Eden Medical Center

“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: 44823 Based on interviews and record reviews, the hospital failed to ensure operational direction and compliance with all Conditions of Participation resulting in one condition-level deficiency (Nursing Services) not being met when: 1. One of 30 sampled patients (Patient 30) was administered ten times the prescribed dose of norepinephrine (a critical medication used to manage severe life-threatening low blood pressure). As a result, Patient 30 suffered symptoms of norepinephrine overdose including ventricular tachycardia (abnormally fast heartbeat) and a heart attack. Patient 30 required medical intervention and had to stop Continuous Renal Replacement Therapy (CRRT, a type of life-saving hemodialysis [a life-saving treatment for kidney failure that removes waste from the blood] for critically ill patients with kidney failure). Patient 30 passed away a few hours later. (Refer to A-0405) 2. Registered Nurse (RN) 1 and Registered Nurse (RN) 2 did not complete hand-off communication (exchange of patient information when care is being transferred between care providers) during change of shift for one of 30 sampled patients (Patient 30). The hand-off did not include intravenous (IV) line tracing (tracing IV line connections from source [at the infusion pump] to site [location where IV is inserted into the body]). As a result, RN 2 found an incorrect IV line tracing one and a half hours from start of her shift. Patient 30 passed away a few hours later (Refer to A-0398). 3. One of 30 sampled patients (Patient 30) was assigned Registered Nurse (RN) 1 who did not complete competency training on Continuous Renal Replacement Therapy (CRRT, a type of life-saving hemodialysis [a life-saving treatment for kidney failure that removes waste from the blood] for critically ill patients with kidney failure). RN 1 completed CRRT classroom training but did not have the required shadow shift (shift where a trainee is paired with a certified staff who is trained and competent). In May 2025, there were three additional nursing staff who did not complete the required shadow shift experiences but were assigned to patients on CRRT. Nursing staff without CRRT competency could potentially affect patient care, safety, and well-being (Refer to A-0397). The cumulative effects of these system failures resulted in the hospital’s inability to provide quality nursing care in a safe setting in accordance with the Conditions of Participation: Nursing Services.”

“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: 44823 Based on interviews and record reviews, the hospital failed to assign a certified nurse to one of 30 sampled patients (Patient 30) who was on Continuous Renal Replacement Therapy (CRRT, a type of life-saving dialysis for critically ill patients with kidney failure). This failure had the potential of impacting Patient 30’s care, safety, and well-being. Findings: During a record review of Patient 30’s admission record, Patient 30 presented to the Emergency Department (ED) on 5/8/25 at approximately 2:05 p.m. for altered mental status. On the “Emergency Department Note,” dated 5/8/25, Patient 30’s diagnoses were End Stage Renal Disease (ESRD, when kidneys stop working) on hemodialysis (a life-saving treatment for kidney failure that removes wastes from the blood), severe sepsis (a life-threatening extreme inflammatory reaction to an infection that can cause organ damage), pneumonia (lung infection), acute encephalopathy (sudden decline in brain function), and hypoglycemia (low blood sugar). The ED note indicated Patient 30 was transferred to the Intensive Care Unit (ICU) on 5/8/25 at approximately 8:47 p.m. Per Medical Doctor (MD) 1’s “Progress Note” on 5/9/25, MD 1 noted Patient 30 was transitioned to CRRT. On 5/10/25, CRRT treatment was discontinued due to Patient 30’s hemodynamic instability (body’s inability to maintain adequate blood pressure and blood flow). During a record review of Patient 30’s progress note, Registered Nurse (RN) 1 noted on 5/10/25 at 2:44 p.m. the CRRT machine clotted (clogged) off and had to be changed. During a record review of Patient 30’s “Progress Note”, Medical Doctor (MD) 2 noted on 5/10/25 at 4:33 p.m., Patient 30 had abnormal cardiac rhythm consistent of STEMI (STEMI, ST wave elevation myocardial infarction [heart attack]) and CRRT was stopped. During an interview on 7/16/25, at 10:25 a.m., with Director of Intensive Care Unit (DICU), DICU stated RN 1 was new to CRRT, had just completed the class but did not have a shadow shift (shift where a nurse trainee is paired with a CRRT certified nurse). Per DICU, ICU has a binder with a list of CRRT certified nurses who completed classroom training and shadow shifts. During an interview on 7/16/25, at 1:00 p.m., with RN 1, RN 1 stated during her shift, Patient 30’s CRRT filter clotted and was replaced. Per RN 1, she only received 4 hours of CRRT training. During an interview on 7/17/25, at 9:00 a.m., with Registered Nurse (RN) 3, RN 3 stated she was resource nurse (RN who provides support, guidance, and direct patient care to other nurses) during that shift. Per RN 3, nurses should have four hours of classroom training and then two shadow shifts. RN 3 added a nurse trainee would be assigned to the CRRT machine and the certified nurse would be watching the patient. Per RN 3, RN 1 did not have shadow training. During an interview on 7/17/25, at 9:57 a.m., with DICU, DICU stated starting 4/17/25, CRRT new users had two eight-hour days of training with one shadow shift. During a concurrent interview and record review on 7/17/25, at 9:57 a.m., with DICU, the “CRRT New Users Shadow Experience Log - 2025” and “ICU Patient List”, dated May 2025, were reviewed. DICU stated the log indicated RN 1 did not have any shadow shift experience and should not have been assigned a patient on CRRT. Per “ICU Patient List”, three additional nurses who did not complete shadow shifts should not have been assigned patients on CRRT. During a record review of the facility’s policy and procedure (P&P) titled, “Continuous Renal Replacement Therapy (CRRT)”, dated 4/30/25, the P&P indicated, “The CRRT procedure and system monitoring will be performed by the Critical Care RN who has completed inservice and demonstrated competency.””

