Good Samaritan Hospital

“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: 38068 Based on interview and record review, the hospital failed to ensure nursing staff followed their policy and procedures when: 1. Nursing staff released only 2 milliliters (ml, unit of measurement) of air from transradial (TR) band (medical wristband used to stop bleeding) during TR band deflation procedure for two of three patients (Patients 11 and 17) and 2. Registered Nurse D (RN D) did not offer Social Services support for one of three patients (Patient 13) when Patient 13 verbalized that she had a traumatic experience at Emergency Department (ED). Findings: 1a. Review of Patient 11’s medical record indicated diagnoses that included hypertension (HTN, high blood pressure) and diabetes mellitus (DM,-a disorder characterized by difficulty in blood sugar control and poor wound healing). On 12/13/26, Patient 11’s undergone cardiac catheterization (a test or treatment that use of thin, flexible tube called catheter to treat or diagnose some heart conditions). Right radial artery (a blood vessel that supplies blood to wrist and hand) was accessed for the procedure for the catheter to be inserted. The procedure ended at 9:05 a.m. Review of the Patient 11’s Cardiac Catheterization Laboratory Short Stay Record (CCLSSR) indicated only 2 ml of air was released every 15 minutes from TR band on 2/13/26 from 10:30 a.m. to 11:00 a.m. and at 11:15 a.m. to 2:15 p.m. only 2 ml of air was removed and replaced back due to oozing of blood. During an interview Registered Nurse E (RN E) on 8/27/26 at 11:07 a.m., she confirmed she only released 2 ml of air from Patient 11’s TR band on right wrist during TR band deflation procedure on 2/13/26. Review of Patient 11’s medical record with Clinical Informatics Specialist (CIS) on 8/27/26 at 9:13 a.m., indicated there was no physician’s order to release only 2 ml of air during TR deflation procedure. 1b. Review of Patient 17’s medical record indicated she undergone cardiac catheterization on 2/13/26. Right radial artery was accessed for the procedure for the catheter to be inserted. Review of the Patient 17’s CCLSSR indicated only 2 ml of air was released every 15 minutes from TR band on 2/13/26 from 2:50 p.m. to 4:05 p.m. during deflation procedure. Review of Patient 17’s medical record with Quality Management Coordinator (QMC) on 8/31/26 at 10:23 a.m., indicated there was no physician’s order to release only 2 ml of air from TR band during deflation procedure. During an interview and record review with the Chief Nursing Officer (CNO) and Assistant Chief Nursing Officer (ACNO) on 8/28/26 at 3:42 p.m., they both acknowledged a physician’s order is needed to release only 2 ml of air during TR deflation procedure for Patients 11 and 17 because the one written in the hospital policy and procedures is 3 ml. Review of the hospital policy and procedures dated 2/19/25 title, “ Radial Artery Compression Device” indicated “C. Gradual Process of Deflation-Removal of Radial Compression Device 1. Withdraw 3 ml of air from the balloon and observe for any bleeding. 2. If there is no bleeding, continue to remove 3 ml of air from the balloon every 15 minutes until the balloon is deflated completely. 3. If bleeding occurs at any time during deflation process, re-inject 3 ml of air and wait 15 minutes before repeating the steps above until balloon is deflated. 2. Review of Patient 13’s ED medical record indicated she received medications such as recuronium (a fast acting medication that relaxes skeletal muscles and causes temporary paralysis) and propofol (a medication use to provide sedation) at ED on 12/25/25. Patient 13 was discharged from the ED on 12/26/25 at 1:11 a.m. Review of Patient 13’s nurses notes dated 12/26/25 at 12:38 a.m., indicated Patient 13 verbalized to RN D that Patient 13 was traumatized by the experience regarding the medications that given to Patient 13 at ED. Patient was referring to being able to be awake and hear but unable to move and felt like she was going into a panic attack. Further review of Patient 13’s medical record indicated there was no referral to social services had been made for psychosocial evaluation or referral for follow-up for mental services support if patient develops anxiety or late ill effects from the traumatic experience at ED. During an interview with Social Service Manager (SSM) she stated that the hospital had 24 hours on call social services. Social service staff will go to the hospital to see patients whenever they are needed for psychosocial assessment. She acknowledged that since Patient 13 verbalized that she was traumatized by the experience at ED, RN D should have referred the patient to social service for psychosocial evaluation and to follow up with primary care physician (PCP) if mental health support is needed by the patient after discharged. During an interview with RN D on 8/31/26 at 4:02 p.m., she confirmed Patient 13 verbalized to RN D that Patient 13 had traumatic experience with the above administered medications at ED. RN D stated she did not know that hospital social services was available to call on that night 12/25/25 - 12/26/25. RN D stated she thought that social services are only available during the day. RN D acknowledged that if she had known that there was social services 24 hours on call for referral, she should have called them to assess Patient 13’s psychosocial status prior to discharge on 12/26/25. During an interview with the CNO on 8/28/26 at 3:42 p.m., she acknowledged that additional instruction should have been included in Patient 13’s discharge instruction to follow-up with her PCP if Patient 13 develops anxiety later on. Review of the facility’s policy and procedures dated 8/20/25 titled “Discharged Planning” indicated “Procedure Steps: A. Screening... 2. The request for a discharge planning evaluation does not require a physician’s order and can be requested by any member of the healthcare team, the patient or patient’s support system and/or decision maker/caretaker(s). B. Discharge Planning Evaluation... 2. Upon identification of the need for a discharge planning evaluation, regardless of payer source, the assessment should encompass the need for psychosocial or physical care, treatment, and services post discharge or transfer. This evaluation should occur timely, so as not to delay the discharge of the patient and be documented in the medical record...””

“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: 38068 Based on interviews and record review, the hospital failed to ensure medications were administered in accordance with the physician’s orders and/or hospital policy and procedures (P&P) for 3 out of 5 sampled patients (Patients 13, 31, and 32) when: 1. There was no documentation of propofol (medication given intravenously [directly into the vein] to provide sedation and to control stress response in mechanically-ventilated [form of life support that helps patient breathe through a ventilator] patients) titration (an increase or decrease in medication dose in response to the patient’s clinical status) and RASS (Richmond Agitation Sedation Score, a validated tool that aids in assessing a patient’s level of consciousness on a scale of integers ranging from positive 4 to minus 5 [+4 to -5]) assessment during the administration for Patients 13 and 32. 2. Precedex (medication to provide sedation for intubated and mechanically-ventilated patients) for Patient 31 was not titrated as per physician’s order. These failures resulted in unclear medication documentation; and administration of medication outside of ordered parameters, creating a potential risk of the patients experiencing underdosing or inadequate treatment; or overdosing, posing the risk of side effects from these sedative medications such as oversedation and heart rates or blood pressures dropping to unsafe levels. Findings: 1a. Review of Patient 13’s Emergency Department (ED) record indicated she had history of recurrent hip dislocations with history of hip replacement. On 12/25/25 at 9:37 p.m., Patient 13 was brought into the ED due to left hip pain. Further review of Patient 13’s ED record with Registered Nurse Clinical Informatics (RNCI) on 8/25/26 at 2:55 p.m., indicated she was intubated (placement of a flexible plastic tube into the windpipe to maintain an open airway) on 12/25/25 at 9:55 p.m. The physician ordered propofol on 12/25/25 at 9:45 p.m. for sedation as follows: “Propofol 1,000 mg [milligrams]100 ML [milliliter]; “Initial rate: 5 mcg/kg/min [micrograms]kilogram/minute] “Titrate up or down by: 5 mcg/kg/min every: 5 minutes; “GOAL: maintain RASS: -1 [meaning “Drowsy - not fully alert, but has sustained awakening (eye-opening/eye contact) to voice (>10 second)”]; “**Maximum rate: 50: mcg/kg/min (Facility recommended max rate: 50: mcg/kg/min) **; “Maintain goal for: 30 minutes, then titrate down to lowest rate that maintains goal.; ** If drip is at ZERO rate, notify provider immediately if drip needs to be titrated up **...” A review of the Patient 13’s ED record with QMC on 8/26/26 at 10:23 a.m., indicated propofol was started on 12/25/25 at 10:10 p.m., at 5 mcg/kg/min, as ordered; there was no documented RASS assessment at this time. The only documented propofol titration and RASS documentation was conducted on 12/25/25 at 11:10 p.m. (one hour later) which was +1 (restless, anxious, apprehensive but movements not aggressive or vigorous). During a concurrent interview and record review of Patient 13’s ED record with Registered Nurse C (RN C), on 8/28/26 at 1:40 p.m., she stated she titrated the propofol and conducted RASS assessments as ordered by the physician. RN C confirmed she did not find any documentation of propofol titration and RASS assessment on 12/25/25 from 10:10 p.m. to 11:05 p.m. She acknowledged she should have documented the propofol titration and RASS assessment as ordered by the physician. During an interview with the Chief Nursing Officer (CNO) on 8/28/26 at 3:42 p.m., she stated RN C should have documented the propofol titration and RASS assessments in Patient 13’s medical record as ordered by the physician “because if it not documented it means it is not done.” 27000 1b. On 9/1/26, a review of Patient 32’s ED record with QMC indicated he was an elderly patient, brought into the ED on 8/21/26 for intracranial hemorrhage (a serious medical emergency where blood collects inside the skull or brain tissue) due to cerebral aneurysm (bulge or ballooning in a blood vessel in the brain). Continued review of Patient 32’s ED record indicated he was intubated on 8/21/26 at 5:45 a.m. On 8/21/26 at 5:29 a.m., the physician ordered propofol via IV infusion, as follows: “Propofol 1,000 MG/100 ML... “Initial rate: 5 mcg/kg/min “Titrate up or down by: 5 mcg/kg/min every: 5 minutes “GOAL: maintain RASS: -1 “**Maximum rate: 50: mcg/kg/min (Facility recommended max rate: 50: mcg/kg/min) **... “Maintain goal for: 30 minutes, then titrate down to lowest rate that maintains goal. “** If drip is at ZERO rate, notify provider immediately if drip needs to be titrated up**...” A review of Patient 32’s ED record with the QMC indicated propofol was started on 8/21/26 at 6 a.m., at 5 mcg/kg/min, as ordered; there was no documented RASS at this time. The next documented propofol titration happened on 8/21/26 at 7:35 a.m. (1 hour and 35 minutes later), at which time the propofol rate was 5 mcg/kg/min, and the RASS was -2 (Light Sedation - Briefly awakens to voice [eye opening & contact < 10 seconds]). During a concurrent interview and record review with RN A, who is an Intensive Care Unit nurse, on 9/1/26 at 10:25 a.m., she reviewed Patient 32’s ED record and stated she could not find any documentation of propofol titration and RASS assessment from 6 a.m. to 7:35 a.m. on 8/21/26. She acknowledged there should have been documentation of the titration and corresponding RASS. During a concurrent interview and record review with RN B, who is an ED nurse, on 9/1/26 at 11:20 a.m., she stated propofol is “titrated every 5 minutes until the patient reaches the goal RASS; then you maintain the same rate until the patient is within the goal RASS for 30 minutes, then you titrate down, to see if the [downward] titration still keeps the patient at the same RASS level.” After reviewing Patient 32’s ED record for propofol titration, RN B stated she was not sure what titration was made and what the patient’s RASS levels were, as there was no documentation between 6 a.m. and 7:35 a.m. on 8/21/26. She confirmed there should been documentation of the titration steps and corresponding RASS during this time. During an interview with the Assistant Chief Nursing Officer (ACNO), on 9/1/26 at 1:25 p.m., when asked how often the nursing staff should document the titration and corresponding RASS for sedation medications via intravenous drips, she stated, “You follow either the physician’s order or the policy.” She stated if the physician’s order does not dictate how often to document, then the staff should follow the hospital policy. A review of the hospital’s P&P titled “Sedation/Analgesia: Adult and Pediatric”, effective date 10/15/25, indicated the following under INTRA-PROCEDURE ASSESSMENT AND MONITORING: “B. The patient must be monitored continually throughout the procedure and the following, at a minimum, will be documented... 