A-398) D. Registered Nurse (RN) 9 did not address the fever (sudden rise in a body temperature of 101 degrees Fahrenheit [F, a temperature scale, 38.3 degrees Celsius [C, a temperature scale], the average normal body temperature is generally accepted as 98.6°F [37°C]) for one of 30 sampled patients (Patient 12), Patient 12 ’ s body temperature of 102.6 was not communicated to the attending physician. This deficient practice resulted in Patient 12 ’ s delay in emergent assessment and treatment and may cause seizures and deterioration of Patient 12 ’ s medical condition. (Refer to A-398) E. For one of 30 sampled patients (Patient 13), Patient 13 ’ s neurological assessments (evaluates the nervous system [brain, spinal cord, nerves] through observation and physical checks, focusing on mental status) were not followed, in accordance with the physician ’ s order. This deficient practice had the potential to result in Patient 13 ’ s delay in treatment and may result in further health complications for Patient 13 due to uncompleted neurological assessment to evaluate Patient 13 neurological conditions and may cause deterioration of Patient 13 ’ s medical condition. (Refer to A-398) F.To label with date and time tubing is to be change the primary intravenous (IV) tubing (a flexible tube used to deliver fluids, medications, nutrition, or blood directly into a person ’ s bloodstream through a vein) for one of 34 sampled patients (Patient 27) per the facility ’ s guidelines. This deficient practice had the potential to result in Patient 27 increased risk for intravascular catheter related infections. (Refer to A-398). G..Conduct pain reassessment after administration of pain medication for two of 30 sampled patients (Patients 8 and Patient 9), Patients 8 and Patient 9 ’ s who were in pain, pain reassessment (pain reassessment includes a pain scale uses numbers from 0 to 10, with 0 representing no pain and 10 representing the worst pain possible, location of pain, character of pain, and duration of pain) was not completed after pain medication administration to determine if treatment was effective, in accordance with the facility ’ s policy and procedures for pain management (Refer to A-398)This deficient practice had the potential for Patient 8 and Patient 9 ’ s pain not to be managed adequately. . 2. For two of 30 sampled patients (Patients 12 and Patient 14), Patients 12 and 14 ’ s individualized nursing care plan (provides a means of communication among health care providers) for Urinary Tract Infection (UTI) was not initiated in accordance with the facility ’ s policy and procedure (P&P). This deficient practice had the potential to result in delayed provision of care to the patients by not identifying Patients 12 and 14 ’ s needs and risks. (Refer to A-396). 3. The facility did not provide evidence of completed annual skills competency (the level of performance that a nurse is expected to achieve, which combines their knowledge, skills, abilities, and judgment) and education for one of seven sampled registered nurses (RN 11), in accordance with the facility ’ s policy and procedure. This deficient practice had the potential for RN 11 to carry out nursing duties in which RN 11 may not be competent of performing, which could potentially compromise patient safety. (Refer to A-397). 4.. Ensure that a pain level assessment met requirements for administration for one of 30 sampled patients (Patient 25) in accordance with the facility ’ s policy and procedure after a narcotic [opioid (a class of drug used to reduce moderate to severe pain) medication for pain relief] was given to Patient 25 without an indication of pain. This deficient practice had the potential to result in Patient 25 being unnecessarily sedated and a possible delay in Patient 25 ’ s recovery. (Refer to A-410). The cumulative effect of these deficient practices resulted in the facility ’ s inability to provide quality health care in a safe environment.”

“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: 45774 Based on interview and record review the facility failed to ensure a safe setting for one of 34 sampled patients (Patient 24), when Patient 24 was scheduled for discharge and the wrong patient was removed, via ambulance, from the facility and taken to Patient 24 ’ s home address. This deficient practice had the potential to leave both patients unattended during the transportation process or harmed. Findings: During a review of Patient 24 ’ s “History and Physical (H&P, a formal and complete assessment of the patient and the problem)”, dated 4/22/24 at 3:36 p.m., Patient 24 ’ s H&P indicated that Patient 24 was admitted to the facility on 4/22/24 for unspecified anemia (having fewer than normal healthy red blood cells). Patient 24 had a primary medical history of bile duct adenocarcinoma (a type of cancer that forms in the glands lining the bile ducts [a small tube that carries bile, a digestive fluid, to help break down fats and remove waste]), s/p biliary stent placement (a procedure that inserts a small tube into a blocked or narrowed bile duct to hold it open and restore the flow of bile), chronic obstructive pulmonary disease (COPD, a progressive lung disease that blocks airflow, making it hard to breathe), hypertension (HTN, high blood pressure), alcohol abuse (EtOH abuse, a pattern of alcohol use that involves problems controlling your drinking even when it causes problems), benign prostatic hyperplasia (BPH, a common non-cancerous enlargement of the prostate gland), alcoholic cirrhosis (the final stage of severe, long-term liver damage from heavy alcohol use), emphysema (a lung disease that damages the tiny air sacs [alveoli] in the lungs making it hard to breathe), hyperlipidemia (high cholesterol, having too many fats [lipids] in the blood), and deaf (having little or no ability to hear). During a record review of Patient 24 ’ s “Plan of Care” case manager (CM) notes, dated 4/30/24 at 2:31 p.m., Patient 24 ’ s CM note indicated that Patient 24 was scheduled for discharge home, via ambulance, with hospice (specialized care for people with life-limiting illnesses) care. Patient 24 ’ s discharge arrangements were coordinated via the hospice agency in collaboration with the hospice agency ’ s contracted transportation company and discussed with Case Manager 1 (CM 1). During a record review of Patient 24 ’ s “Plan of Care” social worker (SW) notes, dated 4/30/24 at 3:41 p.m., Patient 24 ’ s SW note indicated that Patient 24 ’ s caregiver was aware and agreeable to receiving Patient 24 at their home address. Hospice arranged transportation, and the bedside nurse was updated. The planned transportation time was 4:00 p.m. During an interview on 1/6/26 at 11:06 a.m., with Social Worker 1 (SW 1), SW 1 stated that their job classification was a discharge planner/clinical liaison at that time. SW 1 stated their job duties consisted of arranging home health (HH, professional medical care provided in a person ’ s home to help them recover from illness/surgery or manage a chronic condition) and hospice needs, which included discharge accommodations with hospice. Per SW 1 each hospice agency uses their own transportation company and not necessarily the same transportation companies utilized by the facility. SW 1 is unable to recall any incident involving the wrong patient being removed from the facility and taken to Patient 24 ’ s home address. During an interview on 1/6/26 at 11:25 a.m., with CM 1, CM 1 stated that when a patient is scheduled for discharge involving durable medical equipment (DME, reusable medical devices prescribed by a doctor for long-term use at home to help manage health conditions), HH, or hospice, a request is sent to “The Hub” (a group of staff members in the facility that coordinates with HH/Hospice agencies to arrange insurance approved services as recommended by a physician) to begin the steps required for the discharge process. The orders are sent to the patient ’ s insurance company, and a list of approved agencies are reported to the Hub staff members, who notify the patient/representative of their choices. An agency is then selected by the patient/representative, followed by an interview between the patient/representative and the agency (this may be in-person or via telephone). Once the informed contracts (between the patient/representative and agency) are in place, the Hub staff assists the agency with ensuring the patient ’ s home receives all recommended equipment/items prior to the patient being discharged. The Hub staff communicates the discharge plans to the patient, the patient ’ s physician and nursing staff to facilitate a smooth transition. The nurse verifies the information with the transportation company at pick-up. CM 1 reported remembering “something being reported” about a wrong patient being picked up but cannot recall the details of the event or who the patient was. During an interview on 1/6/26 at 2:41 p.m., with the Director of Risk Management (DRM), DRM reported having no knowledge of a transportation issue involving the wrong patient occurring on 4/30/24. DRM reported not being employed with the facility at that time but does not recall receiving any information regarding the wrong patient being discharged/transported. During an interview on 1/6/26 at 4:10 p.m., with DRM, DRM reported the facility having an incident report (a record/documentation of an unexpected occurrence) on file for Patient 24 involving a wrong patient being discharged/transported on 4/30/24. Per DRM, the facility is not at liberty to share or allow viewing of the incident report. DRM stated there was no mention of the name of the other patient involved. During an interview on 1/7/26 at 12:30 p.m., with the hospice agency ’ s transportation/ambulance driver (TD), the TD stated that they (the TD and a colleague) arrived to pick up Patient 24 as scheduled with the room number provided. Upon arrival, Patient 24 ’ s assigned nurse was “busy” with “multiple discharges” and verbally confirmed the scheduled pick up with a “brief” report given but did not provide a “face sheet” to confirm the identity of the patient as normally conducted. Per TD, there was no hand-off report (a communication process for transferring pertinent patient information from one healthcare worker to another during patient care transition) required when a patient was scheduled for discharge to their home address, as all information needed was provided by their dispatch operator. TD indicated that a “discharge summary (a medical document summarizing a patient ’ s hospital stay)” was provided by Patient 24 ’ s assigned nurse and the patient was transported to their home address. Upon arrival at Patient 24 ’ s home address, the receiving party (caregiver) stated that the patient transported was the wrong patient. TD stated that it was then discovered that the received discharge summary was for a patient different than the patient that was scheduled to be picked up. Per TD, the unidentified patient was returned to the facility where the hospital was already made aware of the incident possibly by Patient 24 ’ s caregiver. TD reported being escorted to the appropriate patient (Patient 24) by a facility case manager and transported the patient. TD further expressed the inability to recall the other involved patient ’ s name, the assigned nurse ’ s name, or the case manager ’ s name due to “occurring so long ago”. TD reported no longer having the discharge summary allegedly received in error. Per TD, there were no signatures or vital signs required by the ambulance company prior to transportation. During an interview on 1/7/26 at 2:08 p.m., with the director of acute care (DAC), the DAC reported somewhat recalling an incident where the wrong patient was discharged. The DAC stated that the unit had 2 patients scheduled for transport on 4/30/24 and without speaking to the nurse the ambulance driver picked up the wrong patient and transported the patient. The DAC reported an inability to recall any identifiers for the patients involved; however, according to the DAC, this was a serious situation as it could have led to harm for both patients. The patient removed could have missed important medications/treatments while away from the facility and/or placed in a dangerous environment, and Patient 24 could have been discharged from the system and left unattended also missing required medications/treatments. During an interview on 1/7/26 at 2:08 p.m. with the nurse manager (NM 7), NM 7 reported not being aware of any incident involving a wrong patient being discharged. Per NM 7, whether the transportation is arranged by a hospice agency or via a facility contracted ambulance company, a bedside hand-off is required prior to any patient being discharged. The patient must also be identified by an acceptable identifier prior to discharge. NM 7 stated that a patient being discharged and taken to the wrong home/facility or the wrong patient being picked up is a serious occurrence that would be very concerning for the patient ’ s safety as it may lead to serious harm. During an interview on 1/7/26 at 3:05 p.m. with the hospice agency ’ s former manager, the former manager reported that the facility gave the transportation/ambulance company the wrong patient. During a review of Patient 24 ’ s registered nurse note dated 4/30/24 at 3:35 p.m., Patient 24 ’ s assigned nurse documented that “per hospice nurse, everything was arranged and Patient 24 ’ s representative agreed to accept Patient 24. There was no further documentation regarding the discharge process, or the actual pick-up for Patient 24. The assigned nurse on 4/30/24 was not available for interview. During a review of the facility ’ s “Inpatient Census” for 4/30/24, a patient was identified in the room number provided by the hospice agency ’ s TD as the room number that the incorrect patient was picked up from. During a review of Patient 31 ’ s “Electronic Health Record (EHR, a digital version of a patient ’ s complete medical history/record)”, Patient 31 ’ s EHR indicated that on 4/30/24, Patient 31 was assigned to the room number provided by the hospice agency ’ s TD. Patient 31 was scheduled for transportation by cabulance (a non-emergency medical transport service using vans or modified vehicles to transport people with disabilities or health needs) at 5:00 p.m. to a skilled nursing facility (SNF, provides services for patients after a hospital stay for illness, injury, or surgery). Patient 31 was discharged at 5:35 p.m. There was no narrative documentation of Patient 31 ’ s discharge/transport or any associated problems with Patient 31 ’ s discharge/transport. During an interview on 1/8/26 at 10:07 a.m. with ANM 2, ANM 2 stated that the facility ’ s protocol was for an ambulance driver to check in with the unit secretary when arriving to pick-up/transport a patient. A face sheet (a one-page, quick reference, summary of a patient ’ s critical information) is provided to the driver by the unit secretary once the patient ’ s discharge/transfer status is verified. The ambulance driver is given the patient ’ s room number and the name of the assigned nurse. The assigned nurse, or charge nurse if the assigned nurse is busy, would be notified of the transportation/ambulance staff ’ s arrival. The nurse would then meet the ambulance driver in the patient ’ s room to conduct a bedside hand-off report. The patient ’ s identity is verified (via the patient ’ s armband, asking the patient their name, etc.). The nurse would then remove all IV lines, tubing, etc. The patient ’ s vital signs are assessed. The patient ’ s belongings are given to the patient or ambulance driver, and the patient is transferred to the gurney and discharged. The nurse is required to document in the “discharge checklist (a section of the facility ’ s documentation system consisting of a checklist of items required prior to a patient to be discharged)”. ANM 2 stated that vital signs are always performed before a patient is discharged, unless the patient refuses. During an interview on 1/8/26 at 3:45 p.m. with DRM, DRM could not rule out Patient 31 as the patient wrongly transported to Patient 24 ’ s home address. Per DRM, there was no documentation of the other patient ’ s identity and unfortunately there was no name provided on the facility ’ s incident report. DRM stated that the facility does not have a discharge policy. During a review of the facilities “Hospice Discharge List” for 4/30/24, there were three patients scheduled for discharge with one patient on the oncology medical-surgical unit (Patient 24) and two on the neurology telemetry unit.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 45774 Based on interview and record review, the facility failed to ensure for two of 30 sampled patients (Patients 12 and Patient 14), Patients 12 and Patient 14 ’ s individualized nursing care plan (provides a means of communication among health care providers) for Urinary Tract Infection (UTI, an infection in the bladder/urinary tract) was initiated in accordance with the facility ’ s policy and procedure (P&P). This deficient practice had the potential to result in delayed provision of care to the patients by not identifying Patients 12 and Patient 14 ’ s needs and risks. Findings: 1. During a review of Patient 12 ’ s “History & (and) Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 1/3/2026, indicated Patient 12 ’ s active hospital problem list included Urinary tract infection (UTI, an infection in the bladder/urinary tract). During a concurrent interview and record review on 1/6/2026 at 10:48 a.m., with Sepsis Telemetry Assistant Nurse Manager (Nse Mgr 6), Nse Mgr 6 verified Patient 12 ’ s “Care Plan” did not include a care plan that addresses Patient 12 ’ s UTI. Nse Mgr 6 stated the Patient 12 ’ s care plan for UTI was important to know the plan and interventions for nursing care guidance. During a review of the facility ’ s policy and procedure (P&P) titled, “Plan of Care,” revised in 6/2022, the P&P indicated, “A. The Registered Nurse (RN) is accountable to assure the development of a patient-centric, interprofessional, individualized plan of care. 1. Initial Plan of care- Initiated POC within 4 hours of admission. Review any appropriate previous/prior patient encounter (s) related to licensed independent practitioner (LIP) history, admission, medication, health history, allergies and immunizations ....2.Comprehensive POC-within 24 hours following admission, the RN assures completion of a comprehensive interprofessional Plan of care informed by comprehensive nursing assessment, admission data, provider notes, testing results, and interprofessional collaboration ....” 2. During a review of Patient 14 ’ s “History & (and) Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 11/16/2025, indicated Patient 14 was admitted to the facility for Intraparenchymal hemorrhage (bleeding directly into the brain ’ s functional tissue, often caused by uncontrolled high blood pressure, head injury or underlying issues). During a review of a Patient 14 ’ s “Medication Administration Report (MAR),” dated 1/7/2026, the MAR indicated a physician ’ s order for Patient 14 to receive the following: Rocephin (antibiotic, treats bacterial infections) 1 g (gram-a unit of measurement) intravenous (IV-in the vein) every 24 hours for UTI with start date of 12/2/2025; and, Unasyn (antibiotic, treats bacterial infections)) 3 g (gram-a unit of measurement) intravenous (IV-in the vein) 4 times per day for UTI with start date of 12/4/2025. During a concurrent interview and record review on 1/7/2026 at 10:05 a.m., with Cardiac Telemetry Assistant Nurse Manager (ANM 1), ANM 1 verified Patient 14 ’ s “Care Plan” did not include a care plan that addresses Patient 14 ’ s UTI. ANM 1 stated the Patient 14 ’ s care plan for Urinary tract infection (UTI, an infection in the bladder/urinary tract) was important to know the plan and interventions for nursing care guidance. ANM 1 stated Patient 14 ’ s UTI care plan was expected to be added on 12/2/2025. During a review of the facility ’ s policy and procedure (P&P) titled, “Plan of Care,” revised in 6/2022, the P&P indicated, “A. The Registered Nurse (RN) is accountable to assure the development of a patient-centric, interprofessional, individualized plan of care. 1. Initial Plan of care- Initiated POC within 4 hours of admission. Review any appropriate previous/prior patient encounter (s) related to licensed independent practitioner (LIP) history, admission, medication, health history, allergies and immunizations ....2.Comprehensive POC-within 24 hours following admission, the RN assures completion of a comprehensive interprofessional Plan of care informed by comprehensive nursing assessment, admission data, provider notes, testing results, and interprofessional collaboration ....3. Ongoing management of the POC-The RN is responsible to update the POC as needed to reflect the patient ’ s current, active needs. As a patient ’ s needs change (e.g.: new diagnosis or procedure, resolve problem, recognition of changing goals or strategies, etc.) the POC should be revised to reflect those changes ...””

