Providence St Mary Medical Center

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 47394 Based on observation, interview, and record review, the facility failed to ensure the nursing staff supervised and evaluated the nursing care for one of 34 sampled patients (Patient 21), when the nursing staff did not follow up with the responsible physician for Patient 21’s diet or nourishment (food or nutrients that help patients stay healthy) order from August 9, 2026, at 3:44 PM, through August 11, 2026, at 1:58 PM (1 day and 22 hours without food). This failure had the potential to cause alteration in nutritional or food status which could negatively affect Patient 21’s diet and water status that required for energy, health and healing, and could prolonged hospitalization. Findings: During a review of Patient 21’s “History and Physical” (H&P-a document containing demographic information), dated August 9, 2026, at 3:46 PM, the H&P indicated, Patient 21 was admitted to the facility on August 9, 2026, with the chief complaint of slurred speech. Patient 21 had history of dementia (a condition in which mental ability is interfered with daily life affecting memory, thinking and behavior) and myocardial infraction (an irreversible death of heart muscle due to prolonged lack of oxygen). During a concurrent observation and interview on August 11, 2026, at 10:16 AM, in Patient 21’s room, with Telemetry (a unit where patients are connected to the heart monitors are treated) Manager 1 (TM 1), Patient 21 was observed holding a green color emesis (vomit) bag and was gagging, no intravenous (IV-into the vein) fluid was connected to Patient 21. TM 1 verified and confirmed that Patient 21 had no IV fluids. TM 1 stated, she would verify with the primary Registered Nurse (RN) regarding Patient 21’s nutritional status. During a concurrent interview and record review on August 12, 2026, at 10:30 AM, with the Quality Assurance Registered Nurse (QA RN), Patient 21’s “Physician Order”, dated August 9, 2026, at 3:43 PM, was reviewed. The “Physician Order” indicated, Patient 21 had an order written as “ ...starting diet is Nothing Per Oral (mouth) [NPO] unless otherwise specified, Nurse to place an appropriate diet order for each stage of progression until tolerating indicated diet ...” The QA RN verified and explained, the initial diet order was written as NPO, RN would need to evaluate Patient 21, and advance Patient 21’s diet as appropriate and tolerate. The QA RN stated, she was unable to provide any documented evidence to show the nursing staff’s communication or request to the responsible provider regarding Patient 21’s diet order. A follow-up concurrent interview and record review on August 12, 2026, at 10:32 AM, with the QA RN, Patient 21’s “Intake (amount of food or fluids taken in by the patient) and Output (amount of bodily fluid or excretion)” (I&O), dated August 9, 2026, at 6:28 PM, through August 11, 2026, at 4:06 PM, were reviewed. The I&O, from August 9, 2026, at 6:28 PM, through August 11, 2026, at 4:06 PM, indicated as “0”. The QA RN verified and confirmed the I&O was documented as “0”. During an interview on August 13, 2026, at 11:15 AM, with RN 1, RN 1 stated, it is the responsibility of the RN to follow up on the diet order and clarify the order with the responsible physician when concern arises. During a concurrent interview and record review on August 14, 2026, at 10:08 AM, with TM 1, the facility’s policy and procedure (P&P) titled, “Nursing standard of care-policy”, dated December 2025, was reviewed. The P&P indicated, “ ...Policy: ...Nutritional Assessment: A. Initial nutritional assessment: ... Timing: conduct a nutritional assessment upon admission and during the initial patient evaluation. Reassess as needed based on the changes in patient’s condition or nutritional status .... Components:. Dietary intake: evaluate the patient’s current dietary intake, including type and amount of food consumed. B. Documentation: record keeping: document the nutritional assessments finding in the patient’s medical record, including dietary intake, weight, BMI, any identified nutritional concerns. Updates: update that documentation regularly and whenever there are significant changes in the patient’s nutritional status .... F. Interdisciplinary collaboration: team approach: collaborate with physicians, nurses, dietitians, and other health care providers to address nutritional needs comprehensively”. TM 1 stated, the policy was not followed. TM 1 further stated, RN should have documented the follow up with the physician and the speech therapist (a trained healthcare expert in dealing with patients’ swallowing food and liquids) for Patient 21’s diet order.”

“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: 51269 Based on observation, interview, and record review, the facility failed to ensure medications were administered in accordance with physician orders and accepted standards of practice for three of 34 sampled patients (Patient 2, 4, and 11), when the nursing staff did not document a complete pain assessment before or after pain medication administration. This failure had the potential to place patients at risk for ineffective pain management and had the potential to result in patients’ safety from preventable medication errors with discrepancy, and undetected adverse reactions (unintended response from medication) which could negatively affect patients’ health, safety, prolonged hospitalization, and lead to actual harm or death. Findings: a. During a review of Patient 2’s “ED [Emergency Department] Note-Physician” (ED Note-a doctor’s note that includes reason for visit, history, medical decision making, and treatment provided), dated March 9, 2026, the ED Note indicated, Patient 2 was brought to the facility with right flank pain (pain on the right side of the lower back). During an interview on August 13, 2026, at 11:21 AM, with Registered Nurse (RN 1), RN 1 stated, the nursing staff are expected to do a complete pain assessment before and after pain medication administration which includes the pain score (a number indicating the severity of the pain with 0 being no pain and 10 being the worst pain a patient feels), location of pain, if it radiates (goes somewhere else), and if anything makes the pain better or worse. During an interview on August 13, 2026, at 1:25 PM, with RN 2, RN 2 stated, the nursing staff are expected to do a complete pain right before and after pain medication administration for the continuation of care. RN 2 added that the reassessment for pain depends on the route (how a medication is given), for intravenous (IV-through the vein) it is 15 minutes, for intramuscular (IM- in the muscle) it is 30 minutes, and by mouth (PO) it is an hour. RN 2 stated that the nursing staff are required to reassess to ensure the medication was effective. During a concurrent interview and record review on August 13, 2026, at 1:45 PM, with the Emergency Department Manager (EDM), Patient 2’s “Flowsheet” (part of the electronic health record used to tract patient’s information overtime such as pain, restraints, and medication), dated March 9, 2026, was reviewed. The “Flowsheet” indicated, on March 9, 2026, at 1:55 PM, Patient 2’s pain was assessed with a score of 8 (there was no location). The EDM verified and confirmed Patient 2’s pain assessment. During a follow up concurrent interview and record review on August 13, 2026, at 1:47 PM, with the EDM, Patient 2’s “Medication Administration Record” (MAR- record of the medication given to a patient), dated March 9, 2026, was reviewed. The MAR indicated as follows: On March 9, 2026, at 1:55 PM: Morphine (medication to treat pain) 4 milligram (mg- unit of measurement) IM was administered, On March 9, 2026, at 5:37 PM: hydrocodone-acetaminophen (Norco-a combination of medication to treat pain) 5-325 mg PO was administered. The EDM verified there was no documented evidence that Patient 2’s pain was assessed immediately before Norco was administered and no documented evidence of pain level assessment after receiving Morphine and Norco. The EDM stated it is important to assess pain before the administration of a medication to establish patients’ baseline and one hour after administration to see the effectiveness of the medication. b. During a review of Patient 4’s ED Note, dated April 18, 2026, the ED Note indicated, Patient 4 was brought to the facility with a laceration (a cut or tear to the skin) to the right side of the head after jumping out of a moving vehicle. During an interview on August 13, 2026, at 11:21 AM, with RN 1, RN 1 stated, the nursing staff are expected to do a complete pain assessment before and after the pain medication administration which includes the pain score, location of pain, if it radiates, and if anything makes the pain better or worse. During an interview on August 13, 2026, at 1:25 PM, with RN 2, RN 2 stated, the nursing staff are expected to do a complete pain right before and after pain medication is administered for the continuation of care. RN 2 added that the reassessment for pain depends on the route, for IV it is 15 minutes, for IM it is 30 minutes, and PO it is an hour. RN 2 stated that the nursing staff are required to reassess to ensure the medication was effective. During a concurrent interview and record review on August 13, 2026, at 1:49 PM, with the EDM, Patient 4’s “Flowsheet”, dated April 18, 2026, and MAR, dated April 18, 2026, were review. The “Flowsheet” and MAR indicated as follows: On April 18, 2026, at 3:12 AM: Patient 4’s pain was assessed with a score of 6 to the back of the head, On April 18, 2026, at 3:12 AM: Morphine 2 mg IV was administered. The EDM verified the nursing staff did not reassess Patient 4’s pain within one hour after Morphine was administered. The EDM stated it is important to reassess one hour after administration to see the effectiveness of the medication. c. During a review of Patient 11’s ED Note, dated March9, 2026, the ED Note indicated, Patient 11 was brought to the facility with a left leg pain after a motor vehicle accident. During an interview on August 13, 2026, at 11:21 AM, with RN 1, RN 1 stated, the nursing staff are expected to do a complete pain assessment before and after the pain medication administration which includes the pain score, location of pain, if it radiates, and if anything makes the pain better or worse. During an interview on August 13, 2026, at 1:25 PM, with RN 2, RN 2 stated, the nursing staff are expected to do a complete pain right before and after pain medication is administered for the continuation of care. RN 2 added that the reassessment for pain depends on the route, for IV it is 15 minutes, for IM it is 30 minutes, and PO it is an hour. RN 2 stated that the nursing staff are required to reassess to ensure the medication was effective. During a concurrent interview and record review on August 13, 2026, at 1:51 PM, with the EDM, Patient 11’s “Flowsheet”, dated March 9, 2026, and MAR, dated March ,9, 2026 were review. The “Flowsheet” and MAR indicated as follows: On March 9, 2026, at 1:27 AM: Patient 11’s pain was assessed with a score of 10 (no location documented), On March 9, 2026, at 4:56 AM: Morphine 4 mg IV was administered (3 hours and 29 minutes after pain was assessed). The EDM verified there was no documented evidence that Patient 11’s pain was assessed immediately before Morphine was administered and no documented evidence of pain level assessment after receiving Morphine. The EDM stated it is important to assess pain before the administration of a medication to establish patients’ baseline and one hour after administration to see the effectiveness of the medication. During a follow up concurrent interview and record review on August 14, 2026, at 9:15 AM, with the Emergency Department Director (EDD), the facility’s P&P titled, “Nursing Standard of Care-Policy,” dated December 2025, was reviewed. The P&P indicated “ ...Pain assessment and Reassessment ....components: Assess the intensity, location, quality, duration, and factors that alleviate ...the pain ....Pain reassessments: ....reassessment is recommended to occur at the time of peak effectiveness within 15-60 minutes following treatment (depending on the type of intervention) ...documentation: record all pain assessments and reassessments in the patient’s medical record, including pain score, intervention provided, and response ...” The EDD stated it is important for the nursing staff to document more than just the score of pain to get a “full picture” of the patient’s presentation. The EDD stated that the policy was not followed for patient 2, 4, and 11. The EDD added that it is important to assess the pain before a medication administration to obtain the baseline and after to obtain the effectiveness of the medication.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 47360 Based on interview and record review, the Governing Body (GB- a group of people responsible for the overall direction and management of an organization) failed to provide adequate oversight to ensure a safe and quality of care for a universe of 203 patients admitted on October 9, 2025, when, the GB did not provide oversight of quality improvement measures implemented for high risk medication administration, or ensure an effective safety and quality improvement program of the Massive Transfusion Protocol (MTP - an emergent blood transfusion plan that allows medical professionals to rapidly give a patient large amounts of blood products to treat severe bleeding),the policy and procedure did not include nursing expectations specific to documentation of blood units transfused during an MTP which resulted in inaccurate and incomplete nursing documentation and did not include secondary nurse verification. (Refer to A-0049) The cumulative effect of this systemic problem resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 47360 Based on interview and record review, the facility failed to maintain an effective and ongoing hospital wide, Quality Assessment and Performance Improvement (QAPI) program for 203 of 203 patients, admitted on October 9, 2025, when QAPI failed to monitor, collect and analyze quality data for high alert medication administration, nursing assessments, infection control practices prior to administering medications and Massive Transfusion Protocol (MTP - an emergent blood transfusion plan that allows medical professionals to rapidly give a patient large amounts of blood products to treat severe bleeding). (Refer to A-273). The cumulative effects of these systemic problems resulted in the hospital’s inability to identify problem prone areas and ensure the provision of quality health care and nursing services in a safe environment and had the potential to cause adverse health outcomes (undesirable and harmful effects on someone’s health) which could interfere with the patients’ medical care and may jeopardize the health and safety of patients requiring emergency services.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 47360 Based on interview, and record review, the facility failed to maintain an organized Nursing Services for eight of 39 sampled patients (Patient 1, 3, 16, 20, 23, 35, 36 and Patient 38), as evidenced by: 1. For Patients (16 and 20), licensed nurses failed to perform neurological assessments (neuro check - assesses patient alertness, movement, sensation, coordination, vision, speech and language) every 4 hours as per the policy and procedure and physician orders. (Refer to Tag A-0398) 2. For Patients (35 and 36), Patient medications were carried with the licensed nurse throughout the unit. (Refer to Tag A-0398) 3. For Patients (35 and 36), Patient health information was left visible and accessible on the computer workstations. (Refer to Tag A-0398) 4. For Patient 1, received a 50 milligrams (mg- unit of measurement) of Tenecteplase (a medication that dissolves blood clots, used to treat heart attacks and ischemic strokes [when blood flow to the brain is interrupted by a blood clot]) a ‘high alert’ (medication a drug that carries a high risk of causing significant harm to a patient if there is an error in its use) instead of the ordered dose of 25 mg. (Refer to Tag A-0405) 5. For Patient 36, Registered Nurse 4 (RN 4) did not disinfect the rubber septum of medication vials prior to medication vials entry. (Refer to Tag A-0405) 6. For Patient 36’s medications were left unattended on the workstation by RN 4. (Refer to Tag A-0405) 7. For Patient 3, Massive Transfusion Protocol (MTP - an emergent blood transfusion plan that allows medical professionals to rapidly give a patient large amounts of blood products to treat severe bleeding) nursing documentation was inconsistent with blood product received with start and stop times, there was no documented evidence of two nurse verification, unit blood type and expiration, and discrepancies between physician and nursing charting on how many blood units and type of blood units were transfused. (Refer to Tag A-0410) 8. For Patient 23, MTP nursing documentation of two units transfused was entered 10 hours prior to patient’s arrival to the Emergency Department (ED) and there was no evidence of two nurse verification, unit blood type, and expiration. (Refer to Tag A-0410) 9. For Patient 38, MTP nursing documentation did not include blood product unit number documentation for two units transfused and there was no documented evidence of two nurse verification, unit blood type and expiration. (Refer to Tag A-0410) The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of safe and quality nursing care in a safe environment, medication error, inadequate patient monitoring, and the potential for bleeding, infection, and blood transfusion reaction delayed healing which significantly jeopardized the health and safety of patients.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 47360 Based on interview and record review, the Governing Body (GB - a group of people responsible for the overall direction and management of an organization) failed to identify and ensure a safe environment and provide a quality of care for 203 of 203 patients admitted on October 9, 2025, when the GB did not provide oversight on: 1. For Patient 1, received a 50 milligrams (mg- unit of measurement) of Tenecteplase (a medication that dissolves blood clots, used to treat heart attacks and ischemic strokes [when blood flow to the brain is interrupted by a blood clot]) a ‘high alert’ (medication a drug that carries a high risk of causing significant harm to a patient if there is an error in its use) instead of the ordered dose of 25 mg. 2.For Patient 3, Massive Transfusion Protocol (MTP - an emergent blood transfusion plan that allows medical professionals to rapidly give a patient large amounts of blood products to treat severe bleeding) nursing documentation was inconsistent with blood product received with start and stop times, there was no documented evidence of two nurse verification, unit blood type and expiration, and discrepancies between physician and nursing charting on how many blood units and type of blood units were transfused. 3.For Patient 23, MTP nursing documentation of two units transfused was entered 10 hours prior to patient’s arrival to the Emergency Department (ED) and there was no evidence of two nurse verification, unit blood type, and expiration. 