“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: 44823 Based on interviews and record reviews, the hospital failed to ensure hand-off communication (exchange of patient information when care is being transferred between care providers) was completed for one of 30 sampled patients (Patient 30). The hand-off between Registered Nurse (RN) 1 and Registered Nurse (RN) 2 did not include intravenous (IV) line tracing (tracing IV line connections from source [at the infusion pump] to site [location where IV is inserted into the body]). This failure of not performing IV line tracing during hand-off resulted in RN 2 not able to verify Patient 30’s IV line connections. RN 2 performed Patient 30’s IV line tracing one and a half hours after the start of her shift and found Patient 30’s IV line connections incorrect. Patient 30 passed away a few hours later. Findings: During a record review of Patient 30’s admission record, Patient 30 presented to the Emergency Department (ED) on 5/8/25 at approximately 2:05 p.m. for altered mental status. On the “Emergency Department Note”, dated 5/8/25, Patient 30’s diagnoses were End Stage Renal Disease (ESRD, when kidneys stop working) on hemodialysis (a life-saving treatment for kidney failure that removes waste from the blood), severe sepsis (a life-threatening extreme inflammatory reaction to an infection that can cause organ damage), pneumonia (lung infection), acute encephalopathy (sudden decline in brain function), and hypoglycemia (low blood sugar). The ED note indicated Patient 30 was transferred to the Intensive Care Unit (ICU) on 5/8/25 at approximately 8:47 p.m. During an interview on 7/15/25, at 2:30 p.m., with Risk Specialist (RS), RS stated during hand-off communication, RN 1 and RN 2 did not perform IV line tracing. RS stated staff familiar and comfortable with another staff’s work might have skipped a step during hand-off. During an interview on 7/16/25, at 10:25 a.m., with Director of Intensive Care Unit (DICU), DICU stated during hand-off communication, both nurses (leaving and arriving) should go in the patient’s room, trace (IV) lines, and all information given is correct. Per DICU, hand-off did not happen on 5/10/25 during change of shifts between RN 1 in AM shift and RN 2 in PM shift. During an interview on 7/16/25, at 11:13 a.m., with RN 2, RN 2 stated on 5/10/25, she received hand-off from RN 1 at Patient 30’s bedside. RN 2 stated she also received hand-off from RN 1 the previous two days. RN 2 added on 5/10/25, she did her IV tracer line inspection after hand-off with RN 1 because RN 1 had a busy shift. RN 2 stated on 5/10/25, she did her tracer line inspection at 8:30 p.m. Per RN 2, she did not go through each (AM) shift like she should have. RN 2 stated tracing the line was part of the hand-off. Per RN 2, if there were not much changes in a patient’s status, she would check all the IV lines after hand-off. During an interview on 7/16/25, at 1:00 p.m., with RN 1, RN 1 stated her shift was from 7:00 a.m. to 7:30 p.m.. Per RN 1, she stated she took care of Patient 30 for two consecutive AM shifts. RN 2 was the incoming nurse for PM shift and RN 2 also took care of Patient 30 for two consecutive PM shifts. Per RN 1, she went to get what she thought was IV medication phenylephrine (a critical medication used to manage severe life-threatening low blood pressure) from the medication room, started to administer to Patient 30, and proceeded with the rest of her shift. During an interview on 7/16/25, at 1:30 p.m., with Registered Nurse (RN) 5, RN 5 stated on 5/10/25, RN 2 called her to Patient 30’s bedside. After RN 2 traced Resident 30’s IV line connections, RN 2 found the medication infusing was incorrect and was infusing at the wrong strength. A new bag of phenylephrine was ordered at 300 mg/min (milligram per minute) at 45ml/hr (milliliter per hour), however, Levophed (medication to treat life-threatening low blood pressure) was hung at 45ml/hr. RN 3 stated a wrong (IV) bag with wrong strength was infusing. Patient 30 passed away a few hours later. During a record review of the facility’s policy and procedure (P&P) titled, “Hand-off Communications - Guidelines for Communication”, dated 1/16/25, the P&P indicated, “Patient hand-offs include up-to-date information regarding the patient’s diagnosis, care treatment, current condition, medication, services, any recent or anticipated changes to be aware and on alert for the next interval of care.””