4. Pain level and level of consciousness every 5 minutes.” 2. On 8/31/26, a review of Patient 31’s ED record with the QMC indicated he was brought into the ED on 8/30/26 at 9:05 a.m. for shortness of breath and altered mental status (a sudden, unexpected change in how a person thinks, behaves, or stays aware of their surroundings). On 8/30/26 at 9:28 a.m., Patient 31 was intubated, and subsequently placed on propofol to keep the patient sedated while being on the ventilator. Continued review of Patient 31’s clinical record indicated Patient 31 was transferred from the ED to the NSICU (Neuroscience Intensive Care Unit: highly specialized, round-the-clock care for adults with serious neurological conditions and injuries. brain or spine conditions), on 8/30/26 at 1449 (2:49 p.m.). On 8/30/26 at 2208 (10:08 p.m.), the physician ordered: “DexmedeTOMIDine (PRECEDEX) 400 MCG/4 ML INJ [injection] - 400 MCG (4 ML)... “Initial rate: 0.2 mcg/kg/hr [hour] “Titrate up or down by: 0.1 mcg/kg/hr every: 10 minutes “ GOAL - maintain: RASS -1 “**Maximum rate: 1.4: mcg/kg/hr....” On 8/31/26 at 12:55 p.m., a review of Patient 31’s Precedex titration record with the QMC indicated Precedex was initiated on 8/30/26 at 2218 (10:18 p.m.) at 0.2 mcg/kg/hr, as ordered. The RASS was at +1 (Restless: Anxious, apprehensive but movements not aggressive or vigorous). Seven minutes later, on 8/30/26 at 2225 (10:25 p.m.), it was titrated up to 0.3 mcg/kg/hr; the RASS was +1. At 22:30 (10:30 p.m.), or 5 minutes later, the Precedex rate was titrated up to 0.4 mcg/kg/hr; the RASS was -1. During a concurrent interview and record review with the ACNO on 8/31/26 at 1:30 p.m., she reviewed Patient 31’s Precedex’s initial titration and verified the first two titration was too fast, not consistent with the physician’s order, which indicated to titrate every 10 minutes. During a concurrent interview and record review with RN F on 8/31/26 at 3:45 p.m., he stated he initiated the Precedex titration for Patient 31. After a few moments of review, RN F stated he should have waited 10 minutes between the changes in Precedex titration. He confirmed it was not titrated as ordered. A review of the hospital’s P&P titled “Administration of Medication,” effective 8/20/25, indicated, “Healthcare providers administering medications are responsible to use all patient safety guidelines including: 1. Verifying the... RIGHT time...””

“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: 46001 Based on observation, interview, and record review, the hospital failed to ensure that policies and procedures for safe surgical and procedural verification were implemented for 1 of 3 sampled patients (Patient 19). These failures resulted in a wrong-patient procedure and placed Patient 19 at risk for serious harm, including aspiration and complications related to unnecessary anesthesia and invasive procedures. Findings: A review of Patient 19’s clinical record, “the Emergency Department Provider Report” dated 8/22/2024, indicated that Patient 19 was a 97-year-old male who presented to the emergency department with shortness of breath. The patient arrived via ambulance from home, where he lived with family. The history was limited due to the patient’s baseline dementia (a progressive, irreversible syndrome characterized by a severe loss of cognitive functions-memory, language, and problem-solving-that interferes with daily life). A review of Patient 19’s clinical record “History and Physical” dated 8/23/2024 indicated that Patient 19 had a past medical history including hypertension (high blood pressure, the force of blood pushing against your artery walls is consistently too high), hyperlipidemia [a common condition characterized by high levels of fats (lipids), such as cholesterol and triglycerides, circulating in the blood], coronary artery disease, dementia, alert and oriented ×1 at baseline, asthma (a chronic, non-curable lung disease causing airway inflammation, swelling, and mucus production, resulting in wheezing, coughing, chest tightness, and shortness of breath), gout, and was a nonsmoker. The patient was admitted to the general medical floor for further evaluation and management of an asthma exacerbation. A review of Patient 19’s surgical procedure flowsheet dated 9/2/2024 indicated that a esophagogastroduodenoscopy [EGD, a procedure using a flexible camera to examine the esophagus, stomach, and duodenum (first part of the small intestine) to diagnose and treat issues like ulcers, bleeding, or pain] with biopsy (a medical procedure to remove a small sample of tissue or cells for examination under a microscope by a pathologist to diagnose diseases like cancer, infections, or inflammation) procedure was performed as the followings: Anesthesia start time: 10:06 a.m. Anesthesia stop time: 10:40 a.m. Surgical start time: 10:18 a.m. Surgical stop time: 10:36 a.m. Anesthetic technique: General anesthesia A review of Patient 19’s “Operative Report” dated 9/3/2024, indicated that an EGD with biopsy procedure was performed. The impression included esophagitis in the distal and mid-esophagus, with multiple biopsies obtained. An addendum to the operative report stated: “This procedure was performed on the incorrect patient.” A review of Patient 19’s clinical record indicated there was no physician order and no informed consent for EGD with biopsy; No NPO (nothing by mouth) order; no procedural preparation was completed prior to the procedure. During a concurrent interview and record review with the Director of Regulatory Compliance (DRC) on 1/13/2026 at 2:29 p.m., the DRC reviewed Patient 19’s clinical records and confirmed that there was no EGD with biopsy order, no NPO (no oral intake) order, and no informed consent for the EGD with biopsy procedure. The DRC stated that no procedural preparation was completed because Patient 19 was not the intended patient, and his roommate had been scheduled for the procedure. During a concurrent interview and record review with the Operating Room Manager (ORM) on 1/13/2025 at 3:17 p.m., the ORM reviewed Patient 19’s surgical procedure flowsheet and confirmed that Patient 19 received general anesthesia. The ORM stated that Patient 19 should have maintained NPO for approximately eight hours prior to the procedure. The ORM confirmed that failure to maintain NPO status places a patient at increased risk for aspiration during the administration of sedation or anesthesia. The ORM further stated that adherence to NPO requirements is critical for patient safety, as aspiration may compromise breathing and oxygenation and may result in a prolonged hospital stay. During an interview with the ORM on 1/13/2026 at 4:42 p.m., the ORM stated that when an EGD nurse comes to the medical floor to pick up a patient, the nurse should receive a bedside report from the floor nurse and verify the patient’s identity by checking the armband. He further stated that in the EGD preparation area, the team should verify patient identification again prior to the procedure. During the time-out, the team should identify the patient, check the armband, read the consent aloud, and ensure team agreement before starting the procedure. During a video interview with the surgeon (SG) on 1/13/2026 at 4:29 p.m., SG stated that the nursing staff should have verified the patient’s identification. SG further stated that during the time-out, she did not personally verify the patient’s identification armband and did not recall any other team members checking the armband prior to proceeding with the procedure. During a telephone interview with Registered Nurse (RN) A on 1/14/2026 at 9:58 a.m., RN A stated that on 9/2/2024, she went alone to the medical floor to pick up the patient, although the usual practice was for two nurses to go together. She obtained the chart for the intended patient (Patient 19’s roommate) at the nurse’s station. A floor nurse assisted RN A and proceeded ahead of her to the patient’s room. The floor nurse stood at Patient 19’s bed (the incorrect patient) and unplugged the bed from the wall. RN A stated that she relied on the floor nurse and did not check Patient 19’s identification armband prior to transport. RN A then transported Patient 19 to the endoscopy unit. RN A further stated that Patient 19 was non-verbal and did not respond to conversation at the preparation area. RN A further stated that during the time-out, four team members were present, including SG, AG (anesthesiologist), RN A and RN B. RN A confirmed that she did not check Patient 19’s armband during time-out and did not recall any other team member verifying it. RN A stated that the team should have checked patient 19’s armband and verified the patient’s name and date of birth prior to proceeding with the procedure. During an interview with the ORM on 1/14/2025 at 10:10 a.m., the ORM stated that during the time-out, every team member must agree that the correct patient is present and that it is the responsibility of all team members to verify the patient’s identity prior to proceeding with the procedure. A review of the hospital’s policy and procedure titled “Sedation/Analgesia: Adult and Pediatric” effective date: 10/15/2025 indicated “professional administering sedation/Analgesia (PAS): the PAS must complete and document and assessment of the patient prior to administering sedation/analgesia, including but not limited to 1. history: NPO status, adverse reactions to sedation or analgesics, pertinent medical history...NPO Guidelines/Adult...before elective procedure, adult patients with normal gastric emptying times should be NPO for solid food for at least 6-8 hours(6hours for light meals, 8 hours for heavy meals), and clear liquids for at least 2 hours. Patients at higher risk of aspirating gastric contents (e.g., patients with prolonged gastric emptying times) may need to be NPO longer...” A review of the hospital ‘s policy and procedure titled “Safe Procedural and Surgical Verification. “effective date 12/20/2023, indicated the verification process, which starts during the pre-procedure phase, will be conducted throughout all phases of procedural care, and will include the continuous sharing of pertinent information to include correct patient, procedure, and side/site...at time-out, which is led by the surgeon/proceduralist, will be performed immediately prior to starting the procedure by completing a final verification of correct patient, and all questions and concerns will resolved prior to incision or start of the procedure...””