4.For Patient 38, MTP nursing documentation did not include blood product unit number documentation for two units transfused and there was no documented evidence of two nurse verification, unit blood type and expiration. These failures resulted in the facility’s inability to deliver care without GB oversight ,identify and prevent a high risk medication overdose error and monitor the MTP process the policy and procedure did not include nursing expectations specific to documentation of blood units transfused during an MTP which resulted in inaccurate and incomplete nursing documentation and did not include secondary nurse verification and had the potential to cause adverse health outcome such as life threatening bleeding, transfusion reaction, and could negatively affect patients’ health, safety, and/or lead up to death. Findings: During an interview on October 15, 2025, at 9:35 AM, with the Chief of Staff (COS), the survey team’s finding for Patient 1, when nursing failed to scan the medication barcode and a secondary nurse verification prior to administration of a “high-risk” medication resulting in an overdose of Tenecteplase, was discussed. The COS stated that the Tenecteplase medication error was shared with the board. The COS stated, bar-code scanning of medication prior to administration has been a focus for monitoring and the Emergency Department has been at 90% compliance. The COS stated, there is an active departmental investigation into the Tenecteplase medication error and efforts will be put into place once gaps are identified to ensure medication administration safety. The survey team’s finding for Patients 3, 23 and 38, the policy and procedure did not include nursing expectations specific to documentation of blood units transfused during an MTP which resulted in inaccurate and incomplete nursing documentation and did not include secondary nurse verification. The COS stated, the Trauma Medical Director (TMD) reports to the Medical Executive Committee regularly and his reports are reviewed with the Governing Board. The COS stated, the facility’s trauma program is about one year old now and MTP process has been reviewed and revised during that time when gaps are identified. The COS stated, the facility MTP policy and procedure was approved by the facility’s Trauma leadership team, the Medical Executive Committee and then approved by the Governing Board. The COS stated, there are some opportunities to specify processes during MTP administration and with documentation by nursing. The COS stated, the Governing Board is responsible for the oversight of the Quality Assurance and Performance Improvement (QAPI) team. The COS stated, the Governing Board is responsible for patient safety and the quality of care provided by the hospital. During a review of the facility policy and procedure (P&P) titled, “Quality Assurance & Performance Improvement (QAPI) and Patient Safety Plan,” dated April 2025, the P&P indicated, “ ...III. Governance infrastructure: community ministry board: the community ministry board bears ultimate accountability, authority, and responsibility for the quality, safe safety, experience, and value of all patient care services provided by the ministry, including the appointment of the medical staff ...”. During a review of the facility document titled, “Amended and Restated Bylaws of [Name of Hospital],” undated, the document indicated, “ ...10.1 Board Responsibility. The Board shall require: that the Medical and Administrative Staffs prepare and maintain adequate and accurate medical records for all patients, and B the person responsible for each basic and supplemental medical service cause written policies and procedures to be developed and maintained and that such policies be approved by the Board ...”.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 47360 Based on interview and record review the facility failed to provide emergency medical care in a safe setting for one of 39 sampled patients (Patient 1) when, Patient 1, received a 50 milligrams (mg- unit of measurement) of Tenecteplase (a medication that dissolves blood clots, used to treat heart attacks and ischemic strokes [when blood flow to the brain is interrupted by a blood clot]) a ‘high alert’ (medication a drug that carries a high risk of causing significant harm to a patient if there is an error in its use) instead of the ordered dose of 25 mg. This failed practice resulted in Patient 1 receiving two more computerized tomography scans (CT - uses X-rays and a computer to create detailed cross-sectional “slices” of your body, which are then reassembled into a 3D image) to evaluate Patient 1 for bleeding, exposing the patient to more radiation (a high amount of energy, which can lead to tissue damage and long term side effects) and transfer to a secondary hospital for a higher level of care for the increased potential of life threatening bleeding in the brain and internal organs. Findings: During a concurrent interview and record review on October 8, 2025, at 10:50 AM, with Quality Coordinator 1 (QC 1), Patient 1’s “Electronic Medication Administration Record” (eMAR - records medication orders and administration of medication to the patient), dated October 5, 2025, was reviewed. The “eMAR” dated October 5, 2025, at 12:31 PM indicated, Registered Nurse (RN 1) was to give Tenecteplase 25 milligrams (mg - unit of measurement) Intravenous (administered directly into the vein) once. The “Administration Information” dated October 5, 2025, at 12:40 PM indicated Tenecteplase 50mg intravenous injection was administered to Patient 1. QC 1 stated, RN 1 gave Tenecteplase 50mg instead of Tenecteplase 25mg as ordered. QC 1 stated, the documentation includes a second nurse signing off on the medication, but it was signed off 14 minutes after it was documented as administered. QC 1 further stated, there is a comment that the incorrect dose was given by RN 1 and the ED physician was notified. During a concurrent interview and record review on October 8, 2025, at 11:15 AM, with the Emergency Department Manager (EDM), Patient 1’s “eMAR: Administration Information” dated October 5, 2025, was reviewed. The EDM stated, Tenecteplase is a “high-alert” medication and requires two nurses to sign off on the medication before administering. The EDM stated, RN 1 prepared the Tenecteplase and administered the Tenecteplase prior to scanning the medication into the “eMAR” and did not verify with a second nurse resulting in the incorrect dose of Tenecteplase being given. The EDM stated, RN 1 notified the physician and RN 2 performed the dual verification in the “eMAR” and charted the medication error. The EDM stated, the physician ordered a subsequent CT of the brain and CT of the abdomen to evaluate the patient for bleeding to monitor for bleeding, which can be a complication of Tenecteplase, especially since Patient 1 received double the dose intended. The EDM stated, Patient 1 did not develop any bleeding, but did develop angioedema (swelling) to the lips, which is a possible side-effect of Tenecteplase and was transferred to a secondary hospital for a higher level of care, in the event Patient 1 required further neurological intervention related to the potential complications of bleeding. During an observation and interview on October 8, 2025, at 11:53 AM, in the ED medication room, with the Stroke Navigator (SN), Tenecteplase was accessed from the automated medication dispensing machine. The Tenecteplase was removed and noted to be packaged with dosing instructions and directions indicating “MAX DOSE: 25mg”. The SN stated, the Tenecteplase comes in a 50 mg vial that is reconstituted (add a liquid to a powdered medicine to turn it into a usable liquid solution) by the nurse per the manufacturer’s instructions. The SN stated, there is a big sticker on the medication package stating, “MAX DOSE 25mg =5mL”. The SN also provided the “Badge Buddy” (a reference tool that is connected to the hospital identification badge) she was wearing, for Tenecteplase which indicated dosing instructions including “Max Dose: 25mg”. The SN stated, Tenecteplase is a “high-alert medication” because it can cause bleeding in the brain and other organs which can be life-threatening complications. The SN further stated, RN 1 should have referenced the Tenecteplase packaging and “Badge Buddy” which both reflect the facility’s policy and procedure, scanned the medication and verified the dosage with another nurse prior to administering the medication. RN 1 was not available for interview. During a concurrent interview and record review on October 9, 2025, at 3:34 PM, with RN 2, Patient 1’s “Administration Information” dated October 5, 2025, at 12:40 PM, was reviewed. The “Administration Information” indicated, RN 2 cosigned the administration of Tenecteplase 50mg approximately 14 minutes after the medication was actually administered. RN 2 sated, RN 1 had administered the Tenecteplase to Patient 1, before scanning the medication and requesting a second nurse to cosign. RN 2 stated, at that time RN 1 was advised to notify the physician of the medication error and the cosign was completed to ensure proper documentation. RN 2 stated, the Tenecteplase should have been scanned, and a dual nurse should have checked prior to the administration to ensure it was the right patient receiving the right dose, for the right reason at the right time. RN 2 stated, Tenecteplase should always be scanned and verified by a second nurse before administration to the patient because it has a potential to cause bleeding and further complications. During a review of Patient 1’s “ED [Emergency Department] Notes: Medical Decision Making “ ...Patient last known well time at [ 8: 45] this morning. At this time a code stroke was called ...consult of [Name of Neurologist] of tele-neurology (an audio/video conference with a doctor specializing in issues with the brain and nervous system) who did independently evaluate patient ...he did recommend Tenecteplase ....However shortly after the [Tenecteplase] was administered I was advised by the patient’s nurse that she was accidentally given 50 [mg] of Tenecteplase instead of 25 [mg] ...Tele neurology was advised of the situation ...recommended a stat (now) CT as well as a fibrinogen (a protein that helps stop bleeding by helping blood clots to form) level. I also did a CT abdomen pelvis as the patient was having flank pain after the [Tenecteplase] was administered ...[Name of Managed Healthcare Provider] representative ...feels that the patient will need to be transferred to a higher level of care for possible complication ....[Medical Doctor 2] ...did state that he would not be admitting the patient and will need to go to HLOC [higher level of care] ...”. During a review of Patient 1’s “ED Provider Notes”, dated October 5, 2025 from [Facility 2], the “ED Provider Notes” indicated, “ ...no significant improvement in lip swelling and patient with hoarse voice ...therefore as concern for impending airway impingement (blockage of airflow through windpipe to lungs), patient was intubated (a breathing tube placed in the windpipe to provide airflow), patient was intubated for airway protection ...”. During a review of the facility’s P&P titled , “Tenecteplase (TNKase) Intravenous Administration for Acute Ischemic Stroke” dated, October 2025, the P&P indicated, “ ...Tenecteplase 50 mg strength for [Acute Ischemic Stroke] (AIS ([Acute Ischemic Stroke] - when a blood clot blocks the blood supply the brain, cutting off blood flow and oxygen to brain cells). When the 50mg vial size is used for AIS, additional dispensing safeguards should be implemented as appropriate to ensure medication ...B. Preparation (reconstitution) ...Determine the appropriate dose of Tenecteplase based on patient weight and withdraw the correct volume (mL) from the reconstituted vial into the syringe. Discard any unused solution. There should always be waste as the maximum dose is 25 mg ...D. Administration ...6. Tenecteplase is a high-risk medication. Independent double-check and dual MAR cosign are required ...”. During a review of the facility’s P&P titled, “Acute Stroke Management - Primary Stroke Center (PSC)” dated July 2025, the P&P indicated, “ ...ISCHEMIC STROKE PATIENTS RECEVING TENECTEPLASE ...[Tenecteplase] is considered a high-risk medication and requires verification and sign off by 2 caregivers ...”. During a review of the facility’s “education document” titled, “Tenecteplase for Acute Ischemic Stroke” undated, the “education document” indicated, “ ...Before Administering, remember: Dual sign-off/ safety time-out, Complete the 5-rights (5 rights of medication administration: right patient, right drug, right dose, right route, and right time) ...”. During a review of the facility’s P&P “Patient Rights and Responsibilities” revised on August 2023, the P&P indicated, “... Procedure Guidelines: A. Patient Rights, 13. Receive care in a safe setting... .””

“DATA COLLECTION & ANALYSIS CFR(s): 482.21(a), (b)(1),(b)(2)(i), (b)(3) (a) Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes ... (2) The hospital must measure, analyze, and track quality indicators ... and other aspects of performance that assess processes of care, hospital service and operations. (b)Program Data (1) The program must incorporate quality indicator data including patient care data, and other relevant data such as data submitted to or received from Medicare quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions. (2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and .... (3) The frequency and detail of data collection must be specified by the hospital’s governing body. This Standard is not met as evidenced by: 47360 Based on interview and record review, the Quality Assessment and Performance Improvement (QAPI) program failed to monitor, collect and analyze quality data for 203 of 203 patients admitted on October 9, 2025 when 1. For Patients (16 and 20), licensed nurses failed to perform neurological assessments (neuro check - assesses patient alertness, movement, sensation, coordination, vision, speech and language) every 4 hours as per the policy and procedure and physician orders. 2. For Patients (35 and 36), Patient medications were carried with the licensed nurse throughout the unit. 3. For Patients (35 and 36), Patient health information was left visible and accessible on the computer workstations. 4. For Patient 1, received a 50 milligrams (mg- unit of measurement) of Tenecteplase (a medication that dissolves blood clots, used to treat heart attacks and ischemic strokes [when blood flow to the brain is interrupted by a blood clot]) a ‘high alert’ (medication a drug that carries a high risk of causing significant harm to a patient if there is an error in its use) instead of the ordered dose of 25 mg. 5. For Patient 36, Registered Nurse 4 (RN 4) did not disinfect the rubber septum of medication vials prior to medication vials entry. 6. For Patient 36’s medications were left unattended on the workstation by RN 4. 7. For Patient 3, Massive Transfusion Protocol (MTP - an emergent blood transfusion plan that allows medical professionals to rapidly give a patient large amounts of blood products to treat severe bleeding) nursing documentation was inconsistent with blood product received with start and stop times, there was no documented evidence of two nurse verification, unit blood type and expiration, and discrepancies between physician and nursing charting on how many blood units and type of blood units were transfused. 8. For Patient 23, MTP nursing documentation of two units transfused was entered 10 hours prior to patient’s arrival to the Emergency Department (ED) and there was no evidence of two nurse verification, unit blood type, and expiration. 9. For Patient 38, MTP nursing documentation did not include blood product unit number documentation for two units transfused and there was no documented evidence of two nurse verification, unit blood type and expiration. These failures resulted in the hospital’s inability to identify problem prone areas (likely to cause errors) and ensure the provision of quality health care and nursing services in a safe environment and four patients (Patient 1) receiving an overdose of Tenecteplase a high alert medication, incomplete with documentation discrepancies related to MTP for three patients and had the potential to cause preventable adverse health outcomes that could negatively affect patient’s health and safety who sought care in the facility. Findings: During a review of the facility document titled, “Quality & Patient Safety Council (QPSC)” dated August 19, 2025, the document indicated, “ ...Patient Safety Event Reporting and Follow-up ...presented on patient safety event reporting, emphasizing the importance of complete documentation ...”. The document did not include mention of “high alert” medication or MTP. During an interview on October 15, 2025, at 10:30 AM, with the Director of Quality (DOQ), the following potential finding was reviewed. - For Patient 1, when nursing failed to scan the medication barcode and a secondary nurse verification prior to administration of a “high-risk” medication resulting in an overdose of Tenecteplase. Additionally discussed about the missing nursing assessments, vital signs check, and infection prevention practices during medication administration. The DOQ stated, leadership was currently performing a root cause analysis (RCA - a problem-solving method that focuses on finding the fundamental reason a problem occurred) regarding the Tenecteplase overdose. The DOQ stated, pharmacy monitors medication errors through the event reporting system and address any issues noted to see if there are gaps in the process that need to be addressed. The DOQ stated, she knows the pharmacy is monitoring bar-code scanning of medication, which is currently 90-95 percent (%) in the Emergency Department (ED), rather than override of the bar code scanning during medication administration. The DOQ stated there is no current monitoring related specifically to high alert medications. The DOQ further stated, there are no documented observation-based audits related to “high alert medication” or dual nurse sign off. During a continued interview on October 15, 2025, at 10:40 AM, with the DOQ, the following potential finding was reviewed. - For Patients 3, 23 and 38, the policy and procedure did not include nursing expectations specific to documentation of blood units transfused during an MTP which resulted in inaccurate and incomplete nursing documentation and did not include a secondary nurse verification. The DOQ stated, 100% of all trauma cases in the ED are reviewed by the trauma staff. The DOQ stated, the focus is on the entire trauma response and outcome, but not specific to MTP. The DOQ stated that focus was shifted to the MTP process and documentation during this survey when inaccurate charting and discrepancies were found in Patient 3, 23, and 38’s MTP charting. The DOQ stated, prior to the survey, there were no documented observational audits of blood unit checks by two nurses. The DOQ stated, there were no audits for MTP documentation because the charting is difficult to follow and prior to the complaint the facility had not have any issues noted with the MTP process. During a review of the facility’s policy and procedure (P&P) titled, “Quality Assurance & Performance Improvement (QAPI) and Patient Safety Plan,” dated April 2025, indicated, “ ... The Quality Division ... In collaboration with the Pharmacy and Nursing Departments, oversees the routine collection and analysis of patient safety data. Additionally, focused patient safety teams and work groups are charged by the Quality Counsel ... to collect data, perform analyses and trending, draw conclusions, and make recommendations aimed at improving patient safety. Trending of adverse events, environmental safety issues, aggregate data collection and review of sentinel events in similar organizations are part of proactive identification and management of risks to patient safety and are used to prevent similar occurrences ...””