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 45774 Based on interview and record review, the facility failed to provide complete annual skills competency (the level of performance that a nurse is expected to achieve, which combines their knowledge, skills, abilities, and judgment) and education for one of seven sampled registered nurses (RN 11), in accordance with the facility ’ s policy and procedure for “Competency Assessment.” This deficient practice had the potential for RN 11 to carry out nursing duties in which RN 11 may not be competent of performing, which could potentially compromise patient safety. Findings: During a concurrent interview and personnel employee file review on 1/8/2026 at 10:00 a.m. with the Regional Manager (RM), OSD (Operations and Service Delivery) Regulatory Analyst (RA), and Executive Director of Quality and Educator (EDQ), , the RA, and the EDQ, reviewed Registered Nurse 11 (RN 11) ’ s personnel employee file and the RA stated the RN 11 worked in the Medical surgical Unit (a unit that provides care for adults with a variety of health issues that are non-critical), from 7/25/2022 to present. And RN 11 ’ s abuse (intentional maltreatment of an individual that may cause physical or psychological injury) annual competency was not completed for the year 2025. The EDQ stated the facility did not have a policy regarding annual competencies, however, it was the unit managers responsibility to make sure their staff has annual competencies for abuse training and education completed. During a concurrent interview with Nurse Manager for Cardiac Telemetry (Nse Mgr 2), Nse Mgr 2 on 1/8/2026 at 3:26 p.m., the Nse Mgr 2 stated abuse annual competencies were necessary to ensure Registered Nurses skills were for abuse training meeting the requirements and to ensure safety patient services. Nse Mgr 2 stated the Nurse Managers were responsible to ensure their nursing staff were completing the annual competencies for abuse training and education. During a concurrent interview and personnel employee file review on 1/9/2026 at 09:00 a.m. with the EDQ, the EDQ reviewed RN 11’s abuse annual competency titled, “2025 Annual Regulatory Requirements (ARR),” dated 1/1/2024, the EDQ stated there were no other records of further competencies. The EDQ stated RN 11 was missing abuse annual training for the year 2025. During a review of the document title, “Guideline for Required Education,” updated 2025, provided by the facility indicated, “Abuse/Harassment-The patient has the right to be free from all forms of abuse or harassment. The hospital, during its orientation program, and through an ongoing training program, provides all employees with information regarding abuse and neglect, and related reporting requirements, including prevention, intervention, and detection.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 45774 Based on observation, interview, and record review, the facility failed to ensure: A. For one of 30 sampled patients (Patient 24) that a label on a feeding tube container (a way to provide nutrition for patients who are unable to eat or drink by mouth) indicated the date, time, type of feeding, and the initials of the person who initiated the tube feeding required to indicate the need for a tube feeding replacement after 24 hours of use per facility policy and procedure. This deficient practice had the potential for risk of contamination (growing microorganisms, such as bacteria or parasites, or toxic substances making the feeding unit for consumption) from growth of microorganisms from prolonged use of the feeding tube. , which may result in gastrointestinal (digestive pathway from the mouth to the anus) problems for Patient 24 such as diarrhea, abdominal pain, vomiting, etc. B. For one of 30 sampled patients (Patient 24), Patient 24 ’ s two peripherally (pertaining to the outer parts of the body, such as the arms and legs) inserted intravenous (IV, access directly into the blood stream) lines were labeled in accordance with the facility ’ s policy and procedure regarding comprehensive vascular (having to do with blood vessels and circulation) access management. The deficient practice had the potential to result in complications such as growth of bacteria (organisms which may cause an infection) or other germs entering Patient 24 ’ s blood stream that may lead to a deterioration in Patient 24 ’ s medical condition and a prolonged hospital stay. C. For one of 30 sampled patients (Patient 7), who reported bilateral (both) arm and back pain was not given pain medication for pain in accordance with the facility ’ s policy and procedure. This deficient practice resulted Patient 7 ’ s delay of pain relief and had the potential for Patient 7 to suffer from unresolved pain and may cause deterioration of Patient 7 ’ s medical condition. D. Registered Nurse (RN) 9’s addressed the fever (sudden rise in a body temperature of 101 degrees Fahrenheit [F, a temperature scale, 38.3 degrees Celsius [C, a temperature scale], the average normal body temperature is generally accepted as 98.6°F [37°C]) for one of 30 sampled patients (Patient 12), Patient 12 ’ s body temperature of 102.6 was not communicated to the attending physician. This deficient practice resulted in Patient 12 ’ s delay in emergent assessment and treatment and may cause deterioration of Patient 12 ’ s medical condition. E. For one of 30 sampled patients (Patient 13), Patient 13 ’ s neurological assessments (evaluates the nervous system [brain, spinal cord, nerves] through observation and physical checks, focusing on mental status) were followed, in accordance with the physician ’ s order. This deficient practice had the potential to result in Patient 13 ’ s delay in treatment and may result in further health complications for Patient 13 due to uncompleted neurological assessment to evaluate Patient 13 neurological conditions and may cause deterioration of Patient 13 ’ s medical condition. F.To label with date and time tubing is to be change the primary intravenous (IV) tubing (a flexible tube used to deliver fluids, medications, nutrition, or blood directly into a person ’ s bloodstream through a vein) for one of 34 sampled patients (Patient 27) per the facility ’ s guidelines. This deficient practice had the potential to result in Patient 27 increased risk for intravascular catheter related infections. G..Conduct pain reassessment after administration of pain medication for two of 30 sampled patients (Patients 8 and Patient 9), Patients 8 and Patient 9 ’ s who were in pain, pain reassessment (pain reassessment includes a pain scale uses numbers from 0 to 10, with 0 representing no pain and 10 representing the worst pain possible, location of pain, character of pain, and duration of pain) was not completed after pain medication administration to determine if treatment was effective, in accordance with the facility ’ s policy and procedures for pain management This deficient practice had the potential for Patient 8 and Patient 9 ’ s pain not to be managed adequately. . Findings: A. During a review of Patient 24 ’ s History and Physical, (H&P, a formal and complete assessment of the patient and the problem), dated 12/1the H&P indicated, Patient 24 was admitted on 12/24/2025 with a chief complaint of abdominal pain, pneumonia (an infection/inflammation in the lungs), possible fluid overload (when the body has too much fluid, causing swelling) due to cirrhosis (scarring in the liver that can lead to liver failure), a history of chronic obstructive pulmonary disease (COPD – a chronic lung disease causing difficulty in breathing), dementia (a progressive state of decline in mental abilities), and hypertension (HTN – high blood pressure). During a concurrent interview and observation on 1/05/2025 at 10:57 a.m. with the Director of ICU (DICU) at Patient 24 ’ s bedside, the tube feeding was observed infusing did not have a label indicating the type of feeding, the date and time feeding was initiated, or the initials of the person who initiated the feeding. DICU stated the feeding was a two-bag system, one bag for the tube feeding and another bag alongside for sterile water. DICU stated the sterile water bag had a date and time, but no initials of who initiated the feeding. DICU stated the feeding would need to be labeled with the type of feeding infusing, along with the date, time, and initials of who initiated feeding. During a concurrent interview and record review on 1/05/2026 at 3:10p.m. with ICU Nurse Manager (Nse Mgr) 4, Patient 24 ’ s records were reviewed. The physician order dated 12/30/2025 at 6:25 p.m. indicated, “Continuous tube feeding carbohydrate controlled; Glucerna 1.2; rate 60.” Patient 25 ’ s chest x-ray dated 12/17/2025 indicated, “Enteric (a method of providing nutrition, fluids, and medications into the digestive system either by mouth or through a feeding tube) tube tip in the gastric lumen (the inner space of the stomach).” During an interview on 1/07/2026 at 10:44 a.m. with Intensive Care Unit (ICU, a specialized hospital ward that provides treatment and round-the-clock monitoring for people who are critically ill or injured) Registered Nuse (RN) 8, RN 8 stated an unlabeled tube feeding can cause the nurse to not know when to hang the next feeding, what feeding is being used, or cause growth in bacteria if feeding tube is left up longer than 24 hours. RN 8 stated harm could come to patient if the feeding is not labeled per policy. During a review of the facility ’ s policy and procedure (P&P) titled, “Feeding Tubes (NGT [a tube inserted through the nose, down the throat, and into the stomach], OG [a tube going in through the mouth and into the stomach], GT [a tube placed directly into the stomach for feedings], JT [a tube inserted directly into the intestine bypassing the stomach]),” last revised 11/2021, indicated, “Refer to Lippincott for instructions except where noted otherwise in special considerations below.” The Lippincott website was provided in the P&P. During a review of the “Lippincott Procedures – Enteral (delivering nutrients directly into the stomach) tube feedings, gastric,” revised 12/15/2025, the procedure indicated, “Make sure that the enteral formula container is labeled with the patient ’ s identifiers; formula name (and strength, if diluted); date and time of formula preparation; date and time that the formula was hung; administration route, rate, and duration (if cycled or intermittent); initials of the person who prepared, hung, and checked the enteral formula against the order; expiration date and time; dosing weight (if appropriate); and notation ENTERAL USE ONLY – NOT FOR IV (intravenous, directly into the vein) USE.” B. During a review of Patient 24 ’ s History and Physical, (H&P, a formal and complete assessment of the patient and the problem), dated 12/1” indicated, Patient 24 was admitted on 12/24/2025 with a chief complaint of abdominal pain, pneumonia (an infection/inflammation in the lungs), possible fluid overload (when the body has too much fluid, causing swelling) due to cirrhosis (scarring in the liver that can lead to liver failure), a history of chronic obstructive pulmonary disease (COPD – a chronic lung disease causing difficulty in breathing), dementia (a progressive state of decline in mental abilities), and hypertension (HTN – high blood pressure). During a concurrent interview and observation on 1/05/2025 at 10:57 a.m. with the Director of ICU (DICU) and Chief Medical Officer (CMO) at Patient 24 ’ s bedside, Patient 24 was observed to have an intravenous (IV - intravenous access directly into the blood stream) insertion site on left antecubital (the front of the elbow) area covered with a transparent dressing and an IV insertion site on the back of Patient 24 ’ s left hand covered with a transparent dressing. DICU stated the IV insertion sites should be labeled with the date and time of IV insertion and the name of the person who placed the IVs. DICU stated the nurses knew when the dressings needed to be changed, which would be either when dressings were saturated or after several days of dressings being in place. DICU stated with no date on IV insertion site dressings, there was not a manner to determine how long the dressings were in place, potentially causing harm to the patient if dressings or IV sites were left in place too long. During an interview on 1/07/2026 at 10:44 a.m. with Intensive Care Unit (ICU, a specialized hospital ward that provides treatment and round-the-clock monitoring for people who are critically ill or injured) Registered Nuse (RN) 8, RN 8 stated that without a date, time, and initials on an IV site, the nurses would not know when to change the IV or dressing and a delay can cause a risk for infection. During a record review of the facility ’ s policy and procedure titled, “Comprehensive Vascular Access Management,” last revised 05/2023, indicated, “4. Frequency of dressing changes: a. Dressings are to be changed every seven (7) days or earlier if soiled, damp, or loose ... 5. The dressing will be labeled, indicating the date of insertion.” “Peripheral and Midline Policy ...a. Peripheral IV catheters are replaced when clinically indicated, in the absence of IV related complications. Refer to Lippincott.” During a record review of Lippincott ’ s “IV Catheter Insertion” Procedure, revised 9/15/2025, the procedure indicates, “Label the IV dressing with the current date or the date the dressing is due to be changed as directed by your facility.” C. During a record review of Patient 7 ’ s “Patient Care Timeline,” dated 8/28/2025, the Patient 7 ’ s Care Timeline indicated Patient 7 was presented to the Emergency Department (ED) for Back Pain. During a concurrent interview and record review on 1/5/2026 at 1:41 p.m., with Sepsis Telemetry Assistant Nurse Manager, (Nse Mgr 6), the “Vital Signs,” dated 8/28/2025 was reviewed. The vital signs indicated the following: On 8/28/2025 at 2:09 a.m., Patient 7 ’ s pain rating was 8/10 (pain score 7-10 is severe pain) to bilateral (both) arms. On 8/28/2025 at 8:31 a.m., Patient 7 ’ s pain rating was 7/10 (pain score 7-10 is severe pain) to back. During a concurrent interview and record review on 1/5/2026 at 2:20 p.m., the Nse Mgr 6 verified Patient 7 did not received any pain medication and non-pharmacological (healthcare interventions that do not involve the use of medications) interventions were not implemented during Patient 7 ’ s ED visit. Nse Mgr 6 stated nonpharmacological pain interventions should have been implemented. During a concurrent interview and record review on 1/5/2026 at 2:20 p.m., with Nse Mgr 6, Nse Mgr 6 stated Patient 7 ’ s, “Social Worker Consult Note,” dated 8/28/2025 at 11:29 a.m. was reviewed. Patient 7 ’ s Social Worker Consult note indicated, “Patient reports she wants her arms amputated due to chronic pain, but that she ’ s been told that won ’ t happen ...states “Anything can happen, I just don ’ t want to be in pain ...” During a concurrent interview and record review on 1/5/2026 at 2:24 p.m., the Nse Mgr 6 stated expectation would be for Patient 7 ’ s pain to be addressed and nurses could have escalated (speed up) Patient 7 ’ s severe pain level to the provider in triage so pharmacological interventions can be initiated and remind the physician about the needed pain management and for Patient 7 ’ s to experience comfort during the ED visit. During a review of the facility ’ s policy and procedure (P&P) titled, “Patient Rights and Responsibilities,” revised on 2/2022, the P&P indicated, “9. Appropriate assessment and management of your pain, information about pain, pain relief measures and to participate in pain management decisions. You may request or reject the use of any or all modalities to relieve pain, including opiate medication, if you suffer from severe chronic intractable pain. The doctor may refuse to prescribe the opiate medication but, if so, must inform you that there are physicians who specialize in the treatment of severe chronic intractable pain with methods that include the use of opiates.” D. During a review of Patient 12 ’ s “History & (and) Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 1/3/2026, the H&P indicated Patient 12 was admitted to the facility for colon mass (an abnormal growth or a lump in the colon [large intestine]). The H&P further indicated, Patient 12 ’ s active hospital problem list included Urinary tract infection (UTI, an infection in the bladder/urinary tract). During a concurrent interview and record review on 1/6/2026 at 10:48 a.m., with Sepsis Telemetry Assistant Nurse Manager, (Nse Mgr 6), the “Vital Signs,” dated 1/3/2026 was reviewed. The vital signs indicated the following: On 1/3/2026 at 8:08 a.m., Patient 12 ’ s oral (by mouth) temperature was 102.6 F (the average normal body temperature is generally accepted as 98.6°F [37°C]) (no reassessment was documented until 2:00 p.m.) On 1/3/2026 at 2:00 p.m., Patient 12 ’ s axillary (axilla, armpit) temperature was 99.0 F During a concurrent interview and record review on 1/6/2026 at 11:00 a.m., the Nse Mgr 6 verified there were no records of RN 9 reassessment of Patient 12 ’ s body temperature on 1/3/2026 at 8:08 a.m. until 5 hours and 52 minutes later. Nse Mgr 6 verified RN 9 documented on 1/3/2026 at 2:00 p.m. an axillary body temperature of 99.0 F. During a concurrent interview and record review on 1/6/2026 at 11:00 a.m., the Nse Mgr 6 verified RN 9 the assigned nurse for Patient 12 did not notify the physician about the oral temperature of 102.6 F. and no non-pharmacological (healthcare interventions that do not involve the use of medications) interventions were implemented. Nse Mgr 6 stated RN 9 was expected to inform Patient 12 ’ s physician about the oral temperature of 102.6 F and cooling measures interventions should have been implemented. During a concurrent interview and record review on 1/8/2026 at 3:56 p.m., the Assistant Nurse Manager for Oncology (Nse Mgr 8) stated Patient 12 ’ s temperature of 102.6 the expectation would be to contact the physician immediately within the same hour, initiate cooling measures, and reassessed the body temperature within 3-4 hours of the interventions. Nse Mgr 8 verified Patient 12 ’ s temperature of 102.6 was not communicated to Patient 12 ’ s physician. During a review of the facility ’ s policy and procedure (P&P) titled, “Scope of Service: Medical Surgical-Oncology,” revised on 8/2021, indicated, “The goals of Medical/surgical-oncology are to: Utilize the Interdisciplinary approach in planning and implementing care. Provide a safe physical environment. ...Comprehensive care is achieved by using the nursing process as a framework and utilizing an interdisciplinary approach including collaboration between the physicians, patient, and family/significant other, and other hospital personnel as appropriate. Treatment modalities/Methods utilized-The nursing process is applied to address physiological, psychological, socio-cultural and spiritual needs of the adult inpatient. Therapeutic modalities/methods utilized in the provision of care include nursing assessment, intravenous therapy, fluid and electrolyte balance, medication administration, airway management, psycho-social care, safety management, pain management, chemotherapy, biotherapy, infection control practices and patient/family education ...” E. During a review of Patient 13 ’ s “History & (and) Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 12/18/2025, the H&P indicated Patient 13 was admitted to the facility for Cerebral Aneurysm (a bulge or ballooning in a blood vessel in the brain that can leak or rupture, causing a life-threatening bleed.) During a concurrent interview and record review on 1/6/2026 at 3:19 p.m., with Cardiac Telemetry Assistant Nurse Manager (ANM 1), ANM 1 verified Patient 13 ’ s physician order “Neuro checks (evaluates the nervous system [brain, spinal cord, nerves] through observation and physical checks, focusing on mental status) Q (every) 15 minutes x 4 (four consecutive times) ; Q (every) 30 minutes: x 2 (two consecutive times); Q (every) 1 hour: x 4 (four consecutive times); Q 4 hours (every 4 hours consecutively): until discontinued, order comments: Until discharge,” start date/time: 12/16/2025 at 12:49 p.m. was reviewed. In the same interview with ANM 1 on 1/6/2026 at 3:19 p.m., the ANM 1 stated Patient 13 ’ s physician order “Neuro checks (evaluates the nervous system [brain, spinal cord, nerves] through observation and physical checks, focusing on mental status) Q 4 hours (every 4 hours consecutively): until discontinued, order comments: Until discharge,” start date/time: 12/17/2025 at 1:23 p.m. was reviewed. During a concurrent interview and record review on 1/6/2026 at 4:15 p.m., with Cardiac Telemetry Assistant Nurse Manager (ANM 1), Patient 13 ’ s “Neuro flowsheet,” dated 12/17/2025 was reviewed. The flowsheet indicated: On 12/17/2025 at 9:00 a.m., Patient 13 ’ s Neuro assessment indicated “cognitive/neuro/behavioral WDL (withing normal limits): arousability (refers to the ease with which someone can be awakened or stimulated from sleep or unconsciousness), Level of Consciousness: lethargic (abnormally drowsy), Arousal Level (state of alertness, energy, and readiness): arouses to voice, Orientation: oriented x4 (someone who is alert and oriented to person, place, time and event), Speech: clear; logical, Mood/Behavior: anxious, Swallowing signs/symptoms: was not documented, Memory Deficit: intact, sensory Impairment: blurred vision, left eye.” On 12/17/2025 at 7:46 p.m., Patient 13 ’ s Neuro assessment indicated “cognitive/neuro/behavioral WDL (withing normal limits): WDL, Level of Consciousness: Alert, Arousal Level (state of alertness, energy, and readiness): was not documented, Orientation: oriented x4 (someone who is alert and oriented to person, place, time and event), Speech: spontaneous; clear, Mood/Behavior: calm, Swallowing signs/symptoms: was not documented, Memory Deficit: intact, Muscle tone assessment: within normal limits, sensory Impairment: was not documented.” In the same interview on 1/6/2026 at 4:15 p.m., the ANM 1 stated Patient 13 ’ s Neuro assessment was missing on 12/17/2025 at 01:00 p.m. and 05:00 p.m. During a concurrent interview and record review on 1/6/2026 at 4:20 p.m., with ANM 1, Patient 13 ’ s “Neurosurgery Progress Note,” dated 12/17/ 2025 was reviewed. The progress note indicated “[Patient 13] is now Hospital Day: 2 s/p (status post, after) bifrontal craniotomy (a neurosurgical procedure to access lesions or remove tumors at the front skull base and front lobes) ....q4hr (every 4 hours consecutively) Neuro checks ...” ANM 1 stated Patient 13 ’ s assigned nurse was expected to follow Patient 13 ’ s physician orders for neuro assessment. ANM 1 stated the importance of neuro assessments is to see any changes in Patient 13 ’ s cognitive, behavior, orientation, and swallowing due to the recent brain surgery. During a review of the facility ’ s policy and procedure (P&P) titled, “Scope of Service: Telemetry,” revised on 12/2019, the P&P indicated, “The goals of Telemetry are to: Provide therapeutic and compassionate patient care. Utilize the interdisciplinary approach in planning and implementing care ...Comprehensive care is achieved by using the nursing process as a framework and utilizing an interdisciplinary approach including collaboration between the physicians, patient, and family/significant other, and other hospital personnel as appropriate. Treatment modalities/Methods utilized-The nursing process is applied to address physiological, psychological, socio-cultural and spiritual needs of the adult inpatient. Therapeutic modalities/methods utilized in the provision of care include nursing assessment, IV therapy, fluid and electrolyte balance, medication administration, infection control practices and patient/family education. Types of Patients Served Admission to the telemetry will be based upon severity of illness and intensity of service required to provide appropriate quality patient care. Telemetry is the unit that is used to care for patients requiring continuous cardiac monitoring and/or is the primary unit for continuous neurological assessment ...” F. During a review of Patient 27 ’ s “History and Physical (H&P, a formal and complete assessment of the patient and the problem)”, dated 1/3/26 at 9:40 a.m., indicated that Patient 27 presented to the emergency department for severe abdominal pain for two days along with constipation (infrequent bowel movements and/or stools hard, difficult, or painful to pass). Patient 27 ’ s workup revealed findings suggestive of acute cholecystitis (sudden inflammation of the gallbladder). Patient 27 was admitted to the hospital for surgical evaluation. Patient 27 had a history of depression (a mood disorder causing persistent sadness, loss of interest, and changes in sleep, appetite, and energy that interfere with daily life). During an observation on 1/5/26 at 11:13 a.m., with Registered Nurse 10 (RN 10), Patient 27 was noted to have an IV tube connected to the left arm actively infusing (delivering fluids, medications, or blood directly into the bloodstream) fluid. The IV bag (a medical container holding sterile fluids, medications, or nutrients) appeared to be newly hung and full. The IV tubing contained a light brown “change Friday” label around the drip chamber (the clear bulb in IV tubing that fills with fluid, allowing healthcare providers to see drops forming to control the flow rate and prevent air bubbles). The label did not contain a date, time, or initial. During an interview on 1/5/26 at 11:15 a.m., with RN 10, RN 10 stated that Patient 27 ’ s IV bag was recently hung by RN 10; however, RN 10 was not aware of who changed the IV tubing or when it was changed, perhaps night shift per RN 10. RN 10 stated that there was no way of knowing which “Friday” the tubing should be changed as there was no date indicated. RN 10 further stated that it was important to change the IV tubing per policy to prevent infection. RN 10 stated that if the tubing change was unknown, the tubing should have been changed with the IV bag change to prevent infection and maintain sterility (the absence of all viable microorganisms/germs). During a concurrent interview and observation on 1/5/26 at 11:20 a.m., with Nurse Manager 1 (NM 1), NM 1 stated that medications coming from the pharmacy (where medicinal drugs are dispensed and stored) were delivered containing a patient identifier (pieces of information that reliably link a patient to their medical records and treatments), date, and time scheduled to be administered (given). All unit stocked (goods or pharmaceuticals on hand within a specific nursing unit or department) medications were required to be labeled with date, time, room number and initials of the administering nurse. NM 1 further stated that primary IV tubing should be changed every four days (every 96 hours) and should be identified with a label indicating the day and time, date, room number, and RN initials. NM 1 pointed to the units “IV Tubing Labeling” guidelines visibly hanging in each medication room on the unit which corroborates NM 1 ’ s statements. During a review of Patient 27 ’ s Medication Administration Record (MAR, a legal document tracking every medication given to a patient), Patient 27 ’ s MAR did not indicate documentation of an IV tubing change on Thursday (1/1/26), Friday (1/2/26), Saturday (1/3/26), Sunday (1/4/26), or Monday (1/5/26) per the facility ’ s recommendations to change every four days or every 96 hours. During a review of the facility ’ s “IV Tubing Labeling” guidelines, the guideline posted in the medication room on 5 North East (5NE) indicated: Hang Day/Time Label Change Day / Time Monday Change Friday Tuesday Change Saturday Wednesday Change Sunday Thursday Change Monday Friday Change Tuesday Saturday Change Wednesday Sunday Change Thursday IV tubing change Q96Hours (4 days) primary Label with the following: Day and Time, Date, Room Number, and RN Initials Know Why and Comply (Practice Change Rationale): Infection Prevention: Decreases need to break a sterile system until warranted Stewardship: Decrease plastic waste, helping ministry stay green Decrease cost associated with changing tubing earlier than clinically indicated G.. During a review of Patient 8 ’ s “History & (and) Physical (H&P, a formal and complete assessment of the patient and the problem),” dated 9/30/25, the H&P indicated Patient 8 was admitted to the facility for Abdominal Pain. The H&P further indicated, Patient 8 ’ s active hospital problem list included bowel perforation (a life-threatening hole in the gastrointestinal tract, allowing digestive contents to leak into the abdomen, causing severe infection). During a review of Patient 8 ’ s “Medication Administration Report (MAR)” dated 1/5/2026, the MAR indicated a physician ’ s order for Patient 8 to receive the following: - Norco (pain medication) 5-325 milligram (mg-a unit of measurement) 1-2 tablet oral (PO, by mouth) every 4 hours as needed (PRN) for moderate pain (pain score of 4-7 is moderate pain), severe pain (pain score of 8-10 is severe pain), “Administration Instructions: Moderate pain: Give if pain is not controlled with acetaminophen and NSAID or if not ordered. Severe pain: Give with acetaminophen and NSAID as ordered. If dose range is ordered, initial dose must be the lowest dose. If ineffective upon reassessment, repeat lowest dose after at least 60 mins. For future doses, administer last effective dose at the next allowable time unless the patient prefers the lowest dose, with start date of 9/30/25. During a concurrent interview and record review, on 1/5/26 at 2:26 p.m., with Sepsis Telemetry Assistant Nurse Manager (Nse Mgr 6), Nse Mgr 6 verified Patient 8 ’ s MAR indicated on 10/1/25 at 10:34 a.m., Patient 8 was administered Norco 5-325 mg tablet PO. The corresponding pain assessment indicated Patient 8 ’ s pain score was 5 (moderate pain). During a concurrent interview and record review, on 1/5/26 at 3:00 p.m., with Nse Mgr 6, Nse Mrg 6 verified Patient 8 ’ s MAR indicated on 10/2/25 at 8:47 a.m., Patient 8 was administered Norco 5-325 mg tablet PO. The corresponding pain assessment indicated Patient 8 ’ s pain score was 4 (moderate pain). During a concurrent interview and record review, on 1/5/26 at 3:00 p.m., with Nse Mgr 6, the Nse Mgr 6 verified there was no documentation of Patient 8 ’ s pain reassessment after pain medication was administered on 10/1/25 at 10:34 a.m. and on 10/2/25 at 8:47 a.m. The Nse Mgr 6 stated the nurse should reassess the patient 8 ’ s pain within 60minutes after administration of PO pain medication to know if the medication was working and to follow the physician’s order. During a review of the document title, “Addendum A: [Name of the Facility] Assessment and Documentation Guidelines for Nursing,” undated, provided by the facility indicated “Pain assessment: Ongoing- Pain rating with every set of full vital signs, prior to administering pain medication, following administration of pain medication to assess effect, following procedures/interventions associated with causing pain ...” During a review of the facility ’ s policy and procedure (P&P) titled, “Medication Range Orders,” revised on 5/2024, the P&P indicated, “A. For pain medications: assessment, monitoring and objective measures will be done as per ministry-specific pain management policy. Evidence-based pain and sedation assessment tools appropriate for the patient should be used. The information and objective measures obtained during the assessment include, but are not limited to: 1. The patient’s tolerance to pain and acceptable intensity of pain (pain goal) 2. The intensity of pain utilizing an appropriate pain scale 3. Response to pain management intervention 4. Level of sedation when appropriate (e.g., for opioids) 5. Respiratory status when appropriate (e.g., for opioids) B. For non-pain medications, follow assessment and monitoring parameters per provider order or ministry-specific policy. C. Reassess the patient when drug approximately reaches peak effect if needed per provider order or ministry-specific policy: 1. After at least 30 minutes for IV administration (if ordered frequency is less than 30 minutes, RN will perform reassessment prior to giving the next dose.) 2. After at least 60 minutes for PO/ IM/SQ/ Rectal/Topical/ Other Non-IV Route administration D. Re-assessment is completed and documented according to patient condition and expected response to intervention. Evaluation of plan is recommended if expected response does not occur. E. Assessment of adverse effects will be done per provider order or ministry-specific policy. F. Timing of subsequent doses within the ordered range is based on the last administered dose. G. Provider will be contacted for inadequate response after the dose and/or frequency of the medication has been maximized or if intolerable adverse effects occur.” 2. During a review of Patient 9 ’ s “History & (and) Physical (H&P),” dated 9/22/25, the H&P indicated Patient 9 was evaluated for preoperative clearance (a comprehensive medical evaluation before surgery to assess a patient ’ s overall health to ensure they are stable for the procedure) for a Right Hemicolectomy (a surgery to remove one side of the colon [large intestine], joining the remaining bowel ends afterward.) During a review of Patient 9 ’ s “Medication Administration Report (MAR)” dated 1/5/2026, the MAR indicated a physician ’ s order for Patient 9 to receive the following: -Toradol (pain medication) 15 milligram (mg-a unit of measurement) intravenous (IV-in the vein) every 6 hours as needed (PRN) for pain with a start date of 9/30/25. During a concurrent interview and record review, on 1/5/26 at 3:22 p.m., with Sepsis Telemetry Assistant Nurse Manager (Nse Mgr 6), Nse Mgr 6 verified Patient 9 ’ s MAR indicated on 10/1/25 at 8:39 a.m., Patient 9 was administered Toradol 15 mg IV. The corresponding pain assessment indicated Patient 9 ’ s pain score was 6 (moderate pain). Nse Mrg 6 verified Patient 9 ’ s MAR indicated on 10/1/25 at 5:06 p.m., Patient 9 was administered Toradol 15 mg IV. The corresponding pain assessment indicated Patient 9 ’ s pain score was 5 (moderate pain). During a concurrent interview and record review, on 1/5/26 at 3:22 p.m., with Nse Mgr 6, Nse Mrg 6 verified Patient 9 ’ s MAR indicated on 10/2/25 at 3:10 p.m., Patient 9 was administered Toradol 15 mg IV. The corresponding pain assessment indicated Patient 9 ’ s pain score was 5 (moderate pain). During a concurrent interview and record review, on 1/5/26 at 3:40 p.m., with Nse Mgr 6, the Nse Mgr 6 verified there was no documentation of Patient 9 ’ s pain reassessment after pain medication was administered on 10/1/25 at 8:39 a.m., on 10/1/25 at 5:06 p.m. and on 10/2/25 at 3:10 p.m. The Nse Mgr 6 stated the nurse should reassess the patient 9 ’ s pain within 30minutes after administration of IV pain medication to know if the medication was working. During a review of the document title, “Addendum A: [Name of the Facility] Assessment and Documentation Guidelines for Nursing,” undated, provided by the facility indicated “Pain assessment: Ongoing- Pain rating with every set of full vital signs, prior to administering pain medication, following administration of pain medication to assess effect, following procedures/interventions associated with causing pain ...” During a review of the facility ’ s policy and procedure (P&P) titled, “Medication Range Orders,” revised on 5/2024, the P&P indicated, “A. For pain medications: assessment, monitoring and objective measures will be done as per ministry-specific pain management policy. Evidence-based pain and sedation assessment tools appropriate for the patient should be used. The information and objective measures obtained during the assessment include, but are not limited to: 1. The patient’s tolerance to pain and acceptable intensity of pain (pain goal) 2. The intensity of pain utilizing an appropriate pain scale 3. Response to pain management intervention 4. Level of sedation when appropriate (e.g., for opioids) 5. Respiratory status when appropriate (e.g., for opioids) B. For non-pain medications, follow assessment and monitoring parameters per provider order or ministry-specific policy. C. Reassess the patient when drug approximately reaches peak effect if needed per provider order or ministry-specific policy: 1. After at least 30 minutes for IV administration (if ordered frequency is less than 30 minutes, RN will perform reassessment prior to giving the next dose.) 2. After at least 60 minutes for PO/ IM/SQ/ Rectal/Topical/ Other Non-IV Route administration D. Re-assessment is completed and documented according to patient condition and expected response to intervention. Evaluation of plan is recommended if expected response does not occur. E. Assessment of adverse effects will be done per provider order or ministry-specific policy. F. Timing of subsequent doses within the ordered range is based on the last administered dose. G. Provider will be contacted for inadequate response after the dose and/or frequency of the medication has been maximized or if intolerable adverse effects occur.””

