HospitalInspections.org

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.

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.

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.

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 ...".

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... ."

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 ..."

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 ..."

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 ...."

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 ..."

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 ...