“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: 47360 Based on interview and record review, the facility failed to ensure licensed nurses followed and implemented the nursing policy and procedures (P&P) for four of 39 sampled patients (Patient 16, 20, 35, 36) when: 1. Nursing failed to perform neurological assessments (neuro check - assesses patient alertness, movement, sensation, coordination, vision, speech and language) per physician orders for two patients (Patient 16 and 20). This failure had the potential to delay in identification of a change in patient condition and medical intervention, which could lead to worsening of patient condition. 2. Patient medications were carried with the licensed nurse throughout the unit for two observed patients (Patients 35 and 36). This failure had the potential to cause medication errors and possible medication diversion (when a medication is taken for use by someone other than whom it is prescribed). 3. Patient health information was left visible and accessible on the computer workstations for two of observed patients (Patient 35 and 36). This failure had the potential for unauthorized access to confidential patient health information. Findings: 1a. During a review of Patient 16’s “Face Sheet” (includes patient demographics and admission information), dated October 8, 2025, the “Face Sheet” indicated, Patient 16 was admitted to the telemetry (continuously monitoring a patient’s vital signs, such as heart rate, blood pressure, and oxygen saturation, using wireless technology) unit for evaluation of left-sided numbness. During a concurrent interview and record review on October 13, 2025, at 10:30 AM, with the Quality Coordinator (QC 1), Patient 16’s “Orders,” dated October 8, 2025, at 4:59 PM, was reviewed. The “Orders” indicated Patient 16 was admitted on October 8, 2025, at 4:59 PM, and discharged on October 9, 2025, at 2:33 PM, with an order to have “neuro checks with vital signs”. The QC 1 stated, since Patient 16 was admitted to the telemetry unit, Patient 16 would require vital sign monitoring and documentation every four hours, and neuro checks would need to be performed every four hours as well. During a continued, concurrent interview and record review on October 13, 2025, at 10:33 AM, with the QC 1, Patient 16’s “Assessment Flowsheet”, dated October 8, 2025 - October 9, 2025, was reviewed. The “Assessment Flowsheet” indicated, neuro checks completed during Patient 16’s admission to the facility occurred at the following times: October 8, 2025, at 5:09 PM October 9, 2025, at 3:15 AM (10 hours after the previous assessment) October 9, 2025, at 10:18 AM (7 hours from the previous assessment) QC 1 stated, there should have been neuro checks completed every four hours for Patient 16, but the chart reflected that the neuro checks were only being done once a shift and not with vital signs as specified in Patient 16’s orders. 1b. During a review of Patient 20’s “Face Sheet”, dated October 8, 2025, the “Face Sheet” indicated, Patient 20 was admitted to telemetry with the diagnosis of transient ischemic attack (TIA - a temporary episode of stroke-like [an interruption of blood flow to the brain] symptoms, such as numbness, weakness, or confusion, that lasts a few minutes to up to 24 hours before completely resolving). During a concurrent interview and record review on October 13, 2025, at 1:45 PM, with the QC 1, Patient 20’s “Orders,” dated October 8, 2025, at 8:33 AM, was reviewed. The “Orders” indicated Patient 20 was admitted on October 8, 2025, at 8:33 AM, was discharged on October 9, 2025, at 9:07 PM, and was ordered to have “neuro checks with vital signs”. The QC 1 stated that Patient 20 was admitted to the telemetry unit, so Patient 20 would require vital sign monitoring and documentation every four hours which would require neuro checks to be completed every four hours as well. During a continued, concurrent interview and record review on October 13, 2025, at 1:48 PM, with the QC 1, Patient 20’s “Assessment Flowsheet,” dated October 8, 2025, to October 9, 2025, was reviewed. The “Assessment Flowsheet” indicated, neuro checks completed during Patient 20’s admission to the facility occurred at the following times: October 8, 2025, at 9:05 AM October 8, 2025, at 3:15 PM (6 hours from the previous assessment) October 8, 2025, at 10:34 PM (7 hours from previous assessment) October 9, 2025, at 9:11 A M (11 hours from previous assessment) QC 1 stated, Patient 20 was admitted to the telemetry unit and there should have been neuro checks completed every four hours, but the “Assessment Flowsheet” shows the neuro checks were not done every four hours with vital signs per physician’s orders. During a concurrent interview and record review on October 15, 2025, at 8:51 AM, with Registered Nurse 5 (RN5), the facility’s policy and procedure (P&P) titled, “Vital Signs” dated February 2023, was reviewed. The “P&P” indicated, “ ...Purpose: To establish guidelines for monitoring vital signs ...C. Vital signs will be recorded in the EMR [electronic medical record]. D. The standard times for vital signs to be taken are as follows: 1. Ordered routine, or no specific order: a. 0800, b.1600, c. 2100 ...2. Vitals ordered every four (4) hours are as follows: a. 0800, b. 1200, c. 1600, d. 2000, e. 2400 - optional; Dependent upon condition of patient f. 0400 ...” RN 5 stated, patients admitted to telemetry require vital signs to be checked and documented every four hours on the schedule mentioned in the P&P. RN 5 stated, when neuro-checks are ordered by the physician to be completed with vital signs, then it is expected that the patient will have a neuro check performed and documented by nursing every four hours. RN 5 stated, a neuro check includes assessing the level of consciousness [alertness], assessment of extremities for movement, strength and sensation, speech and the National Institutes of Health Stroke Scale (NIHSS - an assessment of the neurological system that determines the severity of a stroke). During a review of the facility “P&P” titled, “Assessment - Reassessment Patient Care Policy” dated August 2023, the “P&P” indicated, “ ...D. Reassessment of the patient will be conducted by a Registered Nurse ... 1. The patient shall be reassessed: a. To determine response to medication, treatment and nursing interventions ...c. At unit-specified intervals and protocols ...2. Reassessments shall be documented on nursing documentation in the electronic health record ...” 49613 2a. During a concurrent observation and interview on October 13, 2025, at 11:29 AM, in the Emergency Department (ED) medication room, Registered Nurse 3 (RN 3) prepared an injection of lorazepam (generic for Ativan, a controlled medication to treat anxiety) for Patient 35. RN 3 withdrew one milligram (mg) of lorazepam from the medication vial into a syringe. RN 3 then carried the syringe and empty vial to Patient 35’s bedside. RN 3 stated Patient 35 did not need the medication yet. RN 3 then held the lorazepam syringe and vial in her hand and left Patient 35’s bedside. During an observation on October 13, 2025, at 11:55 AM, in the ED medication room, RN 3 was observed holding a syringe containing clear liquid and an empty lorazepam vial in her hand. During a review of Patient 35’s electronic health record, “face sheet” indicated Patient 35 presented to the ED on October 13, 2025, at 9:41 AM with an admitting diagnosis of diabetic ketoacidosis (DKA, medical emergency due to very high blood sugar). The record indicated physician’s orders, dated October 13, 2025, for lorazepam 1 mg intravenously (IV, into the vein) for one dose. The medication administration record (MAR), dated October 13, 2025, indicated Patient 35 received lorazepam 1 mg IV at 12:03 PM. During an interview on October 13, 2025, at 3:39 PM, RN 3 stated she held Patient 35’s lorazepam syringe and empty vial in her hands from the time she prepared the medication in the ED medication room until the time she administered the medication to Patient 35. RN 3 stated she documented the lorazepam administration in Patient 35’s MAR. During an interview on October 14, 2025, at 11:19 AM, the Director of Pharmacy (DOP) stated nurses were supposed to obtain medications immediately before the time of use. The DOP stated medications not immediately administered to patients needed to be discarded to “alleviate the potential for diversion or contamination.” The DOP acknowledged RN 3 carried Patient 35’s lorazepam syringe and vial for thirty minutes. The DOP further stated RN 3 should have either immediately administered the lorazepam to Patient 35 or wasted the medication. 2b. During an observation on October 13, 2025, at 11:38 AM, in the ED medication room, RN 4 obtained medications for Patient 36, including one vial of methocarbamol (generic for Robaxin, a medication to treat muscle pain) 1000 mg. RN 4 carried the medications to Patient 36’s bedside. During a medication pass observation and interview on October 13, 2025 at 11:48 AM, RN 4 administered two medications to Patient 36 and did not administer methocarbamol. RN 4 stated Patient 36 would get the methocarbamol later. RN 4 placed the methocarbamol vial in her pocket and left Patient 36’s bedside. During a review of Patient 36’s electronic health record, the face sheet and history indicated Patient 36 presented to the ED on October 13, 2025, at 10:38 AM, with back pain. The record indicated physician’s orders, dated October 13, 2025, for methocarbamol 1000 mg IV for one dose. The MAR, dated October 13, 2025, indicated Patient 36 received methocarbamol 1000 mg IV at 12:08 PM. During an interview on October 13, 202,5 at 3:49 PM, RN 4 stated she did not administer methocarbamol to Patient 36 during the medication pass observation. RN 4 further stated she kept the methocarbamol vial until Patient 36 was ready for the medication. During an interview on October 14, 2025, at 12:13 PM, RN 4 stated she carried Patient 36’s methocarbamol in her pocket after the medication pass observation on October 13, 2025. RN 4 stated she then kept the methocarbamol vial with her at the computer workstation until Patient 36 was ready for the medication. During an interview on October 14, 2025, at 12:18 PM, the Emergency Department Manager (EDM) stated if a nurse prepared a medication and did not immediately administer it, they could “maybe” hold the medication for a “couple minutes.” The EDM further stated a nurse should not walk around with or hold onto a medication for an extended time period. The EDM agreed, holding onto medications for an extended time risked a possible medication error. The EDM stated the surveyor’s observations were not consistent with nursing standards of practice. A review of the facility’s policies and procedures (P&P), titled, “Medication - Administration - Policy,” dated June 2023, the P&P indicated: “PURPOSE: To establish safe, effective systems of administration ...of drugs ...” A review of the facility’s P&P, titled, “Storage of Medications - Policy,” dated September 2025, indicated: “ ...Mediations required to meet patient care needs will be removed from secondary storage areas when needed ...” and “ ...Medications shall be maintained in the original packaging provided by Pharmacy during transit and shall not be removed from that packaging until immediately prior to administration ...” and “ ...Should medication need to be returned to the Pharmacy or a secondary storage area ...The medication should be returned to Pharmacy or the secondary storage area as soon as possible ...” 3a. During a concurrent observation and interview on October 13, 2025, at 11:33 AM, in the ED, RN 3 was observed leaving Patient 35’s bedside. Patient 35’s full name, date of birth, medical record number, and active medication orders were visible in the electronic health record (EHR) on the bedside computer screen. The Pharmacy Operations Manager (PM) acknowledged RN 3 had not logged out of the EHR before walking away. During an interview on October 13, 2025, at 3:39 PM, RN 3 stated nurses were supposed to close the EHR before stepping away for “security.” RN 3 acknowledged she did not close Patient 35’s EHR and stated she should have minimized or closed the EHR before she left the computer. 3b. During a concurrent observation and interview on October 13, 2025 at 11:49 AM in the ED, RN 4 was observed leaving Patient 36’s bedside. Patient 36’s full name, date of birth, medical record number, medication orders, and urinalysis (lab results from urine sample) were visible in the EHR on the bedside computer screen. The PM acknowledged RN 4 had not logged out of the EHR before walking away. During an interview on October 13, 2025, at 3:49 PM, RN 4 acknowledged she did not close Patient 36’s EHR. RN 4 stated she was supposed to log out of the EHR or turn off the computer before walking away and she should have done so. During an interview on October 14, 2025, at 10:26 AM, the Director of Quality (DOQ) stated the expectation was for nursing staff to protect patient information so only people involved in the patient’s care had access. The DOQ further stated the expectation was for the nurse to log out of the EHR when leaving the computer workstation. During an interview on October 14, 2025, at 12:14 PM, when asked about nurses leaving Patient 35 and 36’s information visible on the computer, the EDM stated the nurses were supposed to log out of the patients’ EHR. The EDM further stated staff were supposed to log out anytime they walk away from the EHR or their computer. A review of the facility’s P&P, titled, “Administrative Requirements for Protected Health Information Standard - Corresponds to General Privacy Policy,” dated September 2023, the P&P indicated: “ ...entity shall implement privacy procedures that comply with the ...privacy policies ...” and “ ...General Computer Security ...Computer monitors/screens shall be positioned in such a way that confidential information cannot be easily viewed by the general public or others without a need to know ...When computers or other electronic devices are not in use, the user shall log off any application containing confidential information or use password protected screen savers to safeguard against unauthorized access ...””