“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: 45774 Based on interview and record review, the facility failed to ensure that a pain level assessment met requirements for administration for one of 30 sampled patients (Patient 25) in accordance with the facility ’ s policy and procedure after a narcotic [opioid (a class of drug used to reduce moderate to severe pain) medication for pain relief] was given to Patient 25 without an indication of pain. This deficient practice had the potential to result in Patient 25 being unnecessarily sedated and a possible delay in Patient 25 ’ s recovery. Findings: During a review of Patient 25 ’ s “History and Physical (H&P, a formal and complete assessment of the patient and the problem), dated 1/04/2026, indicated, Patient 25 was admitted to the facility for respiratory failure (a condition in which the lungs cannot release enough oxygen into the blood) and an allergic reaction (the body ’ s response to a substance causing symptoms ranging from mild to life-threatening) requiring intubation (a procedure to insert a tube into the windpipe to maintain an open airway for breathing support). During a concurrent interview and record review on 1/06/2026 at 11:24 a.m. with Nurse Manager (Nse Mgr) 4, Patient 25 ’ s “Medication Administration Record (MAR),” dated 1/04/2026 was reviewed. Patient 25 ’ s MAR indicated a physician order for Morphine (a narcotic pain reliever) 2 milligrams (mg, a unit of measure) intravenous (IV, given directly into the blood stream) every 4 hours PRN (given as needed or requested). Patient 25 ’ s MAR indicated, on 1/04/2026 at 12:11 p.m. Morphine 2 mg was given. Nse Mgr 4 stated Patient 25 ’ s Total Critical-Care Pain Observation Tool (CPOT, a tool used to score pain ranging from 0 to 8, with a score of 3 or greater suggesting pain), indicated Patient 25 ’ s Total CPOT score was 0. Nse Mgr 4 stated Patient 25 ’ s nursing flowsheet (a tool used to document and track a patient ’ s medical information over time) dated 1/04/2026 at 12:00 p.m. indicated Patient ’ s 25 facial expressions were relaxed, body movements were absent, muscle tension were relaxed, ventilator (a medical device to help support or replace breathing) was tolerated (no resistance), and that there were no indicators of pain present. Nse Mgr 4 stated there was no indication for Morphine to be administered. Nse Mgr 4 stated Patient 25 ’ s end of shift nurse ’ s note dated 1/04/2026 covering time period from 12:00 p.m. to 4:00 p.m. did not have a reference to a pain medication being needed or administered. During an interview on 1/07/2026 at 10:44 a.m. with Registered Nurse (RN) 8, RN 8 stated it was important to monitor narcotic pain medication administration closely because of the negative impact narcotics could have on respirations. During a review of the facility ’ s policy and procedure (P&P) titled, “Medication Range Orders,” last revised 05/2024, indicated, “A. As needed or ’ PRN ’ orders must have specific time intervals and indications,” “Orders that do not meet the above requirements (A-B) will be clarified with the provider by pharmacy or nursing,” and “For pain medications: assessment, monitoring and objective measure will be done as per ministry-specific pain management policy. Evidence-based pain and sedation assessment tools appropriate for the patient should be used. The information and objective measures obtained during the assessment include but are not limited to: ...2. The intensity of pain utilizing an appropriate pain scale ...4. Level of sedation when appropriate (e.g., for opioids) and 5. Respiratory status when appropriate (e.g., for opioids).””