“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: 46393 Based on interviews and record reviews, the hospital failed to ensure medications were administered in accordance with physician orders, hospital policies, and accepted standards of practice for one of 30 sampled patients (Patient 30). Patient 30, a critically ill patient in the Intensive Care Unit (ICU), was administered ten times the prescribed dose of norepinephrine (a critical medication used to manage severe life-threatening low blood pressure) IV (intravenous, into the veins) for approximately six hours. This failure resulted in Patient 30 suffering symptoms of norepinephrine overdose, such as severe cardiac (heart) complications, including ventricular tachycardia (abnormally fast heartbeat) and a heart attack. Patient 30 required medical interventions including the administration of amiodarone (a critical medication used to treat serious life-threatening irregular heartbeat) and had to stop Continuous Renal Replacement Therapy (CRRT, a type of life-saving hemodialysis [a life-saving treatment for kidney failure that removes waste from the blood] for critically ill patients with kidney failure). Patient 30 passed away a few hours later. Findings: A review of Patient 30’s clinical records, including the Emergency Department (ED) patient care timeline and provider progress notes dated 5/8/25, indicated Patient 30 was brought to the ED by ambulance with altered mental status (awareness or behavior changed from normal), had a history of End Stage Renal Disease (ESRD, when kidneys stop working) on hemodialysis, and was admitted to the ICU on 5/8/25 at approximately 8:47 p.m. Additionally, Patient 30’s ED progress notes on 5/8/25 indicated diagnoses including severe sepsis (a life-threatening extreme inflammatory reaction to an infection that can cause organ damage), pneumonia (lung infection), acute encephalopathy (sudden brain dysfunction not caused brain damage), and hypoglycemia (low blood sugar). A review of Patient 30’s “Progress notes,” dated 5/9/25 at 12:27 a.m. by one of the hospital’s Nephrologists (doctor specialized in kidney diseases) indicated, Patient 30 was unable to tolerate hemodialysis due to low blood pressure and was transitioned to CRRT. A review of Patient 30’s clinical record indicated the following Physician Orders: - On 5/9/25 at 11:06 a.m.: Phenylephrine (a critical medication used to manage severe life-threatening low blood pressure) 100 mg (milligram, unit of measurement)/250 ml (milliliters, unit of measurement) D5W (dextrose 5% in water, a mixture of sugar and water) MAX (maximum concentration) IV drip (infusion, directly into the bloodstream), titrate (adjust) 0 to 45 ml/hr (hour), starting dose 30 mcg (micrograms, unit of measurement) / min (minute), incremental dose 10 mcg/min, every 10 minutes, Goal: SBP (systolic blood pressure, pressure in arteries when heart pumps blood) greater than 90 mmHg (millimeters of mercury, unit of measurement); - On 5/9/25 at 11:56 a.m.: Norepinephrine 8 mg/250 ml D5W IV drip (standard concentration), titrate 0 to 37.5 ml/hr, starting dose 5 mcg/min, incremental dose 1 mcg/min, every 1 minute, Goal: MAP (mean arterial pressure, the average blood pressure in arteries) greater than 65 mmHg; and - On 5/10/25 at 11:37 a.m., scheduled to start on 5/10/25 at 4 p.m.: Norepinephrine 30 mg/300 ml D5W IV drip (maximum concentration), titrate 0 to 12 ml/hr, starting dose “Same mcg/min rate as prior bag (Note max concentration),” incremental dose 1 mcg/min, every 1 minute, Goal: MAP greater than 65 mmHg. A review of Patient 30’s “Progress notes,” dated 5/10/25 by Medical Doctor (MD) 2 indicated: - On 5/10/25 at 4:33 p.m., “Called to bedside by RN [registered nurse] for abnormal cardiac rhythm with...VTach [ventricular tachycardia]...12 lead EKG [electrocardiogram, medical test that measures the heart’s electrical activity] c/w [consistent with] STEMI [ST-Elevation Myocardial Infarction, a type of heart attack]...Patient was on CRRT, that was stopped...hypertensive [high blood pressure]...appears uncomfortable, gasping and in pain...IV Amiodarone bolus [a single large dose of medication] 300 mg IV given x 1 [one time]...reviewed EKG with cardiology [doctor specialized in heart diseases]...agrees with likely STEMI...” - On 5/10/25 at 6:49 p.m., “Patient remains very ill and unstable...too unstable for CRRT and it had to be stopped...code status [patient’s wishes regarding emergency medical treatment if heart stops] changed to DNR [Do Not Resuscitate, no life saving measures to restart the heart if it stops].” A review of Patient 30’s “Progress notes,” dated 5/10/25 at 8:40 p.m. by RN 2 indicated, “Critical drip titration [adjustment of IV infusion] initiated d/t [due to] med [medication] error...” A review of Patient 30’s “Progress notes,” dated 5/11/25 at 12:18 a.m. by MD 1 indicated, “Death Pronouncement...Asystole [heart was completely stopped]. No pulse. No spontaneous breathing. Time of death: 00:17 [12:17 a.m.]