“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: 47360 Based on observation, interview and record review, the facility failed to ensure nursing staff prepared and administered medications as per accepted standards of practice and hospital policy and procedure (P&P) for two of 39 sampled patients (Patient 1 and 36) when: 1. For Patient 1, received a 50 milligrams (mg- unit of measurement) of Tenecteplase (a medication that dissolves blood clots, used to treat heart attacks and ischemic strokes [when blood flow to the brain is interrupted by a blood clot]) a ‘high alert’ (medication a drug that carries a high risk of causing significant harm to a patient if there is an error in its use) instead of the ordered dose of 25 mg. This failed practice resulted in a preventable medication error for Patient 1 and receiving two more computerized tomography scans (CT - uses X-rays and a computer to create detailed cross-sectional “slices” of your body, which are then reassembled into a 3D image) to evaluate Patient 1 for bleeding, exposing the patient to more radiation (a high amount of energy, which can lead to tissue damage and long term side effects) and transfer to a secondary hospital for a higher level of care for the increased potential of life threatening bleeding in the brain and internal organs. 2a. For Patient 36, Registered Nurse 4 (RN 4) did not disinfect the rubber septum of medication vials prior to medication vials entry. This failure had the potential to expose patients to preventable infections. 2b. Patient 36’s medications were left unattended on the workstation by RN 4. This failure had the potential to result in medication error and diversion. Findings: 1. During a review of Patient 1’s “HPI” [History and Physical Information - contains patient medical history and their current medical issues], dated October 5, 2025, the “HPI” indicated, Patient 1 was brought in by ambulance with a chief complaint of right-sided weakness and slurred speech. During a concurrent interview and record review on October 8, 2025, at 10:50 AM, with Quality Coordinator (QC 1 ), Patient 1’s “Electronic Medication Administration Record” (eMAR - records medication orders and administration of medication to the patient), dated October 5, 2025, was reviewed. The “eMAR” dated October 5, 2025, at 12:31 PM, indicated, Registered Nurse 1 (RN 1 ) was to give Tenecteplase 25 milligrams (mg - unit of measurement) Intravenous (administered directly into the vein) once. The “Administration Information” dated October 5, 2025, at 12:40 PM indicated Tenecteplase 50mg intravenous injection was administered to Patient 1. QC 1 stated, RN 1 gave Tenecteplase 50mg instead of Tenecteplase 25mg as ordered. QC 1 stated, the documentation includes a second nurse signing off on the medication but was signed off 14 minutes after it was documented as administered. QC 1 further stated, there is a comment that the incorrect dose was given by RN 1 and the ED physician was notified. During a concurrent interview and record review on October 8, 2025, at 11:15 AM, with the Emergency Department Manager (EDM), Patient 1’s “eMAR: Administration Information” dated October 5, 2025, was reviewed. The “eMAR: Administration Information” indicated, Tenecteplase 50mg instead of Tenecteplase 25mg as ordered and a comment was added, “ ...incorrect dose given by RN, MD notified ...” and was signed off by a second RN 14 minutes after administration. The EDM stated, Tenecteplase is a “high-alert” medication and requires two nurses to sign off on the medication before administering. The EDM stated, RN 1 prepared the Tenecteplase and administered the Tenecteplase prior to scanning the medication into the “eMAR” and did not verify with a second nurse resulting in the incorrect dose of Tenecteplase being given. The EDM stated, RN 1 notified the physician and RN 2 performed the dual verification in the “eMAR” and charted the medication error. The EDM stated, the physician ordered a subsequent CT of the brain and CT of the abdomen to evaluate the patient for bleeding to monitor for bleeding, which can be a complication of Tenecteplase, especially since Patient 1 received double the dose intended. The EDM stated, Patient 1 did not develop any bleeding, but did develop angioedema (swelling) to the lips, which is a possible side-effect of Tenecteplase and was transferred to a secondary hospital for a higher level of care, in the event Patient 1 required further neurological intervention related to the potential complications of bleeding. During an observation and interview on October 8, 2025, at 11:53 AM, in the ED medication room, with the Stroke Navigator (SN), Tenecteplase was accessed from the automated medication dispensing machine. The Tenecteplase was removed and noted to be packaged with dosing instructions and directions indicating “MAX DOSE: 25mg”. The SN stated, the Tenecteplase comes in a 50 mg vial that is reconstituted (add a liquid to a powdered medicine to turn it into a usable liquid solution) by the nurse per the manufacturer’s instructions. The SN stated, there is a big sticker on the medication package stating, “MAX DOSE 25mg =5mL”. The SN also provided the “Badge Buddy” (a reference tool that is connected to the hospital identification badge) she was wearing, for Tenecteplase which indicated dosing instructions including “Max Dose: 25mg”. The SN stated, Tenecteplase is a “high-alert medication” because it can cause bleeding in the brain and other organs which can be life-threatening complications. The SN further stated, RN 1 should have referenced the Tenecteplase packaging and “Badge Buddy” which both reflect the facility’s policy and procedure, scanned the medication and verified the dosage with another nurse prior to administering the medication. RN 1 was not available for interview. During a concurrent interview and record review on October 9, 2025, at 3:34 PM, with RN 2, Patient 1’s “Administration Information” dated October 5, 2025, at 12:40 PM, was reviewed. The “Administration Information” indicated, RN 2 cosigned the administration of Tenecteplase 50mg approximately 14 minutes after the medication was actually administered. RN 2 sated, RN 1 had administered the Tenecteplase to Patient 1, before scanning the medication and requesting a second nurse to cosign. RN 2 stated, at that time RN 1 was advised to notify the physician of the medication error and the cosign was completed to ensure proper documentation. RN 2 stated, the Tenecteplase should have been scanned, and a dual nurse should have checked prior to the administration to ensure it was the right patient receiving the right dose, for the right reason at the right time. RN 2 stated, Tenecteplase should always be scanned and verified by a second nurse before administration to the patient because it has a potential to cause bleeding and further complications. During a review of Patient 1’s “ED [Emergency Department] Notes: Medical Decision Making “ ...Patient last known well time at [8: 45] this morning. At this time a code stroke was called ...consult of [Name of Neurologist] of tele-neurology (an audio/video conference with a doctor specializing in issues with the brain and nervous system) who did independently evaluate patient ...he did recommend Tenecteplase ....However shortly after the [Tenecteplase] was administered I was advised by the patient’s nurse that she was accidentally given 50 [mg] of Tenecteplase instead of 25 [mg] ...Tele neurology was advised of the situation ...recommended a stat (now) CT as well as a fibrinogen (a protein that helps stop bleeding by helping blood clots to form) level. I also did a CT abdomen pelvis as the patient was having flank pain after the [Tenecteplase] was administered ...[Name of Managed Healthcare Provider] representative ...feels that the patient will need to be transferred to a higher level of care for possible complication ....[Medical Doctor 2] ...did state that he would not be admitting the patient and will need to go to HLOC [higher level of care] ...”. During a review of Patient 1’s “ED Provider Notes”, dated October 5, 2025 from [Facility 2], the “ED Provider Notes” indicated, “ ...no significant improvement in lip swelling and patient with hoarse voice ...therefore as concern for impending airway impingement (blockage of airflow through windpipe to lungs), patient was intubated (a breathing tube placed in the windpipe to provide airflow), patient was intubated for airway protection ...”. During a review of the facility’s P&P titled , “Tenecteplase (TNKase) Intravenous Administration for Acute Ischemic Stroke” dated, October 2025, the P&P indicated, “ ...Tenecteplase 50 mg strength for AIS ([Acute Ischemic Stroke] - when a blood clot blocks the blood supply the brain, cutting off blood flow and oxygen to brain cells). When the 50mg vial size is used for AIS, additional dispensing safeguards should be implemented as appropriate to ensure medication ...B. Preparation (reconstitution) ...Determine the appropriate dose of Tenecteplase based on patient weight and withdraw the correct volume (mL) from the reconstituted vial into the syringe. Discard any unused solution. There should always be waste as the maximum dose is 25 mg ...D. Administration ...6. Tenecteplase is a high-risk medication. Independent double-check and dual MAR cosign are required ...”. During a review of the facility’s P&P titled, “Acute Stroke Management - Primary Stroke Center (PSC)” dated July 2025, the P&P indicated, “ ...ISCHEMIC STROKE PATIENTS RECEVING TENECTEPLASE ...[Tenecteplase] is considered a high-risk medication and requires verification and sign off by 2 caregivers ...”. During a review of the facility’s “education document” titled, “Tenecteplase for Acute Ischemic Stroke” undated, the “education document” indicated, “ ...Before Administering, remember: Dual sign-off/ safety time-out, Complete the 5-rights (5 rights of medication administration: right patient, right drug, right dose, right route, and right time) ...”. 32097 2a. A review of Patient 36’s “face sheet” indicated, Patient 36 was admitted on October 13, 2025, due to multiple medical problems including acute cystitis with hematuria (a condition characterized by inflammation of the bladder accompanied by blood in the urine). On 10/13/25, at 11:35 AM, in the Emergency Department (ED), RN 4 was observed during Patient 36’s medication administration process in the presence of the Director of Quality, Pharmacy Operation Manager and the ED Manager (EDM). RN 4 pulled the following medications from the automated dispensing cabinet: One vial of cefepime 2 grams (gm) (antibiotic used to treat infection), One vial of methocarbamol 1000 milligram (mg) per 10 milliliters (ml) (used to relax the muscles), One vial of ondansetron 4 mg per 2 ml (used to prevent/treat severe nausea and vomiting), two vials of sterile water for injection 10ml and one sodium chloride 100 ml mini bag plus. RN 4 took the medications to Patient 36’s bedside which was in the hallway, next to computer workstation on wheels (WOW). RN 4 placed the medications on the WOW. RN 4 removed cefepime 2 gm vial cap and sterile water for injection 10 ml x 2 vials caps. RN then withdrew 10 ml sterile water from each of the two vials without disinfecting the rubber septum prior to entry and injected 20 ml sterile water into the cefepime vial without disinfecting the cefepime vial rubber septum prior to entry. RN 4 agitated the cefepime vial to dissolve the powder, withdrew the reconstituted medication and administered it to Patient 36. RN 4 then removed ondansetron 4 mg/2ml cap and withdrew the solution without disinfecting the rubber septum of the vial prior to entry. RN 4 administered ondansetron to the patient. During an interview on 10/13/25 at 3:49 PM, RN 4 stated the vials are covered with a cap, so it was not necessary to wipe the rubber stopper with alcohol swab. Then she said maybe she should have wiped but was not sure. RN 4 said she probably should have wiped the vial tops with alcohol but acknowledged she did not do it for the medication pass observed. During an interview on 10/14/25 at 12:15 PM, the EDM stated her expectation is once the cap is removed from the vial, the top should be “scrubbed” with alcohol prior to inserting a needle and withdrawing medication. During an interview on 10/14/25 at 3:26 PM, the Director of Education/Chief Nurse stated all clinicians including RN 4, go through medication administration training including hands on training including intravenous medication preparation and compounding as part of competencies. She stated nurses should use aseptic techniques whether they are reconstituting or compounding intravenous medication. The medication vial septum should be disinfected once the cap is removed. She said “absolutely” when asked if wiping the vial top before withdrawing solution for injection is nursing standard of practice. She stated the hospital follows Lippincott nursing standard of practice. Review of the hospital’s Policy titled “Medication Administration” last revised 6/2023, the P&P indicated “... to disinfect the vial’s rubber septum before piercing by wiping (and using friction) with a sterile 70 % isopropyl alcohol, ... or other approved antiseptic swab. Allow the septum to dry before inserting a needle or other device into the vial.” Review of Lippincott Solutions (Nursing standard of practice implemented in the hospital) provided by hospital titled “IV Solution Preparation, Adding Medications to the Containers” last reviewed on 9/2025, indicated “... For medication from a vial: remove the lid from the medication vial. Perform a vigorous mechanical scrub of the vial stopper using an alcohol pad. Allow it to dry completely. If you must dilute the medication, perform a vigorous mechanical scrub of the port of the diluent container using an alcohol pad, allow it to dry completely, and then withdraw the necessary volume of diluent.” Review of American Journal of Infection Control (a nationally recognized journal whose articles are peer-reviewed covering clinical topics as well as original research) dated 53 (2025) 990-991, indicated to disinfect the diaphragms (septum) of medication vials with sterile 70% alcohol using friction for 15 seconds and allow them to dry prior to each entry. This includes after removing the cap of the vial, as the cap is considered a dust cover. b. During an observation on 10/13/25, at 11: 35 AM, RN 4 left Patient 36’s medications on WOW and went to the nursing station and did not ask anyone to watch the medications. RN 4 returned, dropped off supplies on the WOW, then left the medications on WOW again and went into another room for gloves. RN 4 then prepared the medications and administered them to Resident 36. During an interview on 10/13/25 at 3:49 PM, RN 4 acknowledged she left the medications unsupervised when she went to obtain the green cap and also the gloves, RN 4 stated she should have watched the medications the whole time. During an interview on 10/14/25 at 11:03 AM, the DOP stated medications should not be left unattended; medication errors and diversions are of concern if left unattended. The DOP stated the nursing staff need to maintain security, maintain chain of custody, and that medications should always be watched. The DOP acknowledged the nurse dropping the medications on the workstation and leaving the workstation did not count as continuous visual observation per policy. Review of the hospital’s Policy titled “Storage of Medication” last revised 9/2025, indicated “... medications will be maintained in a secure manner during in transit storage. For the purposes of this policy, “secure” mean any one of the following: Physically maintaining control of the medication on the staff member’s person until administration. Placing the medication on or in an area that is under continuous visual observation of authorized staff ....””