“DISCHARGE PLANNING - EARLY IDENTIFICATION CFR(s): 482.43(a) The hospital’s discharge planning process must identify at an early stage of hospitalization those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge planning and must provide a discharge planning evaluation for those patients so identified as well as for other patients upon the request of the patient, patient’s representative, or patient’s physician. This Standard is not met as evidenced by: 45774 Based on observation, interview and record review, the facility failed to provide adequate discharge planning evaluation to Patient 1 who was predetermined for hospitalization for further treatment and evaluation due to high-risk chest pain and ended up discharged AMA. This deficient practice leaded to Patient 1 was lost for 2 days after discharged AMA from facility and was eventually found in critical condition and unconscious, leading to hospitalization in a critical care unit. Finding: During a review of the medical record for Patient 1, Patient 1 ’ s facesheet indicated Patient 1 was from a secured skilled nursing facility (SNF). During a record review of Patient 1 ’ s History and Physical (H&P - medical assessment where a healthcare provider gathers a patient’s medical background and performs a physical examination) dated 12/20/25 at 3:42 AM, the H&P indicated that patient 1 ’ s chief complaint was chest pain and shortness of breath. Concurrently, the same record indicated a plan for admission for high-risk chest pain. Hospitalization for further treatment and management was warranted. During a review of the record, nursing note dated 12/20/25 at 9:54 AM written by Registered Nurse 1 (RN1) indicated that Patient 1 arrived unit without paperwork from skilled nursing facility (SNF) . Pt was alert and orientated x 4, answering questions appropriately. Patient 1 stated he is unhoused. Patient 1 became agitated after speaking to the medical doctor and wanted to leave against medical advice (AMA). Education regarding risk of leaving hospital AMA provided, Patient 1 verbalized understanding. AMA document obtained from Patient 1. IV (intravenous) removed and Patient 1 left abruptly and ambulated out. Attending medical doctor notified. Patient 1 was discharged at 9:30 am same day. Concurrently, there is no record of vital sign was obtained in the chart prior Patient 1 left the hospital AMA. During an interview with executive director of quality (EDQ) on 1/6/26 at 10:45 AM, EDQ stated that facility received a phone call from SNF to ask about Patient 1 on 12/20/25 after Patient 1 left AMA, staff from SNF told facility that Patient 1 did not return to SNF and they are a locked facility. During an interview with Registered Nurse (RN1) on 1/7/26 at 10:00 AM; RN1 stated that she did not receive the Patient 1 ’ s SNF transfer records when Patient 1 arrived on the floor. RN 1 stated she did not check EPIC if the SNF transferred records were scanned. Concurrently, RN1 stated that she did not check the Facesheet information and was not aware Patient 1 was from a SNF. RN 1 further stated she did not obtain a set of vital sign before patient left AMA. RN1 stated she normally checked the vital sign before patient discharge and she did not do this one since this is AMA. During concurrent interview and record review of the form titled “Leaving Hospital Against Medical Advice (AMA)” with RN1 on 1/7/26 at 10:15 AM, indicated the physician ’ s (MD1) name on the form was not the physician (MD2) who spoke with Patient 1 regarding the AMA; moreover, there is no physician signature to declare that he has personally explained to the patient the risk and benefits involved in leaving the hospital at this time, the benefits of continued treatment and hospitalization and the alternative, if any, to continued treatment and hospitalization. RN 1 stated the physician on the AMA form should be MD2 instead of MD1, and concur no MD2 signature at the AMA form. During an interview with executive director of quality (EDQ) on 1/6/26 at 10:30 AM, EDQ stated that there was a missed opportunity for further action from RN1 when RN1 learned that Patient 1 arrived on the 4N unit without paperwork from the facility, but Patient 1 was alert and orientated and told RN1 he was “unhoused.” EDQ indicated RN 1 could have called the facility or Patient 1 ’ s representative before he left AMA. During an interview with EDQ on 1/6/26 at 10:40 AM, when asked if AMA is considered a discharge, EDQ stated it is “a matter of semantics” and indicated that AMA is considered discharge. During an interview with the Director of Risk management (DRM) on 1/6/26 at 9:50 am, DRM stated that they do not have a specific policy for AMA. There is a portion of refusal of treatment in the “Consents” policy. DRM further acknowledged that there should be a specific AMA policy for clear guidance in order to ensure a safe AMA discharge process. A review of Patient 1 ’ s ED Provider Note from General Acute Care Hospital (GACH) 2, dated 12/22/25, indicated that Patient 1 was brought to GACH 2 via EMS after being witnessed falling over on the street. Patient 1 reported that he may have lost consciousness. A review of Patient 1 ’ s H&P from GACH 2 dated 12/22/25 indicated Patient 1 was admitted to the ICU for acute on chronic subdural hemorrhage. A review of Patient 1 ’ s Trauma Surgery Discharge Summary from GACH 2, dated 12/26/25, indicated Patient 1 was a missing person from a memory care facility, per police Patient 1 ’ s family was looking for him, and that Patient 1 was being discharged back to a SNF with memory care capabilities. A review of the facility ’ s (GACH 1) policy and procedure title “Discharge Planning” dated 6/2024 indicated that discharge planning is a hospital wide multidisciplinary process which begins during the preadmission or admission phase and is developed throughout the hospitalization. The plan is coordinated and recognizes the patient needs, preferences, goals, and resources ..... for any patient who is without a residence, or homeless, use the ministry specific discharge planning for the homeless policy, the coordinator care for persons without a residence policy, or other related policies. A review of the facility ’ s (GACH 1) policy and procedure titled “Coordinating Care for Patients Who are Without a Residence” dated 2/2023 indicated that all patients will be queried about their housing status ...Patients who are without a residence should be assessed for the following: ability to meet basic needs in their current environment; ability to understand and to have insight regarding their medical status and anticipated needs; mental and social status/functioning ...”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 45774 Based on interview and record review, the facility failed to ensure that surgical needles were intact and without compromise (without bends or breaks), before and/or after used, and prior to closure of the skin, for one of thirty-three (33) sampled patients (Patient 18). This deficient practice resulted in Patient 18 having a retained foreign object (RFO – a surgical item or other foreign material accidently left inside a patient ’ s body after surgery, which should have been removed) from the first craniotomy (brain surgery), and was removed with a second brain surgery. Findings: On 1/6/2026, at 10:40 AM, during concurrent interview with Director of Critical Care (DICU) and record review of Patient 18 ’ s face sheet (a summary document providing key information at a glance, of a patient ’ s demographics, history, medication, and allergies), dated 3/12/2025,, DICU stated patient was admitted to the facility with a diagnosis of intracranial space occupying lesion (any mass or abnormality within the skull that takes up space, pushing on brain tissue and potentially causing increased pressure in the brain, leading to symptoms, including seizures). A review of Patient 18 ’ s history and physical (H&P – a comprehensive medical report detailing a patient ’ s health story, combining their narrative history, with a hands-on examination/physical to form the basis for a diagnosis and treatment), with patient ’ s primary care provider, dated 2/21/2025, indicated the following: Diagnosis included intracranial space-occupying lesion found on diagnostic imaging and malignant tumor in the brain. History of alcohol abuse with elevated liver enzymes. Laboratory studies of blood and urine. Electrocardiography (EKG – a painless quick diagnostic test that records the heart ’ s electrical activity) was borderline. Patients had low risks for complications for surgery. Concurrently, during review of Patient 18 ’ s Surgical H&P Update, dated 3/12/2025, DICU stated the following: There were no changes in the patient ’ s condition since the last H&P was completed, less than 30 days ago. Patient was counseled regarding the procedure, including its indications, risks, potential complications, and alternatives. Consent for procedure was obtained from the patient. Concurrently, during a review of Patient 18 ’ s H&P, dated 3/12/2025, DICU stated the following: History of right parietal craniotomy for tumor resection (tumor removal surgery in the right side of the brain). Patient was agitated after surgery and was transferred to intensive care unit (ICU – a specialized unit for critically ill patients needing constant monitoring, advanced life support, and specialized care for life-threatening conditions). Social history – smoker, marijuana, and recent alcohol use. Diagnostic studies (medical tests to identify or rule out a condition) – computed tomography (CT – uses x-rays and a computer to create a detailed, cross-sectional images/ 3-dimentional views of the inside of the body) of the head, dated 3/12/2025, indicated no hemorrhage, no masses, and no midline shift. Lab for substance abuse – positive for marijuana. Plan included antibiotics, neurology checks (an assessment of a patient ’ s brain functioning), alcohol withdrawal monitoring (assessment of a patient going through alcohol withdrawal), and use of restraints (use of devices to limit a person ’ s movement to prevent immediate harm to themselves). A review of Patient 18 ’ s operative report (a detailed, legally significant document that describes everything that happened during a surgery), dated 3/12/2025, indicated the following: Pre-operative diagnosis – right parietal mass. Anesthesia – general with endotracheal tube (ETT – a hollow plastic tube inserted into the windpipe through the nose to establish and to maintain breathing with a clear airway). Post-operative diagnosis – right parietal low-grade glioma (a slow-growing brain tumor in the right side, causing gradual symptoms including headaches and seizures, requiring surgery to remove). Urine catheter (device to collect urine) and arterial line (a thin device placed in the artery to monitor the blood pressure) were placed. Initial time out was done to identify the correct patient with the correct procedure and the correct site of the operation. Brought in ultrasound machine (device using high-frequency sound waves to create real-time images of internal body structures) to locate tumors and an operative microscope (a specialized optical instrument providing magnified, high-quality, illuminated 3-D views for microsurgery) for surgery. The dura (the tough outermost membrane enveloping the brain) was closed with “4-0 Nurolon” suture (a medical device used to hold body tissues together and approximate wound edges after surgery) overlaid with collagen sponge. At the end, all counts were correct and “final, times two.” No complications. On 1/6/2026, at 1:43 PM, during interview with executive director of perioperative services (Dir OR). Dir OR stated that it was the responsibility of both the surgical technician (a health professional who prepares the operating rooms, sets up the sterile fields, and assists the surgeons and the surgical team by passing instruments and supplies before, during and after operations, ensuring sterility and patient safety) and the surgeon (a medical practitioner qualified to practice surgery) to inspect the surgical instruments for integrity (breaks/damage), before and after use. On 1/6/2026, at 2:55 PM, during concurrent interview with assistant nurse manager of surgical services (Nse Mgr 3) and record review of Patient 18 ’ s Intra-operative report (report performed during a surgical operation), dated 3/12/2025, Nse Mgr 3 stated the following: There were three time-outs for this case. 1st time out (pre-induction time out – before anesthesia was given) was at 8:17 AM, with surgical technician (ST 1), circulating nurse (RN 2), and anesthesia physician present. 2nd time out (pre-incision time out) was done, before the surgery, at 9:17 AM, with ST 1, RN 2, anesthesia physician, neurosurgeon (MD 3) present. The last time out (de-briefing time out – before surgery ended) was at 12:31 PM, with ST 1, RN 2, anesthesia physician, and MD 3 present. During the de-briefing time out, the needles were counted and inspected by ST 1, who observed the needles in the needle counter with RN 2. Concurrently, Nse Mgr 3 stated during the de-briefing process, the needles were counted and not closely inspected to determine if there were any missing tips/pieces, in the needles; and RN 2 did not physically inspect the needles, either, prior to the closing of the surgery. On 1/7/2026, at 2:45 PM, during interview with ST 1, regarding Patient 18 ’ s surgery, dated 3/12/2025, ST 1 stated the following: After needles were used by MD 3, he placed the used needles in the needle counter. Upon receiving the used needles, he inspected the needles for integrity – checks for bent or broken needles. Even if the needle count was correct, he would have to report to the surgeon and the rest of the surgical team, if a needle was bent and/or broken. He did not remember seeing a bent or broken needle, during the last count. The last needle used by MD 3 was very small and difficult to determine if there was a piece broken off and/or missing. He did not remember if RN 2 inspected the needles for integrity during the last count. The last count of needles was correct. A review of Patient 18 ’ s MRI results, dated 3/26/2025, indicated the following: Comparison was done with CTs of the head, dated 3/21/2025 and 3/17/2025. Multiplanar multisequence MRI of the brain without contrast. Status post recent right parietal craniotomy with underlying surgical cavity in the lateral right parietal lobe. There was a single punctate (dots/stains) metallic density on the recent CT, along the posterior aspect of the surgical cavity with significant artifacts on the view. A review of Patient 18 ’ s CT of the head, dated 3/26/2025, indicated single punctate metallic density in the posterior aspect of the surgical cavity. A review of Patient 18 ’ s operative report, dated 3/26/2025, indicated the following: Pre-operative diagnosis – metallic object in tumor cavity, Post-operative diagnosis – needle fragment in tumor cavity. Procedures performed included redo right parietal craniotomy and wound exploration and removal of needle fragments. Indications for procedure – patient had significant agitation with withdrawal symptoms, was reintubated due to oversedation, and magnetic resonance imaging (MRI – a test that creates clear images of the structures inside the body using a large magnet, radio waves, and a computer, used to evaluate, diagnose, and/or monitor medical conditions) was performed with the discovery of a large moving artifact in the tumor cavity with 2-millimeter (mm) hyper density, which was compared to a CT of the head. Under microscopic visualization, surgeon identified a small 2mm fragment, resected it from the tumor cavity, and ordered it for testing at pathology department. All counts were correct and finalized twice. A review of Patient 18 ’ s Surgeon ’ s note, dated 3/26/25, indicated the following: Patient underwent surgery due to a “blooming” artifact seen on MRI and confirmed by CT of the head. The “blooming” artifact was a 2-mm length of a need tip that appeared to have fragmented off a 4-0 Nuralon needle, at the time of dural closure. A post-operative CT of the head demonstrated no further hyper density in the region. A review of Patient 18 ’ s Surgical Pathology Examination, dated 3/28/2025, indicated the following: Ordered 3/26/2025 at 5:58 PM Collected 3/26/2025 at 5:57 PM Received in lab 3/27/2025 at 8:27 AM Result at 3/28/2025 at 12:55 PM Gross description – received foreign body without fixative with patient label. Needle tip was 0.3 cm in length and less than 0.1 cm in diameter. Silver metallic tip of a needle – gross examination only. A review of facility ’ s Counts - Performing Sharps/Instruments/Sponges policy, dated 9/2020, indicated the following: All counts are completed audibly, visually, and concurrently by the Surgical Technician and RN circulator. Sharps and miscellaneous item counts are completed in all procedures, where the likelihood exists that a foreign body could be retained. Sharps are counted by the Circulating RN and Surgical Technician (ST) before the beginning of the procedure, when sharps are added to the sterile field, and immediately prior to closure of a deep or large incision or body cavity. Sharps to be counted included suture needles. The ST remains aware of the location of all sharps on the field. Needles on the needle holders are to and from the surgeon on an exchange basis. Once used, suture needles are placed in a puncture-proof sharp counting device. Broken sharps are passed off to the Circulating RN. All pieces must be accounted for. If all pieces cannot be accounted for, the count is unresolved. The sharps are placed in a safe container/ needle book and are not discarded until the final count is completed. Sharps are counted in the same order, consecutively, from incision to Mayo stand, to table to sharps off-the-field. All suture packages must remain on the field until the end of the case. The nurse practitioner (NP) must maintain awareness of all sharps used in the surgical wound during the procedure and must communicate placement of surgical items in the wound to the perioperative team for notation on the whiteboard. The NP must assist in accounting for surgical items on the surgical field by notifying the ST and RN Circulator about surgical items returned to the surgical field, after the count. The surgeon is notified of incorrect counts, and a recount is done immediately. If the count remains incorrect, after a recount, notify surgeon so the wound may be searched, alert radiology for an x-ray to locate missing item, before patient leaves the OR. RN Circulator documents the unresolved count on the intra-operative record and that the surgeon was notified and completes an unusual occurrence report.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 43236 Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Patient Rights as evidenced by: 1. The facility failed to ensure three of 35 sampled patients (Patient 16, Patient 20, Patient 21) Condition of Admission (COA - a contract between the hospital and the patient regarding treatment and payment for services by the hospital) was signed by the patient and/or patient ’ s representative. This deficient practice resulted in patient rights being violated because the patients and/or their representatives were not aware of the patient rights, treatment, billing process, payment, and services rendered by the hospital. (Refer to A-0117) 2. The facility failed to follow the facility ’ s fall prevention policy for two of 35 sampled patients (Patient 25 and Patient 27). This deficient practice placed Patients 25 and 27 at risk for falls and injury. (Refer to A-0117) 3. The facility failed to ensure one of 35 sampled patients (Patient 1) received safe care by preventing an unauthorized staff from discontinuing infusion of an essential emergency medication for Patient 1 ’ s survival. This deficient practice resulted in Patient 1 undergoing a code blue to be resuscitated (to revive from apparent death) and would have likely resulted in Patient 1 ’ s death. (Refer to A-0144). 4. The facility failed to ensure a radiant infant warmer (a device used to provide heat to maintain a baby ’ s body temperature) had an inspection sticker that was not past due for one of 1 radiant warmers. This deficient practice had the potential for critical medical equipment used to a vulnerable infant to not be available or might malfunction which cause physical harm to the infant. (Refer to A-0144) The cumulative effect of these deficient practices resulted in the facility ’ s inability to provide quality health care in a safe environment.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 43236 Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation (CoP) for Nursing Services was met as evidenced by: 1. The facility failed to ensure a medication was administered according to the doctor ’ s order and if an error was committed that the medication error was documented in the electronic medical record (EMR) for one of 35 sampled patients (Patient 2) per facility policy & procedure (P&P) on medication administration. This deficient practice had the potential to miss dosage errors and potential adverse reaction to the dosage error for Patient 2 which can lead death due to overdose.(Refer A-0398) 2. The facility failed to ensure nursing staff adhered to the hospital policies and procedures for pain assessment for two of 35 sampled patients (Patient 12 and Patient 15). This deficient practice had the potential to result in patients ’ ineffective pain management and relief. (Refer to A-0398) 3. The facility failed to ensure ketamine (a medication that sedates patients and numbs the body but can also cause hallucinations) was given according to the physician ’ s orders for one of 35 sampled patients (Patient 2). This deficient practice had the potential to harm Patient 2 and cause serious side effects. (Refer to A-0405). The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality healthcare in a safe environment.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 31333 Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation (CoP) for Pharmaceutical Services was met as evidenced by: 1. The facility failed to ensure policies and procedures (P&P) related to the medication distribution and medication administration systems were implemented in the Emergency Department (ED). Failure by nursing and pharmacy staff to implement P&Ps specific to the removal of Ketamine (a controlled medications used for sedation (feeling calm and relaxed), immobility, and relief from pain), from the facility ’ s Pyxis (ADS, an automictic dispensing system/services) machine was reviewed for medication accuracy and appropriateness, to ensure ED physician ’ s order was followed and any amount greater than the ordered amount was witnessed by a second nurse and disposed of prior to ketamine administration to one of 35 sampled patients (Patient 2). The deficient practice had the potential to affect over 200 patients seen in the ED between 11/14/2025 – 11/15/2025 who received medications from the ADS used in the ED. The failure to have a second nurse to witness controlled medication removal from the ADS and wasting of the excess dosage resulted in Patient 2 being administered 10 times the prescribed ordered dose of ketamine, resulting in Patient 2 experiencing a high respiratory rate, becoming more somnolent (drowsy or sleepy), having trouble breathing, and requiring the administration of oxygen. (Refer to A-0491) 2. The facility failed to ensure each Crash Cart/Code Cart (a cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel especially during efforts to resuscitate [to bring someone back to life when their heart and breathing have stopped] a patient experiencing cardiac arrest [when the heart stops beating suddenly]) in the facility ’ s Emergency Department (ED) had an inventory sheet of Crash Cart/Code Cart content attached to two out of seven Code Carts (Code Cart 3 Adults and Code Cart 3 Pediatric[Peds]). The facility’s failure to implement their policy and procedure had the potential to affect over 200 patients that visit the ED daily by not responding in an emergency adequately and/or creating a delay in care. (Refer to A-0500). The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality healthcare in a safe environment.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 38310 Based on interview and record review, the facility failed to ensure three of 35 sampled patients ’ (Patient 16, Patient 20, Patient 21) Condition of Admission (COA - a contract between the hospital and the patient regarding treatment and payment for services by the hospital) was signed by the patient and/or patient ’ s representative. This deficient practice resulted in patient rights being violated because the patients and/or their representatives were not aware of the patient rights, treatment, billing process, payment, and services rendered by the hospital. Findings: 1. A review of Patient 16 ’ s face sheet (a document that summarizes the patient ’ s personal and demographic information), dated 4/1/2025, indicated patient was admitted with a diagnosis, which included Failure to Thrive (a syndrome characterized by a decline in health and function, often involving weight loss, decreased appetite, and inactivity). On 4/4/2025, at 11:51 AM, during concurrent interview with assistant nurse manager (ANM 4) and record review of Patient 16 ’ s conditions of admissions (COA), undated, ANM 4 stated Patient 16 did not sign the COA because of patient ’ s medical condition. Concurrently, ANM 4 stated the COA contained information including nursing care, advance directives, and patient rights. A review of facility ’ s Consents policy, dated 8/2021, indicated the following: ...2. Conditions of Admission (COA) provides permission to give basic, simple, common hospital services and medical treatment to the patient. ...4. The COA form specifies what treatment or procedure they are consenting to and by signing the form, the patient acknowledges that, if required by law, they have given their informed consent to their treating physician. ...5. The most commonly used general consent, authorization for treatment, is the one that patients sign upon admission called the conditions of admissions, which provides permission to give basic, simple, common hospital services and medical treatment, not requiring informed consent. A review of facility ’ s Patient Rights and Responsibilities policy, dated 2/2022, indicated the following: Facility staff are expected to respect and uphold the rights and responsibilities of all individuals to whom (patient) care and services are rendered. At the time of admission, each patient will receive a copy of the Patient Rights/Responsibilities statement. Patient Rights included the right to make decisions regarding medical care and to receive as much information about any proposed treatment or procedure to give informed consent. All patient rights apply to the person who has legal responsibility to make decisions regarding medical on the patient ’ s behalf, as indicated in the patient right to formulate advance directives (a written statement of a person ’ s wishes regarding medical treatment, often including a living will, made to ensure those wishes are carried out should the person be unable to communicate them to a physician) 2. A review of Patient 20 ’ s face sheet, dated 3/12/2025, indicated patient was admitted with the diagnosis of acidemia (blood serum that is abnormally acidic). On 4/4/2025, at 11:50 AM, during concurrent interview with ANM 4 and record review of patient ’ s COA, undated, ANM 4 stated Patient 20 did not sign the COA due to patient ’ s medical condition. Concurrently, ANM 4 stated the COA contained information including nursing care, advance directives, and patient rights. A review of facility ’ s Consents policy, dated 8/2021, indicated the following: ...2. Conditions of Admission (COA) provides permission to give basic, simple, common hospital services and medical treatment to the patient. ...4. The COA form specifies what treatment or procedure they are consenting to and by signing the form, the patient acknowledges that, if required by law, they have given their informed consent to their treating physician. ...5. The most commonly used general consent, authorization for treatment, is the one that patients sign upon admission called the conditions of admissions, which provides permission to give basic, simple, common hospital services and medical treatment, not requiring informed consent. A review of facility ’ s Patient Rights and Responsibilities policy, dated 2/2022, indicated the following: Facility staff are expected to respect and uphold the rights and responsibilities of all individuals to whom (patient) care and services are rendered. At the time of admission, each patient will receive a copy of the Patient Rights/Responsibilities statement. Patient Rights included the right to make decisions regarding medical care and to receive as much information about any proposed treatment or procedure to give informed consent. All patient rights apply to the person who has legal responsibility to make decisions regarding medical on the patient ’ s behalf, as indicated in the patient right to formulate advance directives (a written statement of a person ’ s wishes regarding medical treatment, often including a living will, made to ensure those wishes are carried out should the person be unable to communicate them to a physician) 3. A review of Patient 21 ’ s face sheet, dated 4/1/2025, indicated patient was admitted with the diagnosis of pneumonitis (lung tissue inflammation, swelling and irritation). On 4/4/2025, at 11:50 AM, during concurrent interview with ANM 4 and review of Patient 21 ’ s COA, undated, ANM 4 stated patient was unable to sign and did not know why patient did not sign the COA because no reason was indicated. Concurrently, ANM 4 stated the COA contained information including nursing care, advance directives, and patient rights. A review of facility ’ s Consents policy, dated 8/2021, indicated the following: ...2. Conditions of Admission (COA) provides permission to give basic, simple, common hospital services and medical treatment to the patient. ...4. The COA form specifies what treatment or procedure they are consenting to and by signing the form, the patient acknowledges that, if required by law, they have given their informed consent to their treating physician. ...5. The most commonly used general consent, authorization for treatment, is the one that patients sign upon admission called the conditions of admissions, which provides permission to give basic, simple, common hospital services and medical treatment, not requiring informed consent. A review of facility ’ s Patient Rights and Responsibilities policy, dated 2/2022, indicated the following: Facility staff are expected to respect and uphold the rights and responsibilities of all individuals to whom (patient) care and services are rendered. At the time of admission, each patient will receive a copy of the Patient Rights/Responsibilities statement. Patient Rights included the right to make decisions regarding medical care and to receive as much information about any proposed treatment or procedure to give informed consent. All patient rights apply to the person who has legal responsibility to make decisions regarding medical on the patient ’ s behalf, as indicated in the patient right to formulate advance directives (a written statement of a person ’ s wishes regarding medical treatment, often including a living will, made to ensure those wishes are carried out should the person be unable to communicate them to a physician)”