“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: 27000 Based on observation, interview, and record review, the hospital failed to ensure that safe pharmaceutical services had been provided and that these services meet the needs of each patient as evidenced by: 1. The hospital failed to develop and implement policies and procedures (P&P) to minimize medication errors as in accordance with accepted professional standards when it did not have: a. Global P&P addressing medication administration rights (right patient, right drug, right dose, right route, and right time) for physicians and other licensed professionals allowed by law to administer medications besides those for nursing staff; and b. Policy and procedures to establish and implement standardized hand-off or communication process during the transfer of patient information, including medications, to help minimize communication breakdowns and reduce the risk of errors. The lack of P&Ps contributed to a medication error for one of 31 sampled patients (Patient 2). Patient 2 was intended to receive sodium bicarbonate (injectable medication to lower the amount of acid in the blood) but received bupivacaine solution (a local anesthetic; works by blocking the nerves from transmitting pain signals, numbing the targeted area) by mistake. (Refer to A-491) 2. A medication was not stored in accordance with the hospital P&P in one of three Pyxis Medstations (an automatic dispensing cabinet or ADC; computer-based system for the storage and dispensing of medications and supplies). The failure had the potential for the medication to be selected by error during a high-stress situation such as during a medical emergency. (Refer to A-491) 3. The hospital failed to ensure a medication was safely controlled and administered in accordance with accepted standards of practice to meet the needs of one our of 31 sampled patients (Patient 2). An Operating Room (OR) nursing staff (Registered Nurse A), a perfusionist (specialized healthcare professional who operates the heart-lung machine during major surgical procedures), and an anesthesiologist (Physician A, doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures) failed to check the medication label during medication hand-off (the hand-over of the medication from one person to another) or before medication administration for Patient 2. Patient 2 was to receive sodium bicarbonate but received intravenous (IV, directly into a vein) bupivacaine solution by mistake during a surgical procedure. Consequently, Patient 2 required the administration of a reversal agent, intralipid (lipid emulsion, for treating local anesthetic systemic toxicity) solution, to reverse the effects of bupivacaine. The medication error contributed to Patient 2’s death which occurred during the procedure, shortly after the medication error. (Refer to A-500) The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.”

“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: 27000 Based on observation, interviews, and record review, the hospital failed to develop and implement policies and procedures (P&P) to minimize medication errors as in accordance with accepted professional standards; and failed to store a medication in accordance with its P&P, when: 1. The hospital did not have a “global” P&P addressing medication administration rights (right patient, right drug, right dose, right route, and right time) for physicians and other licensed professionals allowed by law to administer medications besides those for nursing staff; and did not have P&P to establish and implement a standardized hand-off or communication process during the transfer of patient information, including medications, to help minimize communication breakdowns and reduce the risk of errors. The lack of P&Ps contributed to a medication error for one of 31 sampled patients (Patient 2). Patient 2 was intended to receive sodium bicarbonate (injectable medication to lower the amount of acid in the blood) but received bupivacaine (a local anesthetic; works by blocking the nerves from transmitting pain signals, numbing the targeted area) by mistake. The medication error contributed to Patient 2’s death during a surgical procedure (Refer to A-0500 for additional information). 2. A medication was not stored in accordance with the hospital P&P in one of three Pyxis Medstations (an automatic dispensing cabinet or ADC; computer-based system for the storage and dispensing of medications and supplies). The failure had the potential for the medication to be selected by error during a high-stress situation such as during a medical emergency. Findings: 1. On 6/17/25 starting at 10:25 a.m., a concurrent interview and review of Patient 2’s clinical record with multiple hospital staff including the Director of Regulatory Compliance (DRC), Director of Quality (DOQ), and the Director of Pharmacy (DOP) indicated Patient 2 was a 76-year old patient admitted to the hospital with diagnoses including a heart attack (also known as myocardial infarction, a serious condition that occurs when a blood clot blocks blood flow to the heart) and history of hypertension (high blood pressure) and hyperlipidemia (high lipids in the blood). The interview and record review reflected the following: - On 5/12/25 at 5:24 p.m., Patient 2 arrived in the Emergency Department after two weeks of intermittent worsening midback pain. - On the same day, on 5/12/25, she was diagnosed with NSTEMI (non-ST segment elevation myocardial infarction, which is a type of heart attack), unstable angina (a heart problem that causes sudden chest pain, often while resting), and coronary artery disease (condition where build-up of plaque in the heart’s arteries that could lead to heart attack or ischemic stroke), and was admitted to the Critical Care Unit (CCU, specialized hospital department that gives care to people who are critically ill). - During the hospital stay, on 5/14/25, Patient 2 underwent a heart bypass surgery called coronary artery bypass grafting (CABG; where a healthy blood vessel, typically taken from the chest, arm, or leg, is grafted onto the coronary artery, creating a new path for blood to flow to the heart muscle) with 3 grafts. - A day later, on 5/15/25, she was brought back to the Operating Room (OR) for an emergent procedure called redo sternotomy (surgical procedure that involves cutting through the sternum to access the heart and surrounding structures), sternal washout (procedure that involves washing or cleaning out debris, contaminants, or excess fluid of the surgical area) because of the worsening lactate (or lactic acid, is a natural byproduct of cellular metabolism often caused by impaired tissue oxygenation) elevation as well as uncorrectable acidosis (excessive buildup of acid in the body fluids, causing the blood pH to drop below the normal range). On 6/17/25 at 11:40 a.m., a review of Patient 2’s Anesthesia Record (the main document of medications administered for the relief of pain and sensation during the procedure), dated 5/15/25, with the DRC, the DOQ, and the DOP indicated Patient 2 was in the OR Room 5 (OR5) for an emergent “redo sternotomy, sternal washout” on 5/15/25 at 1:42 p.m. A review of the hand-written narrative in this Anesthesia Record, written by the anesthesiologist (Physician A, doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures), indicated, “After 7 amps [ampules] of bicarb [sodium bicarbonate], depleting the in-room supply additional bicarb was acquired from central Pyxis. Inadvertently administering bupivacaine... following the bupivacaine, BP [down arrow] [blood pressure dropped], Epi [epinephrine, medication to increase BP] and cardiac [heart] massage started, Intralipid [lipid emulsion administration for treating local anaesthetic systemic toxicity] was administered, patient defibrillated [controlled electric shock to restore the normal rhythm] to ROSC [return of spontaneous circulation], 3 total arrests were successfully defibrillated before fulminant [severe and sudden in onset] right heart failure. Time of death 1605 [4:05 p.m.].” During a concurrent interview and record review with multiple hospital staff including the DRC and the DOP on 6/17/25 at 11:45 a.m., the DRC explained that during Patient 2’s washout surgery on 5/15/25, Physician A requested for more sodium bicarb to be brought in. Registered Nurse (RN) A, who was the nurse on duty, went to the Pyxis in the surgery area (SURPX) to remove 4 vials of sodium bicarb but she grabbed 4 vials of bupivacaine by mistake. The DOP showed a picture of the two medication vials: the sodium bicarb came in as 8.4%,1 milliEquivalent (unit of measurement) per milliliter (mL) injection solution; and the bupivacaine came in 0.25%, 125 milligrams (mg, unit of measurement) per 50 mL, injection solution. Each was in a 50-mL glass vial containing clear, water-like solution. The DOP stated both medications were stored in the Pyxis tower (a vertical unit of the Pyxis, designed for storing multiple large-volume medications; where the user can have access to multiple medications when the tower door is opened). During an interview with the Patient Safety Director (PSD) on 6/17/25 at 12:05 p.m., in the presence of the DRC, the DOQ, and the DOP, the PSD stated she got notified right away after the medication error occurred. She immediately went to the OR while the team was still there. She explained the bupivacaine was inadvertently administered instead of sodium bicarbonate. She further explained, during the surgery, Physician A requested for more sodium bicarb to be brought into the OR, the nurse ran to the Pyxis outside of OR5, “accidentally grabbed the bupivacaine, handed it to the perfusionist, who handed to [Physician A] who administered it.” The DOP stated the medication error was reported internally on 5/16/25 as a “Sentinel Event” (a patient safety event [not primarily related to the natural course of a patient’s illness or underlying condition] that reaches a patient and results in death, severe harm, or permanent harm). During an interview with the Vice President of Surgical Services (VPSS) in the presence of the DRC on 6/17/25 at 3:03 p.m., the VPSS stated she was part of the investigation after the medication error happened. She explained RN A removed the bupivacaine vials instead of the intended sodium bicarb vials, and did not check the label on the vials to make sure it was the correct medication. She handed it to the perfusionist who handed it to Physician A, who administered the whole vial of bupivacaine (125 mg). The VPSS stated each person was supposed to check for the correct medication before handing off to another person, and before medication administration. She added, “The expectation is for them to call out what they are doing, what they are giving, to treat it like a code [medical emergency in which a team of medical personnel work to revive an individual].” She stated this was an unusual situation where the medication was brought in during a case, so the medication was not in the sterile field (area established with sterile surgical drapes around a patient’s surgical site and on the table/tray that will hold the instruments and necessary surgical items). During the survey, on 6/18/25 at 9:07 a.m., the DRC and DOQ were asked to provide a “global policy” addressing the medication administration by physicians and other licensed disciplines allowed by law to administer medications, the DRC stated she checked the hospital policies and medical staff bylaws but she could not find any other policy than the one already provided to the surveyors titled “Administration of Medications by Nursing.” A review of the hospital’s P&P titled “Administration of Medications by Nursing,” reviewed 8/2023, indicated, “Administration of Medications in eMAR [electronic Medication Administration Record] 1. The licensed nurse checks the patient’s allergies... 