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 47360 Based on observation, interview and record review, the facility failed to verify and record transfused blood products during Massive Transfusion Protocol (MTP - an emergent blood transfusion plan that allows medical professionals to rapidly give a patient large amounts of blood products to treat severe bleeding) activation per the standards of care for three of 39 sampled patients(Patient 3, 23, and 38) when: 1. For Patient 3, MTP nursing documentation had inconsistencies with blood product received with start and stop times, there was no documented evidence of two nurse verification, unit blood type and expiration, and discrepancies between physician and nursing charting on how many blood units and type of blood units were transfused. 2. For Patient 23, MTP nursing documentation of two units blood transfused was documented 10 hours prior to patient’s arrival to the Emergency Department (ED) and there was no documented evidence of two nurse verification, unit blood type, and expiration. 3. For Patient 38, MTP nursing documentation did not include blood product unit number for two units transfused and there was no documented evidence of two nurse verification, unit blood type and expiration. These failed practice s resulted in inaccurate documentation, prevented rapid reconciliation of total numbers and type of blood products were used and what was returned to the blood bank during these MTP events which caused confusion on the number of blood product units patients received during MTP, and the potential for patients to receive the wrong blood product which could result in a blood transfusion reaction. Findings: 1. During a review of Patient 3’s “History and Physical” (H&P - document containing patient history and plan for treatment), dated September 28, 2025, the “H&P” indicated, Patient 3 presented to the ED by ambulance after a motor vehicle collision (MVC) with injuries including fractures to right arm and leg, multiple rib fractures and a pneumothorax (collapsed lung). The document further stated, “ ...MTP was ...initiated soon after arrival. In total he [Patient 3] received 5 [units] (u - unit of measurement) PRBC [Packed Red Blood Cells- a concentrated bag of red blood cells, collected from a donor, which are the part of your blood that carries oxygen throughout your body], 4 [units] FFP [Fresh Frozen Plasma (Plasma - part of blood that is collected from a donor, separated from the blood cells, that helps the blood clot)] and 1[unit] Plt [Platelets -disc-shaped cell fragments in your blood that clump together to form a clot and stop bleeding] prior to transported to the OR [operating room] ...” During a concurrent interview and record review on October 9, 2025, at 11:45 AM, with Quality Coordinator 1, Patient 3’s “ED Notes,” dated September 28, 2025, from 6:28 PM through 8:07 PM, were reviewed: The “ED Notes”, time stamped at 6:28 PM, indicated the following units were given to Patient 3: - W125625091938 - PRBC’s Started [6:02 PM] Ended: [6:12 PM] the documentation did not include blood type, expiration date, or second nurse verification of the unit. - W125625090767 - PRBC’s Started [6:12 PM] Ended: [6:18 PM] the documentation did not include blood type, expiration date, or second nurse verification of the unit. - W125625091087 - Platelets Started [6:17 PM] Ended [6:24 PM] the documentation did not include blood type, expiration date, or second nurse verification of the unit. The “ED Notes”, time stamped at 6:38 PM, indicated the following units were given to Patient 3: - Platelet unit W044625335287 Started [6:38 PM] there was no documented evidence to indicate the transfusion “Ended” time. The “ED Notes”, time stamped at 8:07 PM, indicated the following units were given to Patient 3: - PRBC Unit #W125625091045 Finished [6:51 PM] (there was no documented start time) - [Plasma] Unit #W125625092521 Finished [6:43 PM] (there was no documented start time) - Platelet Unit #W125625078432 Started [7:32 PM] Finished [7:49 PM] - PRBC Unit #W125625091705 Started [7:51 PM] Finished [7:55 PM] - Plasma Unit #W044625321003 Started [7:55 PM] Finished [7:57 PM] QC 1 stated, there was missing documentation 1 units stop time and 2 units start time. QC 1 stated, there was a discrepancy between the number of units transfused per the physicians note and nursing notes of Patient 3. QC 1 verified and confirmed as per physician note of 5 units PRBC, 4 Units Plasma and 1 unit Platelets, whereas as per the nursing notes and nursing documentation indicated of 4 units PRBC, 2 units Plasma and 3 units Platelets. QC 1 stated, there was no documented evidence to indicate blood type expiration date or dual nurse verification of these units. QC 1 further stated, there were no other notes in Patient 3’s chart related to the MTP and would need to follow-up with the blood bank for further information. During a continued interview and record review on October 9, 2025, at 3:15 PM, with the Trauma Nurse Navigator (TNN) and the Trauma Medical Director (TMD), Patient 3’s “ED Notes” and “Emergency Blood Release for Massive Transfusion,” dated September 28, 2025, were reviewed. The TNN stated, the expectation by nursing was to chart the unit blood number and start and stop times in the chart, there is no policy with specifics related to charting by nursing. The TNN stated, the House Supervisor (HS) and Registered Nurse caring for the patient should reconcile which units are given and which are returned to the blood bank. During a concurrent interview and record review on October 15, 2025, at 9:00 AM, with the Blood Bank Team Lead (BBTL), Patient 3’s “Emergency Blood Release for Massive Transfusion,” dated September 28, 2025, was reviewed. The “ED Notes” dated September 28, 2025, were reconciled with the “Emergency Blood Release for Massive Transfusion” dated September 28, 2025. The “Emergency Blood Release for Massive Transfusion” indicated the following 2 units in the “ED Notes” were documented as the wrong type of blood unit: - W044652335287 was charted to be a Platelet unit but was a unit of Plasma. - W125625091087 was charted to be a Platelet unit but was a unit of Plasma. The BBTL stated, there was a documentation error with 2 of the units in the “ED Notes”. The BBTL stated it did take further investigation through the facility’ s [Name of electronic blood bank system] to reconcile the number of units Patient 3 was issued during the MTP and which units were returned because the documentation was unclear in Patient 3’s chart. The BBTL stated, there was no handwritten charting on Patient 3 ‘s “Emergency Blood Release for Massive Transfusion” which units were transfused and which were returned to the blood bank. 2. During a review of Patient 23’s “Face Sheet” the “Face Sheet” indicated Patient 23 was admitted to the facility’s trauma center emergency department on October 2, 2025, at 7:36 PM. During a review of Pati ent 23’s “Provider note,” dated October 2, 2025, at 7:38 PM, the “Provider Note” indicated, Patient 23 arrived to the ED after being struck by vehicle while crossing the street. Patient 23 suffered bilateral pneumothoraxes (both lungs collapsed), a right flank hematoma (bruising) and multiple right rib fractures (broken bone) and Patient 23 received massive transfusion protocol. The “Provider Note” did not include the number or type of blood units administered to Patient 23. During a concurrent interview and record review on October 13, 2025, at 3:00 PM, with QC 1, Patient 23’s “ED Notes Addendum,” dated October 2, 2025, at 11:34 AM, was reviewed. The “ED Notes Addendum” indicated, “ ...PRBC unit W125625091024 started at 2300 [11:00 PM] ended at 2321 [11:21 PM]; PRBC unit W125625085040 started at 2303 [11:03 PM] ended 2323 [11:23 PM] ...” QC 1 stated, since this note was entered prior to Patient 23’s accident and arrival to the ED, the time entered on the note was an error and inaccurate. QC 1 further stated, there was no documented evidence of two nurse verification of the units, unit blood type or expiration date of transfused units. During a continued concurrent interview and record review on October 13, 2025, at 3:07 PM, with QC 1, Patient 23’s “ED Notes,” dated October 2, 2025, related to MTP transfusions, were reviewed. The “ED Notes”, time stamped at 9:04 PM, indicated the following units were given to Patient 23: - 1ST UNIT PRBC W125625092227 START [7:45 PM] STOP [8:12 PM]. - 2ND UNIT PRBC W125625084708 START [7:47 PM] STOP [8:14 PM] - 1ST UNIT [Plasma] W125625078432 START [8:17 PM] STOP [8:40 PM] The “ED Notes”, time stamped 9:25 PM, indicated the following units were given to Patient 23: - 2ND UNIT [Plasma] W12625059108 START [9:06 PM] STOP [9:20 PM] - 1 UNIT PLATELET W12625086836 START [9:10 PM] STOP [9:26 PM] QC 1 stated there was no documented evidence of two nurse verification of the units, unit blood type or expiration date of transfused units. 3. During a review of Patient 38’s “Trauma H&P,” dated September 18, 2025, the “Trauma H&P” indicated Patient 38 presented to the ED by ambulance on September 17, 2025, at 11:39 PM, after suffering a gunshot wound (GSW) to the face. Patient 38 was intubated (tube placed in a patient’s windpipe to assist with breathing) and hemodynamically stabilized (a person’s blood flow and blood pressure are normal, and their body is getting enough oxygen and nutrients) and transferred to a secondary hospital for a higher level of care. During a concurrent interview and record review on October 15, 2025, at 9:14 AM, with the BBTL, Patient 38’ s “ED notes,” dated September 17, 2025, at 11:40 PM, was reviewed. The “ED Notes” indicated “Tier 1 Trauma “(the highest-level, absolute worst and most complex physically injured patient that requires a specialized team) at time called, code MTP called ... [12:08 AM] 1 unit PRBC started ... [12:17 AM] 1st unit PRBC finished ... [12:19 AM] 1 unit [Plasma] started W125625073069 [12:20 AM] 1st unit [Plasma] Finished ...[12:30 AM] 2nd unit PRBC started ...[12:32] 2nd unit PRBC finished ...[12:32 AM] 2nd unit [Plasma] start W125625080108 ...[12:33 AM] 2nd FFP done ...”. The BBTL stated, the two PRBC units administered during the MTP did not include a unit number in the charting. The BBTL stated, there were four PRBC units released during the MTP per protocol. The BBTL stated, the nursing documentation did not identify which units were transfused and which units were returned to the blood bank. The BBTL stated, a report was run through the [electronic blood bank system] to identify which units were transfused and which were returned to the blood bank. The BBTL stated she did identify which PRBC units were used: W125645083076 and W125625077055. During an observation a nd interview on October 9, 2025, at 9:50 AM, in the ED Bed 1, with Registered Nurse 6 (RN 6), a mock Tier 1 trauma with MTP was initiated. RN 6 was the scribe while a secondary nurse verified patient and the blood product units. RN 6 stated, during an MTP, the blood is received emergently, therefore, nurses are unable to scan each unit into the “Electronic Health Record” (EHR), therefore each transfused blood unit number and start and stop times are documented in the “ED Notes”. RN 6 stated, there are times when a scrap piece of paper is used with the blood unit number stickers (attached to each unit of blood) to help with transcribing the blood unit number into the notes, but the paper is not a formal document and is discarded after the MTP. RN 6 stated, the orders for the specific units are not in the “EHR” and cannot be scanned. RN 6 further stated, it is not a requirement to have the nurse that is providing the read back to sign off on the patient chart that blood was dually verified with another nurse the unit type or blood type. RN 6 stated, the importance of verifying units and ensuring accurate documentation is to prevent the wrong patient from getting the wrong blood products which could cause a blood transfusion reaction, causing further organ damage and to track what units the patient received for continuation of care. During an interview and record review on October 9, 2025, at 3:00 PM, with Trauma Medical Director (TMD) and the Trauma Nurse Navigator (TNN), the facility policy and procedure (P&P) titled, “Massive Transfusion Protocol (MTP) - Adult,” dated February 2025, was reviewed. The P&P indicated, “ ...H. Monitor and Document on “Code MTP” Documentation 1. Times and volumes of colloids, crystalloids, blood, and drugs infused ...3. MTP tracking form to be filled out and returned to the blood [bank] ...The nurse checking the units of blood is responsible for filling in the tracking form ...”. The policy did not include any other expectations regarding process for checking blood units or expectation with regard to charting of blood products transfused in the patient’s chart. The TNN stated, the MTP tracking form, is the “Emergency Blood Release for Massive Transfusion Form” the House Supervisor (HS) uses when retrieving blood from the blood bank. The TNN stated, nursing should be marking units transfused and units returned to the blood bank. The TNN stated, nursing should also be charting unit blood unit numbers with start and stop times in the “ED Notes”. The TNN stated, the documentation of the MTP is not consistent by nursing and there are errors with the charting because staff must type in the information because units are unable to be scanned during an MTP. The TMD stated, the importance of verifying blood units and accurate documentation during an MTP is to ensure the patient receives the right blood products at the right time to prevent blood transfusion reaction, which can be life-threatening. The TMD further stated, it is important to ensure there is tracking of types of units provided during the MTP efforts with regard to the 1:1:1 ratio equal parts plasma, platelets, and packed red blood cells (PRBCs) to a severely hemorrhaging or bleeding patient), which is a standard and works towards stopping the bleeding during a hemorrhagic event. During a review of the facility’s policy and procedure (P&P) titled, “Blood Products - Obtaining and Administration-Protocol,” dated February 2025, the P&P indicated “Purpose: A. To assure that blood products obtained and issued from the Laboratory Blood Bank are accurately dispensed and administered. B. To administer blood to a patient safely and efficiently ...G. Code MTP policy is exempt from this policy ...””

“PHARMACIST SUPERVISION OF SERVICES CFR(s): 482.25(b)(1) §482.25(b)(1) - All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. This Standard is not met as evidenced by: 32097 Based on observation, interview, and record review, the hospital failed to ensure compounding was performed consistent with the hospital’s policy and current United States Pharmacopeia (USP 797 - establishes quality standards for intravenous drug compounding) when one of 39 sampled patients (Patient 37) intravenous (administer into the patient’s vein) vancomycin (an antibiotic used to treat infection) was not compounded in accordance with the hospital policy compounding master formula and as required by USP 797. This failure had the potential to result in medication error. Findings: Patient 37 was admitted on 10/13/25 for multiple medical issues including septic shock (severe sepsis in which the blood pressure fails, and the organs of the body fail to receive sufficient oxygen). During a concurrent observation and interview on October 13, 2025, at 10:29 AM, a bag of vancomycin 2500 milligrams (mg- unit of measurement) in 500 milliliter (ml) sodium chloride 0.9% was observed in refrigerator #1. Closer observation showed vancomycin with expiration date of 10/14/25 was labeled for Patient 37. The Pharmacy Operation Manager stated the vancomycin had been discontinued. Review of Patient 37’s medication orders showed vancomycin 2500 mg in sodium chloride 0.9% 500 ml x one dose, ordered on 10/12/25 in Emergency Department to treat bacteria in the bloodstream. During a concurrent vancomycin compounding record (CR) review and interview on October 13, 2025, at 2:04 PM, the review showed vancomycin CR was missing the diluent. The Pharmacy Operation Manager stated the technician used fluid from the 500 ml sodium chloride 0.9% bag to reconstitute vancomycin vials. Vancomycin master formulation record was then requested. During a concurrent review of vancomycin Master Formulation Record (MFR) provided on October 15, 2025 and interview on October 15, 2025, at 9:14 AM, the Pharmacy Operation Manager acknowledged the hospital did not follow the MFR for Patient 37’s vancomycin compounding. During a follow up interview on October 15, 2025, at 10:50 AM, the Pharmacy Operation Manager verified the pharmacist who signed off the compounded vancomycin should have noticed the missing sterile water diluent in the compounding record. Review of the 2023 USP <797> in the section titled “Master formulation and Compounding Records”, USP <797> indicated a master formulation record (MFR) is a detailed record of procedures that describes how compounded sterile product (CSP) is to be prepared. An MFR must be created for all CSP prepared for more than one patient. Any changes or alterations to the MFR must be approved and documented according to the facility’s policy. MFR must include .... Name, strength or activity, and dosage form of the CSP ... Identities and amount all ingredients; if applicable, relevant characteristics of components ... Complete instructions for preparing the CSP, including equipment, supplies, a description of the compounding steps, and any special precautions .... A compounding record (CR) documents the compounding of each CSP. Review of the hospital’s policy titled “Sterile Compounding Program Policy” last revised September 2024, indicated a master formulation record is developed for all CSPs prepared for more than one patient. Additionally, MFRs must comply with local state board regulations. Amy changes to MFRs must be documented ... USP 797 also requires a compounding record to document the compounding process for individual CSP ...”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 51099 Based on observation, interview, and record review, the facility failed to ensure nursing staff accurately assessed and documented patient condition to support the need for enhanced, continual observation for three of 31 sampled patients (Patients 4, 12, 15) reviewed for sitter (staff member who stays in the patient’s room at all times to watch them closely) /tele-sitter (video camera system that allows staff to watch the patient remotely from a central monitoring station) interventions. This failure had the potential to compromise patient safety by allowing inaccurate assessments to drive care decisions, leading to inappropriate sitter use, delayed interventions, or missed opportunities to prevent patient harm. Findings: 1. During a review of Patient 4’s face sheet (contains demographic and medical information), the face sheet indicated, Patient 4 was admitted to the facility on September 9, 2025, with diagnoses including bilateral knee pain, arthritis (swollen, stiff, painful joints) flare-up (symptoms come back stronger than usual); and difficulty ambulating (walking). During a review of Patient 4’s clinical record, titled “Cognitive/Neuro/Behavioral,” dated September 28 and 29, 2025, it indicated Patient 4 was documented as “Glasgow Coma Scale (GCS - score used to measure how awake and responsive someone is; score 3 is no response, 8 or less is severe brain injury, 15 is fully awake and alert) 15, alert and oriented x4 (knows who they are, where they are, what time it is, and what they are there for), and cooperative.” During a concurrent observation and interview on September 29, 2025, at 10:26 AM, with Nurse Manager 3 (NM 3) in Patient 4’s room, Patient 4 was observed resting in the bed. A tele-sitter was placed at bedside, plugged in and working. NM 3 stated, “Patient is impulsive and gets out of bed without asking.” During a concurrent interview and record review on September 30, 2025, at 10:16 AM, with Quality Management Staff 2 (QMS 2), Patient 4’s clinical record, titled “Safety,” dated September 28 and 29, 2025, was reviewed. “Safety,” indicated Patient 4 had a tele-sitter at bedside. QMS 2 confirmed there was no clinical justification or behavioral description documented in the record to support the need for a tele-sitter. 2. During a review of Patient 15’s face sheet, the face sheet indicated Patient 15 was admitted to the facility on September 28, 2025, with diagnoses including dizziness and fall with head contusion (bruise). During a review of Patient 15’s clinical record, titled “Adult Patient Care Summary (PCS - shows most important information about the patient),” dated September 29, 2025, the PCS indicated Patient 15 was documented as “Within Defined Limits (WDL - every single part of the assessment is normal, and in the expected, healthy range)” under neuro and behavioral assessments. During a concurrent observation and interview on September 29, 2025, at 10:48 AM, with NM 2 in Patient 15’s room, Patient 15 was observed resting in bed with a sitter at bedside. NM 2 stated, “Patient is confused, weak, impulsive and tries to get up out of bed.” A concurrent interview and record review on October 1, 2025, at 9:52 AM, with QMS 2, Patient 15’s clinical record, titled “Safety,” dated September 29, 2025, was reviewed.”Safety” indicated Patient 15 had a sitter at bedside. QMS 2 confirmed there was no other clinical justification or behavioral description documented in the record to support the need for a sitter. 3. During a review of Patient 12’s face sheet, the face sheet indicated Patient 12 was admitted to the facility on September 25, 2025, with diagnoses including chest pain and shortness of breath. During a review of Patient 12’s clinical record, titled “Adult Patient Care Summary (PCS) dated September 29, 2025, the PCS indicated Patient 12 was documented as “Within Defined Limits (WDL - every single part of the assessment is normal, and in the expected, healthy range)” under neuro and behavioral assessments. During a concurrent observation and interview on September 29, 2025, at 1:39 PM, with Nurse Manager 4 (NM 4), in Patient 12’s room, Patient 12 was observed in a chair with family members nearby. A sitter was noted at bedside. NM 4 stated, “Patient 12 needs a sitter because Patient 12 has a habit of taking off the high-flow nasal cannula (oxygen therapy that gives a larger amount of warm, moist oxygen through soft tubes in the nose).” During a concurrent interview and record review on September 30, 2025, at 3:47 PM, with QMS 2, Patient 12’s clinical record, titled “Safety,” dated September 29, 2025, was reviewed. “Safety” indicated Patient 12 had a sitter at bedside. QMS 2 confirmed there was no other clinical justification or behavioral description documented in the record to support the need for a sitter. During a concurrent interview and record review on October 1, 2025, at 10:22 AM, with Risk Management Staff (RMS) and QMS 2, facility’s policy and procedure (P&P) titled, “Sitter Utilization,” revised June 2019, was reviewed. The P&P indicated, “ ...Procedure/Guidelines ...A. Assessment: ...1. The clinical appropriateness for a sitter is determined by the physician and/or the nurse, based on assessment or the patient’s needs ...3. The following will be considered in assessment of a patient for sitter use: a. Assessment for physiological changes including confusion. b. utilization of least restrictive measures. c. the consideration of safe and appropriate use of restraints. d. consequences/potential outcome of a fall ...” RMS and QMS 2 confirmed accurate clinical assessment was important in order to support the need of a sitter. During an interview on October 1, 2025, at 10:45 AM, with Certified Nurse Assistant (CNA), CNA stated, “We often sit for patients who are suicidal, at risk for self-harm, and confused patients. There is usually a strong reason why those patients need a physical sitter.” During an interview on October 1, 2025, at 11:08 AM, with Registered Nurse 2 (RN 2), stated, “Before we initiate a tele-sitter or a sitter, we start with an assessment ...we don’t need a doctor’s order to implement a sitter, it’s per a nurse’s discretion ...” RN 2 further stated it was important to have accurate nursing assessments to justify the need for a tele-sitter or a sitter.”