“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: 43236 Based on observation, interview and record review, the facility failed to: 1. Ensure one of 35 sampled patients (Patient 1) received safe care by preventing the discontinuation of an essential medication for survival by an unauthorized staff member. This deficient practice resulted in Patient 1 undergoing a code blue (a hospital-wide call for help resuscitating a patient when they have stopped breathing, or their heart has stopped beating) and would have likely resulted in Patient 1 ’ s death. 2. Follow the facility ’ s fall prevention policy for two of 35 sampled patients (Patient 25 and Patient 27). This deficient practice placed Patients 25 and 27 at risk for falls and injury. 3. Ensure a radiant infant warmer (a device used to provide heat to maintain a baby ’ s body temperature) had an inspection sticker that was not past due for one of 1 radiant warmers. This deficient practice had the potential for critical medical equipment used to a vulnerable infant to not be available or might malfunction which cause physical harm to the infant. On 4/2/2025, at 3:17 p.m., the survey team called an Immediate Jeopardy (IJ, a situation in which the facility ’ s noncompliance with one or more requirements have, caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Chief Executive Officer, Chief Nursing Officer, Chief Administrative Officer, and Chief Medical Officer. The facility failed to ensure one of 35 sampled patients (Patient 1) received safe care by preventing an unauthorized staff from discontinuing infusion of an essential emergency medication for Patient 1 ’ s survival. The above-mentioned facility administrators were informed of the immediate jeopardy situation regarding the failure to ensure one of 35 sampled patients (Patient 1) received safe care by preventing an unauthorized staff from discontinuing infusion of an essential emergency medication for Patient 1 ’ s survival. On 4/4/2025, at 12:55 p.m., while onsite, the IJ was removed after verifying and confirming the facility’s implementation of the IJ Removal Plan (includes all actions the agency has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely) through observation, interview, and record review, in the presence of the following facility members: Chief Executive Officer, Chief Administrative Officer, Chief Nursing Officer, and Director of Risk Management. The IJ Removal Plan included the following: 1. Responsible Parties-The Chief Administration Officer and the Director of Laboratory Services are responsible for this process. 2. Policy Review- The policy “Specimen Collection and Identification” was reviewed by the Director of Laboratory Services, and no changes were identified at this time. 3. Immediate Actions with Phlebotomists- All (except PTO/LOA) phlebotomists were reeducated to the above policy and have provided an attestation of understanding, General Staff Meeting: All (except PTO/LOA) phlebotomists were in attendance or educated on the meeting minutes which included education around the expectation of adherence to policy “Specimen Collection and Identification” when drawing labs, ensuring all staff understand pump management is outside of their scope, and only an RN can turn a pump off and back on. Competencies- all (except PTO/LOA) phlebotomy staff will complete an annual competency regardless of when last completed. Competency includes the understanding that phlebotomists cannot turn off or on pumps. All phlebotomists starting with afternoon shift on 4/3/25 will be educated and sign an attestation of understanding in huddle before the start of their shift on the following: All Phlebotomy care givers must find the bedside RN to ensure there is communication regarding any limitation that could exist regarding the blood draw. If assigned bedside RN is not immediately available, utilize escalation tree. You can always use the call light for assistance Ask a nearby RN for assistance Ask Unit Coordinator where RN can be located Escalate to charge RN 5. Future Action for Phlebotomist- 1. All new hires during onboarding will receive: Competency completion, which includes the understanding that phlebotomists cannot turn off or on pumps. Policy validation “Specimen Collection and Identification” 6. ICU Immediate Action- All Nurses on shift starting 4/3/25 will be educated in huddle prior to start of shift, and sign an attestation of understanding of the following: Do not ask or allow a phlebotomist to turn off or adjust IV pumps under any circumstances. If an IV pump alarm sounds or if you notice a device that appears to be malfunctioning, promptly assess the situation. Collaborate with phlebotomist prior to allowing the labs to be drawn which includes but is not limited to identifying correct patient, site selection, and concerns with medications running that may interfere or affect lab result. If unsure about appropriateness of lab draw, site selection or other concern, seek clarification from your charge RN, leadership team or through the chain of command. Escalate immediately if issues or safety events occur Nursing is to manage the pumps when needed during lab draw Lab has been educated to follow the chain of command if unable to locate the RN, and given the following recommendations All Phlebotomy care givers must find the bedside RN to ensure there is communication regarding any limitation that could exist regarding the blood draw. If assigned bedside RN is not immediately available, utilize escalation tree. You can always use the call light for assistance Ask a nearby RN for assistance Ask Unit Coordinator where RN can be located Escalate to charge RN Completion Date 4/4/2025. Findings: 1. During a review of Patient 1 ’ s “History & Physical” (H&P), dated 9/14/2024, at 2:22 p.m., the H&P indicated Patient 1 was admitted to the facility ’ s Intensive Care Unit (ICU) for acute respiratory failure with hypoxia (a condition in which the lungs are failing to put oxygen in the blood, leading to low oxygen levels). During a review of Patient 1 ’ s “Physician Orders,” dated 9/15/2024, at 12:06 p.m., the “Order” indicated MD 9 placed Patient 1 on a continuous intravenous (IV - a way of administering fluids, medications, or nutrients directly into a vein) infusion of Levophed (an emergency medication administered through the vein used to treat life-threatening low blood pressure). During a review of Patient 1 ’ s “Physician Progress Note,” dated 9/18/2024, at 6:52 a.m., the “Progress Note” indicated Patient 1 was hypotensive (had low blood pressure) and was being given Levophed. During a review of Patient 1 ’ s “Nursing Progress Note,” dated 9/18/2024, at 7:37 p.m., the “Progress Note” indicated, “Levophed drip running to maintain adequate blood pressure . . . At approximately 1325 [1:25 p.m.] [Registered Nurse (RN) 1] noted upon walking in [Patient 1 ’ s] room, IV pumps were paused ([RN 1] did not pause drips) while phlebotomy [the licensed staff responsible for drawing blood from a patient in order to perform necessary tests] attempted to draw lines. Patient was found to have decreased heart rate, non-responsive and agonally breathing [gasping and labored breathing due to a life-threatening medical emergency]. Immediately called an RRT [Rapid Response Team, a team of health care professionals that help manage patients whose condition is deteriorating] which thereafter became a code blue. Code team at bedside and ROSC [return of spontaneous circulation - when the patient ’ s heart starts beating again by itself after a code blue] was achieved.” During a review of Patient 1 ’ s “Code Documentation,” dated 9/18/2024 at 3:22 p.m., the “Documentation” indicated, “Code blue called as patient was found to be agonal breathing with no pulse . . . After several rounds of CPR [cardiopulmonary resuscitation - an emergency treatment that’s done when someone’s breathing or heartbeat has stopped consisting of chest compressions], the patient had ROSC achieved.” During an interview with the Director of Laboratory Services (DLS), on 4/2/2025, at 10:28 a.m., the DLS stated Phlebotomist 1 went to the ICU to draw a specimen from Patient 1. Phlebotomist 1 turned off the IV infusion pump to obtain the specimen because “she couldn ’ t find a nurse around allegedly.” The DLS stated turning off the Levophed IV infusion was out of scope of practice for the phlebotomist. The DLS further stated that the facility ’ s phlebotomists know that they are supposed to talk to the patient ’ s nurse to turn off the IV pumps before they obtain blood specimens. During an interview with the Director of Critical Care (DCC), on 4/2/2025, at 10:40 a.m., the DCC stated she found out about the incident when RN 1 called for help and a code blue was called. The DCC further stated that at the time Phlebotomist 1 turned off the pump, RN 1 was in the room next door. The DCC further confirmed that the immediate effect of the Levophed infusion being turned off was the code blue. During an interview with the Assistant Nurse Manager, ICU (ANM 2), on 4/4/2025, at 10:45 a.m., ANM 2 stated Levophed is given when a patient has “dangerously low blood pressure” and if Levophed was turned off prematurely, that patient ’ s blood pressure would drop and they would “lose the pulse” (heart rate). During a review of the hospital ’ s policy & procedure (P&P) titled “Specimen Collection and Identification”, dated 9/4/2024, the P&P indicated, “Phlebotomists may draw, if necessary, below the IV infusion site. Ask the RN to turn off the IV infusion for at least 2 minutes . . . When completed, ask the RN to turn the IV infusion back on. Lab [assistants] are not allowed to turn off or turn on the IV infusion.” 2.a. During an observation on 4/2/2025 at 10:06 AM, signage outside Patient 25 ’ s room indicated Patient 25 was on fall precautions. In the patient ’ s room, Patient 25 was resting quietly with the bed in the lowest position; There was a yellow band around Patient 25 ’ s right wrist denoting he was at risk for falling. Both of Patient 25 ’ s lower extremities, including his feet, were cover with elastic bandages but without slip resistant coverings. During an observation on 4/2/2025 at 10:06 AM, Patient 25 used the nurse call system (device at the patient ’ s bedside enabling communication with the nurse when assistance is needed) to asked Registered Nurse (RN 7) if he could stand by the bedside to urinate. RN 7 answered Patient 25 could stand by the bedside to urinate. During an interview on 4/2/2025 at 10:08 AM, the Nurse Manager of 5NE Medical Surgical Unit (NM5NE) stated because there was a risk for falling and potential harm, Patient 25 should have been wearing red slip resistant socks to help prevent a fall. NM5NE added slip resistant socks was impractical since Patient 25 had bandages on his lower extremities. During a review of the flowsheet ’ Morse Scale-Most Recent Current/Last Encounter ’ dated 4/3/2025, indicated the fall risk score for Patient 25 was 60 at this time; This score demonstrated a high risk for falling. During a review of the ’ Fall Policy ’ ID 8018451, this document indicated its purpose is to reduce incidence of preventable falls and the risk of patient injury from a fall. The policy indicated falls can be prevented through identification of patient fall risk factors and implementation of inventions targeted at those risk factors. The ’ Procedure, Assessment ’ section of this policy indicated patients are to be assessed using a fall risk score upon admission, when transferred, during each shift, and when the patient ’ s condition changes, e.g., change in ability to ambulate, medication use, and/or recent fall. The ’ Fall Policy ’ indicated patients with fall score greater than 24 should: be placed on fall precautions, have a yellow fall precautions sign posted outside the patient ’ s room, be wearing red nonskid footwear, be supervised during ambulation, have a ’ Fall Risk ’ indicator on the patient ’ s ID band, use a bed alarm, be instructed to call for help when ambulating or toileting. 2.b. During an observation on 4/2/2025 at 10:35 AM, signage outside Patient 27 ’ s room indicated Patient 27 was on fall precautions. In the patient ’ s room, Patient 27 was resting quietly with the bed in the lowest position and wearing red slip resistant sock; However, Patient 27 was not wearing a band around either of his wrists that indicated he was at risk of falling. During an interview on 4/2/2025 at 10:40 AM, while present outside Patient 27 ’ s room, Nurse Manager 5 NE Medical Surgical Unit (NM5NE) acknowledged that Patient 27 should be wearing a yellow armband that indicated Patient 27 was risk of fall if left unattended. Subsequently, NM5NE stated patients at risk of falls should have red socks on their feet, a yellow arm band should be on their wrists, and the patient ’ s bed should be in the lowest position. At this time, NM5NE was asked to provide nursing assessment for fall risk but this documentation was provided from the NM5NE. During a review of the ’ History and Physical ’ dated 3/14/2025, this document indicated Patient 27 entered the emergency department (hospital department staffed and equipped to provide immediate medical care to patients with serious illness or injury) and presented with worsening right sided hemiparesis (weakness or inability to move one side of the body). This report showed Patient 27 demonstrated severe weakness of the right upper and lower extremities and slurred speech (difficulty speaking). During a review of the patient ’ s Flowsheet dated 3/14/2025 at 11:10 PM, Patient was assessed by nursing staff for Motor Response (action occurring in response to stimuli such as touch or speech). This assessment indicated Patient 27 response to stimuli to his right arm was ataxic (poor muscle control that causes clumsy movements which can affect walking and balance); the response to stimuli to Patient 27 ’ s right leg was also ataxic. During a review of the ’ Fall Policy ’ ID 8018451, this document indicated its purpose is to reduce incidence of preventable falls and the risk of patient injury from a fall. This policy stated falls can be prevented through identification of patient fall risk factors and implementation of inventions targeted at those risk factors. The ’ Procedure, Assessment ’ section of this policy indicated patients are to be assessed using a fall risk score upon admission, when transferred, during each shift, and when the patient ’ s condition changes, e.g., change in ability to ambulate, medication use, and/or recent fall. The ’ Fall Policy ’ indicated patients with fall score greater than 24 should: be placed on fall precautions, have a yellow fall precautions sign posted outside the patient ’ s room, be wearing red non skid footwear, be supervised during ambulation, have a ’ Fall Risk ’ indicator on the patient ’ s ID band, use a bed alarm, be instructed to call for help when ambulating or toileting. 3. During a concurrent observation and interview, on 4/1/2025, at 4:04 p.m., with the Director of Emergency Services (DES), a radiant infant warmer was observed in the resuscitation room of the Emergency Department (ED). The sticker on the radiant warmer indicated “Clinical Engineering – Oct 2024.” The DES stated that the date on the sticker is the date that the preventative maintenance check is due. The DES confirmed that the sticker on the warmer indicated “October 2024” and that it was past due for preventive maintenance. During a review of the “Clinical Work Order,” dated 4/1/2025, at 4:12 p.m., the “Work Order” indicated, “Baby warmer PM [preventative maintenance] sticker is expired since October 2024.” The Work Order also indicated that the warmer is on a six-month preventative maintenance cycle, logged on a computerize system for monitoring of the maintenance cycles. During a review of the hospital ’ s “Medical Equipment Management Plan,” not dated, the “Plan” indicated, “The hospital inspects, tests, and maintains all high-risk equipment . . . The hospital inspects, tests, and maintains non-high-risk equipment identified on the medical equipment inventory.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 43236 Based on observation, interview and record review: 1. The facility failed to ensure a medication was administered according to the doctor ’ s order and if an error was committed that the medication error was documented in the electronic medical record (EMR) for one of 35 sampled patients (Patient 2) per facility policy & procedure (P&P) on medication administration. This deficient practice had the potential to miss dosage errors and potential adverse reaction to the dosage error for Patient 2 which can lead death due to overdose. 2. The facility failed to ensure nursing staff adhered to the hospital policies and procedures for pain assessment for two of 35 sampled patients (Patient 12 and Patient 15). This deficient practice had the potential to result in patients ’ ineffective pain management and relief. Findings: 1. During a review of Patient 2 ’ s “ED (Emergency Department) Triage Note”, dated 11/14/2024, at 8:44 p.m., the “Note” indicated Patient 2 came to the facility ’ s ED complaining of generalized body aches (pain all over the body). During a review of Patient 2 ’ s “Physician Orders,” dated 11/14/2024, at 11:35 p.m., the “Order” indicated Patient 2 ’ s physician (MD 4) ordered 9.7 milligrams (mg - metric unit of measurement, used for medication dosage and/or amount) of ketamine (a medication that sedates patients and numbs the body but can also cause hallucinations) to be given once intravenously (IV - a way of administering fluids, medications, or nutrients directly into a vein) to Patient 2. During a review of Patient 2 ’ s MAR, dated 11/15/2024, the MAR indicated Registered Nurse (RN2) administered 9.7 mg of ketamine at 1:12 a.m. During a review of Patient 2 ’ s “ED Encounter Note,” dated 11/15/2024, at 3:09 a.m., the “Note” indicated, “Patient accidentally given 97 mg instead of 9.7 mg of ketamine -- patient monitored very closely without adverse event, reports improvement in pain. Medical error disclosed to patient.” This was MD 4 ’ s documentation. During a concurrent interview and record review with the ED Assistant Nurse Manager (ANM 1), on 4/3/2025, at 12:18 p.m., Patient 2 ’ s EMR was reviewed. ANM 1 stated there is no documentation by RN 2 to indicate if the correct dose of ketamine was given or that a different dose was given to the patient. During an interview with ANM 1, on 4/3/2025, at 3:19 p.m., ANM 1 stated the nurse should document if the dose given was not what the physician ordered. During an interview with RN 3, on 4/3/2025, at 4:12 p.m., RN 3 stated that she was the primary nurse for Patient 2 and had handed off Patient 2 to RN 2 while RN 3 went on break. RN 3 stated RN 2 gave the incorrect dose of medication while she was on break and she did not document how much ketamine Patient 2 was given because RN 2 gave the incorrect dose of medication. RN 3 did not know if RN 2 documented how much medication was given to the patient. During a review of the hospital ’ s P&P titled “Nursing Medication Administration and Documentation”, effective 11/2023, the P&P indicated, “Drug administration or omission errors, including related to adverse reactions and incompatibilities issues shall be immediately reported to the attending physician, documented in the medical record, and entered as an unusual occurrence report.” 2.a. A review of Patient 12 ’ s face sheet (a document that summarizes the patient ’ s personal and demographic information), dated 3/23/2025, indicated patient ’ s diagnosis included intracranial mass (an abnormal growth within the skull). On 4/2/2025, at 1:53 PM, during concurrent interview with quality management specialist (QM) and record review of Patient 12 ’ s emergency department (ED) records, dated 3/23/2025, QM stated the following: At 1:16 PM, Patient 12 ’ s vital signs (VS – measurements of the body ’ s most basic functions, including body temperature, pulse rate, rate of breathing, and blood pressure, used to monitor or to detect for medical problems) and pain score of 5 out of 10, were obtained upon arrival. At 1:45 PM, physician ordered medication, Tylenol 1000 milligrams (mg) by mouth, for pain relief. At 3:23 PM, registered nurse (RN)12 gave Patient 12 Tylenol 1000 mg by mouth, for pain. Prior to administering Tylenol 1000 mg for pain, RN 12 did not check Patient 12 ’ s pain score, to see if patient was still in pain or in worse pain. After RN 12 gave Patient 12 pain medication, Tylenol 100 mg by mouth, at 3:23 PM, RN 12 did not assess patient ’ s pain score, to check for the effectiveness of the pain medication. A review of facility ’ s Nursing Assessment and Documentation policy, dated 7/2023, indicated that pain score is obtained with every set of full vital signs, prior to administration of pain medication, and after administration of pain medication. A review of facility ’ s Medication Management policy, dated 1/2025, indicated each patient response to medication is monitored for any side effects and is documented in the patient ’ s medical record. A review of facility ’ s Medication Range Orders policy, dated 5/2024, indicated for pain medications, the patient ’ s response to pain management intervention will be assessed and re-assessed and documented for the effectiveness of pain medication. A review of facility ’ s Patient Rights and Responsibilities policy, dated 2/2022, indicated Patient Rights included the right to receive appropriate assessment and management of pain, information about pain, pain relief measures and to participate in pain management decisions. 2.b. A review of Patient 15 ’ s face sheet (a document that summarizes the patient ’ s personal and demographic information), dated 3/19/2025, indicated patient had a diagnosis, which included inflammation of the gallbladder (organ near the liver responsible for storing and releasing substance which helps in fat digestion from the food we eat). On 4/4/2025, at 11:51 AM, during concurrent interview with infection preventionist (IP – a healthcare professional who is dedicated to preventing the spread of infections in healthcare settings, ensuring the safety of patients, staff and visitors by implementing and monitoring infection control practices)1 and record review of Patient 15 ’ s ED records, dated 3/19/2025, IP 1 stated the following: Upon arrival to the ED, at 3:53 PM, patient ’ s VS included pain score of 6 out of 10. Physician ordered pain medication, morphine 4 milligrams (mg – unit of measurement) by intravenous (IV – into the vein) at 4:53 PM. Pain medication, morphine 4 mg was given to patient at 4:58 PM by IV. Prior to administration of pain medication, morphine 4 mg IV, RN 15 did not assess patient ’ s pain score. After administration of pain medication, morphine 4 mg IV, RN 15 did not assess patient ’ s pain score, for response to pain medication. A review of facility ’ s Nursing Assessment and Documentation policy, dated 7/2023, indicated that pain score is obtained with every set of full vital signs, prior to administration of pain medication, and after administration of pain medication. A review of facility ’ s Medication Management policy, dated 1/2025, indicated each patient response to medication is monitored for any side effects and is documented in the patient ’ s medical record. A review of facility ’ s Medication Range Orders policy, dated 5/2024, indicated for pain medications, the patient ’ s response to pain management intervention will be assessed and re-assessed and documented for the effectiveness of pain medication. A review of facility ’ s Patient Rights and Responsibilities policy, dated 2/2022, indicated Patient Rights included the right to receive appropriate assessment and management of pain, information about pain, pain relief measures and to participate in pain management decisions.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 43236 Based on interview and record review, the facility failed to ensure ketamine (a medication that sedates patients and numbs the body but can also cause hallucinations) was given according to the physician ’ s orders for one of 35 sampled patients (Patient 2). This deficient practice had the potential to harm Patient 2 and cause serious side effects. Findings: During a review of Patient 2 ’ s “ED (Emergency Department) Triage Note”, dated 11/14/2024, at 8:44 p.m., the “Note” indicated Patient 2 came to the facility ’ s ED complaining of generalized body aches (pain all over the body). During a review of Patient 2 ’ s “Physician Orders,” dated 11/14/2024, at 10:20 p.m., the “Order” indicated MD 4 ordered 9.7 milligrams (mg - metric unit of measurement, used for medication dosage and/or amount) of ketamine to be given once intravenously (IV - a way of administering fluids, medications, or nutrients directly into a vein) to Patient 2. During a review of Patient 2 ’ s “Medication Administration Record” (MAR - a daily documentation record used by a licensed nurse to document medications and treatments given to a patient), dated 11/14/2024, the MAR indicated RN 3 administered the first dose of ketamine at 11:07 p.m. During a review of Patient 2 ’ s “Physician Orders,” dated 11/14/2024, at 11:35 p.m., the “Order” indicated MD 4 ordered a second dose of 9.7 milligrams of ketamine to be given once intravenously to Patient 2. During a review of Patient 2 ’ s MAR, dated 11/15/2024, the MAR indicated RN 2 administered the second dose of ketamine at 1:12 a.m. During a review of Patient 2 ’ s “ED Encounter Note,” dated 11/15/2024, at 3:09 a.m., the “Note” indicated, “Patient accidentally given 97 mg instead of 9.7 mg of ketamine -- patient monitored very closely without adverse event, reports improvement in pain. Medical error disclosed to patient.” During an interview with the Chief Nursing Officer (CNO), on 4/3/2025, at 9:53 a.m., the CNO stated that the facility gave Patient 2 a “large dose of ketamine, larger than what was ordered to the patient.” During an interview with the Director of Pharmacy Services (DPS), on 4/3/2025, at 12:20 p.m., the DPS stated that Patient 2 was given ten times the ordered dose of ketamine per DPS review of the Pyxis log (automated medication dispensing system used in the hospitals). During an interview with MD 4, on 4/3/2025, at 2:43 p.m., MD 4 stated Patient 2 suffered from chronic pain and “seemed to be having a flare-up,” so MD 4 ordered ketamine. MD 4 stated her expectation was for the nurse to administer to the patient the correct dose of ketamine to the patient. MD 4 further stated a high dose of ketamine could have caused Patient 2 to “become so sedated or sleepy that if they were to choke on their saliva, they wouldn ’ t be able to cough or protect their airway; if a patient isn ’ t able to protect their airway, we would have to intubate [inserting a tube into the patient’s airway to help maintain breathing if the patient is not able to breathe by themselves] them or protect their airway in other ways.” During an interview with RN 3, on 4/3/2025, at 4:12 p.m., RN 3 stated that she was the primary nurse for Patient 2 and had handed off Patient 2 to RN 2 while RN 3 went on break. Prior to going on break, Patient 2 was alert and oriented (a person is awake, aware, and can understand their surroundings, including their identity, location, and the current time) but in pain. When RN 3 returned from break, she noticed that Patient 2 was “yelling and spacing out,” as well as not taking deep breaths, which was different from Patient 2 ’ s behavior prior to RN 3 ’ s break. Oxygen was given to Patient 2 and RN 3 asked RN 2 what happened; RN 2 informed RN 3 of the amount of ketamine she gave. RN 3 stated that is when she found out RN 2 gave Patient 2 the wrong dose of ketamine. RN 3 further stated she told RN 2 that she had given too much ketamine. In the same interview with RN 3, on 4/3/2025, at 4:12 p.m., RN 3 stated that she gave Patient 2 9.7 mg of ketamine which is the ordered dose. She stated RN 2 gave 97 mg of ketamine; RN 2 “moved the decimal over and that ’ s how we discovered she gave too much.” RN 2 stated she told RN 3 that the correct dose was “lower than that, it ’ s a really small amount.” RN 2 further stated that a negative situation could have occurred from the medication error and that Patient 2 could have gone into respiratory distress (difficulty breathing) or become more sedated for a longer period of time. During a review of the hospital ’ s policy & procedure (P&P) titled “Nursing Medication Administration and Documentation”, effective 11/2023, the P&P indicated, “Observe the 7 Rights for safe medication administration always . . . 3. Right dose . . . Staff shall confirm the following prior to each administration of medication: . . . d. Right Dose: Verify the dose matches that prescribed, and that the dose is appropriate and safe for the patient (not too high or too low).””