. Date of death: 5/11/2025...” A review of Patient 30’s “Discharge Summary,” dated 5/11/25 at 12:20 a.m. by MD 1 indicated, “[Patient 30] was admitted to the hospital for treatment of pneumonia and septic shock [life-threatening condition when widespread infection causes dangerously low blood pressure and organ failure]...on the first day of hospitalization was started on CRRT...had progressive increase in vasopressor [critical medications used for dangerously low blood pressure] requirement over the last 48 hours...On 5/10/25 the patient had a medication error, where concentrated norepinephrine was infused instead of phenylephrine. Treatment with CRRT was not possible due to hemodynamic instability [insufficient blood flow to organs] on 5/10/25, following medication administration error. The patient’s sister was informed of this medication error...PSR [Patient Safety Report] completed for medication error. The patient had an episode of ventricular tachycardia and hypertension [high blood pressure]. [EKG] showed ventricular tachycardia and 300 mg amiodarone was administered...still requiring high dose vasopressors. On 5/10/25 the patient was found to have STEMI, with EKG changes and elevated troponin [a protein released by heart muscle during a heart attack]...In the afternoon of 5/10/25 the patient’s code status was changed to DNR...On 5/11/25 the patient’s hemodynamics [blood flow] worsened...The patient developed progressive bradycardia [abnormally low heartbeat] and hypotension [low blood pressure], leading to asystole and cardiac arrest. Time of death 00:17 [12:17 a.m.] on 5/11/25...Cause of death: 1. Septic Shock 2. Pneumonia...other medical conditions contributing to death...medication administration error.” During an interview on 7/15/25 at 8:57 a.m., the Director of Pharmacy (DOP) described the hospital’s barcode scanning process that nursing staff were expected to follow during medication administration. The DOP stated, after nurses retrieved the medication from the automated dispensing cabinet [ADC, machine containing medications] the steps were as follows: 1. Scan the patient’s wristband barcode; 2. Scan the medication barcode; 3. Scan the IV infusion pump (a computerized programmable medical device used to deliver IV medications) barcode; and 4. After scanning was completed, nurse would have attached the medication to the IV infusion pump to begin administration of the medication to the patient. During the same interview on 7/15/25 at 8:57 a.m., the DOP stated all records of barcode scanning were retrievable from the electronic health record (EHR) and the IV infusion pump database. During an interview on 7/15/25 at 2 p.m. with the Clinical Nurse Educator (CNE), the CNE stated interoperability (communication) between the IV infusion pump and the EHR linked nursing documentation of medication rates and doses directly from the pump into the patient’s EHR. The CNE described the nursing interoperability barcode scanning workflow process as follows: 1. Nurses were expected to follow the standard medication administration processes such as verifying the patient’s Five Rights (right drug, right patient, right route, right dose, and right medication); 2. Scan the patient’s wristband barcode; 3. Scan the medication barcode; 4. Scan the IV infusion pump barcode; and 5. After scanning was completed, the nurses would have attached the medication to the pump and administered the medication to the patient. During a group interview on 7/15/25 2:25 p.m. with the DOP and the Pharmacy Manager (PHM), in the presence of the Director of Quality (DQ), regarding Patient 30’s medication error on 5/10/25, the DOP and PHM stated their investigation included: review of Patient 30’s clinical record to determine the timeline of events, interview with the pharmacist and nurse involved, and participation in Root Cause Analysis meetings (RCA, process of discovering the root cause of the error). The DOP and PHM stated their investigation identified that the medication error occurred when Patient 30’s nurse mistakenly attached the concentrated norepinephrine instead of the phenylephrine to the IV infusion pump, then the nurse inadvertently scanned the phenylephrine barcode instead of the norepinephrine barcode which programmed the pump to infuse the concentrated norepinephrine at the dose and rate that was intended for the phenylephrine. During a group interview on 7/15/25 at 2:35 p.m. with the DQ and the Risk Specialist (RS), regarding the hospital’s investigation of the medication error, when asked how the mediation error occurred, the DQ stated the sequence of events for barcode scanning and medication administration processes were not followed by the nurse. Additionally, the DQ stated the nurse had not evaluated the IV tubing (the flexible plastic tube connecting the