2. At the time of administration of a medication, the licensed individual verifies the right patient is receiving the right drug, dose, via the right route at the right time.” A review of the hospital P&P titled “Intraoperative [during the course of a surgical operation] Medications”, dated 8/2024, indicated, “All medications on the sterile field will be verified including medication strength, dosage, and expiration date.” In an interview with the Chief Medical Officer (CMO, who is also an anesthesiologist) in the presence of the DRC on 6/18/25 at 10:05 a.m., when asked if there was a hospital policy governing the medication administration by physicians, the CMO stated he was not aware of any besides that addressed to nursing. He added, “It falls upon the physician to give the right medication as intended.” When asked to explain “sterile field,” the CMO stated it is within the “surgical drape around the patient.” He stated the anesthesiologist and the perfusionist are not in the sterile field. During an interview with RN A on 6/18/25 at 11:02 a.m., she stated, on the day of the event, the perfusionist asked if she could get some sodium bicarb from the Pyxis. She stated she went and got 3 vials from the SURPX, went into OR5, put them on the perfusionist’s table, and told him the medication was there. When asked if she looked at the vials to ensure she got the right medication, RN A stated, “I didn’t look when I retrieved the medication.” She also stated, “I’m not sure why I didn’t look at it before giving it to them. I should look.” During an interview with the perfusionist on 6/18/25 at 2:03 p.m., in the presence of the DRC and the DOQ, he stated Patient 2 “was super ill and very acidotic.” He stated Physician A needed more sodium bicarb, RN A went to retrieve it, “came back, and handed it to me, and I handed it to [Physician A]. It was the wrong medication that was given, that’s what I know.” He added, “Four vials were handed to me. I gave them to [Physician A] who gave the medication.” He stated he did not look at the vials before handing them to Physician A. When asked whether he should have looked, the perfusionist stated, “Yes, but there’s a lot of things going on” as it was a “very hectic and chaotic environment.” An interview was conducted with Physician A on 6/18/25 starting at 2:30 p.m. in the presence of the DRC and DOQ. He explained, during Patient 2’s washout procedure, he had used up 7 vials from the OR5 Pyxis and from the perfusionist’s medication tray. He knew that he needed more as Patient 2 continued to be in an acidotic state. After the perfusionist handed the vials (those that were brought in by RN A) to him, Physician A stated he put them on the back table. He said he was not sure about the duration from the time they were given to him to the time of administration as there were a lot of things going on. He continued, “The vial I picked up turned out to be bupivacaine.” When asked whether he checked the vial for correct medication before administration, he stated, “No, it didn’t happen.” He stated Patient 2’s BP started to drop and she went into arrhythmia (irregular heart rhythms). He stated the team began treating the patient, massaged the heart, gave epinephrine, and “shocked the patient out of arrhythmia.” He continued, “At that point I looked back at the table and saw the four vials said bupivacaine... Immediately following that, we identified the error, announced to the surgeon, and called for intralipid.” He stated the patient had three episodes of V-tach [ventricular tachycardia; a rapid heartbeat originating in the heart’s lower chambers (ventricles), typically with a rate of 100 or more beats per minute], and the team was able to bring the heart back to the level prior to the event by IV intralipid, heart massage, epinephrine administration, and other supportive measures. He further explained, “We brought her back to stable position. She was on her third bag of lipid at this time. The patient’s acidotic status never normalized.... Her lactate continued to increase... When lactate is rising, the patient is dying; their body organs are not getting up the oxygen... After the fourth V-tach, she didn’t recover from it. She developed fulminant heart failure.” During the same interview with Physician A as above, on 6/18/25 at 2:55 p.m., Physician A confirmed he administered the whole vial of bupivacaine (125 mg) to Patient 2 via IV route. When asked about the potential adverse effects from IV bupivacaine administration, Physician A stated hypotension (low BP) and arrhythmia “were potential causes of local anesthetics.” During the continued interview with Physician A on 6/18/25 at 3:03 p.m., when asked whether the medication error caused or contributed to Patient 2’s death, Physician A stated, “The severity of illness was what led to her death.” He added the medication error was discovered within a minute of administration, that “intralipid was given as soon as discovered, and we were able to get her back to the same level as before.” He explained that her acidotic condition led to multi-organ damage including liver failure and bowel ischemia (condition where the blood supply to the intestines is reduced, potentially leading to tissue damage or death). During a telephone interview with the Medical Director of Surgical Services (Physician B) in the presence of the DOQ on 6/23/25 starting at 3:15 p.m., Physician B stated he was informed of the medication error; and as a result, communicated with other anesthesiologists including reminding them to review the medication label and confirm out loud what they are receiving during a procedure. He stated, “In this case, they didn’t look at the label.” He stated they are to review the medication label and call out the medication, such as “confirm bicarbonate” when they receive it. He stated everyone is expected to ensure they are receiving or administering the right medication. When asked if there was a specific policy for physicians administering medications, Physician B stated, “There’s no specific one for physicians. We try to abide by the one for nursing. It applies to everyone who gives medication. In reality, it applies to everyone. Not because you are a physician you don’t have to do that.” When asked for his professional opinion whether the medication error caused or contributed to Patient 2’s death, Physician B stated, “It happened within 3 seconds. In my professional opinion, a lot of things had gone wrong with the patient. She was acidotic which spelled disaster already... The medication error did not help the scenario. It wasn’t the cause of death. Prognosis was already poor for this patient. That doesn’t take away the gravity of this error.” When asked what national standards of practice the hospital followed for anesthesia services, Physician B stated they followed the American Society of Anesthesiologists (ASA) for best practices; and for policies, the hospital followed the Association of periOperative Registered Nurses (AORN, a national organization that provides nursing education, standards, and services that enable optimal outcomes for patients undergoing operative and other invasive procedures). A review of the manufacturer’s Product Information (PI, detailed description of a drug’s uses, dosage range, side effects, drug-drug interactions, and contraindications) for bupivacaine injection, revised 11/2018, reflected it is a local anesthetic indicated to produce local or regional anesthesia (or pain relief) for surgery and other procedures. It works by blocking the nerves from transmitting pain signals, numbing the targeted area. The dosage varies depending on anesthetic procedure, the area to be anesthetized, the depth and duration of anesthesia, etc. The PI indicated the multi-dose bupivacaine 0.25% injection solution can be used for infiltration (injected directly into the tissue at a surgical site to provide pain relief) or nerve blocking (injected near the nerve endings to numb a specific area). Under Adverse Reactions, the PI indicated, “The most commonly encountered acute adverse experiences which demand immediate counter-measures are related to the CNS [central nervous system] and the cardiovascular [relating to the heart and blood vessels] system.” Related to cardiovascular system reactions, the PI indicated, “High doses or unintentional intravascular [inside blood vessels] injection may lead to... hypotention... ventricular arrhythmias, including ventricular tachycardia... and cardiac arrest.” A review of the AORN’s “Guideline for Medication Safety” (MS Guideline), approved March 16, 2023, indicated, “This document provides guidance to perioperative personnel for safe medication management practices. These recommendations, which are based on a systematic review of the available literature, are intended to support perioperative registered nurses (RNs) and other clinicians implementing evidence-based practices in all phases of medication management in the perioperative setting and to decrease the risk of medication errors.” The MS Guideline indicated; “1.3. In collaboration with physicians, pharmacists, nurses, risk and quality personnel, and other identified key stakeholders, develop and maintain policies and procedures that address authority, accountability, responsibility, and patient and personnel safety in all phases of the medication use processes in perioperative care.” Under Communication, the MS Guideline indicated, “5.3. Visually and verbally confirm the medication information when a medication is passed to the licensed independent practitioner for subsequent administration...” Guideline 7.3 of the MS Guideline indicated,” Before administering a medication, verify: right patient, using two health care organization-approved identifiers; right medication; right dose; right route; and right time.” In an email communication with the DRC on 6/26/25 at 12:31 p.m., she was requested to provide a P&P that addressed the standardized handing off process, or method of communication, from one licensed staff to another such as during surgery. In an email response on 6/26/25 at 1:14 p.m., the DRC replied, “I do not have anything that specific, only one regarding medications in the sterile field, which this was not the case.” A review of the AORN’s “Guidelines for Team Communication,” approved January 1, 2024, indicated the “Operating room (OR) is a high-risk sociotechnical [involving social and technical elements] environment with various professionals working in close proximity, and effective team communication in the perioperative and procedural environment is the foundation of optimal patient outcomes.” Guideline 2.1 indicated, “Establish and implement a standardized hand-off process for the transfer of patient information between individuals... The Joint Commission’s [a healthcare accrediting organization] sentinel event database includes reports of inadequate hand-off communication contributing to adverse events, including wrong-site surgery, delay in treatment, falls, and medication errors.” Guideline 2.2 indicated, “Establish an interdisciplinary team at the facility level to develop a standardized hand-off process. A standardized hand-off process helps to identify risks during the perioperative phases so the team can take action to minimize threats to patient safety.” 