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 31333 Based on interview and record reviews, the facility failed to ensure policies and procedures (P&P) related to the medication distribution and medication administration systems were implemented in the Emergency Department (ED). Failure by nursing and pharmacy staff to implement P&Ps specific to the removal of Ketamine (a controlled medications used for sedation (feeling calm and relaxed), immobility, and relief from pain), from the facility ’ s Pyxis (ADS, an automictic dispensing system/services) machine was reviewed for medication accuracy and appropriateness, to ensure ED physician ’ s order was followed and any amount greater than the ordered amount was witnessed by a second nurse and disposed of prior to ketamine administration to one of 35 sampled patients (Patient 2). The deficient practice had the potential to affected over 200 patients seen in the ED between 11/14/2025 – 11/15/2025 who received medications from the ADS used in the ED. The failure to have a second nurse to witness controlled medication removal from the ADS and wasting of the excess dosage resulted in Patient 2 being administered 10 times the prescribed ordered dose of ketamine, resulting in Patient 2 experiencing a high respiratory rate, becoming more somnolent (drowsy or sleepy), having trouble breathing, and requiring the administration of oxygen. Findings: During a review of Patient 2 ’ s “ED (Emergency Department) Triage Note”, dated 11/14/2024, at 8:44 p.m., the “Note” indicated Patient 2 came to the facility ’ s ED complaining of generalized body aches (pain all over the body). During a review of Patient 2 ’ s “Physician Orders,” dated 11/14/2024, at 10:20 p.m., the “Order” indicated MD 4 ordered 9.7 milligrams (mg - metric unit of measurement, used for medication dosage and/or amount) of ketamine to be given once intravenously (IV - a way of administering fluids, medications, or nutrients directly into a vein) to Patient 2. During a review of Patient 2 ’ s “Medication Administration Record” (MAR - a daily documentation record used by a licensed nurse to document medications and treatments given to a patient), dated 11/14/2024, the MAR indicated RN 3 administered the first dose of ketamine at 11:07 p.m. During a review of Patient 2 ’ s “Physician Orders,” dated 11/14/2024, at 11:35 p.m., the “Order” indicated MD 4 ordered a second dose of 9.7 milligrams of ketamine to be given once intravenously to Patient 2. During a review of Patient 2 ’ s MAR, dated 11/15/2024, the MAR indicated RN 2 administered the second dose of ketamine at 1:12 a.m. During a review of Patient 2 ’ s “ED Encounter Note,” dated 11/15/2024, at 3:09 a.m., the “Note” indicated, “Patient accidentally given 97 mg instead of 9.7 mg of ketamine -- patient monitored very closely without adverse event, reports improvement in pain. Medical error disclosed to patient.” During a review of the facility ’ s “ED Pyxis – All Transaction Detail,” between 11/132024 to 11/17/2024, the “All Transaction Detail,” indicated for Patient 2, the following transactions occurred from the ED Pyxis on: -11/14/2025 at 10:31 p.m., removed one vial of ketamine 10 mg/ml (200 mg/20 ml) from facility ’ s Pyxis by RN 3 -11/14/2025 at 10:37 p.m., wastage (destruction/disposal) of ketamine 190.3 mg out of 200 mg of the 10mg/ml (200 mg/20ml) vial, was documented in the facility ’ s Pyxis by RN 3 and witnessed by RN 8 -11/15/2025 at 1:06 a.m., RN 2 accessed the facility ’ s ED Pyxis to verify inventory of ketamine 10 mg/ml (200 mg/20 ml) vial -11/15/2025 at 1:06 a.m., RN 2 accessed the facility ’ s ED Pyxis a second time and removed one vial of ketamine 10 mg/ml (200 mg/20 ml) from the facility ’ s Pyxis, no witness was documented -11/15/2025 at 3:41 a.m., wastage of ketamine 103 mg out of 200 mg of the 10mg/ml (200 mg/20ml) vial, was documented in the facility ’ s Pyxis by RN 2 and witnessed by RN 3, waste reason indicated, Patient 2 was supposed to receive 0.97 ml (9.7 mg) of ketamine. RN 2 accidentally gave 9.7 ml (97 mg), and wasted the remainder of the ketamine which was 10.3 ml (equals 103 mg). During a review of Patient 2 ’ s ED Encounter documentation, Patient Care Timeline indicated the following on: -11/14/2024 at 10:42 p.m., Respiratory Rate (RR, breaths per minute [bpm], normal RR is between 12 and 20 bpm) 18 bpm -11/14/2024 at 11:30 p.m., RR 26 bpm -11/15/2024 at 12:00 a.m., RR 16 bpm -11/15/2024 at 1:11 a.m., RR 45 bpm -11/15/2024 at 1:23 a.m., ED Quick Note: MD at bedside assessing patient -11/15/2025 at 1:31 a.m., ED Quick Note: Patient placed on cardiac monitor, NIBP monitoring, and continuous pulse oximetry During an interview on 4/2/2025, at 1:43 p.m., with the Director of Pharmacy Services (DPS), Pharmacist of Medication Safety and Regulatory (Pharm 1), and the Pharmacy Manager (Pharm 2), Pharm 2 stated the pharmacist review reports that include, discrepancy reports and check for discrepancies between the physician orders and the medications access in the Pyxis. Pharm 2 stated the facility has about 63 Pyxis throughout the hospital with two out of three Pyxis being used in the ED. During an interview with the Chief Nursing Officer (CNO), on 4/3/2025, at 9:53 a.m., the CNO stated that the facility gave Patient 2 a “large dose of ketamine, larger than what was ordered to the patient.” During a concurrent interview and record review on 4/3/2025, at 11:55 a.m., with the Assistant Nurse Manager, ED (ANM 1), Patient 2 ’ s clinical records were reviewed. On 11/15/2024 at 1:11 a.m., ED Encounter documentation indicated Patient 2 RR was 45 bpm, ANM 1 stated a normal RR is between 12 bpm – 20 bpm. ANM 1 stated a RR of 45 is tachypneic, which is rapid breathing and requires physician notification for a high RR. ANM 1 stated there was no documentation on Patient 2 ’ s Medication Administration Record to indicate that Patient 2 was administered a higher dose of ketamine than ordered. ANM 1 stated there was no documentation that RN 2 had a second nurse witnessing the wastage of the excess amount of ketamine before administering ketamine to Patient 2 on 11/15/2024 at 1:06 a.m. On 4/3/2025, at 12:18 p.m., during a concurrent interview and review of facility ’ s ED Pyxis Transaction Detail with DPS, Pharm 1, and Pharm 2, Pharm 1 stated on 11/15/2024 at 1:06 a.m., RN 2 removed from the Pyxis Ketamine 10 mg/ml (200 mg/20 ml) vial and on 11/15/2024 at 3:41 a.m., (two hours and 35 minutes later) RN 2 with RN 3 wasted at the Pyxis 103 mg out of 200 mg. Pharm 1 stated Patient 2 was administered 97 mg (9.7 ml) of ketamine and the order was for 9.7 mg (0.97 ml). Pharm 1 stated Patient 2 was administered 10 times the ordered dose of ketamine. Pharm 1 stated the wasting of ketamine should have been done at the same time the medication was pulled from the Pyxis with a witness. Pharm 2 stated the expectation is for the licensed nurses to follow the facility ’ s policy that requires the licensed nurse to waste excess dose of controlled medication at the time of removal from the Pyxis with a witness inside of the medication room and not after medication administration to the patient. During an interview on 4/3/2025, at 12:37 p.m., with DPS, Pharm 1, and Pharm 2, DPS stated removal of controlled medication, wasting in the medication room with a witness, ensures the correct dose of medication was prepared, before administration to the patient. Pharm 2 stated the process of integrated waste (wasting at the same time the medication is pulled) helps with medication reconciliation (the process of comparing a patient’s medication orders to all of the medications that the patient has been taking) and prevent loss and diversion (when a medication is taken for use by someone other than whom it is prescribed) of controlled medications and there is a designated receptacle in the medication room to waste the controlled medication and there is not a receptacle for disposal in patients rooms. During an interview with MD 4, on 4/3/2025, at 2:43 p.m., MD 4 stated Patient 2 suffered from chronic pain and “seemed to be having a flare-up.,” so MD 4 ordered ketamine. MD 4 stated her expectation was for the nurse to administer to the patient the correct dose of ketamine to the patient. MD 4 further stated a high dose of ketamine could have caused Patient 2 to “become so sedated or sleepy that if they were to choke on their saliva, they wouldn ’ t be able to cough or protect their airway; if a patient isn ’ t able to protect their airway, we would have to intubate [inserting a tube into the patient’s airway to help maintain breathing if the patient is not able to breathe by themselves] them or protect their airway in other ways.” During a follow-up interview on 4/3/2025, at 3:26 p.m., with DPS, Pharm 1, and Pharm 2, DPS stated the facility ’ s policy requires the licensed nurse to return unused medications to the Pyxis within 30 minutes if not used. Pharm 1 stated the pharmacy do not look at timeframe, not looking at if there is a wastage during removal from the Pyxis of a controlled medication that is higher than the dose ordered. Pharm 1 stated the pharmacy became aware of the overdosage of ketamine to Patient 2 when an incident report was done. During an interview with RN 3, on 4/3/2025, at 4:12 p.m., RN 3 stated that she was the primary nurse for Patient 2 and had handed off Patient 2 to RN 2 while RN 3 went on break. Prior to going on break, Patient 2 was alert and oriented (a person is awake, aware, and can understand their surroundings, including their identity, location, and the current time) but in pain. When RN 3 returned from break, she noticed that Patient 2 was “yelling and spacing out,” as well as not taking deep breaths, which was different from Patient 2 ’ s behavior prior to RN 3 ’ s break. Oxygen was given to Patient 2 In the same interview with RN 3, on 4/3/2025, at 4:12 p.m., RN 3 stated that she gave Patient 2, 9.7 mg of ketamine which is the ordered dose. She stated RN 2 gave 97 mg of ketamine; RN 2 “moved the decimal over and that ’ s how we discovered she gave too much.” RN 3 further stated that a negative situation could have occurred from the medication error and that Patient 2 could have gone into respiratory distress (difficulty breathing) or become more sedated for a longer period. During a review of the facility ’ s policy and procedure (P&P) titled, “Inpatient Controlled Substance Management”, effective 2/2023, the P&P indicated, “To establish guidelines for the procurement, receiving, storage, distribution, security, wasting and disposal of all controlled substances and reduce the potential for drug diversion ... The Department of Pharmacy solely controls access to ADS and maintains appropriate assignment of access and security levels in accordance with (the hospital) ADS policy ... WASTE & DISPOSAL OF CONTROLLED SUBSTANCES: - Any full or partial doses of a controlled substance that is removed from the original package and not administered to the patient must be wasted at the ADS ... - Partial doses of controlled substances should be wasted at the time of removal, not after administration. - Wasting of controlled substances requires two persons: the person who removed the medication and a witness. - Wasting of all controlled substances requires an independent witness performed by two licensed personnel (e.g., nurse, pharmacist or LIP) ... - Witness that wasting occurs per policy for safe disposal and in a manner that makes the controlled substance irretrievable ... - The unused portion of injectable or liquid controlled substance shall be drawn into a syringe and squirted into the designated controlled substance waste container ... - Waste containers with any unusable controlled substance product are secured to prevent tampering or made otherwise non-retrievable. - If a controlled substance is NOT administered to the patient and remains intact, it must be returned to the ADS or returned directly to the pharmacy as soon as possible, within 30 minutes from the time of removal, or by the end of case in procedural areas.”

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 31333 Based on observation and staff interview, the facility failed to ensure each Crash Cart/Code Cart (a cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel especially during efforts to resuscitate [to bring someone back to life when their heart and breathing have stopped] a patient experiencing cardiac arrest [when the heart stops beating suddenly]) in the facility ’ s Emergency Department (ED) had an inventory sheet of Crash Cart/Code Cart content attached to two out of seven Code Carts (Code Cart 3 Adults and Code Cart 3 Pediatric[Peds]). The facility ’ s failure to implement their policy and procedure had the potential to affect over 200 patients that visit the ED daily by not responding in an emergency adequately and/or creating a delay in care. Findings: During a concurrent interview and observation of the ED on 4/1/2025 at 2:50 p.m., with the Director of Emergency Services (DES) and Quality Management Specialist (QMS 1), two Crash Carts (Crash Cart 3 Adults and Crash Cart 3 Peds) was observed without a content list attached to each Crash Cart. DES stated there are no content list of medications on the outside of the Crash Carts labeled as Crash Cart #3 Adults and Crash Cart # 3 Peds. During a concurrent interview and observation on 4/1/2025 at 3:00 p.m., with DES and QMS 1, Crash Carts # 5 Adults, Crash Cart # 5 Peds and Crash Cart # 2 were reviewed in the ED with each having an itemized content list in a red folder on the outside of each of the three Crash Carts (Crash Cart # 5 Adults, Crash Cart # 5 Peds, and Crash Cart # 2). QMS 1 acknowledged that two out of five of the Crash Carts reviewed in the ED did not have a Crash Cart/Code Cart content list attached to the Crash/Code Cart. During a review of the facility ’ s policy and procedure (P&P) titled, “Code Cart (Adult, Pediatric, NICU)”, effective 6/2024, the P&P indicated, “To assure all emergency carts/trays/boxes are in a state of readiness for use in an emergency situation ...An inventory sheet of Code Cart content is attached to each cart and reviewed by Code Blue Committee.””

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 43236 Based on observation, interview, and record review the failed to follow facility policy regarding IV (way of administering fluids, medications, or nutrients directly into a vein) site dressing maintenance for 1 of 35 sampled patients (Patient 22); This deficient practice may lead to the introduction of infection through the unprotected IV site (insertion site of the flexible IV tube on the skin). Findings: During an observation on 4/2/2025 at 10:45 AM, there was an op site dressing (transparent dressing placed over the IV site used to prevent contamination) over Patient 22 ’ s right wrist. The dressing was halfway detached from the IV site and appeared wet. During an interview on 4/2/2025 at 10:45 AM, the Nurse Manager of the 5NE Medical/Surgical Unit (NM5NE) stated IV dressings should be changed every 96 hours and more frequently when soiled or damaged. NM5NE proceeded to gather the supplies needed to change the dressing at this time. During a review of the policy ’ Comprehensive Vascular Access Management ’ ID 13167446, this document indicated the following for maintenance of IV sites: -Dressings are to be changed every seven days or earlier if soiled, camp, or loose. -Gauze dressings are to be changed every 48 hours and as needed.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 36329 Based on observation, interview, and record review the facility failed to do the following which may lead to the spread of infection. 1. Clean an ice machine daily as scheduled. 2. Prepare a tray of surgical instruments for sterilization as the facility’s policy and procedure requires. 3. Ensure a sharps container in a patient’s room was emptied according to facility policy. Findings: 1.During an observation on 5/14/2024 at 2:15 PM, in a supply room in the SPD (Sterile Processing Department, area where surgical/procedural instruments are cleaned/sterilized), there was an ice machine at the back of the room. On the left side of the ice attached to the machine was a daily cleaning checklist (log of daily routine cleaning of the machine). The latest documentation of daily cleaning of the machine was 5/10/2024; All the previous dates on the log were signed, acknowledging the ice machine had been cleaned. There was a slight cover of dust on the top of the machine. During an interview on 5/14/2024 at 2:15 PM, the Nurse Surgery Manager stated the ice machine should be cleaned daily so that frequent handling of the machine does not pass to the ice and increase possibility of transmission of infection. During a record review of the Policy/Procedure ‘Ice Machine Cleaning’ (last revised 8/2023), this document indicated the procedure for maintaining infection control for ice machines throughout the facility. This procedure included: using a hospital approved cleaning agent to wipe down exterior surfaces of the machine; clean cleaning clothes, using hospital approved cleaner, reach inside the spout (chute through which ice is dispensed) as far as possible to disinfect; on a weekly basis use line cleaning agent to remove mineral buildup; dust the top of the machine weekly. 2. During an observation in the SPD on 5/14/2024 at 2:18 PM, accompanied by the Nurse Surgery Manager, there was a ‘minor tray’ (tray of surgical instruments used during minor surgical procedures that includes scissors, scalpels, forceps etc.) that the Nurse Surgery Manager opened. Among the instruments were 69 forceps (used to grasp, retract, or stabilize tissue and similar in appearance to scissors). These 69 forceps were mounted on a metal stringer (rod through the handles of the forceps whose purpose is to separate the jaws of these instruments). Of the 69 forceps, 19 of them were in the jaws closed position. During an interview in the SPD on 5/14/2024 at 2:18 PM, the Nurse Surgery Manager acknowledged that all these instruments should be in the jaws open position so steam can reach all surfaces during the sterilization process. During a review of the policy ‘Instrument Cleaning and Processing’ (last reviewed 12/2021), this policy indicated professional guidelines published by AORN (Association of Operating Room Nurses) and AAMI (Association for the Advancement of Medical Instrumentation) are used during the process of sterilizing surgical instruments. During a review of the AAMI standards for steam sterilization (ANSI/AAMI ST79:2017), supplied by the IP on 5/14/2024 at 3:45 PM, this document indicated load configurations (how instruments are positioned in the sterilizer) ‘should ensure adequate air removal, penetration of steam into each package, and steam evacuation’. This document specifies perforated trays or rigid sterilization sets should be placed in a horizontal position in order to prevent shifting of the set, penetration of the sterilant (steam), drainage of condensate, and drying evacuation. 3. During an observation on 5/14/2024 at 12:45 PM, in patient room 2432 accompanied by the IP, there was a sharps container (specially designed containers into which used needles and other medical-waste sharps are discarded) on the far wall of the room. The container was full and a used syringe protruded from the top. During an interview on 5/14/2024 at 12:45 PM, the IP stated that sharps containers should be emptied when about three quarters full as she noted the used syringe from the top of the container. During a record review of the policy ’[Regional] Sharps and Needle Handling and Disposal’ (last reviewed 9/2021), this document indicated devices such used needles, lancets, scapels should be disposed using a sharps container immediately after use. This policy stated in order to prevent personal injury or theft and abuse of sharps, containers are to be closed and changed when they are 2/3 to 3/4 full.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 46333 Based on interview and record review, the facility’s Governing Body failed to assume full legal responsibility for implementing, and monitoring policies governing the facility’s ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) services. The facility’s Governing Body failed to provide oversight for quality health care in a safe environment. The facility did not meet the condition for coverage in governing body and management by failing to: 1. Ensure the medical staff was accountable to the governing body for the quality of care provided to patients. This deficient practice resulted in no on-call physician (ready to give medical care after hours, typically in an emergency or urgent situation) who has knowledge of ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) was available on 4/2/24 when Patient 1 was decannulated (accidental cannula complete exiting the patient’s body). wWhile on ECMO, Medical staff failinged to follow the facility’s Policy and Procedure (P&P) to ensure ECMO services provide by the facility were implemented in a safe manner to avoid potential for patient receiving ECMO bled to death due to inadvertent decannulations (Refer to A049) 2. Ensure surgical services provide qualified physician (group) who instituted CARDIOHELP (an extracorporeal cardiopulmonary support system for the purpose of blood oxygenation and carbon dioxide removal with mechanical circulatory assistance) assured the cannula (medical tube insert into the body) entry site is visible for assessment by nursing staff in accordance with the facility’s policy and procedure (P&P). And ensured the primary physician regarding patient management/direction throughout the ECMO period in accordance with the facility’s policy and procedure (P&P). These deficient practices resulted in nursing staff inability to assess site where the cannula enters the body for securement of the cannula, such as intact sutures. Medical staff failing to follow the facility’s Policy and Procedure (P&P) to ensure ECMO services provided by the facility were implemented in a safe manner to avoid potential for patient receiving ECMO to bleed to death due to unintentional decannulations. (Refer to A-063) 3. Ensure staff adhere to disclosure process to inform the POA (A power of attorney, a legal authorization designated person to make decisions about another person’s medical care) of the unintentional decannulation of patient 1 while on ECMO treatment on 4/2/24, in accordance with the facility’s policy and procedure which causes Patient 1 to bled to death. This deficient practice resulted in Patient 1’s POA was not informed that on 4/2/24, Patient 1 bleed out and died due to unintentional decannulation while on ECMO treatment. (Refer to A-131) 4. Ensure that QAPI (Quality Assessment & Performance Improvement) Committee implemented an effective plan of correction that ensured staff adherence to the facility’s policy and procedure (P&P) titled “CARDIOHELP System Setup, Operation, and Patient Management” after the incident of Patient 1’s unintentional decannulation on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility involving cannulation procedures (insertion of a tube to a big blood vessels). (Refer to A-263, A-283, and A-286) The cumulative effect of these systemic practices resulted in the facility’s inability to ensure the governing body had oversight and accountability for all the facility’s activities and total operations.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 46333 Based on interview and record review, the facility failed to ensure the Condition of Participation for Patient Rights was met as evidenced by: A. The facility’s failure to ensure one of thirty (30) sampled patients (Patient 1’s), ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’’s own organs are too sick or weak to work on their own) cannula ( a tube inserted into a vein) insertion sites is assessed and have available on-call physician to provide care in emergency situation for patient receiving ECMO treatment. This deficient practice resulted in Patient 1’s decannulation (inadvertent removal of a cannula) while on ECMO treatment. (Refer to A -0144) 2. The facility’s failure to ensure one of thirty (30) sampled patients (Patient 1’s), POA (A power of attorney, a legal authorization designated person to make decisions about another person’s medical care) was informed in accordance to the facility’s policy and procedure, of the unintentional decannulation of Patient 1 while on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) treatment on 4/2/24, which causes Patient 1 to bleed out and result in death. This deficient practice resulted in Patient 1’s POA was not informed that on 4/2/24, Patient 1 bleed out and died due to unintentional decannulation while on ECMO treatment. This can lead to breakdown of trust between the facility and the POA; causing POA severe emotional trauma, and stress and a sense of mistrust from the lack of transparency. (Refer to A -0131) Findings: During a review of Patient 1’s “Emergency Department Encounter Note (ED Note, a summary of a patient’s interval status during an emergency department encounter, including narrative and free text data),”dated 3/26/24, the “ED Note” indicated, Patient 1 “Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection.” During a review of Patient 1’s “Operative Report (a report written in a patient’s medical record to document the details of a surgery),” documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had “pump failure (a condition that develops when the heart doesn’t pump enough blood for the body’s needs) and thus underwent a procedure for “placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren’t functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works).” During a review of Patient 1’s “Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,”” dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was “found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient’s body) of the Patient 1’s VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m.” On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, “When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him.” On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, “It is unclear how Patient 1 was decannulated.” EDMD not able to visualize at first due to large dressing over site, after calling time of death, EDMD stated, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. EDMD stated he sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything came out. No suture seen for the cannula that came off, just the Ioban (iodine [chemical element that prevent infection]-impregnated incision drape) holding it down. EDMD stated he spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated. During a concurrent interview and record review on 4/17/24 at 2:50 p.m. with the Director, Risk and Regulatory (DIRR), Patient 1’’s electronic medical record (EMR, an electronic version of a patient’s medical history, that is maintained over time), under titled “Physician notes” was reviewed. DIRR confirmed that no disclosure of Patient 1’s unintentional decannulation (removal of a medical tube) was documented on physicians’ notes. DIRR stated that during her interview with RN 3, RN 3 reported that she informed Patient 1’s wife that Patient 1 had bled out. The DIRR confirmed there was no documentation within Patient 1’s medical record that indicates the disclosure to Patient 1’s POA of the unintentional decannulation that led to his death on 4/2/24. During a review of the facility’s policy and procedure (P&P) titled, “Responding TO/Disclosure of Adverse Events,”” dated August 2021, the P&P indicated, “Prompt, compassionate, and honest communication with the patient and family following an incident is essential. Because of the emotional effects of these events on both the patients and caregivers, this communication process can be difficult for everyone. If handled poorly, injury to both patient and caregivers can be compounded, damaging the patient-caregiver relationship. Open communication and authentic apologies help to dissipate patients’ feelings of anger and mistrust ...Ideally, the initial communication should be from a person with whom the patient has a trusting relationship. Usually, the physician who is responsible for the patient’s care is the most appropriate person. Documentation: All communications with the patient and family are also documented supports the best interests of both the patient and caregivers and advances good patient care””