IV medication bag to a catheter inserted into a vein that delivered liquid medication) to verify which medication was flowing before she administered the medication. During a follow-up group interview and record review on 7/16/25 at 9:15 a.m. with the DOP and PHM, in the presence of the DQ, Patient 30’s clinical records, including the medication administration records (MARs) dated 5/10/25, were reviewed. The DOP and PHM confirmed the medication error occurred on 5/10/25 at 2:53 p.m. when: - RN 1 retrieved the wrong medication, the maximum concentration norepinephrine (30mg/300ml) IV bag, and attached it to the IV infusion pump; - RN 1 inadvertently scanned the wrong barcode on the empty phenylephrine (100mg/250ml) IV bag, instead of the barcode on the attached concentrated norepinephrine (30mg/300ml) IV bag; and - When RN 1 scanned the barcode on the IV infusion pump, the interoperability between the pump and the EHR set the pump to administer the concentrated norepinephrine (30mg/300ml) IV bag at a dose of 300 mcg/min and rate of 45 ml/hr intended for the phenylephrine (100mg/250ml) IV bag because RN 1 scanned the phenylephrine bag in error. During a telephone interview on 7/16/25 at 9:40 a.m., MD 1 stated he took over the care of Patient 30 on 5/10/25 at 6:30 p.m. MD 1 stated he received report from the dayshift doctor that Patient 30 had suffered an arrhythmia (irregular heartbeat), and cardiology evaluated for worsening heart function. MD 1 stated Patient 30’s condition further deteriorated during his shift on the evening of 5/10/25. MD 1 stated RN 2 informed him of the medication error when she discovered the concentrated norepinephrine bag attached to the pump that was programed to administer phenylephrine, and the concentrated norepinephrine was administered at a higher rate than intended. When asked about the potential side effects of receiving high doses of norepinephrine, MD 1 stated that even at lower doses, norepinephrine was known to cause tachycardia. During an interview on 7/16/25 at 10:25 a.m. with the Director of ICU (DICU), regarding Patient 30’s medication error on 5/10/25, the DICU stated: - Patient 30’s phenylephrine drip finished and needed to be changed; - When RN 1 retrieved the medication from the ADC in the medication room, she thought she grabbed the phenylephrine, but she grabbed the norepinephrine by mistake; and - On 5/10/25 at 2:53 p.m. RN 1 attached the norepinephrine to the pump, and thought she scanned the barcode of the norepinephrine bag, but the barcode on the empty bag of phenylephrine was scanned instead. During the same interview on 7/16/25 at 10:25 a.m. with the DICU, regarding the expectation during medication administration and barcode scanning process, the DICU stated nurses were expected to retrieve the medication bag from the medication room, scan the barcode on the bag, and then verify the Five Patient Rights (right drug, right patient, right route, right dose, and right medication) before administering the medication. The DICU stated RN 1 had not followed the medication administration processes when she failed to verify the Five Patient Rights. The DICU stated when the medication administration policy was reviewed with RN 1, RN 1 acknowledged that she should have followed the medication administration policy and accepted responsibility for the error. When asked about the potential side effects of norepinephrine, the DICU stated the side effects were serious cardiac complications such as ventricular tachycardia and STEMI. During an interview on 7/16/25 at 11:15 a.m., RN 2 stated she took over the care of Patient 30 on 5/10/25 at 7 p.m. RN 2 stated she received report from the dayshift nurse (RN 1) that the patient went into ventricular tachycardia, stopped CRRT, and was supposed to switch from standard norepinephrine (8mg/250ml) to the maximum concentration norepinephrine (30mg/300ml), but it was not switched because RN 1 reported she was unable to find the maximum concentration norepinephrine bag. RN 2 stated at approximately 8:30 p.m., she discovered the maximum concentration norepinephrine (30mg/300ml) bag infusing at a rate of 45 ml/hr which was intended for the phenylephrine. RN 2 stated when she discovered the medication error, she called the doctor, stopped the maximum concentration norepinephrine, replaced the IV tubing, and started the phenylephrine. RN 2 stated she called RN 1 to ask her what happened. RN 2 stated she submitted a PSR for the medication error after she spoke to RN 1. During a telephone interview on 7/16/25 at 12:38 p.m., MD 2 stated while covering for another doctor on 5/10/25 at approximately 3 p.m. or 4 p.m. the nurse called when Patient 30 had abnormal EKG changes. MD 2 stated he evaluated the patient, reviewed the 12-lead EKG, had concern for STEMI, and contacted the cardiologist to review the EKG. MD 2 stated the patient looked unstable and uncomfortable, he ordered