2. During a visit to OR5 with the DRC and the DOP on 6/17/25 at 2:45 p.m., a Pyxis Medstation (an ADC) was identified inside OR5. The DOP was asked to open a medication drawer for inspection. A review of a matrix drawer (allows access to multiple medications housed within the same drawer when it’s opened) identified three 5-mL ampules of lidocaine 1.5% with epinephrine (a combination of medications used as local anesthetic for use in certain surgical procedures) injection solutions inside Pocket 30. Two of the ampules had the expiration date of 11/2024. The DOP reviewed the Pyxis’ inventory and stated these ampules were not supposed to be in the Pyxis. During a follow-up interview with the DOP on 6/18/25 at 12:15 p.m., the DOP stated he could not find any reason why the lidocaine/epinephrine ampules were in OR5 Pyxis. He stated, “I think that anesthesia [personnel] dropped them in there. They should be put in the return bin or to give to pharmacy” if not used. During another interview with the DOP on 6/23/25 at 10:03 a.m., the DOP stated the pharmacy did not stock ampules in Pyxis Medstations. He stated anesthesia staff must have used it from a medication kit (a kit containing medications for a specific medical emergency or procedure) and put them in the Pyxis. He additionally stated the OR Pyxis Medstations do not have a return bin, so the medications not used during a procedure should be wasted or returned to the pharmacy. A review of the hospital P&P titled “Patient Care Areas Medication Storage and Security,” reviewed 1/2025, indicated, “The hospital safely stores medications including... Implements policy addressing the control of medication...including safe storage, handling, security, disposition, and return to storage” and “Removes expired... medications and stores them separately from medications available for administration...””

“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: 27000 Based on interview and record review, the hospital failed to ensure a medication was safely controlled and administered in accordance with accepted standards of practice for one out of 31 sampled patients (Patient 2). An Operating Room (OR) nursing staff (Registered Nurse A), a perfusionist (specialized healthcare professional who operates the heart-lung machine during major surgical procedures), and an anesthesiologist (Physician A, doctor who has special training in giving drugs or other agents to prevent or relieve pain during surgery or other procedures) failed to check the medication label during medication hand-off (the hand-over of the medication from one person to another) or before medication administration for Patient 2. Patient 2 was to receive sodium bicarbonate (injectable medication to lower the amount of acid in the blood when blood acid level is high) but received intravenous (IV, directly into a vein) bupivacaine solution (a local anesthetic; works by blocking the nerves from transmitting pain signals, numbing the targeted area) by mistake during a surgical procedure. Consequently, Patient 2 required the administration of a reversal agent, intralipid (lipid emulsion, for treating local anesthetic systemic toxicity) solution, to reverse the effects of bupivacaine. The medication error contributed to Patient 2’s death which occurred during the procedure, shortly after the medication error. Findings: On 6/17/25 starting at 10:25 a.m., a concurrent interview and review of Patient 2’s clinical record with multiple hospital staff including the Director of Regulatory Compliance (DRC), Director of Quality (DOQ), and the Director of Pharmacy (DOP) indicated Patient 2 was a 76-year old patient admitted to the hospital with diagnoses including a heart attack (also known as myocardial infarction, a serious condition that occurs when a blood clot blocks blood flow to the heart). The interview and record review indicated the following events and timelines: - On 5/12/25 at 5:24 p.m., Patient 2 arrived in the Emergency Department [ED] after two weeks of intermittent worsening midback pain. A review of the ED’s History of Present Illness, dated 5/12/25, indicated Patient 2 also had hypertension (high blood pressure), hyperlipidemia (high lipids in the blood), active tobacco use, and “reports that she had a history of a prior cerebral aneurysm [a weakness in a blood vessel in the brain that balloons and fills with blood]... She has had multiple siblings that have had ruptured cerebral aneurysm.” - On the same day, 5/12/25, she was diagnosed with NSTEMI (non-ST segment elevation myocardial infarction, which is a type of heart attack), unstable angina (a heart problem that causes sudden chest pain, often while resting), and coronary artery disease (buildup of plaque in the heart’s arteries that could lead to heart attack or ischemic stroke). Patient 2 was admitted to the Critical Care Unit (CCU, specialized hospital department that gives care to people who are critically ill) 5/12/25 at 10:40 p.m. - On 5/13/25, Patient 2 continued to have intermittent pain. A review of the Critical Care Progress Notes, dated 5/13/25, indicated Patient 2 had a left heart catheterization (medical procedure that involves inserting a catheter into the left side of the heart to assess its function and diagnose or treat certain heart conditions) which showed right coronary artery 50% stenosis (abnormal narrowing) with ejection fraction (EF, measurement of how much blood leaves the left ventricle with each heartbeat) of 35% (normal EF is between 55% and 70%). - On 5/14/25 at 2:49 p.m., Patient 2 underwent a heart bypass surgery called coronary artery bypass grafting (CABG; where a healthy blood vessel, typically taken from the chest, arm, or leg, is grafted onto the coronary artery, creating a new path for blood to flow to the heart muscle) with 3 grafts. A review of the Cardiothoracic (related to the heart and chest cavity) Progress Notes, dated 5/15/25, indicated Patient 2 “was found to have multivessel coronary disease including a left main coronary artery stenosis which is greater than 75%. Based on her symptoms and presentation an intra-aortic balloon pump [a device that controls blood flow from the heart. It deflates when the heart pumps blood out and inflates when the heart rests between beats] was placed in the cardiac catheterization lab. Improved her symptoms. She continued to have chest tightness. Based on this she was taken for emergent coronary artery bypass graft.” - On 5/15/25, a review of the Clinical Report, dated 5/15/25 at 0000 (midnight), indicated the arterial blood gas (ABG) test (measures the oxygen and carbon dioxide levels in your blood as well as blood’s pH balance) was indicative of metabolic acidosis (excessive buildup of acid in the body fluids) with elevated lactate (or lactic acid, is a natural byproduct of cellular metabolism often caused by impaired tissue oxygenation) level. - On 5/15/25 at 1:42 p.m., Patient 2 was brought back to the OR for an emergent procedure called “Redo sternotomy [surgical procedure that involves cutting through the sternum to access the heart and surrounding structures], sternal washout [procedure that involves washing or cleaning out debris, contaminants, or excess fluid of the surgical area].” A review of the 5/15/25 Operative Report indicated Patient 2 was brought to the OR “because of the worsening lactate elevation as well as uncorrectable acidosis with a picture of hematoma [clotted blood that forms in an organ, tissue, or body space]... there was the hopes that by cleaning her out that this would help resolve the acidosis.” The report further indicated, “Sodium bicarbonate was being administered to try and correct her severe persistent acidosis however she inadvertently received bupivacaine intravenously. From this point on the patient became worse hemodynamically [associated with the dynamics of blood flow] and had persistent unprovoked recurrent episodes of ventricular tachycardia [V-tach; a rapid heartbeat originating in the heart’s lower chambers (ventricles), typically with a rate of 100 or more beats per minute] resistant to internal defibrillation [electrical current to restore a normal heart rhythm in cases of potentially fatal arrhythmias or irregular heart rhythms].” The Operative Report continued to describe that, despite the administration of intralipid, heart massage, and multiple defibrillations, the “[r]ight ventricle absolutely continued to dilate [widen/enlarge] and became akinetic [no movement].” - On 5/15/25 at 4:05 p.m., Patient 2 was pronounced dead. On 6/17/25 at 11:40 a.m., a review of Patient 2’s Anesthesia Record (the main document of medications administered for the relief of pain and sensation during the procedure), dated 5/15/25, with the DRC and the DOP indicated Patient 2 was brought into OR Room 5 (OR5) for an emergent “Redo Sternotomy, sternal washout” on 5/15/25 starting at 1:42 p.m. A review of the hand-written narrative in the Anesthesia Record, written by Physician A, indicated, “After 7 amps [ampules] of bicarb [sodium bicarbonate], depleting the in-room supply additional bicarb was acquired from central Pyxis. Inadvertently administering bupivacaine... following the bupivacaine, BP [down arrow] [blood pressure dropped], Epi [epinephrine, medication to increase BP] and cardiac [heart] massage started, Intralipid was administered, patient defibrillated to ROSC [return of spontaneous circulation], 3 total arrests were successfully defibrillated before fulminant [severe and sudden in onset] right heart failure. Time of death 1605 [4:05 p.m.].” During a concurrent interview and record review with multiple hospital staff including the DRC and the DOP on 6/17/25 at 11:45 a.m., the DRC explained that during Patient 2’s washout surgery on 5/15/25, Physician A had used up the sodium bicarb supply in the OR, he requested for more to be brought in. RN A, who was the nurse on duty, went to the Pyxis (an automatic dispensing cabinet [ADC] for the storage and dispensing of medications) in the surgery area (SURPX) to remove 4 vials of sodium bicarb but she grabbed 4 vials of bupivacaine instead. The DOP showed a picture of the two medication vials: the sodium bicarb came in as 8.4%,1 milliEquivalent (unit of measurement) per milliliter (mL) injection solution; and the bupivacaine came in 0.25%, 125 milligrams (mg, unit of measurement) per 50 mL, injection solution. Each was in a 50-mL glass vial containing clear, water-like solution. The DOP stated both medications were stored in the Pyxis tower (a vertical unit of the Pyxis, designed for storing multiple large-volume medications, where the user can have access to multiple medications when the tower door is opened). The sodium bicarb vials were in Bin 1, located on the top rack; and the bupivacaine vials were in Bin 11, directly below Bin 1. On 6/17/25 at 11:50 a.m., a review of the Pyxis Report for the SURPX with the DOP and the DRC indicated RN A removed 4 vials of “sodium bicarbonate” on 5/15/25 at 2:23 p.m. from the SURPX; and another nurse, RN B, accessed the sodium bicarbonate in the SURPX on 5/15/25 at 3:06 p.m. The DRC stated RN A got the bicarb order “but pulled the wrong drug” at 2:23 p.m., and RN B went in the Pyxis at 3:06 p.m. to validate who had pulled the medication, and to see if the bupivacaine vials were placed in the bin for sodium bicarb. She stated there was no misplacing of medications. The DRC stated the medication error was caught sometime between 2:23 p.m. and 3:06 p.m., a period of 43 minutes, on that day. During an interview with the Patient Safety Director (PSD) on 6/17/25 at 12:05 p.m., in the presence of the DRC, the DOQ, and the DOP, the PSD stated she got notified right away after the medication error occurred. She immediately went to the OR while the team was still there. She explained the bupivacaine was inadvertently administered instead of sodium bicarbonate. She further explained, during the surgery, Physician A requested for more sodium bicarb to be brought into the OR, the nurse ran to the Pyxis outside of OR5, “accidentally grabbed the bupivacaine, handed it to the perfusionist, who handed to [Physician A] who administered it.” The DOP stated the medication error was reported internally on 5/16/25 as a “Sentinel Event” (a patient safety event [not primarily related to the natural course of a patient’s illness or underlying condition] that reaches a patient and results in death, severe harm, or permanent harm). In an interview with the DOP on 6/17/25 at 12:34 p.m., he stated he inventoried the bupivacaine vials in the SURPX: there were 28 counts before the incident, and 24 counts after the incident on 5/15/25. During an interview with the Vice President of Surgical Services (VPSS) in the presence of the DRC on 6/17/25 at 3:03 p.m., the VPSS stated she was part of the investigation after the medication error happened. She explained RN A removed the bupivacaine vials instead of the intended sodium bicarb vials, and did not check the label on the vials. She handed it to the perfusionist who handed it to Physician A, who administered the whole vial of bupivacaine. The VPSS stated each person was supposed to check for the correct medication before handing off to another person, and before medication administration. She added, “The expectation is for them to call out what they are doing, what they are giving, to treat it like a code [a medical emergency in which a team of medical personnel work to revive an individual].” During the survey, on 6/18/25 at 9:07 a.m., the DRC and DOQ were asked to provide a “global policy” addressing the medication administration by physicians and other licensed disciplines allowed by law to administer medications, the DRC stated she checked the hospital policies and medical staff bylaws but she could not find any other than the one already provided to the surveyors titled “Administration of Medications by Nursing.” A review of the hospital’s P&P titled “Administration of Medications by Nursing,” reviewed 8/2023, indicated, “Administration of Medications in eMAR [electronic Medication Administration Record] 1. The licensed nurse checks the patient’s allergies... 2. At the time of administration of a medication, the licensed individual verifies the right patient is receiving the right drug, dose, via the right route at the right time.” In an interview with the Chief Medical Officer (CMO, who is also an anesthesiologist) in the presence of the DRC on 6/18/25 at 10:05 a.m., when asked whether the medication error contributed to or caused Patient 2’s death, the CMO stated Patient 2 was “extremely acidotic, which put her in a very grave condition.” He continued, “Would she have died if the medication error didn’t happen? Most likely. Would it excuse the med error? Absolutely not!” He added, “It falls upon the physician to give the right medication as intended.” When asked whether bupivacaine was needed in Patient 2’s surgery, the CMO stated, “No.” When asked about the risks of giving bupivacaine intravenously, the CMO responded, “Full blown cardiac arrest [sudden and unexpected cessation of heart function] is the risk.” During an interview with RN A on 6/18/25 at 11:02 a.m., she stated, on the day of the event, one of the nurses in OR5 asked for help to get medications in. She went to the pharmacy to get the “medication tray for the heart” to give to the perfusionist. When she was about to leave, the perfusionist asked if she could get some sodium bicarb from the Pyxis. She stated she went and got 3 vials from the SURPX, went back into OR5, put them on the perfusionist’s table, and told him the medication was there. When asked if she looked at the vials to ensure she got the right medication, RN A stated, “I didn’t look when I retrieved the medication.” She also stated, “I’m not sure why I didn’t look at it before giving it to them. I should look.” During an interview with the perfusionist on 6/18/25 at 2:03 p.m., in the presence of the DRC and the DOQ, he stated Patient 2 “was super ill and very acidotic.” He stated Physician A needed more sodium bicarb, RN A went to retrieve it, “came back, and handed it to me, and I handed it to [Physician A]. It was the wrong medication that was given, that’s what I know.” He added, “Four vials were handed to me. I gave them to [Physician A] who gave the medication.” He stated he did not look at the vials before handing them to Physician A. When asked whether he should have looked, the perfusionist stated, “Yes, but there’s a lot of things going on” as it was a “very hectic and chaotic environment.” An interview was conducted with Physician A on 6/18/25 starting at 2:30 p.m. He explained Patient 2 had undergone the CABG surgery the day prior, and she was brought back to the OR as she was extremely acidotic; the thought was that it may be caused by bleeding or a clot. During the washout procedure, he had used up 7 vials of sodium bicarb from the Pyxis that was in the room and from the perfusionist’s medication tray. He stated he knew that he needed more as Patient 2 continued to be in acidotic state. After the perfusionist handed the vials (those that were brought in by RN A) to him, Physician A stated he put them on the back table. He said he was not sure about the duration from the time they were given to him to the time of administration as there were a lot of things going on. He continued, “The vial I picked up turned out to be bupivacaine.” When asked whether he checked the vial for correct medication, he stated, “No, it didn’t happen.” He stated Patient 2’s BP started to drop and she went into arrhythmia. He stated the team began treating the patient, massaged the heart, gave epinephrine, and “shocked the patient out of arrhythmia.” He continued, “At that point I looked back at the table and saw the four vials said bupivacaine... Immediately following that, we identified the error, announced to the surgeon, and called for intralipid.” He stated the patient had 3 episodes of V-tach, and the team was able to bring the heart back to the level prior to the event by IV intralipid, heart massage, epinephrine administration, and other supportive measures. He further explained, “We brought her back to stable position. She was on her third bag of lipid at this time. The patient’s acidotic status never normalized... Her lactate continued to increase... When lactate is rising, the patient is dying; their body organs are not getting up the oxygen... After the fourth V-tach, she didn’t recover from it. She developed fulminant heart failure.” During the same interview with Physician A as above, on 6/18/25 at 2:55 p.m., he further explained that Patient 2 “likely had a heart attack 2 weeks prior to admission. She’s been living with this heart attack. She was on the bypass [the heart-lung machine that temporarily takes over the function of the heart and lungs by maintaining the circulation of blood and oxygen throughout the body] and they were trying to wean her off the bypass. She was given the balloon pump...” When asked about the typical use of bupivacaine, Physician A stated it is a local anesthetic, which could be injected into the targeted area to numb it during surgery or procedure, and sometimes a whole vial could be used for a large area. Physician A confirmed he administered the whole vial of bupivacaine to Patient 2 via IV route. When asked about the effects of IV bupivacaine administration, Physician A stated hypotension (low BP) and arrhythmia “were potential causes of local anesthetics.” During the continued interview with Physician A on 6/18/25 at 3:03 p.m., when asked whether the medication error caused or contributed to Patient 2’s death, Physician A stated, “The severity of illness was what led to her death.” He added the medication error was discovered within a minute of administration, that “intralipid was given as soon as discovered, and we were able to get her back to the same level as before.” He explained that her acidotic condition led to multi-organ damage including liver failure and bowel ischemia (condition where the blood supply