“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: 42937 Based on interview and record review, the facility failed to meet the condition of participation of QAPI (Quality Assessment & Performance Improvement) as evidenced by: 1. The QAPI (Quality Assessment & Performance Improvement) Committee failed to ensure staff’s adherence to the facility’s policy and procedure (P&P) titled “CARDIOHELP System Setup, Operation, and Patient Management” after the incident of one of 30 sampled patients (Patient 1’s) unintentional decannulation (accidental cannula complete exiting the patient’s body) on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility involving cannulation (insertion of a tube to a major blood vessel). (Refer to A-283, A-144 and A-395) 2. The QAPI (Quality Assessment & Performance Improvement) Committee failed to ensure one of 30 sampled patients (Patient 1’s) POA (A power of attorney, a legal authorization designated person to make decisions about another person’s medical care) was informed in accordance to the facility’s policy and procedure, of the unintentional decannulation (removal of a medical tubing from the patient’ body) while on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) treatment on 4/2/24, which causes Patient 1 to bleed to death. This deficient practice resulted in Patient 1’s POA was not informed that on 4/2/24, Patient 1 bleed out and died due to unintentional decannulation while on ECMO treatment. (Refer to A-286 and A-131) 3. E The QAPI (Quality Assessment & Performance Improvement) Committee failed to ensure the implementation of an effective preventative measures to prevent the potential reoccurrence of accidental disconnection of medically inserted lines, drains, tubing, and cannulas (tubes that are inserted into a body cavity, duct, or vessel for medical purposes) after an incident of unintentional decannulation of one of 30 sampled patients (Patient 1) that occurred on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility. (Refer to A-286, A-144 and A-395.) The cumulative effect of these systemic practices resulted in the facility’s inability to ensure the condition of participation for quality assurance and performance improvement was met.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 46333 Based on interview, and record review, the facility failed to ensure the Condition of Participation for Nursing Services was met as evidenced by: 1. The facility failed to ensure one of thirty (30) sampled patients (Patient 1), who was on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) and on CRRT (Continuous Renal Replacement, type of blood purification therapy used with patients who are experiencing acute kidney injury) was reposition with at minimum three staff in accordance with the facility ECMO, “New User Class,” guidance to assure one RN has responsibility to assure cannulas does not get pulled out during repositioning of the patient. This deficient practice places Patient 1, who was on ECMO and on CRRT, at increased risk for inadvertent decannulation (accidental cannula complete exiting the patient’s body). (Refer to A-0392) 2. The facility failed to ensure one of thirty (30) sampled patients (Patient 1) was assessed and monitored for changes such as cannula site bleeding, positioning of cannulas, clots, color of blood, connector site for any cracks, and ensuring tubing is secure in accordance with the facility’s policy and procedure, while on ECMO. This deficient practice places patients on ECMO treatment at risk for unintentional disconnection or dislodge of cannula (medical tube inserted into the body) and led to Patient 1’s inadvertent decannulation on 4/2/24 that resulted in his death. (Refer to A-0395) 3. The facility failed to ensure four (4) of the four (4) sampled registered nurses (RN 1, RN 2, RN 3, and RN 4) completed an annual ECMO user competency in accordance with the proposal requested by the Department of Surgery and Department of Medicine to the government body in 2016 to add ECMO treatment to the facility’s services. This deficient practice places Patient 1 and patients treated with ECMO at risk for error in care, compromised patients’ safety, and reduced quality of treatment due to lack of updated knowledge and skills. It could lead to adverse events, delays in critical decision-making, and overall jeopardized the patients’ wellbeing. (Refer to A-0397) The cumulative effect of these systemic practices resulted in the facility’s inability to ensure the condition of participation for nursing service was met.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 46333 Based on interview and record review, the facility’s Governing Body failed to ensure the medical staff was accountable to the governing body for the quality of care provided to patients. This deficient practice resulted in no on-call physician (ready to give medical care after hours, typically in an emergency or urgent situation) who has knowledge of ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) was available on 4/2/24 when one of 30 sampled patients (Patient 1) was decannulated (accidental cannula complete exiting the patient’s body). while on ECMO, Medical staff failing to follow the facility’s Policy and Procedure (P&P) to ensure ECMO services provided by the facility were implemented in a safe manner to avoid potential for patient receiving ECMO to bleed to death due to inadvertent decannulations. Findings: During a review of Patient 1’s “Emergency Department Encounter Note (ED Note, a summary of a patient’s interval status during an emergency department encounter, including narrative and free text data),” dated 3/26/24, the “ED Note” indicated, Patient 1 “Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection.” During a review of Patient 1’s “Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,” dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was “found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient’s body) of the patient’s VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m.” On 4/17/24 at 9:42 AM, during an interview with Registered Nurse (RN) 1, RN 1 stated, “When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician (ready to give medical care after hours, typically in an emergency or urgent situation), but we were not able to reach him.” On 4/18/24 at 10 AM, during an interview with the Director of the Intensive Care Unit (DICU), the DICU stated, “It is difficult to tell who is covering (physician on-call to response to emergency) that day; the nurses will communicate with the physician. There is no set schedule for on-call physicians.” During an interview on 4/18/24 at 12:00 PM with the Director of Risk and Regulatory (DIRR), the DIRR confirmed that the facility has one cardiac thoracic (surgeon that specialty is relating to, involving, or specializing in the heart and chest), surgeon, (Surgeon 1), who has knowledge and oversight of all ECMO cases in the facility. Confirmed with DIRR, the facility didn’t have another physician who has the capability to troubleshoot problems with the ECMO. During an interview with Senior Manager of Human Resource (HR, in charged with finding, screening, recruiting, and training job applicants, as well as administering benefits), (SMHR) on 4/18/24 at 12:26 AM, the SMHR confirmed that surgeon 1 is the only cardiac thoracic surgeon in the facility. Surgeon 1 performed all procedures related to general thoracic, heart lung machine, thoracic aorta (the largest elastic artery in the human body), pacemaker (an artificial device for stimulating the heart muscle and regulating its contractions), pericardium (a fibrous sac that encloses the heart and great vessels), and mediastinum (a space in the chest that holds they our heart and other important structures). During an interview on 4/19/24 at 5:20 p.m. with the Director of Risk and Regulatory (DRR), the DRR stated the ECMO program was not brought up with the government body; the last time ECMO was brought up for review and discussion with the government body was when the program started in 2016. During a concurrent interview and record review on 4/19/24 at 4:00 p.m. the Executive Director of Administrator (EDA), the document titled “Request for Addition of New Procedure: Upon Motion Made, Carried and Seconded,” undated was reviewed. EDA stated, “The proposal requested was by the Department of Surgery and Department of Medicine to the government body on 2016 to add ECMO treatment to the facility’s services.” The proposal document indicated, there will be 8 physicians (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, and MD 8) participants that have received certification on ECMO competency. During a concurrent interview and record review on 4/19/24 at 4:28 p.m. with the Executive Director of Administration (EDA), the “Quality Assurance and Improvement Committee” meeting minutes dated February 2024 were reviewed. The EDA stated that the Quality Assurance and Safety Committee (a committee whose functions are concerned with the arrangements for the purpose of monitoring and improving the quality of the facility) meets monthly with several task forces that report to the Quality Assurance and Improvement Committee (QAPI, team in the facility that seek to prevent, detect, and correct problems in the quality of services provided to individuals and populations) every fourth Wednesday of the month. EDA stated the last report was on March 27, 2024, and the next report is scheduled for April 24, 2024. The facility QAPI reviews policies, programs, and plans for improvement and new projects; however, EDA stated, “Nothing was reviewed regarding the ECMO program. The facility has not identified the need to do process improvement on ECMO because it was not brought up by nursing.” EDA confirmed there have been no QAPI-related projects for ECMO since 2016.”

“CARE OF PATIENTS CFR(s): 482.12(c) In accordance with hospital policy, the governing body must ensure that the following requirements are met: This Standard is not met as evidenced by: 46333 Based on interview and record review, the facility’s Governing Body failed to ensure surgical services provide qualified physician (group) who instituted CARDIOHELP (an extracorporeal cardiopulmonary support system for the purpose of blood oxygenation and carbon dioxide removal with mechanical circulatory assistance) will: 1. Assure the cannula (medical tube insert into the body) entry site is visible for assessment by nursing staff in accordance with the facility’s policy and procedure (P&P). 2. Assure the primary physician regarding patient management/direction throughout the ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) period in accordance with the facility’s policy and procedure (P&P). These deficient practices resulted in nursing staff unable to assess site where the cannula enters the body for securement of the cannula, such as intact sutures. Also resulted in no on-call physician (ready to give medical care after hours, typically in an emergency or urgent situation) who has knowledge of ECMO was available on 4/2/24 when one of 30 sampled patients (Patient 1) was unintentionally decannulated (accidental cannula complete exiting the patient’s body) while on ECMO, Medical staff failing to follow the facility’s Policy and Procedure (P&P) to ensure ECMO services provide by the facility were implemented in a safe manner to avoid potential for patient receiving ECMO to bleed to death due to unintentional decannulations. Findings: 1. During a review of Patient 1’s “Emergency Department Encounter Note (ED Note, a summary of a patient’s interval status during an emergency department encounter, including narrative and free text data),” dated 3/26/24, the “ED Note” indicated, Patient 1 “Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection.” During a review of Patient 1’s “Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,” dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was “found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient’s body) of the patient’s VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m.” During a concurrent interview and record review on 4/16/24 at 2:36 p.m. with the Director of the Intensive Care Unit (DICU), Patient 1’s Flowsheet (documents of the patient assessment regarding the patient’s condition) titled, “Timeline,” dated from 4/1/24 through 4/2/24 was reviewed. The Timeline indicated, “puncture side left groin, base of the wound unable to assessed,” was documented by nursing throughout the time that Patient 1 was on ECMO treatment (from 3/26/24 through 4/2/24). The DICU stated, “the site (cannula entry site on the patient left groin) was not visible due to the gauze covering it (cannula entry site on the patient left groin).” DICU also stated, “Patients who come to ICU unit after operation to insert cannula, often have the site cover by gauze dressing when transfer into ICU (Intensive Care Unit, a unit in a hospital providing around- the -clock care for critically ill or injured patients) The RN does not touch the dressing or change the dressing, the surgeon will change the dressing.” DICU confirmed, nursing staff have reached out to the surgeon (Surgeon 1) to change the dressing, but the dressing was not change since Patient 1 had the canula inserted on 3/26/24. Nursing staff did not escalate through the chain of command (the communication of problems/concerns to a higher level of authority such as from Department Chair to Chief of Staff and so on). On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, “When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him.” During a review of Patient 1’s “Operative Report (a report written in a patient’s medical record to document the details of a surgery),” documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had “pump failure (a condition that develops when the heart doesn’t pump enough blood for the body’s needs) and thus underwent a procedure for “placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren’t functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works).” On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, “It is unclear how Patient 1 was decannulated.” EDMD not able to visualize at first due to large dressing over site. After calling time of death, EDMD stated, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of Patient 1. EDMD stated he sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything came out. No suture seen for the cannula that came off, just the Ioban (iodine [chemical element that prevent infection]-impregnated incision drape) holding it down. EDMD stated he spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated. During an interview on 4/17/24 at 12:15 p.m. with the Cardiac thoracic and vascular Surgeon (Surgeon 1), Surgeon 1 stated “Dressing change, there are no set formula of changing (changing the dressing) about a week or 10 days, nurses can do it.” Surgeon 1 stated, “I have seen it (the patient’s dressing) every day.” During a review of the facility’s policy and procedure (P&P) titled, “Comprehensive Vascular Access Management” regional clinical standard,” dated September 2019, the P&P indicated, for peripheral saline lock (device allows easy access to the peripheral vein for intermittent IV fluids or medications), short-term non-tunneled central venous access device (short term, venous access device [VAD], medical access line allow medication administration for 2-3 weeks), long-term tunneled central VAD (long-term, VAD, medical access line allow medication administration more than 3 weeks), peripheral inserted central venous catheter (PICC, a long, thin tube that’s inserted through a vein in your arm to administered medication), and for Port-a-cath (a combination of a portal and a catheter device used to draw blood and give treatments), all medical access devices mention should have a transparent dressing. During a review of the facility’s policy and procedure (P&P) titled, “CARDIOHELP System Setup, Operation, and Patient Management,” dated August 2020, the P&P indicated, “Cannula insertion sites should be frequently assessed to rule out excessive bleeding, hematoma formation, cannula kinking or cannula rotation or dislodgement. Verify the cannula remains securely fastened in place. Use dressings that allow the site to be visually assessed ... The CARDIOHELP System may be initiated, inserted, and maintained by those physicians who are privileged in ECMO. The qualified physician (group) who instituted CARDIOHELP will be the primary physician regarding patient management/direction throughout the ECMO period. 2. On 4/18/24 at 10 AM, during an interview with the Director of the Intensive Care Unit (DICU), the DCCU stated, “It is difficult to tell who is covering (physician on-call to response to emergency) that day; the nurses will communicate with the physician. There is no set schedule for on-call physicians.” During an interview on 4/18/24 at 12:00 PM with the Director of Risk and Regulatory (DIRR), the DIRR confirmed that the facility has one cardiac thoracic surgeon (a doctor who performs surgery on the organs in the chest, such as the heart, lungs and part of the alimentary canal that connects the throat to the stomach, (Surgeon 1), who has knowledge and oversight of all ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) cases in the facility. As confirmed with DIRR, the facility does not have another physician who has the capability to troubleshoot problems with the ECMO. During an interview with Senior Manager of HR (SMHR) on 4/18/24 at 12:26 AM, SMHR confirmed that surgeon 1 is the only cardiac thoracic surgeon in the facility. Surgeon 1 performed all procedures related to Surgeon 1 related to general thoracic, heart lung machine, thoracic aorta (the largest elastic artery in the human body), pacemaker (an artificial device for stimulating the heart muscle and regulating its contractions), pericardium (a fibrous sac that encloses the heart and great vessels), and mediastinum (a space in the chest that holds the heart and other important structures). During a concurrent interview and record review on 4/19/24 at 4:00 p.m. the Executive Director of Administrator (EDA), the document titled “Request for Addition of New Procedure: Upon Motion Made, Carried and Seconded,” undated was reviewed. EDA stated, “The proposal requested was by the Department of Surgery and Department of Medicine to the government body on 2016 to add ECMO treatment to the facility’s services.” The proposal document indicated, there will be 8 physicians (MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, MD 7, and MD 8) participants that have received certification on ECMO competency. During a review of the facility’s policy and procedure (P&P) titled, “CARDIOHELP System Setup, Operation, and Patient Management,” dated August 2020, the P&P indicated, “Cannula insertion sites should be frequently assessed to rule out excessive bleeding, hematoma formation, cannula kinking or cannula rotation or dislodgement. Verify the cannula remains securely fastened in place. Use dressings that allow the site to be visually assessed ... The CARDIOHELP System may be initiated, inserted, and maintained by those physicians who are privileged in ECMO. The qualified physician (group) who instituted CARDIOHELP will be the primary physician regarding patient management/direction throughout the ECMO period. During a review of the facility’s policy and procedure (P&P) titled, “Comprehensive Vascular Access Management” regional clinical standard,” dated September 2019, the P&P indicated, for peripheral saline lock (device allows easy access to the peripheral vein for intermittent IV fluids or medications), short-term non-tunneled central venous access device (short term, venous access device [VAD], medical access line allow medication administration for 2-3 weeks), long-term tunneled central VAD (long-term, VAD, medical access line allow medication administration more than 3 weeks), peripheral inserted central venous catheter (PICC, a long, thin tube that’s inserted through a vein in your arm to administered medication), and for Port-a-cath (a combination of a portal and a catheter device used to draw blood and give treatments), all medical access devices mention should have a transparent dressing.”

“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: 46333 Based on interview and record review, the facility failed to ensure one of thirty (30) sampled patients (Patient 1’s), POA (A power of attorney, a legal authorization designated person to make decisions about another person’s medical care) was informed in accordance to the facility’s policy and procedure, of the unintentional decannulation (removal of a medical tubing from the patient’ body) of Patient 1 while on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) treatment on 4/2/24, which causes Patient 1 to bleed to death. This deficient practice resulted in Patient 1’s POA was not informed that on 4/2/24, Patient 1 bled out and died due to unintentional decannulation while on ECMO treatment. This can lead to breakdown of trust between the facility and the POA, causing POA severe emotional trauma, and stress and a sense of mistrust from the lack of transparency. Findings: During a review of Patient 1’s “Emergency Department Encounter Note (ED Note, a summary of a patient’s interval status during an emergency department encounter, including narrative and free text data),”dated 3/26/24, the “ED Note” indicated, Patient 1 “Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection.” During a review of Patient 1’s “Operative Report (a report written in a patient’s medical record to document the details of a surgery),” documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had “pump failure (a condition that develops when the heart doesn’t pump enough blood for the body’s needs) and thus underwent a procedure for “placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren’t functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works).” During a review of Patient 1’s “Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,”” dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was “found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient’s body) of the Patient 1’s VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m.” On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, “When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him.” On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, “It is unclear how Patient 1 was decannulated.” EDMD not able to visualize at first due to large dressing over site, after calling time of death, EDMD stated, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. EDMD stated he sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything came out. No suture seen for the cannula that came off, just the Ioban (iodine [chemical element that prevent infection]-impregnated incision drape) holding it down. EDMD stated he spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated. During a concurrent interview and record review on 4/17/24 at 2:50 p.m. with the Director, Risk and Regulatory (DIRR), Patient 1’’s electronic medical record (EMR, an electronic version of a patient’s medical history, that is maintained over time), under titled “Physician notes” was reviewed. DIRR confirmed that no disclosure of Patient 1’s unintentional decannulation (removal of a medical tube) was documented on physicians’ notes. DIRR stated that during her interview with RN 3, RN 3 reported that she informed Patient 1’s wife that Patient 1 had bled out. The DIRR confirmed there was no documentation within Patient 1’s medical record that indicates the disclosure to Patient 1’s POA of the unintentional decannulation that led to his death on 4/2/24. During a review of the facility’s policy and procedure (P&P) titled, “Responding TO/Disclosure of Adverse Events,”” dated August 2021, the P&P indicated, “Prompt, compassionate, and honest communication with the patient and family following an incident is essential. Because of the emotional effects of these events on both the patients and caregivers, this communication process can be difficult for everyone. If handled poorly, injury to both patient and caregivers can be compounded, damaging the patient-caregiver relationship. Open communication and authentic apologies help to dissipate patients’ feelings of anger and mistrust ...Ideally, the initial communication should be from a person with whom the patient has a trusting relationship. Usually, the physician who is responsible for the patient’s care is the most appropriate person. Documentation: All communications with the patient and family are also documented supports the best interests of both the patient and caregivers and advances good patient care””

“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: 42937 Based on interview and record review, the facility failed to ensure one of thirty (30) sampled patients (Patient 1’s), ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) cannula (a tube inserted into a vein) insertion sites were assessed for securement and any signs of infection (such as redness, swelling, or pus drainage) and have an available on-call physician to provide care in emergency situation for patient receiving ECMO treatment. This deficient practice resulted in Patient 1’s decannulation (inadvertent removal of a cannula) while on ECMO treatment causing excessive bleeding and death of Patient 1. On 4/18/2024 at 5:22 p.m., the survey team called an immediate jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements has caused, or is likely to cause, a serious injury, harm, impairment, or death to a patient) in the presence of the Director of Risk and Regulatory (DRR), the Chief Executive Officer (CEO), the Executive Director Risk & Patient Safety, the Director of Risk and Regulatory, and the Accreditation Program Manager. The facility failed to establish a safe process to monitor and provide an emergency response for Patient 1, who had an unintentional decannulation (accidental cannula complete exiting the patient’s body) while receiving ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) treatment and bled to death. An on-call physician (a physician who is ready to give medical care after hours, typically in an emergency or urgent situation), who has knowledge of ECMO, was unavailable. On 4/19/2023, at 7:22 p.m., while the survey team was onsite at the facility, the IJ was removed in the presence of the Chief Nursing Officer (CNO), the Manager of Accreditation Program (MAP), the Director of Risk and Regulatory (DRR), and the Nurse Manager (NM) after the facility submitted an acceptable IJ Removal Plan (interventions to correct the deficient practice). The elements of the IJ Removal Plan were verified and confirmed by the survey team through observations, interviews, and record review. The IJ Removal Plan indicated that on April 11, 2024, the facility suspended their ECMO (Extracorporeal Membrane Oxygenation) program indefinitely; by April 19, 2024, the ECMO program was terminated. The facility provides emails sent on 4/19/24 to all facility’s leaders indicating the ECMO program has been terminated. The team reviewed with the DRR an on-call schedule for cardiac thoracic (relating to, involving, or specializing in the heart and chest), and vascular surgery (open surgeries and minimally invasive procedures that treat a range of blood vessel problems) that has been established. On April 18, 2024, the facility placed the following safety stand-down plan into place: The survey team reviewed with the DRR the “Culture of Safety sign-in sheet” and attestation for the following: Surveillance of surgical site (area of the body where medical lines or tubing is inserted) and dressings of medical devices such as central lines (a thin, flexible tube that is inserted into a vein), hemodialysis catheters (medical tubing used for exchanging blood to and from a machine and a patient), PICC (peripheral inserted central catheter, a thin tube that’s inserted through a vein), port-a-cath (a device used to draw blood and give treatments, including intravenous fluids, and blood transfusions), arterial lines (a thin, flexible tube that is placed into an artery), IABP (intra-aortic balloon pump, a device that helps the heart pump more blood), Impella (Percutaneous Ventricular Assist Device, heart pump used to help maintain blood flow), and CRRT (Continuous renal replacement therapy, a type of blood purification therapy). Charge Nurses review with the primary nurses the following: MD (Doctor of Medicine) orders; if there are no orders, request an order from the MD; escalate any concerns; and document MD notification in EMR (electronic medical record, a digital version of the paper charts in clinician offices, clinics, and hospitals). Laminated copies of the 2024 Chain of Command flowchart for all nursing units. Findings: During a review of Patient 1’s “Emergency Department Encounter Note (ED Note, a summary of a patient’s interval status during an emergency department encounter, including narrative and free text data),” dated 3/26/24, the “ED Note” indicated, Patient 1 “Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection.” During a review of Patient 1’s “Operative Report (a report written in a patient’s medical record to document the details of a surgery),” documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had “pump failure (a condition that develops when the heart doesn’t pump enough blood for the body’s needs) and thus underwent a procedure for “placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren’t functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works).” During a review of Patient 1’s “Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,” dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was “found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient’s body) of the patient’s VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m.” During a review of Patient 1’s “Operative Report (a report written in a patient’s medical record to document the details of a surgery),” documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had “pump failure (a condition that develops when the heart doesn’t pump enough blood for the body’s needs) and thus underwent a procedure for “placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren’t functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works).” On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, “When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him.” On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, “It is unclear how Patient 1 was decannulated. EDMD not able to visualize at first due to large dressing over site, after calling time of death, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. Sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything come out. Sent photo but Surgeon, but he did not respond after. No suture seen for the cannula that came off, just the Ioban holding it down. Spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated, did not mention about the suture. On 4/17/23, at 9:00 a.m., during an interview with RN2 (Registered Nurse 2), RN2 stated that she and RN1 was assigned to care for Patient 1. On 4/2/23 around 4:30 a.m., patient’s 1 ECMO machine started alarming and when RN3 (the charge nurse) assess the cannulas entry site by pulling back the dressing on the left femoral, there was a “hissing” and “pop” sound, then there was blood everywhere. Patient bled to death, there was not much time, time of death was called at 4:45 a.m., RN 2 stated, “time of death was called about 10-15 minutes from when the alarm went off.” RN 2 also confirmed that the ECMO Circuit Checklist is done every hour. RN 2 confirmed for Patient 1, nurses cannot assess ECMO cannula entry site because there is a gauze dressing over the cannula entry site and Ioban on top of the cannulas’ entry site. RN stated, “nurses cannot change dressing, that is of concern because nurse is not able to assess the surgical site with the gauze covering the cannulas’ entry site.” On 4/17/24, at 9:40 am., during an interview with RN1 (Registered Nurse 1), RN1 stated that after Patient 1 passed, it was found out that 1 of 2 ECMO cannula was out. Normally a cannula should be sutured to patient skin, the cannula that came out has no indication that it was sutured in. Surgeon should also do the initial dressing change; its last dressing change was on 3/26/24. Ideally a surgical dressing site is change within 24-48 hours. There should have been a follow up or escalation to chain of command to change or inspect patient 1 ECMO surgical site. Dressing has not been changed since 3/26/24, it was not escalated or brought up to leadership. On 4/18/24 at 10:00 a.m., during an interview with the Director of Intensive Care Unit (DICU), the DCCU stated, “It is difficult to tell who is covering that day, the nurses will communicate with the physician. There is no set schedule of on call physician.” On 4/18/24 at 12:00 p.m., during an interview with the Director of Risk and Regulatory (DIRR), the DRR confirmed that the facility has only one cardiac thoracic surgeon, (Surgeon 1), who has knowledge and oversight of all ECMO cases in the facility. As confirmed with DIRR, the facility does not have another physician who has the capability to troubleshoot problems with the ECMO. During a review of Patient 1’s “Active LDA (assessment documentation of patient line, drains and airway,” dated 4/2/24 at 4:00 a.m., the “flowsheet” indicated, Patient 1 surgical incision on the left groin was noted “unable to assess”, and its dressing was last changed on 3/26/2024. During a concurrent interview and record review on 4/19/24 at 4:00 p.m. the Executive Director of Administrator (EDA), the document titled “Request for Addition of New Procedure: Upon Motion Made, Carried and Seconded,” was reviewed. The proposal requested was by the Department of Surgery and Department of Medicine to the government body on 2016 to add ECMO treatment to the facility’s services. The proposal document indicated the following physician participants to have received a certificate of training: Surgeon 1, MD 1, MD 2, MD 3, MD 4, MD 5, MD 6, and MD 7.”