pain medication, stopped CRRT, informed the family, and the patient’s code status was changed to DNR. MD 2 stated he was not aware of the medication error until the next day when MD 1 gave report. MD 2 stated his understanding of the medication error was that norepinephrine was given in error and was running at the higher rate programmed for phenylephrine. When asked about the potential side effects of receiving high doses of norepinephrine, MD 2 stated it could have caused tachycardia which could have precipitated a cardiac event like MI (myocardial infarction, a heart attack) and arrhythmia. During a telephone interview on 7/16/25 at 1 p.m., RN 1 stated she took care of Patient 30 during the dayshift from 7 a.m. to 7:30 p.m. on 5/10/25. RN 1 stated, during her shift the patient was unstable, the CRRT filter was clogged and after she changed the filter, the phenylephrine IV bag ran out. RN 1 stated she ran to the ADC in the medication room, grabbed what she thought was phenylephrine from the ADC, scanned the patient, scanned the medication bag, switched out the medication bag and proceeded with the rest of the shift. RN 1 stated she was informed of the medication error via telephone by RN 2 on 5/10/25 at approximately 8:45 p.m. shortly after her shift ended. RN 1 stated she asked RN 2 to complete a PSR for the medication error. RN 1 stated she self-reported the medication error as soon as she arrived home that same evening. During an interview on 7/16/25 at 1:25 p.m., Pharmacist (PH) 1 stated on 5/10/25 Patient 30 was unstable, on CRRT, and needed multiple vasopressors. PH 1 stated on 5/10/25 the norepinephrine concentration was ordered to switch from the standard concentration to the maximum concentration. PH 1 stated he informed RN 1 of the plan to switch the concentration of norepinephrine during morning rounds on 5/10/25. PH 1 stated the intended dose and rate of the maximum concentration norepinephrine should have been started at the same dose and rate as the prior standard concentration norepinephrine bag when it was time for the nurse to change the bag. During a follow-up concurrent group interview and record review on 7/16/25 at 1:47 p.m. with the DOP, PHM, and the DQ, Patient 30’s MAR and Event/Alarm Log for the IV infusion pump, dated 5/10/25 were reviewed. It indicated, on 5/10/25, between 2:53 p.m. to 8:42 p.m., for approximately 6 hours, the total dose of norepinephrine administered to Patient 30 was 28,867 mcg delivered from both the concentrated norepinephrine IV bag and the standard concentration norepinephrine IV bag. The group confirmed the intended dose of norepinephrine should have been 2,716 mcg. The group acknowledged Patient 30 received approximately 10 times over the intended dose of norepinephrine which was infused over six hours on 5/10/25, between 2:53 p.m. to 8:42 p.m. When asked about the potential side effects of receiving high doses of norepinephrine, the PHM stated there would have been adverse cardiac effects such as tachycardia and MI. A review of the norepinephrine drug information from Lexi-Drugs (a comprehensive drug information resource), dated 7/4/25, provided by the hospital, indicated, “Adverse reactions...cardiac arrhythmia...” A review of the Prescribing Information (PI, detailed description of a drug’s uses, doses, warnings, and side effects) for norepinephrine, dated 5/2021, retrieved from DailyMed (a public website maintained by the U.S. Food and Drug Administration), indicated, “Warnings and precautions...cardiac arrhythmias...Overdosage...may result in...decreased cardiac output (when the heart is unable to pump enough blood to meet the body’s needs).” During a review of the hospital’s policy and procedures (P&P) titled, “Medication Administration,” dated 1/18/24, indicated, “All medications shall be administered following the medication administration procedure...Purpose...To administer medication in an efficient, accurate and safe manner...To ensure the patient’s Five Rights: the right drug, right dose, right route, right time, and right patient...To decrease the potential for medication errors...To ensure that medications ordered by physicians are appropriately administered...” During a review of the hospital’s P&P titled, “Invasive Lines Connections,” dated 1/18/24, indicated, “Purpose...To maximize standardization of processes to assure safe connections and prevention of misconnections...Practice...Invasive Line Connections to Patients...When connecting any administration set to any indwelling port or device, the line connection safety mnemonic, T.R.A.C.E.R, shall be used by personnel to assure that the intended and desired connection is made and prevent misconnections...Trace existing lines from source to site, Read existing labels, Affix labels if/where required, Connect compatible lines without forcing or adapting, Examine the new connection, Retrace and confirm source to site.””