to the intestines is reduced, potentially leading to tissue damage or death). During a telephone interview with the Medical Director of Surgical Services (Physician B) in the presence of the DOQ on 6/23/25 starting at 3:15 p.m., Physician B stated he was informed of the medication error; and as a result, communicated with other anesthesiologists including reminding them to review the medication label and confirm out loud what they are receiving during a procedure. He stated, “In this case, they didn’t look at the label.” He stated they are to review the medication label and call out the medication, such as “confirm bicarbonate” when they receive it. He stated everyone is expected to ensure they are receiving or administering the right medication. He explained, “It applies to everyone. Not because you are a physician you don’t have to do that.” When asked for his professional opinion whether the medication error caused or contributed to Patient 2’s death, Physician B stated, “It happened within 3 seconds. In my professional opinion, a lot of things had gone wrong with the patient. She was acidotic which spelled disaster already... The medication error did not help the scenario. It wasn’t the cause of death. Prognosis was already poor for this patient. That doesn’t take away the gravity of this error.” When asked what national standards of practice the hospital followed for anesthesia services, Physician B stated they followed the American Society of Anesthesiologists (ASA) for best practices; and for policies, the hospital followed the Association of periOperative Registered Nurses (AORN, a national organization that provides nursing education, standards, and services that enable optimal outcomes for patients undergoing operative and other invasive procedures). A review of the manufacturer’s Product Information (PI, detailed description of a drug’s uses, dosage range, side effects, drug-drug interactions, and contraindications) for bupivacaine injection, revised 11/2018, reflected it is a local anesthetic indicated to produce local or regional anesthesia (or pain relief) for various surgical and diagnostic procedures. It works by blocking the nerves from transmitting pain signals, numbing the targeted area. The dosage varies depending on anesthetic procedure, the area to be anesthetized, the depth and duration of anesthesia, etc. The PI indicated the multi-dose bupivacaine 0.25% injection solution can be used for infiltration (injected directly into the tissue at a surgical site to provide pain relief) or for nerve blocking (injected near the nerve endings to numb a specific area). Under Adverse Reactions, the PI indicated, “The most commonly encountered acute adverse experiences which demand immediate counter-measures are related to the CNS [central nervous system] and the cardiovascular [relating to the heart and blood vessels] system.” Related to cardiovascular system reactions, the PI indicated, “High doses or unintentional intravascular [inside blood vessels] injection may lead to... hypotention... ventricular arrhythmias, including ventricular tachycardia... and cardiac arrest.” A review of the AORN’s “Guideline for Medication Safety” (MS Guideline), approved March 16, 2023, indicated, “This document provides guidance to perioperative personnel for safe medication management practices. These recommendations, which are based on a systematic review of the available literature, are intended to support perioperative registered nurses (RNs) and other clinicians implementing evidence-based practices in all phases of medication management in the perioperative setting and to decrease the risk of medication errors.” The MS Guideline indicated; “1.3. In collaboration with physicians, pharmacists, nurses, risk and quality personnel, and other identified key stakeholders, develop and maintain policies and procedures that address authority, accountability, responsibility, and patient and personnel safety in all phases of the medication use processes in perioperative care.” Under Communication, the MS Guideline indicated, “5.3. Visually and verbally confirm the medication information when a medication is passed to the licensed independent practitioner for subsequent administration...” Guideline 7.3 of the MS Guideline indicated, “Before administering a medication, verify: right patient, using two health care organization-approved identifiers; right medication; right dose; right route; and right time.” During an email communication with the DRC on 6/26/25 at 12:31 p.m., a request was made to provide a policy that addressed the handing off medication, or a standardized method of communication, from one licensed staff to another such as during surgery. In an email response on 6/26/25 at 1:14 p.m., the DRC replied that she did not have anything specific to this process. A review of the AORN’s “Guidelines for Team Communication,” approved January 1, 2024, indicated the “Operating room (OR) is a high-risk sociotechnical [involving social and technical elements] environment with various professionals working in close proximity, and effective team communication in the perioperative and procedural environment is the foundation of optimal patient outcomes.” Guideline 2.1 indicated, “Establish and implement a standardized hand-off process for the transfer of patient information between individuals... The Joint Commission’s [a healthcare accrediting organization] sentinel event database includes reports of inadequate hand-off communication contributing to adverse events, including wrong-site surgery, delay in treatment, falls, and medication errors.” Guideline 2.2 indicated, “Establish an interdisciplinary team at the facility level to develop a standardized hand-off process. A standardized hand-off process helps to identify risks during the perioperative phases so the team can take action to minimize threats to patient safety.” A review of the ISMP (the Institute for Safe Medication Practices, a nonprofit patient safety organization with recognized national expertise in medication error prevention) Guidelines for the Safe Use of Automated Dispensing Cabinets 2019, it indicated, “Core Safety Process # 8 Develop Procedures for Accurate ADC Withdrawal and Transfer to the Bedside for Administration Processes must be developed to reduce the risk or mitigate the harm associated with accessing a medication without an order, or the selection and administration of the wrong medication, dose, route, or frequency due to medication retrieval errors from the ADC.” The Core Safety Process 8.3 of the Guidelines indicated, “To limit the risk of wrong drug/dose/formulation selections from ADCs... Confirm accurate selection by visually comparing the drug label to the order... This manual check should include: 1. Drug identification (generic name and/or brand name if available) 2. Validation of drug concentration, dose, and dosage form.””

“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: 46001 Based on interview and record review, the hospital failed to follow the procedures of the hospital when there was no documentation indicating wound treatment was implemented as ordered for two of three patients (Patients 3 and 8). These failures had the potential for patients’ needs not being met and worsening health conditions. Findings: 1. A review of Patient 3’s History and Physical indicated Patient 3 was admitted to the hospital on 1/09/25, and the chief complaint was intracranial hemorrhage (a type of stroke that causes bleeding within the skull). A review of Patient 3’s Wound Care Note, dated 1/20/25, indicated that Patient 3 had two wounds: wound #1, located on the right nostril, had scattered dry scabs with blanchable redness. The treatment plan for this wound were to cleanse with normal saline, pat dry, apply Aquaphor, and leave open to air, to be done daily. Wound #2, located on the left medial upper leg, was a deroofed blister. The treatment plan for this wound were to clean with normal saline, pat dry, apply TheraHoney, and cover with a foam dressing, to be done every other day and as needed for soiling. A review of Patient 3’s Wound Care Notes, dated 1/24/25, indicated that the patient had a pressure injury wound: wound #3, located on the right upper inner nare, was a deep tissue pressure injury. The treatment plan for this wound were to cleanse with normal saline, pat dry, apply a thin layer of Triad cream, to be done daily, and leave open to air. A review of Patient 3’s nursing documentation revealed no record indicating that Aquaphor was applied to wound #1 on 1/22/25 and 1/23/25, that TheraHoney and foam dressing were applied to wound #2 on 1/24/25 and 1/26/25, and that Triad cream was applied to wound #3 on 1/25, 1/26, and 1/27/25. During a concurrent interview and record review with the wound care nurse (WCN) on 3/19/2025 at 10:00 a.m., the WCN stated that the wound care nurse assessed the patient’s wounds and recommended the treatment plan. The bedside nurse should be responsible for changing the dressings daily or as ordered. The WCN confirmed that there was no documentation indicating Aquaphor was applied to wound #1 on 1/22/25 and 1/23/25, no documentation showing TheraHoney and foam dressing were applied to wound #2 on 1/24 and 1/26/25, and no documentation indicating Triad cream was applied to wound #3 on 1/25, 1/26, and 1/27/25. 2. A review of Patient 8’s History and Physical indicated Patient 8 was admitted to the hospital on 1/24/25, and the chief complaint was acute respiratory failure. A review of Patient 8’s Wound Care Note, dated 1/28/25, indicated that Patient 8 had two pressure injury wounds: wound #1, located on the midback over the spine, was an unstageable pressure injury, and wound #2, located from the coccyx to the bilateral buttocks, was a deep tissue pressure injury. The treatment plan for both wounds included cleaning with normal saline, patting them dry, applying triad, and covering them with a foam dressing daily. A review of Patient 8’s nursing documentation revealed no record indicating that Triad and foam dressing were applied to wound #1 and wound #2 on 2/1, 2/2 and 2/6/25. During a concurrent interview and record review with the WCN on 3/21/2025 at 10:27 a.m., the WCN reviewed Patient 8’s nursing documentation and confirmed that there was no documentation indicating that Triad and foam dressing were applied to wound #1 and wound #2 on 2/1, 2/2 and 2/6/25. A review of the hospital’s policy, Wound Assessment and Management: Vascular, Surgical, and Pressure, effective dated 12/20/2023, indicated, “Wounds will be assessed with every dressing change ... Every dressing change will include the following assessment: Location, Wound Bed Description... All wound dressings must be dated, timed, and include the initials of the person who changed the dressing.””