“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: 46333 Based on interview and record review, the QAPI (Quality Assessment & Performance Improvement) Committee failed to ensure staff adherence to the facility’s policy and procedure (P&P) titled “CARDIOHELP System Setup, Operation, and Patient Management” after the incident of one of 30 sampled patients (Patient 1’s) unintentional decannulation (accidental cannula complete exiting the patient’s body) on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility involving cannulation (insertion of a tube to a major blood vessel). Findings: During a concurrent interview and record review on 4/19/24 at 4:28 p.m. with the Executive Director of Administrator (EDA), the facility’s QAPI meeting minutes from 2/22/23 through 2/28/24 was reviewed. There was no discussion regarding review of policy, programs improvement, data collection for the ECMO program. The EDA stated, “There is a Harm Committee, which is under the QAPI. Harm Prevention Committee, (team that prevents, preventable harm to patient and reduction of risk of unnecessary harm associated with health care), meets at the end of the month, monthly.” The ECMO program have not been brought up in their (Harm Prevention Committee’s) meetings because there was no event at that time. EDA stated, “Quality tracks patient safety indicator. Other program like L&D are being monitor but ECMO program was not part of the monitoring by QAPI committee.” During a review of the facility’s policy and procedure (P&P) titled, “CARDIOHELP System Setup, Operation, and Patient Management,” dated August 2020, the P&P indicated, “Cannula insertion sites should be frequently assessed to rule out excessive bleeding, hematoma formation, cannula kinking or cannula rotation or dislodgement. Verify the cannula remains securely fastened in place. Use dressings that allow the site to be visually assessed ... The CARDIOHELP System may be initiated, inserted, and maintained by those physicians who are privileged in ECMO. The qualified physicians (group) whom instituted CARDIOHELP will be the primary physician regarding patient management/direction throughout the ECMO period.””

“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: 46333 Based on the interview and record review, the QAPI (Quality Assessment and Performance Improvement) failed to: 1. Ensure one of 30 sampled patients (Patient 1’s) POA (A power of attorney, a legal authorization designated person to make decisions about another person’s medical care) was informed in accordance to the facility’s policy and procedure, of the unintentional decannulation (removal of a medical tubing from the patient’ body) while on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) treatment on 4/2/24, which causes Patient 1 to bleed to death. This deficient practice resulted in Patient 1’s POA was not informed that on 4/2/24, Patient 1 bleed out and died due to unintentional decannulation while on ECMO treatment. 2. Ensure the implementation of an effective preventative measures to prevent the potential reoccurrence of accidental disconnection of medically inserted lines, drains, tubing, and cannulas (tubes that are inserted into a body cavity, duct, or vessel for medical purposes) after an incident of unintentional decannulation of one of 30 sampled patients (Patient 1) that occurred on 4/2/24. This deficient practice can lead to the reoccurrence of unintentional disconnection from medical devices for patients receiving treatment in the facility. Findings: 1. During a concurrent interview and record review on 4/17/24 at 2:50 p.m. with the Director, Risk and Regulatory (DIRR), Patient 1’s electronic medical record (EMR, an electronic version of a patient’s medical history, that is maintained over time), under titled “Physician notes” was reviewed. DIRR confirmed that no disclosure of Patient 1’s unintentional decannulation (removal of a medical tube) was documented on physicians’ notes. DIRR stated that during her interview with RN 3, RN 3 reported that she informed Patient 1’s wife that Patient 1 had bled out. DIRR confirmed there was no documentation within Patient 1’s medical record that indicates the disclosure to Patient 1’s POA of the unintentional decannulation that led to his death on 4/2/24. 2. During a concurrent interview and record review on 4/19/24 at 4:28 p.m. with the Executive Director of Administrator (EDA), the facility’s QAPI meeting minutes from 2/22/23 through 2/28/24 was reviewed. There was no discussion regarding review of policy, programs improvement, data collection for the ECMO program. The EDA stated, “There is a Harm Committee, which is under the QAPI. Harm Prevention Committee, (team that prevents, preventable harm to patient and reduction of risk of unnecessary harm associated with health care), meets at the end of the month, monthly.” The ECMO program have not been brought up in their (Harm Prevention Committee’s) meetings because there was no event at that time. EDA stated, “Quality tracks patient safety indicator. Other program like L&D are being monitor but ECMO program was not part of the monitoring by QAPI committee.””

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 46333 Based on interview and record review, the facility failed to ensure one of thirty (30) sampled patients (Patient 1), who was on ECMO (Extracorporeal Membrane Oxygenation, is an advanced therapy that is sometimes used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) and on CRRT (Continuous Renal Replacement, type of blood purification therapy used with patients who are experiencing acute kidney injury) was reposition with at minimum three staff in accordance with the facility ECMO, “New User Class,” guidance to assure one RN has responsibility to assure cannulas (medical tube inserted into the body) does not get pulled out during repositioning of the patient. This deficient practice places Patient 1, who was on ECMO and on CRRT, at increased risk for inadvertent decannulation (accidental cannula complete exiting the patient’s body). Findings: During a review of Patient 1’s “Emergency Department Encounter Note (ED Note, a summary of a patient’s interval status during an emergency department encounter, including narrative and free text data),” dated 3/26/24, the “ED Note” indicated, Patient 1 “Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with severe crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG (electrocardiogram, a test to record the electrical signals in the heart) showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection.” During a review of Patient 1’s “Operative Report (a report written in a patient’s medical record to document the details of a surgery),” documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had “pump failure (a condition that develops when the heart doesn’t pump enough blood for the body’s needs) and thus underwent a procedure for “placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren’t functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works).” During a review of Patient 1’s “Emergency Code Blue (page over head in the hospital for staff to be summoned to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,” dated 4/2/24, the Emergency Code Blue note indicated Patient 1 was “found to be in extremis and severe distress (a state of extreme great suffering of body or mind). There has been an inadvertent (not resulting from deliberate planning; unintentional) decannulation (accidental cannula complete exiting the patient’s body) of the patient’s VA (venous [carries dark red, oxygen, or poor blood in the veins]-arterial [carries red blood that has been oxygenated in the lungs]) ECMO circuit. The time of death was called at 4:45 a.m.” During an interview on 4/17/24 at 9:03 a.m. with Registered Nurse (RN) 2, RN 2 stated, Patient 1 was repositioning at 4:00 a.m. by herself and RN 1. RN 2 stated she was on one side of the bed and RN 1 was on one side of the bed. During repositioning of the patient both nurses have their hands on the air tape. Confirmed with RN 1 there were two nurses during the repositioning of Patient 1 at 4:00 a.m. On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, “When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him.” On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, “It is unclear how Patient 1 was decannulated. EDMD not able to visualize at first due to large dressing over site, after calling time of death, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. Sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything come out. Sent photo but Surgeon, but he did not respond after. No suture seen for the cannula that came off, just the ioban holding it down. Spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated, did not mention about the suture. During a review of Patient 1’s “View Doc Flowsheet (documentation that identifies the actual flow of events in a process),” dated 4/2/24 at 4:00 a.m., the “flowsheet” indicated, Patient 1 was reposition on 4/2/24 at 4:00 a.m. from the right side to the left side (by two nurses as indicated in interview above on 4/17/24 at 9:03 a.m. with Registered Nurse (RN) 2). During an interview on 4/17/24 at 3:12 p.m. with Registered Nurse (RN) 4, who is the destinated super user (someone who knows a lot about the program) of ECMO (RN) 4, RN 4 stated, the process of repositioning a patient who is on ECMO and CRRT, “We use a four-man team; three staff and one RN who is destinated to be responsible to monitor and protect the of the ECMO’s lines and cannulas.” RN 4 further confirmed that to prevent dislodging, kinking or decannulation of the ECMO’s cannulas, a minimum of three RNs is required to reposition a patient receiving ECMO treatment. During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of the Intensive Care Unit (DICU), the facility’s Power Points (a presentation program developed to creates a slide show of important topic) for ECMO education materials that is taught to RNs by the DICU titled, “Extra Corporeal Membrane Oxygenation (ECMO): Cardio Help New User Class,” undated was reviewed. The power points indicated, “Basic ICU Care: Minimum 3 people, Primary RN responsible for cannula.” The DICU stated, “During repositioning of a patient receiving ECMO a minimum of three people is required when repositioning of the patient. One RN has to primary hold and monitor the ECMO canula.””

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 46333 Based on interview and record review, the facility failed to ensure one of thirty (30) sampled patients (Patient 1) was assessed and monitored for changes such as cannula site bleeding, positioning of cannulas, clots, color of blood, connector site for any cracks, and ensuring tubing is secure in accordance with the facility’s policy and procedure, while on ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own). This deficient practice places patients on ECMO treatment at risk for unintentional disconnection or dislodge of cannula (medical tube inserted into the body) and led to Patient 1’s inadvertent decannulation on 4/2/24 that resulted in his death. Findings: During a review of Patient 1’s “Emergency Department Encounter Note (ED Note, a summary of a patient’s interval status during an emergency department encounter, including narrative and free text data),” dated 3/26/24, the “ED Note” indicated, Patient 1 “Presents to the emergency department (ED, specific area in a hospital that is organized to provide emergency care to people) for evaluation of acute (sharp or severe in effect; intense) onset chest pain. Reportedly occurred at approximately 3 a.m. the patient (Patient 1) woke up with sever crushing substernal (often described as crushing or pressure-like feeling, radiating to the jaw and/or left arm) chest pain ...His initial EKG showed concern for possible STEMI (ST-Segment Elevation Myocardial Infarction, the most severe type of heart attack) ...Patient had worsening respiratory status and mental status thus his wife was consented for procedure. Patient (Patient 1) was intubated (a procedure that a tube is inserted down the throat and into the windpipe to support breathing) for airway protection.” During a review of Patient 1’s “Operative Report (a report written in a patient’s medical record to document the details of a surgery),” documented by Surgeon 1, dated 3/26/24, the report indicated Patient 1 presented earlier today with what appears to be a myocardial infarction (heart attack). He underwent emergent cardiac catheterization, which involves passing a thin flexible tube (catheter) into the right or left side of the heart. Patient 1 had “pump failure (a condition that develops when the heart doesn’t pump enough blood for the body’s needs) and thus underwent a procedure for “placement and initiation of extracorporeal membrane oxygenation (a type of artificial life support that can help a person whose lungs and heart aren’t functioning correctly) and transesophageal echocardiography (a test used to assess how well the heart works).” During a review of Patient 1’s “Emergency Code Blue (page over head in the hospital for staff to be summon to a patient requiring resuscitation or otherwise in need of immediate medical attention, most often as the result of a respiratory or cardiac arrest) Note,” dated 4/2/24, the note indicated Patient 1 was “found to be in extremis and severe distress. There has been an inadvertent decannulation of the patient’s VA (venous [carries dark red, oxygen-poor blood in the veins-arterial [carries red blood that has been oxygenated in lungs]) ECMO circuit ...Time of death was called at 4:45 a.m.” During an interview on 4/17/24 at 9:00 a.m. with Registered Nurse (RN) 2, RN 2 stated she and another nurse, Registered Nurse (RN) 1, were assigned to care for patient 1 on 4/2/23. RN 2 stated around 4:30 AM, the patient ECMO machine started alarming, and when RN 3 assessed the cannulas entry site by pulling back the dressing on the left femoral (top portion of the long bone in the upper part of the leg), there was a “hissing” and “popping” sound, and then there was blood everywhere. RN 2 further stated, “The patient bled to death; there was not much time; the time of death was called at 4:45 AM. The time of death was called about 10-15 minutes from when the alarm went off.” RN 2 also confirmed that the process during the care of a patient on ECMO, is RN to assess and monitor for items on the “Hourly Cardio Help Circuit Checklist,” every hour. On 4/17/24 at 9:42 AM, during an interview with RN 1, RN 1 stated, “When we removed the blanket, we heard a hiss and pop, and blood started to gush out. We tried to call the on-call physician, but we were not able to reach him.” During an interview on 4/17/24 at 10:49 a.m. with the Nurse Educator of ICU (NEDICU), the NEDICU stated, “Hourly Cardio Help Circuit Checklist” is part of the safety process, nurses are require completing the check list during the care of a patient on ECMO treatment. On 4/17/24 at 11:56 AM, during an interview with emergency department physician (EDMD), EDMD stated that he responded to a code event of Patient 1, code was for an unintentional ECMO decannulation (medical tubing insert into the body, blood flows through). EDMD stated, upon seeing Patient 1, there appears to be a large amount of blood in his groin, and there was no pulse (unable to feel pulsation of the heartbeat or see heart rhythm on a heart monitor). EDMD stated, “It is unclear how Patient 1 was decannulated. EDMD not able to visualize at first due to large dressing over site, after calling time of death, he was able to take out dressing to investigate further because it was odd for the cannula to spontaneously come off, upon examination of site, noted 1 of 2 ECMO cannula was completely out and entirely out of patient 1. Sent photo to Surgeon 1, to review because he (Surgeon 1) was in disbelief that anything came out. Sent photo but Surgeon, but he did not respond after. No suture seen for the cannula that came off, just the Ioban holding it down. Spoke with Surgeon 1 after the incident, mention to him that the ECMO cannula decannulated, did not mention about the suture. During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), the facility’s ECMO safety checklist titled, “Hourly Cardiohelp Circuit Checklist,” dated from 3/26/24 (date initiated ECMO treatment for Patient 1) through 4/2/24 (date of unintentional decannulation of Patient 1) was reviewed. The check list indicated “Use one sheet per Shift (initials = checked and done).” The following items require checking every hour: Venous cannula (medical tube inserted in the vein): Bleeding, position, clots, color of blood Arterial cannula (medical tube inserted in the artery): Bleeding, position, clots, color of blood Puncture site: Bleeding, position Pressures: Document all elements in ECLS Flowsheet in EPIC Stopcocks (an operated valve regulating the flow of a liquid or gas through a pipe): Off to circuit & capped & Tight connection to Luer lock (a screw connection that creates a leak-free seal) Connector: Any cracks? Tubing is secure, clots. Centrifugal Pump (a pump that uses an impeller to move water or other fluids): air, clots, blood flow Oxygenator: clots, leaks De-Airing Port (Yellow): CAP ON-Do Not Burp Heater: Water Bathe temp, patient temp, water level, watercolor & remain ON. Adjust temperature per MD order! Gas Flow Meter: Tubing connections to flowmeter and oxygenator, Gas source connections to wall outlets, sweep setting, oxygen setting. Dates of entries on the “Hourly Cardio Help Circuit Checklist,” by RNs are as follow: Night shift, 3/26/24 at 7:00 p.m. through 3/27/24 at 6:00 a.m., was completed with the RN’s initials. Day shift, 3/27/24 at 7:00 a.m. through 3/27/24 at 6:00 p.m. Not completed, No hourly initial by the RN Night shift, 3/27/24 at 7:00 p.m. through 3/28/24 at 6:00 a.m. Not completed, No hourly initial by the RN Day shift, 3/28/24 at 7:00 a.m. through 3/28/24 at 6:00 p.m., was completed with the RN’s initials. Night shift, 3/28/24 at 7:00 p.m. through 3/29/24 at 6:00 a.m. Not completed, No hourly initial by the RN Day shift, 3/29/24 at 7:00 a.m. through 3/29/24 at 6:00 p.m., was completed with the RN’s initials. Night shift, 3/29/24 at 7:00 p.m. through 3/30/24 at 6:00 a.m., was completed with the RN’s initials. Day shift. 3/30/24 at 7:00 a.m. through 3/30/24 at 6:00 p.m. was completed with the RN’s initials. Night shift: 3/30/24 at 7:00 p.m. through 3/31/24 at 6:00 a.m. Not completed, No hourly initial by the RN Day shift: 3/31/24 at 7:00 a.m. through 3/31/24 at 6:00 p.m. Not completed, No hourly initial by the RN Night shift: 3/31/24 at 7:00 p.m. through 4/1/24 at 6:00 a.m. Not completed, No hourly initial by the RN Day shift 4/1/24 at 7:00 a.m. through 4/1/24 at 6:00 p.m. was completed with the RN’s initials. Night shift, 4/1/24, at 7:00 p.m., through 4/2/24 (date that Patient 1 had inadvertent decannulation at 4:30 a.m.) at 6:00 a.m. Not completed, no hourly initial by the RN The DICU stated the RN caring for the patient receiving ECMO should submit a completed report of the “Hourly Cardio Help Circuit Checklist” by the end of shift to the ICU’s supervisor.” DICU confirmed that there are several missed documentations for several days of the “Hourly Cardio Help Circuit Checklist” for Patient 1. During a review of the facility’s policy and procedure (P&P) titled, “In keeping with the mission and values of (name of the facility) adopts the “Comprehensive Vascular Access Management” regional clinical standard,” dated September 2019, the P&P indicated, for peripheral saline lock (device allows easy access to the peripheral vein for intermittent IV fluids or medications), short-term non-tunneled central venous access device (short term, venous access device [VAD], medical access line allow medication administration for 2-3 weeks), long-term tunneled central VAD (long-term, VAD, medical access line allow medication administration more than 3 weeks), peripheral inserted central venous catheter (PICC, a long, thin tube that’s inserted through a vein in your arm to administered medication), and for Port-a-cath (a combination of a portal and a catheter device used to draw blood and give treatments), all medical access devices mention should have a transparent dressing. During a review of the facility’s policy and procedure (P&P) titled, “Cardiohelp System Setup, Operation, and Patient Management,” dated August 2020, the P&P indicated, “Use the “Hourly Cardiohelp Circuit Checklist” (Attachment A) to assess for changes such as signs of coagulation, cracks, system leaks, etc ...Trained ICU RNs and/or Perfusionists (A certified medical technician responsible for extracorporeal [situated outside the body] oxygenation of the blood) must continuously monitor the patient, the volume status, the circulation parameters and the system.””

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 46333 Based interview and record review, the facility failed to ensure four (4) of the four (4) sampled registered nurses (RN 1, RN 2, RN 3, and RN 4) completed an annual ECMO (Extracorporeal Membrane Oxygenation, an advanced therapy that is used to do the work of the heart and lungs when a patient’s own organs are too sick or weak to work on their own) user competency in accordance with the proposal requested by the Department of Surgery and Department of Medicine from the government body in 2016 to add ECMO treatment to the facility’s services. This deficient practice places Patient 1 and patients treated with ECMO at risk for error in care, compromised patients’ safety, and reduced quality of treatment due to lack of updated knowledge and skills. It could lead to adverse events, delays in critical decision-making, and overall jeopardized the patients’ wellbeing. Findings: a. For Registered Nurse 1: During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), RN 1’s training on ECMO on sign-in logs and an excel spread sheet that indicates what date RNs completed training created by the DICU was reviewed. The spread sheet indicated the last training RN 1 received was on 10/9/2019 for attending a “Cardiohelp Refresher Course,” over 4 years since RN1 was evaluated on ECMO competency. Also reviewed with the DICU the sign-in log titled, “Cardiohelp Refresher Fall 2019,” dated 11/14/2019 indicated RN 1 was in attendant. DICU confirmed that RNs are not required to complete annual competency on ECMO . b. For Registered Nurse 2: During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), RN 2’s training on ECMO sign-in logs and an excel spread sheet that indicates what date RNs completed training created by the DICU was reviewed. DICU stated RN 2 was being trained by RN 1 on 4/2/24. DICU stated the required training for RNs to become ECMO user and care for patient on ECMO are to attend a “New User” training, attend a “Wet Lab (hand-on training, exercise),” and worked with a preceptor for 3 shifts caring for patient on ECMO . RN 2 completed the “New User,” training on 1/26/22, and complete “ECMO Wet Lab,” on 2/3/22. The spread sheet indicated the last training RN 2 received was on 1/26/22 for attending the “New User Lecture,” over a year since RN 1 was evaluated on ECMO competency. DICU confirmed that RNs are not required to complete annual competency on ECMO. c. For Registered Nurse 3: During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), RN 3’s training on ECMO sign-in logs and an excel spread sheet that indicates what date RNs completed training created by the DICU was reviewed. The spread sheet indicated the last training RN 3 received was on 10/18/2019 for attending a “Cardiohelp Refresher Course,” over 4 years since RN 1 was evaluated on ECMO competency. Also reviewed with the DICU the sign-in log titled, “Cardiohelp Refresher Fall 2019,” dated 10/18/19 indicated RN 1 was in attendance. DICU confirmed that RNs are not required to complete an annual competency on ECMO. d. For Registered Nurse 4: During a concurrent interview and record review on 4/19/24 at 10:40 a.m. with the Director of ICU (DICU), RN 4’s training on ECMO sign-in logs and an excel spread sheet that indicates what date RNs completed training created by the DICU was reviewed. The spread sheet indicated the last training RN 4 received was on 10/21/2019 for attending a “Cardiohelp Refresher Course,” over 4 years since RN4 was evaluated on ECMO competency. Also reviewed with the DICU the sign-in log titled, “Cardiohelp Refresher Fall 2019,” dated 10/21/2019 indicated RN4 was in attendant. DICU confirmed that RNs are not required to complete annual competency on ECMO. During a concurrent interview and record review on 4/19/24 at 4:00 p.m. the Executive Director of Administrator (EDA), the document titled “Request for Addition of New Procedure: Upon Motion Made, Carried and Seconded,” was reviewed. The proposal requested was by the Department of Surgery and Department of Medicine to the government body on 2016 to add ECMO treatment to the facility’s services. The proposal document indicated, “Requirements to Maintain Clinical Competence: Annual Competencies and training for the ECMO team and operator of the unit.””