“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: 46658 Based on interview and record review, the facility failed to ensure travel nurses competencies were evaluated according to facility policy when one of four sampled nursing staff (RN 1, Registered Nurse 1) did not complete unit specific annual competencies for over three years. This failure resulted in the facility not ensuring travel nurses were competent to provide care to patients. Findings: During a concurrent interview and record review on 11/21/24, at 2:40 p.m., with Nursing Director of Labor and Delivery (NDLD), RN 1’s employee competency record was reviewed. NDLD stated RN 1 was a travel nurse and had been working consecutive travel contracts in the Labor and Delivery (LD, unit which babies are born) unit since 2021. NDLD stated RN 1’s initial LD unit competency evaluation was completed on 10/2021. NDLD indicated RN 1 did not have annual competency evaluations since that initial evaluation. NDLD stated nursing staff directly hired by the facility were required to have annual competency evaluation but was unsure if the policy applied to travel nurses. During an interview on 11/21/24, at 3:20 p.m., with RN 1, RN 1 stated they did not participate in annual LD unit competency evaluations. RN 1 stated they had worked at the facility since 2021 in the LD department. RN 1 stated they had completed online education provided by their travel agency, but did not include hands on demonstration of skills. During a concurrent interview and record review on 11/21/24, at 3:50 p.m., Clinical Manager (CM), CM stated nursing staff were required to complete two types of competency evaluations an annual hospital wide and unit specific competency evaluation. CM stated they had not personally performed any unit specific competencies evaluations for RN 1. CM stated review of unit records did not indicate RN 1 had completed LD unit competencies other than an initial evaluation in 10/2021. CM stated RN 1’s travel agency had online continuing education which RN 1 had completed but did not know if the continuing education conformed with LD unit competencies. During an interview on 11/21/24, at 4:20 p.m., with human resources vice president (HRVP), HRVP stated the facility did not have policy or current practice to ensure annual unit specific competency evaluations for travel nurses were completed. During a record review of RN 1’s travel contract record, indicated RN 1 worked five contracts with the facility in the LD department during the following dates: 1. 10/29/23 to 2/10/24, 2. 2/28/24 to 6/1/24, 3. 6/19/24 to 7/20/24, 4. 8/15/24 to 9/14/24, 5. 10/27/24 to 2/8/25. During a record review of a sample facility competency assessment titled, “Department Competency Assessment: Labor and Delivery Registered Nurse,” undated, the sample competency assessment indicated demonstration of skills such as: “demonstrate how to connect fetal monitor(device to monitor fetal heart rate)...demonstrate proper set-up and location of infant transport warmer (device to maintain newborn temperature) in Main OR ...demonstrate calculation of Quantitative Blood Loss (QBL) and Cumulative QBL Total.” During a review of facility policy and procedure (P&P) titled, “Temporary Staff from Outside Agencies Policy,” dated 4/21/2020, the P&P indicated “the department is accountable for verifying that an evaluation of competency has been documented on all agency staff if required for accreditation ...the manager should evaluate the assignment every six months.” During a review of facility P&P titled, “Competency Assessment - Nursing Staff,” dated 5/16/2024, the P&P indicated the policy was intended to “ensure that staff are competent to provide nursing care to patients ...annual competency evaluation will be carried out by the Nurse manager and/or nurse educator(s). Annual core and unit specific competencies will be identified by the following: Performance Improvement Activities, Educational Needs Assessment, New Advances in Technologies, State Requirements, Joint Commission Requirements, Federal Requirements, High Risk, Low Volume and Problem Prone Areas.””

“COMPLIANCE WITH LAWS CFR(s): 482.11 Compliance with Federal, State and Local Laws This Condition is not met as evidenced by: 34714 Based on interview and record review, the governing body failed to ensure operational direction and compliance with all Conditions of Participation resulting in one condition-level deficiency (Infection Control) not being met. The facility failed to adhere to Centers for Disease Control guidelines for surveillance to identify and resolve the serious, systemic and recurring problem involving the infection surveillance process which placed 65 of 73 sampled patients at risk for undiagnosed and untreated bloodborne pathogens. Findings: 1. The governing body failed to ensure infection surveillance included all patients affected by inadequately disinfected rectal probes (instrument inserted into the anus, to visualize the rectum, a part of the gastrointestinal tract). (Refer to A-0770) These failures had a cumulative effect and created these systemic deficits which resulted in the hospital’s inability to ensure patient safety and quality healthcare.”

“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: 34714 Based on interview and record review, the governing body failed to ensure operational direction and compliance with all Conditions of Participation resulting in one condition-level deficiency (Infection Control) not being met. The facility failed to adhere to Centers for Disease Control guidelines for surveillance to identify and resolve the serious, systemic and recurring problem involving the infection surveillance process which placed 65 of 73 sampled patients at risk for undiagnosed and untreated bloodborne pathogens. Findings: 1. The governing body failed to ensure infection surveillance included all patients affected by inadequately disinfected rectal probes (instrument inserted into the anus, to visualize the rectum, a part of the gastrointestinal tract). (Refer to A-0770) These failures had a cumulative effect and created these systemic deficits which resulted in the hospital’s inability to ensure patient safety and quality healthcare.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 34714 Based on interview and record review, the hospital failed to ensure operational direction and compliance with all Conditions of Participation resulting in a condition-level deficiency (Infection Control) not being met. The facility failed to adhere to centers for disease control guidelines for surveillance of patients exposed to potentially infectious devices. By not contacting 65 of 73 patients exposed to inadequately disinfected rectal probes (instrument inserted into the anus, to visualize the rectum, a part of the gastrointestinal tract) the facility was unable to provide surveillance for signs and symptoms of infection related to use of contaminated rectal probes. Findings: 1. Failure to ensure infection surveillance included all patients affected by inadequately disinfected rectal probes. (Refer to A-0770) This systemic failure had a cumulative effect which resulted and created the systemic deficit the inability which resulted in the hospital’s inability to ensure patient safety and quality healthcare.”