“LICENSURE OF HOSPITAL CFR(s): 482.11(b) The hospital must be - o Licensed; or o Approved as meeting standards for licensing established by the agency of the State or locality responsible for licensing hospitals. This Standard is not met as evidenced by: 37686 Based on observation, interview, and document review, the hospital placed patients in the hallway of the emergency department (ED) without first obtaining program flexibility (permission granted by The California Department of Public Health for the hospital to have flexibility from regulatory requirements if the hospital can demonstrate that the proposed alternative does not compromise patient care). This deficient practice had the potential to compromise the health, safety, and dignity of the patients. Findings: During an observation on 2/3/25 at 11:17 a.m., accompanied by the emergency department manager (EDM), the hospital’s ED was inspected. There were approximately six patients lying in beds that were placed in the ED hallway. During a concurrent interview with the EDM, he acknowledged the above observation and confirmed that when there are no available rooms in the ED, the patients do have to be placed in the hallway. During an interview with the manager of regulatory compliance (MRC) on 2/4/25 at 8:14 a.m., the MRC confirmed the hospital did not obtain program flexibility to place patients in the hallway of the ED. The MRC stated she was not aware the hospital could apply for this specific type of program flexibility. During an interview with the vice president of quality (VPQ) on 2/4/25 at 8:34 a.m., the VPQ confirmed the hospital did not obtain program flexibility to place patients in the hallway of the ED. On 2/7/25 at 4:05 p.m., the hospital provided an untitled document that showed the patients who were placed in the ED hallway from 2/3/25 to 2/7/25. The document indicated 34 patients were placed in the ED hallway during this timeframe. During a follow-up observation on 2/10/25 at 8:50 a.m., accompanied by the EDM, the hospital’s ED was inspected. There were three patients lying in beds that were placed in the ED hallway. The EDM confirmed this observation. According to the California Code of Regulations, Title 22, Article 8, section 70809(c), “Patients shall not be housed in areas which have not been approved by the Department for patient housing and which have not been granted a fire clearance by the State Fire Marshal...””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to obtain an order for the use of restraints (any manual method or device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely) timely for one of three patients (Patient 13) when Patient 13 was placed in a restraint and an order was not obtained immediately. This failure had the potential to result in an inappropriate use of restraints. Findings: Review of Patient 13’s medical record indicated she was admitted to the facility on 12/11/24 with fever (elevated body temperature) and lethargy (state of tiredness or drowsiness). Review of Patient 13’s Restraint Documentation indicated the application of restraints for Patient 13 started on 12/19/24 at 7:23 a.m. It indicted a soft restraint was placed on Patient 13’s left upper extremity. Review of Patient 13’s Order Record, dated 12/19/24 indicated the patient had an initial order for restraints on 12/19/24 at 9:38 a.m. During an interview and concurrent record review on 12/24/24 at 10:37 a.m. the Manager of Regulatory Compliance (MRC) stated it was okay for a nurse to place restraints on a patient prior to a physician order, but the nurse has to get an order as soon as possible. The MRC reviewed the hospital’s restraint policy and confirmed Patient 13’s restraint order should have been obtained within minutes after the restraint was initiated. Review of the hospital’s policy, “Patient Restraint/Seclusion,” dated 7/1/2023 indicated, “When a physician or other licensed practitioner, authorized by State law to order restraints, is not available to issue a restraint or seclusion order, an RN with demonstatrated competence may initate restraint or seclusion use based upon face-to-face assessment of the patient. In these emergency situations, the order must be obtained during the emergency application or immediately (within minutes) after the restraint or seclusion is initiated.””

“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: 36623 Based on interview and record review, the hospital failed to follow the procedures of the hospital when: 1. Two of five patients (Patient 15 and 28) in the Emergency Department (ED) were not placed on a cardiac monitor timely. 2. There was no documentation indicating wound treatment was implemented as ordered for one of three patients (Patient 20). These failures had the potential for patients’ needs not being met and worsening health conditions. Findings: 1a. Review of Patient 15’s Emergency Provider Report, dated 12/16/24 indicated the patient, “was sent to the ED for a low-grade fever, irregular heart rate, and renal cell cancer.” The report indicated he was seen by a provider on 12/16/24 at 7:10 p.m. Review of Patient 15’s ED orders, indicated he had an order for cardiac monitoring, dated 12/16/24 at 7:23 p.m. Review of Patient 15’s Emergency Patient Record indicated an electrocardiogram (EKG, a test that records the electrical activity of the heart) was done at 8:08 p.m. Further review of Patient 15’s Emergency Provider Report, dated 12/16/24 indicated EKG interpretation: time 8:08 p.m., heart rate 143 beats per minute, atrial fibrillation (AFib, a type of arrythmia or irregular heartbeat when the upper chambers of the heart [atria] beat to quickly), rapid ventricular response (RVR, when the contractions of the upper chambers of heart causes the lower chambers [ventricles] to beat too quickly). Review of Patient 15’s Emergency Notes, dated 12/16/24 at 8:44 p.m. indicated the patient’s heart rate was elevated during vitals signs rounding. It indicated Patient 15 was in AFib RVR. Review of Patient 15’s Emergency Patient Record indicated the time the patient was placed on the cardiac monitor on 12/16/24 at 9:30 p.m. During an interview and concurrent record review on 12/20/24 at 10:45 a.m., the Director of Emergency Services (DES) reviewed Patient 15’s ED record and stated with the patient’s EKG results AFib RVR, Patient 15 should be in a monitored bed. During an interview and concurrent record review on 12/26/24 at 10:12 a.m., the Emergency Department Clinical Nurse Coordinator (EDCNC) stated patients presenting with cardiac concerns are placed on a cardiac monitor whenever they are put in a room. He stated ED staff try to get patients into a room as fast as they can. The EDCNC reviewed Patient 15’s ED record and stated on 12/16/24, the day Patient 15 was in the ED, the department was very busy. He stated Patient 15 was placed in a recliner before he was moved into a room at 9:30 p.m. 1b. Review of Patient 28’s Emergency Provider Report, dated 12/19/24 indicated the patient presented to the ED with persistent left-sided chest pain. The report indicated Patient 28 was seen by a provider on 9:43 a.m. Review of Patient 28’s ED orders, indicated he had an order for cardiac monitoring, dated 12/19/24 at 9:51 a.m. Review of Patient 28’s Emergency Patient Record indicated cardiac monitoring for Patient 28 occurred on 12/19/24 at 1:57 p.m. During an interview and concurrent record review on 12/26/24 at 10:12 a.m., the EDCNC reviewed Patient 28’s ED record and confirmed Patient 28 arrived in the ED on 12/19/24 at 9:41 a.m. and Patient 28 was placed on a cardiac monitor on 12/19/24 at 1:57 p.m. He stated that it seems like a long time. During an interview on 12/26/24 at 11:16 a.m., the EDCNC confirmed Patient 28 first got in a room on 12/19/24 at 1:57 p.m. and that was the first time he was on continuous cardiac monitoring. He stated in an ideal situation, a patient with a cardiac-related issue will be placed in a room and on a cardiac monitor right after triage. According to “Evidence-based Management of Atrial Fibrillation in the Emergency Department,” dated 4/1/18, indicated the standard care for every patient with atrial fibrillation included, “all patients who are symptomatic, unstable, or have AF with RVR) require a cardiac monitor, oxygen if hypoxic [low levels of oxygen], appropriate IV [intravenous] access, frequent blood pressure monitoring, and application of defibrillation pads.” 2. Review of Patient 20’s History and Physical, dated 11/6/20 indicated the patient was admitted on 10/23/20 and the chief complaint was ventilator-dependent respiratory failure. Review of Patient 20’s Wound Care Note, dated 11/2/20 indicated the patient had a deep tissue pressure injury on the coccyx (bottom of the spine). The note indicated the Assessment/treatment plan was to cleanse with normal saline, apply, sensicare barrier, then cover with mepilex daily and as needed. Patient 20’s nursing documentation was reviewed. There was no documentation that indicated wound dressing changes were done on 11/5/20, 11/7/20, 11/8/20, and 11/9/20. During an interview on 12/24/24 at 10:52 a.m., the wound nurse (WN) stated when the wound nurse sees a patient’s wound, they make recommendations for the treatment plan. She stated if we put in a recommendation, it is expected that the bedside nurse does the daily treatment. The WN verified there was no documentation that indicated wound dressing changes were done on 11/5/20, 11/7/20, 11/8/20, and 11/9/20. Review of the hospital’s policy, Wound Assessment and Management: Vascular, Surgical, and Pressure, dated 6/18/2020 indicated, “Wounds will be assessed with every dressing change ... Every dressing change will include the following assessment: Location, Wound Bed Description.””