“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: 47394 Based on interview and record review, the facility failed to ensure the nursing staff adhered to the policy and procedure (P&P) for fall prevention and management when one of 31 sampled patients (Patient 22) who was at high risk for fall, did not receive/document all fall prevention interventions (steps/actions taken to improve the situation). This failure had increased the risk of patient falling which might have contributed Patient 22’s unwitnessed fall and jeopardized the health and safety. Findings: During a review of patient 22’s “Face sheet” (contains demographic data), dated March 10,2025, indicated, Patient 22 was admitted to the facility with the diagnosis of Pneumonia (a condition in which the air sacs in lungs get infected and collect fluids). During a review of Patient 22’s “history and Physical” (H&P), dated March 10,2025 ,the H&P indicated Patient 22 had a history of coronary artery bypass graft ( a surgical procedure to treat blocked coronary artery[ an artery in heart] with a healthy artery),diabetes mellitus( a condition in which blood sugar is high in blood) and ethanol (alcohol) dependence, blisters on feet ,cough. Patient 22 was diagnosed as acute with chronic heart failure (a condition in which heart does not pump as needed). During a concurrent interview and record review on September 30,2025, at 8:55 AM, with Quality Management Staff (QMS 1), Patient 22’s “electronic health record flowsheet” (EHRF- an electronic document where patient’s assessment and other information are documented) was reviewed. The EHRF indicated ,Patient 22 was admitted on March 10,2025 at 10:32 PM, with the Morse fall risk assessment (a tool used to assess the risk for fall, scoring from 0-20 no risk or low risk, 25 - 44 medium risk, 45 or more is a high risk score) was scored as 50 (high risk).The QMS 1 stated, the interventions (steps taken to address the issue) for high fall risk were yellow fall risk band and yellow nonskid socks ,high fall risk sign on room, bed and chair alarms to signal patient movement ,consider using a fall mat. During a concurrent interview and record review on September 30,2025, at 4:45 PM, with QMS 1, Patient 22’s EHRF was reviewed. The EHRF indicated, on March 13,2025, at 7:30 AM and March 14,2025, at 7:30 AM only safety checks /rounds were completed for fall prevention interventions. The QMS 1 acknowledged that the EHRF is missing the documentation for fall prevention including the bed alarm was armed (activated on) and in use at the time of fall. The QMS 1 stated, the nurse’ s are expected to complete the fall prevention interventions as per policy. During a phone interview on October 1,2025, at 8:30 AM, with Registered Nurse 1(RN 1), RN 1 acknowledged that patient 22 was a high fall risk patient and was on high flow oxygen (a process in which oxygen therapy is applied through nose) via nasal canula (a tube through oxygen is delivered to the patient). RN 1 stated that patient 22 could be a patient considered to have a tele sitter (a person who remotely observes the patient through the camera for their safety) or a sitter at bedside for his safety.RN 1 stated he cannot recall whether the bed alarm was on. RN 1 further stated, when he saw Patient 22 on floor on March 14,2025, his oxygen canula was out from his nose and the patient was turning blue and unresponsive. During a concurrent interview and record review on October 1,2025, at 9:36 AM, with Nurse Manger 1(NM 1) facility’s policy and procedure (P&P) titled “Fall management prevention” dated June 6,2025 was reviewed. The P&P indicated, “ ... purpose the purpose of this policy is to establish framework and guidelines for screening patient risk for falls utilizing valid and reliable tools assessing patient for specific fall risk factors, interviewing of patient history, implementing interventions for mitigating the risk for falls, actions in the event of a fall and post fall assessment and documentation. The screening, assessment and recommended interventions are designed to prevent and/or reduce the number and severity of falls in the classification of anticipated physiological falls. The goal of the initiative is prevention of injury .....iii. High risk for fall:2. Implement the following nurse driven interventions: ..d. Initiate bed and or chair alarm to signal patient movement ... j. consider using a fall mat. .l. Consider increasing purposeful rounding to anticipate and address patient needs ....r. If patient impulsive, unable to reorient and unable to retain instructions consider remote visual monitoring or constant observer”. NM 1 stated, that the policy was not followed.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 47394 Based on interview and record review, Facility A failed to implement and maintain its Emergency Medical Treatment and Active Labor Act (EMTALA), policy and procedures (P&Ps), for six of 31 sampled patients (Patient 4,6,10,11,13, and Patient 15) when: 1. One of 31 sampled patients (Patient 6) presented to Facility A seeking emergency medical care after water breakage/ruptured membrane (a process which happens before labor/childbirth) and was not logged. (Refer to Tag A- 2405). 2. The L&D EMTALA log was incomplete and did not include the reason for visit for four of 31 sampled patients (Patient 10,11,13,15). (Refer to Tag A-2405). 3. One of 31 sampled patients (Patient 6) was not triaged (the process of sorting patient into groups based on their need for care) by nursing or medical screening exam (MSE- an examination performed by a qualified medical provider to determine if a patient has and emergency condition) received. (Refer to Tag A-2406). 4. One of 31 sampled patients (Patient 4) was not triaged or assigned a Maternal Fetal Triage Index (MFTI - the process of sorting pregnant patients into groups based on their need for care) level of urgency was not done. (Refer to Tag A-2406). The cumulative effects of these failures resulted in six of 31 sampled patients who came to L&D unit for emergency medical care was not triaged or received MSE, which could delay treatment for critical medical conditions and potentially cause harm to the patient and fetus.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 47394 Based on interview and record review, Facility A failed to maintain a centralized log for the Labor and Delivery (L&D) unit per it’s Emergency Medical Treatment and Active Labor Act (EMTALA) policy and procedure (P&P) for five of 31 sampled patients (Patient 6,10, 11, 13, and 15) when: 1. Patient 6, who was 36 weeks pregnant, presented to Facility A seeking emergency medical care after water breakage/ruptured membrane (a process which happens before labor/childbirth) and was not logged. This failure resulted in emotional distress due to Patient 6’s uncertainty about the priority of care for her and her baby, and which could jeopardize the health and safety of the patient and her unborn baby. 2. The L&D EMTALA log was not completed and did not include the reason for visit for four of 31 sampled patients (Patient 10,11,13,15). This failure resulted in an inappropriate evaluation of the patients who presented to L&D unit which will delay the care and cause high risk for the patients and their unborn babies. Findings: 1.An unannounced visit was conducted on April 1, 2025, through April 3, 2025, to investigate a possible EMTALA violation. There was no documented evidence to indicate Patient 6 was registered on Facility A’s Emergency Department (ED) or obstetric (OB- specialty for pregnancy and childbirth) logs, nor was there documentation indicating Patient 6 received a medical screening examination (MSE- an examination performed by a qualified medical provider to determine if a patient has and emergency condition), to rule out if an emergency medical condition existed or that the patient was medically stabilized. During a review of Patient 6’s documents from Facility B, “face sheet” (demographic data), indicated Patient 6 was a 40-year female presented to Facility B with the diagnosis of pregnancy of 36 weeks and 5 days. During a review of Patient 6’s documents from Facility B “Progress Note”, dated March 15, 2025, at 12:42 PM, by Physician 1 (P1), the “Progress Note” indicated, Patient 6 had grossly ruptured membrane since 6:00 AM on March 15, 2025. During a telephone interview with Patient 6, on April 1, 2025, at 8:50 AM, Patient 6 stated she was presented to Facility A, on March 15, 2025, after her water was broken at 6:00 AM. Patient 6 stated, she was checked in at Facility A’s ED with the front desk and they redirected her to the L&D unit. Patient 6 stated a nurse came out and provided with a form to fill out and told her that the facility was in full capacity and had to wait for a long time. Patient 6 further stated she was wearing a black shirt, peach sweater and pants. During a concurrent interview and record review on April 1,2025, at 3:00 PM, with Labor and delivery Manager (L&DM), Facility A’s document “Labor and delivery Emergency department Log (L&D ED Log)”, for March 2025, was reviewed. The “L&D ED Log” indicated, Patient 6 was not logged and only 2 patients were logged on March 15,2025. The L&DM verified and confirmed Patient 6 was neither logged nor MSE done. L&DM further stated it was expected that patients who comes to L&D unit should be logged and MSE completed to ensure they are evaluated, treated and stabilized the patient prior to be transferred to another facility. During an interview on April 2, 2025, at 2:15 PM, with Registered Nurse 1 (RN 1), RN 1 stated, she recalls Patient 6, and she gave the form to Patient 6 to fill the demographic information. RN 1 further stated that she was unable to recall any other conversation with Patient 6. During a concurrent interview and record review on April 3,2025, at 8:35 AM, with RN 2, “video recording” on March 15, 2025, at 7:47 AM was reviewed. RN 2 stated, she recalls Patient 6 as a patient with 36 weeks gestation and having labor symptoms but not remembering what the exact problem was. RN 2 further stated, she called the L&D unit and gave a brief report about Patient 6 that was send to L&D ED unit with EDT. During a concurrent interview and review of Facility A’s recorded video surveillance (video recording) on April 3,2025, at 8:58 AM, with Emergency Department Technician (EDT), video recording dated March 15, 2025, 7:47 AM to 8:00 AM was reviewed. The video recording indicated, the following: AT 7:47 AM, Patient 6 came by herself to the ED front desk and was talking to the person at the front desk. At 7:48 AM, Emergency department Technician (EDT) offered a wheelchair to Patient 6 to go to L&D unit and Patient 6 refused and was walking with EDT to L&D unit. At 7:51 AM, Patient 6 came to L&D unit waiting area with the EDT. AT 8:00 AM, Patient 6 left the L&D unit. The EDT stated, she recalls Patient 6 and she was walking with Patient 6 to L&D unit with the red bag( a bag used for L&D patients if they have an emergency delivery through the route to L&D unit, which also called as Baby on arrival bag).EDT further stated, she remembers that she gave a brief report about Patient 6 to RN 1. During a concurrent interview and review of Facility A’s recorded video surveillance on April 3, 2025, at 9:22 AM, with the Labor and Delivery Manger (L&DM), video recording, dated March 15, 2025, from 7:47 AM to 8 :00 AM was reviewed and indicated, the following: AT 7:47 AM, Patient 6 came by herself to the Emergency Department front desk and was talking to the person at the front desk. At 7:48 AM, Emergency department Technician (EDT) offered a wheelchair to Patient 6 to go to L&D unit and Patient 6 refused and was walking with EDT to L&D unit. At 7:51 AM, Patient 6 came to L&D unit waiting area with the EDT. AT 8:00 AM, Patient 6 left the L&D unit. The L&D M verified and confirmed Patient 6 was presented to the L&D unit waiting area on March 15,2025 and she left the unit. During a concurrent interview and record review on April 3,2025, at 9:50 AM, with L&DM, the facility’s P&P titled, “Screening, stabilization and transfer of individuals with emergency medical condition”, dated June 2023, and “OB Emergency department Scope of Service”, dated May 2023, were reviewed. The P&P for “Screening, stabilization and transfer of individuals with emergency medical condition” indicated, “ ...Central Log-refers to the log maintained by hospital that documents each patient that comes to ED seeking assistance and documents such patient’s disposition ...I. Central log data will be entered by department designee on each patient presenting for emergency for emergency treatment. The central log must indicate whether the individual refused treatment or transfer, was refused treatment, or was transferred prior to stabilization, admitted and treated, stabilized and transferred, or discharged...” The P&P for “OB Emergency department Scope of Service” indicated, “ ...B. The OB ED delivers care to pregnant patients of all ages, 20 weeks gestation or greater, who are expecting uncomplicated emergency and/or remedial problems associated with pregnancy .... D.1.Assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay to inquire about payment status ...” The L&D M stated these policies were not followed as the Patient 6 was not logged or received MSE. During an interview on April 3, 2025, at 1:17 PM, with Physician (Phys 2), Phys 2 stated, pre-rupture of membrane (PROM- a condition in which the membrane is ruptured before the delivery of the baby) is a condition which needs to be evaluated. During an interview on April 3, 2025, at 1:50 PM, with the Director of Quality Management (DQM), the DQM stated, Patient 6 should have been logged and received MSE. 47360 2a. During a review of the facility’s document titled “OB Events Log” dated November 2024, the “OB Events Log” indicated, Patient 10 arrived to the labor and delivery department (L&D) on November 2, 2024, at 2:17 PM and her disposition was entered as AMA [left Against Medical Advice of the medical provider: doctor and was educated on risks]/Eloped [left the department]. The “OB Events Log” did not include reason for Patient 10’s visit or the time Patient 10 left AMA. During a concurrent interview and record review on April 2, 2025, at 2:55 PM, with the L&D Nursing Supervisor (NS), Patient 10’s “Physician [doctor] OB Triage Notes Addendum [a change or clarification made to an existing document]” dated November 2, 2024, was reviewed. The “Physician OB Triage Notes Addendum” indicated, Patient 11 arrived with complaints of bilateral lower extremity edema (swelling to both legs) for one week and elevated blood pressure and after consulting the doctor decided to leave AMA. The NS stated, either nursing or registration staff will register a patient to the department and this information flows to the log. The registration should include the reason the patient has presented to L&D. 2b. During a review of facility’s document titled “OB Events Log” dated October 2024, the “OB Events Log” indicated, Patient 11 arrived to the labor and delivery department (L&D) on October 15, 024 at 7:42 PM, and her disposition was entered as LBWS (left without being seen by a medical provider, such as a doctor or nurse midwife). The “OB Events Log” did not include reason for Patient 10’s visit or the time Patient 11, LWBS. During a concurrent interview and record review on April 2, 2025, at 2:40 PM, with the L&D Nursing Supervisor (NS), Patient 11’s visit from October 15, 2024, was reviewed. The visit indicated, Patient 11 arrived to the unit at 7:42 PM and LWBS at 8:25 PM, there was no documented reason for visit or notes regarding Patient 11’s this visit. The NS stated, there should be a chief complaint listed when a patient is registered to the department and more notes as to calling for patient in the waiting room. 2c. During a review of the facility’s document titled “OB Events Log” dated November 2024, the “OB Events Log” indicated, Patient 13 arrived at L&D on November 24, 2024, at 8:28 PM and her disposition was entered as LWBS. The “OB Events Log” did not include reason for Patient 13’s visit or the time Patient 13 LWBS. During a concurrent interview and record review on April 2, 2025, at 3:25 PM, with the NS, Patient 13’s “Visit” from, November 24, 2024, was reviewed. The “Visit” indicated, Patient 13 arrived to the unit at 8:28 PM and LWBS at 8:35 PM, there was no documented reason for visit or notes regarding patient during this visit. The NS stated, there should be a chief complaint listed when a patient is registered to the department and a reason as to why the patient LWBS. 2d. During a review of the facility document titled “OB Events Log” dated February 2025, the “OB Events Log” indicated, Patient 15 arrived at L&D on February 15, 2025, at 1:01 PM and her disposition was entered as LWBS. The “OB Events Log” did not include reason for Patient 15’s visit. During a concurrent interview and record review on April 2, 2025, at 3:40 PM, with the NS, Patient 15’s “Visit” from February 15, 2025, was reviewed. The “Visit” indicated, Patient 13 arrived to the unit at 1:01 PM and LWBS at 1:30 PM, there was no documented reason for visit or notes regarding patient during this visit. The NS stated, there should be a chief complaint listed when a patient is registered to the department and a reason as to why the patient LWBS. Additionally, Patient 15’s, “Triage Consent/ED Sign in Sheet” dated February 15, 2025, was reviewed. The “Triage Consent/ED Sign In Sheet” indicated, Patient 15’s reason for visit was feeling lightheaded and fainted. The NS stated, the reason for visit should have been added when patient registered to the unit as Patient 15 filled out the triage form. During a concurrent interview and record review on April 3, 2025, at 11:45 AM, with the Labor and Delivery Manager (L&DM), the facility’s “OB Events Log” for the past six months, October 2024 through March 2025, was reviewed. The “OB Events Log” was missing multiple entries for reason for visit and disposition times. The L&DM stated, the data that has been input into the log was inconsistent and incomplete. The L&DM further stated the reason for visit and disposition time should be entered for each encounter for trending and reference purposes and the log should be consistent with that information. The LD&M stated, the log data entry is the responsibility of either the registration clerk or the nurses on the L&D unit and agreed there is a trend of incomplete data entry on patients with dispositions of LWBS and AMA. During a review of the facility’s policy and procedure (P&P) titled, “Screening, Stabilization and Transfer of Individuals with Emergency Medical Condition”, dated June 2023, the P&P indicated, “ ...Central Log-refers to the log maintained by hospital that documents each patient that comes to ED seeking assistance and documents such patient’s disposition ...I. Central log data will be entered by department designee on each patient presenting for emergency for emergency treatment. The central log must indicate whether the individual refused treatment or transfer, was refused treatment, or was transferred prior to stabilization, admitted and treated, stabilized and transferred, or discharged...”.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 47394 Based on interview and record review, the facility failed to ensure its policy and procedures (P&P’s) for an appropriate Medical Screening Examination (MSE-an examination performed by a qualified medical provider to determine if a patient has and emergency condition), within the capability of Facility A’s Emergency Department (ED) and Labor &Delivery (L&D) unit was conducted to determine if an emergency medical condition (EMC) existed and were implemented for two of 31 sampled patients (Patient 6 and Patient 4) when : 1. Patient 6, who was 36 weeks pregnant presented to Facility A’s labor and delivery (L&D) unit and was not triaged (the process of sorting patient into groups based on their need for care) by nursing or a qualified MSE was received. This failure resulted in Patient 6 not being appropriately triaged or received MSE to determine Patient 6 had an EMC, as a result Patient 6 sought treatment at Facility B and underwent C- section (cesarian section-a surgical procedure done for child birth) for an EMC which had the potential to severely impact the health and welfare of both patient and fetus (unborn baby) . 2. Patient 4 was not triaged or assigned a Maternal Fetal Triage Index (MFTI - the process of sorting pregnant patients into groups based on their need for care) level of urgency. This failure had the potential to severely impact the health and welfare of the patients (Patient 4) and their fetus (unborn baby). Findings: 1.An unannounced visit was conducted on April 1, 2025, through April 3, 2025, to investigate a possible EMTALA violation. There was no documented evidence to indicate Patient 6 was registered on Facility A’s Emergency Department (ED) or obstetric (OB- specialty for pregnancy and childbirth) logs, nor was there documentation indicating Patient 6 received a medical screening examination (MSE) to rule out if an emergency medical condition existed or that the patient was medically stabilized. During a review of Patient 6’s documents obtained from Facility B “face sheet” (demographic data), indicated Patient 6 was a 40-year female presented to Facility B with the diagnosis of pregnancy of 36 weeks and 5 days. During a review of Patient 6’s document from Facility B, titled “Progress Note”, dated March 15, 2025, at 12:42 PM, by Physician 1 (P1), the “Progress Note” indicated, Patient 6 had grossly ruptured membrane since 6:00 AM on March 15, 2025. During a concurrent interview and record review on April 1,2025, at 3:00 PM, with Labor and Delivery Manager (L&DM), Facility A’s document “Labor and delivery Emergency department Log (L&D ED Log)”, for March 2025, was reviewed. The “L&D ED Log” indicated, Patient 6 was not logged and only 2 patients were logged on March 15,2025. The L&DM verified and confirmed Patient 6 was neither logged nor MSE done. L&DM further stated that it was expected that patients who comes to L&D unit should be logged and MSE completed to ensure they are evaluated and treated and stabilized the patient prior to be transferred to another facility. During an interview on April 2, 2025, at 2:15 PM, with Registered Nurse 1 (RN 1), RN 1 stated, she recalls Patient 6, and gave the form to Patient 6 to fill the demographic information.RN1 further stated, Patient 6 was not registered so she has not received MSE and it is expected that all patients who come to L&D should be registered and received MSE. During a concurrent interview and record review on April 3,2025, at 9:50 AM, with L&DM, the facility’s policy and procedure (P&P) titled, “Screening, stabilization and transfer of individuals with emergency medical condition”, dated June 2023, and “OB Emergency department Scope of Service”, dated May 2023, were reviewed. The P&P for “Screening, stabilization and transfer of individuals with emergency medical condition” indicated, “ ...Medical screening Exam (MSE): the screening process performed by a physician, or another Qualified Medical Person (QMP) required to determine with reasonable clinical confidence whether an Emergency Medical Condition (EMC) does or does not exist. The MSE should be performed to the extent necessary to determine whether an EMC exist, and it represents a spectrum. It can range from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies and procedures such as laboratory tests, x rays, and /or other diagnostic tests and procedures.B..1. Delay the provision of a MSE, stabilizing treatment, or appropriate transfer in order to inquire about individual’s method of payment or insurance status;or ...B. 1. A MSE must be performed for: a. Every individual described above. b. An individual who present anywhere on hospital property that is not a Dedicated Emergency Department as defined above and seek treatment for a potential EMC ...2. MSE process: a. Within the capability of the DED, the MSE should be performed to the extent sufficient to determine within reasonable medical probability whether an EMC exists”. The P&P for “OB Emergency department Scope of Service” indicated, “ ...B. The OB ED delivers care to pregnant patients of all ages, 20 weeks gestation or greater, who are expecting uncomplicated emergency and/or remedial problems associated with pregnancy .... D.1.Assessment, evaluation, management and treatment, that is appropriate and timely, to patients with obstetric conditions without delay to inquire about payment status ...3. Provision of care that begins in the pre -hospital settings (provided by Emergency Medical Services-EMS), continues in the OB ED and concludes with the patient being admitted, transferred per EMTALA regulations or discharged ....1. Patients entering the OB ED shall be assessed by an RN.” The L&D M stated these policies were not followed as the Patient 6 was not logged or received MSE. 2. During a review of Patient 4’s “Admission Note” (AN), dated March 21,2025, the “AN”, indicated, Patient 4 was a 31 year old female with 38 weeks of gestational age (common term used during pregnancy to describe how far along the pregnancy is). During a concurrent interview and record review on April 2,2025, at 1:20 PM, with Labor and Delivery Manager (L&DM), Patient 4’s “Flow Sheet” dated March 21,2025 was reviewed. The “Flow sheet” indicated, Patient 4’s MFTI was not documented upon admission to L&D unit. The L&DM stated, it is expected to do the triaging which is necessary that the patient is evaluated and triaged right, so the physician can check the patient fast. During a concurrent interview and record review on April 3,2025, at 9:50 AM, with L&DM, the facility’s policy and procedure (P&P) titled, “OB Emergency department Scope of Service”, dated May 2023, were reviewed. The P&P indicated, “ ...Patient Assessment.4. Patients will be classified according to the Maternal Fetal Triage Index (MFTI).” The L&DM stated, Policy was not followed as patient records were missing MFTI. During an interview on April 3,2025, at 1:50 PM, with the Director of Quality Management (DQM), the DQM stated, MFTI was not completed, and it is expected to be completed when the patients arrive at the ED.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 46696 Based on interview and record review, the Governing Body (GB) failed to provide adequate oversight to ensure safe and effective patient care for three of 35 sampled patients (Patient 11, Patient 27, and Patient 34) when the GB did not implement a quality improvement program as evidenced by: 1. A thoracentesis (a procedure that drains extra fluid from around a lung with a needle) was performed on the opposite side of the chest versus what was written on the informed consent in the interventional radiology (IR- medical procedure that use imaging techniques to diagnose and treat medical conditions without major surgery) (refer to A 049). 2. A standard fall precautions (simple ways to prevent falls) was implemented when a shower curtain to prevent water from spraying onto the floor creating a fall risk (a tool used to determine the patient is a high risk for falling, scoring from 0-20 no risk or low risk 25 - 44 medium risk, 45 or more is a high risk score ), was not in place for one patient (refer to A 049). 3. Infection control and prevention practices was followed prior to administering intravenous (IV - an access to receive medicines in the vein) medication. (Refer to A 049) The cumulative effects of these systemic practices resulted in the hospital’s inability to provide quality health care in a safe environment by undergoing unnecessary pain, potential for infection and prolonged hospitalization.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 46696 Based on interview and record review, the hospital failed to maintain an effective and on-going hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program for a universe of 220 patients as evidenced by the facility’s failure to identify the collected data of the following issues : 1. A thoracentesis (a procedure that drains extra fluid from around a lung with a needle) was performed on the opposite side of the chest versus what was written on the informed consent in the interventional radiology (IR- medical procedure that use imaging techniques to diagnose and treat medical conditions without major surgery) (Refer to A 283). 2. A standard fall precautions (simple ways to prevent falls) was implemented when a shower curtain to prevent water from spraying onto the floor creating a fall risk (a tool used to determine the patient is a high risk for falling, scoring from 0-20 no risk or low risk 25 - 44 medium risk, 45 or more is a high risk score ), was not in place for one patient (Refer to A 283). 3. Infection control and prevention practices was followed prior to administering Intravenous (IV - an access to receive medicines in the vein) medication. (Refer to A 283) The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality nursing care and patient safety and had the potential to cause adverse health outcomes which could interfere with the patient’s medical care and may jeopardize the health and safety.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 47360 Based on interview and record review, the hospital failed to maintain an effective and organized nursing services for three of 35 sampled patients (Patient 11, Patient 27, and Patient 34) as evidenced by: 1. A thoracentesis (a procedure that drains extra fluid from around a lung with a needle) was performed on the opposite side of the chest versus what was written on the informed consent in the interventional radiology (IR- medical procedure that use imaging techniques to diagnose and treat medical conditions without major surgery) for one patient (Patient 11). (Refer to A 398). 2. A standard fall precautions (simple ways to prevent falls) was implemented when a shower curtain to prevent water from spraying onto the floor creating a fall risk (a tool used to determine the patient is a high risk for falling, scoring from 0-20 no risk or low risk 25 - 44 medium risk, 45 or more is a high risk score ), was not in place for one patient (Patient 27). (Refer to A398). 3. For Patient 34, a licensed nurse failed to scrub the peripheral intravenous (PIV - a small plastic tube inserted through the skin into the vein to deliver medicines and fluids) connector with alcohol (to disinfect the IV-line site) when administering medications (Refer to A 398). The cumulative effect of these systemic problems resulted in the hospital’s inability to provide a consistent and adequate nursing services in a safe environment and resulted in developing a pneumothorax (a collapsed lung when air leaks into the chest) that required increased monitoring, multiple x-rays (pictures of the inside of the body, which exposes a patient to radiation) and the potential for unnecessary pain, infection, injury, and prolonged hospitalization. .”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 46696 Based on interview and record review, the Governing Body (GB) failed to provide oversight to ensure safe and effective patient care for three of 35 sampled patients (Patient 11, Patient 27, and Patient 34) when the GB did not implement a quality improvement program when : assessment of patient fall or slip hazards leading to fall risk (a tool used to determine the patient is a high risk for falling, scoring from 0-20 no risk or low risk 25 - 44 medium risk, 45 or more is a high risk score ), a thoracentesis (a medical procedure that drains extra fluid from around a lung with a needle) was performed on the opposite side of the chest versus what was written on the informed consent in the interventional radiology (IR- medical procedure that use imaging techniques to diagnose and treat medical conditions without major surgery) and the infection control and prevention practices prior to administering Peripheral Intravenous (PIV - a small plastic catheter inserted through the skin into the vein to provide medicines or fluids) medicines. These failures resulted in the facilities failure to deliver care with GB oversight, increasing patient risk of injury, infection, provide a safe patient care environment with adequate supervision and lack of implementation of policy and procedure which could jeopardize the health and safety of the patients and the potential for acquiring hospital infection, injury, and prolonged hospitalization. Findings: During an interview on October 10, 2024, at 11:05 AM, with the Director of Quality (DOQ), the DOQ stated, the hospital had not identified an issue with standardizing a timeout (a pause before a surgical or invasive procedure to confirm correct patient, procedure, and site) procedure for Interventional radiology. The DOQ stated, facility currently do not track any metrics or data regarding patient slip hazards and PIV. During an interview on October 10, 2024, at 1:00 PM, with the Governing Board Chair (GBC), the GBC stated, the Governing board serves at the Fiduciary Body (a person or organization acts on behalf of others and is legally bound in act in their best interests) , patient safety body, peer review support for the medical Executive Committee of the hospital. The GBC further stated the Governing board is responsible for the overall governing and oversight of the hospital. During a review of the “Community Ministry Board [Facility Name] minutes” dated August 28, 2024, the “Community Ministry Board [Facility Name] minutes” indicated, no data was presented on standardized Time out procedure in the IR department, monitoring of patient slip or fall hazards and Intravenous (IV - in the vein) access prior to administering medication. During an interview on October 10, 2024, at 1:15 PM, with the GBC, the GBC stated, the Governing board was not aware that there was no standardized time out procedure in the IR department, monitoring of patient slip or fall hazards and IV access prior to administering medication were not being tracked by the quality department. The GBC stated, if the quality department was not tracking this, the GB will not be aware of it. The GBC further stated, the hospitals Quality committees are the tools the GB use to identify hospital issues, if QAPI committee were not aware of any of these issues then the governing body would not be aware. During a review of the facility’s policy and procedure (P&P), titled, “Quality Assurance & Performance Improvement (QAPI) and Patient Safety Plan”, the P&P indicated, “The [Facility Name] board delegates the functions of and responsibility for performance improvement, quality assurance, patient safety, patient experience to the appropriate Community Ministry Board for the Southern California service Area.