“LEADERSHIP RESPONSIBILITIES CFR(s): Standard: Leadership responsibilities (1) The governing body must ensure all of the following: (i) Systems are in place and operational for the tracking of all infection surveillance, prevention, and control, and antibiotic use activities, in order to demonstrate the implementation, success, and sustainability of such activities. This Standard is not met as evidenced by: 34714 Based on interview and record review, the governing body failed to ensure a process was in place for surveillance of potential infection in 65 of 73 (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94 and 95) sampled patients who had procedures completed between 2016 through 2023 with inadequately disinfected rectal probes (instrument inserted into the anus, to visualize the rectum, a part of the gastrointestinal tract). The facility failure to contact and initiate surveillance to 65 of 73 patients exposed during a procedure has the potential to result in undiagnosed and untreated infection and spread of infection, including human immunodeficiency virus (HIV). Findings: During a review of a letter dated 1/8/24, written by the Director of Accreditation, Regulation and Licensing (DIR ARL), the letter indicated the facility had knowledge of inadequate disinfection of rectal probes. The letter indicated between multiple patient’s procedures, the used rectal probes had not received the required high-level disinfection (complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores) after each procedure. During a concurrent interview and record review on 2/26/23 at 11:30 a.m., with Director of Quality and Professional Services (DQPS) the DQPS provided an untitled list of patient names. SDPM stated the seven patient names on the list indicated the patients who had been contacted by the hospital about exposure to inadequately disinfected rectal probes. During a concurrent interview and record review on 2/29/24 at 9:10 a.m., with DQPS, a document titled, “[hospital name] Rectal Probe Patient List,” was reviewed. DQPS stated the list included the names of all patients who had procedures completed with rectal probes between 2016 through 2023 at the hospital. DQPS stated there were a total of 73 patient names on the list who were exposed to inadequately disinfected rectal probes during procedures. During an interview on 2/28/24 at 11:30 a.m., with the Medical Director (MD), the MD stated he had reviewed patients charts of patients who had procedures with rectal probes in the last year from October 2022 through October 2023. The MD stated letters were only sent to the seven (1, 2, 3, 4, 5, 6 and 7) patients exposed during the time of October 2022 through October 2023. The MD stated there was no contact or review of patients exposed to the inadequately disinfected rectal probes prior to October 2022 because he considered the risk of infection to be very low. MD stated the hospital became aware of the lack of adequate rectal probe disinfection in November 2023 but delayed contacting the patients (1, 2, 3, 4, 5, 6 and 7) exposed in the last year until January 2024. During a review of the documents titled, “[hospital name] Rectal Probe Patient List,” and the untitled document with a list of seven patients notified of inadequately disinfected rectal probes, the review indicated 65 patients were not contacted about their exposure to inadequately disinfected rectal probes. During a review of the rectal probe manufacturer instructions titled, “[manufacturer name] Medical User Guide Care and Cleaning,” dated 6/2023, the manufacturer instructions indicated if the “device contacts mucous membranes (lining of a body cavity including the gastrointestinal tract)” or “enters otherwise sterile tissue,” the probes required reprocessing including “high-level disinfection or sterilization.” During a review of the Centers for Disease Control (CDC) article titled, “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008,” dated May 2019, the guidelines indicated, a category IB (Strongly recommended for implementation and supported by certain experimental, clinical, or epidemiologic studies and a strong theoretical rationale) recommendation as follows, “Disinfection Strategies for Other Semicritical Devices ...a. Even if probe covers have been used, clean and high-level disinfect other semicritical devices such as rectal probes, vaginal probes, and cryosurgical probes ...Use a high-level disinfectant at the FDA-cleared exposure time ...b ...Do not use a lower category of disinfection or cease to follow the appropriate disinfectant recommendations when using probe covers because these sheaths and condoms can fail.” During a review of the CDC article, “Terms, Definitions, and Calculations Used in CDC HIV Surveillance Publications,” dated 3/16/22, the article indicated, “HIV infection is classified as stage 3 (AIDS) when the immune system of a person infected with HIV becomes severely compromised ... and?or the person becomes ill with an opportunistic infection. In the absence of treatment, AIDS usually develops 8 to 10 years after initial HIV infection; with early HIV diagnosis and treatment, this may be delayed by many years.” During a review of the CDC article titled, “Healthcare Investigation Guide,” dated 8/10/23, the guide indicated, “Responding to information identified during assessment of health care encounters. Site visit identifies major breaches in infection prevention and control that are high-risk for bloodborne pathogen transmission ... 2. A patient notification recommending bloodborne pathogen testing should be conducted for all potentially exposed patients, even if additional cases and/or a source-patient are not identified. The scope of the patient notification will depend largely on how long the unsafe practice had been occurring in the facility.””