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 46696 Based on interview and record review, the hospital failed to maintain an effective and on-going hospital wide, data driven Quality Assessment and Performance Improvement (QAPI) program for a universe of 220 patients , when the facility failed to identify the collected data of the issues regarding monitoring of fall risk assessment (a tool used to determine the patient is a high risk for falling, scoring from 0-20 no risk or low risk 25 - 44 medium risk, 45 or more is a high risk score ), a thoracentesis (a procedure that drains extra fluid from around a lung with a needle) was performed on the opposite side of the chest versus what was written on the informed consent in the interventional radiology (IR- medical procedure that use imaging techniques to diagnose and treat medical conditions without major surgery) and the infection control and prevention practices prior to administering intravenous (IV - an access to receive medicines in the vein) medication. These failures resulted in the hospital’s inability to identify the problem prone areas to ensure the provision of quality nursing care, patient safety and had the potential to cause adverse health outcomes which could interfere with the patient’s medical care and may jeopardize the health and safety. Findings: During an interview on October 10, 2024, at 11:05 AM, with the Director of Quality (DOQ), surveyors discussed the concerns and findings during the survey including the timeout (a pause before a surgical or invasive procedure to confirm correct patient, procedure, and site) procedure in the IR, assessment of patient slip hazards leading to fall risk, and infection prevention practices prior to administering peripheral IV (PIV- a small palstic tube inserted in to the vein to deliver medicines and fluids) medication. The DOQ stated, the hospital had not identified an issue with standardizing a timeout procedure for Interventional radiology. The DOQ further stated, Quality Committee does not have any metrics that the facility tracks related to Interventional Radiology services in this area, the Interim Director just started 3 months ago and is trying to figure out what the hospital should be tracking, however the quality department is still responsible for quality, and the QAPI committee needs to be following that data. The DOQ stated, facility currently do not track any metrics or data regarding patient slip hazards and PIV. The DOQ further stated the quality department was responsible for identifying these issues along with nursing management. During a review of “Quality & Patient Safety Council Minutes,” dated August 20, 2024, the “Quality & Patient Safety Council Minutes” indicated, there was no reporting of interventional radiology (IR) metrics, falls or slip hazards and PIV access data. During a review of “Quality & Patient Safety Council Minutes,” dated September 16, 2024, the “Quality & Patient Safety Council Minutes” indicated, there was no reporting of IR metrics, falls or slip hazards and PIV access data. During a review of the facility’s policy and procedure (P&P) titled, “Quality Assurance & Performance Improvement (QAPI) and Patient Safety Plan”, dated October 2024, the P&P indicated, “The [Facility Name] board delegates the functions of and responsibility for performance improvement, quality assurance, patient safety, patient experience to the appropriate Community Ministry Board for the Southern California service Area. Routine reports from Clinical institutes or service lines, hospital units/departments, performance improvement/safety committees, operations and patient care councils/ committees, medical quality committees and reported to the appropriate Community Ministry board and ministry executive Leadership team.”

“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: 47360 Based on observation, interview, and record review, the facility failed to ensure all licensed nurses adhere to the facility’s policy and procedure (P&P) for three of 35 sampled patients (Patient 11, Patient 27, and Patient 34) when: 1. For Patient 11, a thoracentesis (a procedure that drains extra fluid from around a lung with a needle) was performed on the opposite side of the chest versus what was written on the informed consent in the interventional radiology (IR- medical procedure that use imaging techniques to diagnose and treat medical conditions without major surgery). This failure resulted in Patient 11 developing a pneumothorax (a collapsed lung when air leaks into the chest) that required increased monitoring, multiple x-rays (pictures of the inside of the body, which exposes a patient to radiation) and the potential for worsening of Patient 11’s condition including unnecessary pain, infection, and prolonged hospitalization. 2. A standard fall precautions (simple ways to prevent falls) was implemented when a shower curtain to prevent water from spraying onto the floor creating a fall risk was not in place for one patient (Patient 27). This failure had the potential to increase the risk for patient falls, unnecessary injury and potentially increasing the length of hospitalization. 3. A nurse failed to scrub the Intravenous (IV - an access to receive medicines in the vein) connecter with alcohol (to disinfect the IV-line site) when administering medications for one patient (Patient 34). This failure had the potential to cause infections by the unnecessary exposure to potential contaminants at the IV connector can be pushed in to the patient’s IV line which can negatively affect the health and safety of the patient. Findings: 1. A review of Patient 11’s “History and Physical” (H&P), dated July 28, 2024, the H&P indicated, Patient 11’s chief complaint was shortness of breath with a past medical history of lung cancer (tumor). A further review of the H&P indicated, the assessment included Left pleural effusion (fluid in the left lung space), and the plan was consulted the IR for left thoracentesis. A review of Patient 11’s “Patient Consent” dated, July 29, 2024, indicated, “ ...Image guided left thoracentesis ...”. The “Patient Consent” indicated consent was reviewed and signed by both Patient 11 and the Nurse Practitioner Interventional Radiology (NPI). A review of Patient 11’s “Progress Notes” dated July 30, 2024, indicated, “ ...discussed attempt to right thoracentesis and no fluid retuned prior to completing left thoracentesis ...Discussed subsequent imaging which revealed a right pneumothorax ...Imaging...Result Date: 7/29/2024 ...[X-Ray] Chest ...There is a 5-10% right pneumothorax. This is new compared with prior ...”. During a concurrent interview and record review on October 9, 2024, at 8:50 AM, with NPI, Patient 11’s “Registered Nurse (RN) Sedation Documentation “ dated July 29, 2024, was reviewed. The “[RN] Sedation Documentation” did not include laterality (side) of thoracentesis, timeout (a pause before a surgical or invasive procedure to confirm correct patient, procedure, and site) prior to the procedure, or relevant images reviewed prior to procedure. The NPI stated, the nursing documentation was not complete. The NPI stated, a “timeout” was not standardized in the IR department and not every nurse performs it the same or incorporated the same information in each time out. The NPI stated, Patient 11’s images were displayed, but draped and performed the thoracentesis on the right side because she was looking at the x-ray wrong. The NPI further stated, the right thoracentesis resulted in Patient 11’s righ t-sided pneumothorax of 5-10%. During a follow up concurrent interview and record review, on October 9, 2024, at 9:00 AM, with NPI, the facility’s policy and procedure (P&P) for perioperative services titled, “Universal Protocol- Policy”, dated February 2024, was reviewed. The P&P indicated, “ ...Time Out Procedure: A. After positioning, draping and immediately prior to the incision a Time Out will be performed. The Time Out is consistently initiated by the radiologist and includes active communication among all relevant members of the team ...it is conducted in standardized mode (that is, the procedure is not started until all questions and/or concerns are resolved). The following information is verified during the Time Out:1. Correct patient identity. 2. Confirmation that the correct side and site are marked. 3. Agreement on the procedure to be done. 4. An accurate procedure informed Consent form is signed and witnessed ...”. The NPI stated, she was not aware of this policy and had not been performing Time Out in this way before a procedure. The NPI further stated, a Time Out performed in this manner could have prevented Patient 11 from having a thoracentesis on the wrong side and prevented Patient 11’s pneumothorax. During a concurrent interview and record review, on October 10, 2024, at 11:00 AM, with the Director of Imaging Services (DIS) and the Quality Director (QD), the facility’s P&P titled, “Universal Protocol- Policy”, dated February 2024, was reviewed. The P&P indicated, “ ...The purpose of this Universal Policy is to outline the processes to verify the identity of the patient, the procedure(s) to be performed, the correct site and correct side ...for all operative and other invasive procedures ...the procedure will not be initiated until ALL components of the Time Out are validated ...The appropriate documentation in patient record indicating that all team members participated in the Time Out process ...” The DIS stated, the Time Out was not done per policy or documented per policy prior to Patient 11’s thoracentesis. The DIS stated, the purpose of the Time Out was to determine the correct patient will receive the correct procedure at the correct site and that the team is all in agreement that the correct procedure will be performed. The QD stated, the IR Time Out was not a standardized practice, the IR department was not following a specific template to ensure the Time Out was being performed effectively. RN attended this procedure was unavailable to interview as the RN was a traveler nurse (a nurse who works temporarily at the facility). 2. A review of Patient 27’s “History and Physical” (H&P - a document that gives a summary of a patient’s medical history), the H&P indicated Patient 27 was admitted to the hospital on September 25, 2024, with diagnoses of sepsis (the body’s extreme response to an infection), cellulitis of buttock (a bacterial infection that affects the skin and underlying tissues), and acute kidney injury (when the kidneys suddenly can’t filter waste products from the blood). During an interview on October 7, 2024, at 11:40 AM, with Patient 27, Patient 27 stated, “I am afraid I am going to slip and fall due to my special shower.” During an observation on October 7, 2024, at 11:58 AM, in Patient 27’s bathroom, observed a dialysis (a procedure that removes waste products and excess fluid from the blood when the kidneys are unable to function properly) hose connection in place of the shower head, a shower curtain track was mounted without a shower curtain, and tile flooring without a slip mat. During a subsequent interview on October 7, 2024, at 12:04 PM, with Patient 27, he stated he has been in this room for 2-3 days and never had a shower curtain or proper shower head. Patient 27 further stated the splash from the shower made the floor slippery. During a concurrent observation and interview on October 7, 2024, at 12:08 PM, with the Medical/Surgical Manager (MSM) inside Patient 27’s bathroom, the MSM stated the dialysis hose connection was not for Patient 27 and should have been replaced with the shower head. The MSM stated, “I could see how the floor could be slippery from the spray from the shower.” The MSM further stated there should have been a shower curtain hanging. During a review of Patient 27’s fall risk assessment record dated October 7, 2024, at 8:00 AM, indicated, Patient 27 had a fall risk score of 30 (Medium) on the Morse Fall Risk Assessment Tool (a rapid and simple method of assessing a patient’s likelihood of falling, scoring from 0-20 no risk or low risk 25 - 44 medium risk, 45 or more is a high risk score). During a concurrent interview and record review on October 10, 2024, at 2:18 PM, with the MSM, the hospital’s policy and procedure (P&P) titled, “Fall Risk Assessment and Interventions,” dated August 2023, was reviewed. The P&P indicated, “ ...IV ... A Evaluation of fall risk ...3. Level of fall risk will be outline per fall risk assessment and interventions implemented accordingly ...b. Moderate Risk- 25-45 points ...B. Standard Fall Risk Interventions ... 1. The following interventions can be initiated by the health care team, for ALL inpatient and observational status patients, based on the registered nurse assessment of the patient ...(h.) Minimize environmental trip or slip hazards ...”. The MSM acknowledged that the dialysis hose connection over the shower head with splash from the shower makes high risk for fall and the P&P was not followed. 3. During a review of Patient 34’s “History and Physical” (H&P), the H&P indicated,”[Patient 34] is a 61 year old female with a Past Medical History of diverticulosis ( a condition where small pouches, called diverticula, form in the colon or large intestine), obesity (a chronic disease that occurs when the body stores too much fat), and diabetes mellitus (a chronic disease that occurs when the body doesn’t produce enough glucose (a type of sugar) or cannot use glucose properly).” During an observation on October 8, 2024, at 9:12 AM, in Room 264B, A Medical Surgical Registered Nurse (MSRN1) was observed giving IV Pantoprazole (a medication used to treat heartburn and certain other conditions caused by too much acid in the stomach) 40 milligram (mg- a unit of mass) IV Push (injecting a medication or fluid directly into a patient’s bloodstream through an intravenous line). MSRN1 removed the protective cap from Patient 34’s IV connection site and connected a Normal saline (NS) flush to flush the IV prior to administration. After flushing the IV site with NS, MSRN1 connected the IV Pantoprazole to the IV connection site without scrubbing the IV connection site with alcohol. After administering the IV Pantoprazole MSRN1 disconnected the IV syringe and continued flushing the IV site with NS, MSRN1 did not scrub the IV connection site prior to attaching the NS flush. During an interview on October 8, 2024, at 9:20 AM, with the Manger of Medical Surgical unit (MMS), the MMS stated, after the first access the nurse needed to scrub the connector each time. During a concurrent interview and record review, on October 10, 2024, at 10:42 AM, with the MMS, the facility’s Policy and Procedures (P&P) titled, “Intravenous Therapy- Policy” dated December 2023, was reviewed. The P&P indicated, “Procedure: IV Push and IV Piggyback E. When administering IV push through and existing line, cleanse all ports vigorously and thoroughly with alcohol, allow to dry before accessing. Close flow clamp and inject the drug at the appropriate rate.” The MMS stated, [MSRN1] did not scrub the hub between accesses per the policy, she should have done this to prevent infections.”