HospitalInspections.org

Based on interviews, medical record, document and policy review, the hospital failed to effectively organize and deliver safe, quality nursing services to patients in the Emergency Department as evidenced by:

A. Based on interview, clinical record review, and facility policy review, the facility failed to ensure policies for intravenous (IV, through the vein) medication administrations and nursing assessments of patients in the Emergency Department (ED) were implemented for two of 35 sampled Emergency Department patients (Patient 1 and 22) when:

1. Midazolam (a medication that is used to help a patient relax or sleep during a medical procedure) was administered to Patient 1 by Registered Nurse 3 (RN-3) without required monitoring in place;

2. No evidence of an initial nursing assessment was done for Patient 1; and

3. No nursing re-assessment was documented after the administration of pain medication for Patient 22 which may have precluded the patient from having effective pain management.

These failures resulted in a lack of nursing assessment, evaluation, and monitoring per facility's policies for Patients 1 and 22 and had potential to delay care and treatment decisions for Patients 1 and 22 (Refer to A0398). Additionally, these failures contributed to Patient 1's respiratory depression and subsequent death. (Refer to A 0398 and A0410).

The cumulative effect of these failures resulted in the hospital's inability to provide effective, safe and quality nursing services in accordance with the statutorily-mandated Conditions of Participation Nursing Services.

Based on interview, clinical record review, and facility policy review, the facility failed to ensure policies for intravenous (IV, through the vein) medication administrations and nursing assessments of patients in the Emergency Department (ED) were implemented for two of 35 sampled Emergency Department patients (Patient 1 and 22) when:

1. Midazolam (a medication that is used to help a patient relax or sleep during a medical procedure) was administered to Patient 1 by Registered Nurse 3 (RN-3) without required monitoring in place;

2. No evidence of an initial nursing assessment was done for Patient 1; and

3. No nursing re-assessment was documented after the administration of pain medication for Patient 22 which may have precluded the patient from having effective pain management. .

These failures resulted in a lack of nursing assessment, evaluation, and monitoring per facility's policies for Patients 1 and 22 and had potential to delay care and treatment decisions for Patients 1 and 22.

These failures contributed to Patient 1's respiratory depression and subsequent death.

Findings:

1. Review of Patient 1's ED Triage (preliminary assessment) Note upon arrival, indicated Patient 1 arrived in the ED on 10/29/23 at 4:55 p.m. by ambulance from home. The note further indicated Patient 1 had weakness, slurred speech, and a history of Congestive Heart Failure (CHF, a chronic condition where the heart is weak and unable to pump blood effectively to the body). Patient 1 was triaged with an emergency severity index of 3 (ESI, a tool used in the emergency department for triage, 3 was considered urgent).

Review of Medical Doctor (MD) 1's note, titled "ED Physician Notes", dated 10/29/23 at 9:53 p.m. (after Patient 1's death at 8:24 p.m.) included the following:

Patient 1 had a history CHF, ischemic myopathy (heart damage) with an ejection fraction of 28% (amount of blood that pumps out of the heart with normal percentage between 50-70) and daily alcohol ingestion. The note further indicated MD 1's initial assessment indicated Patient 1 appeared tired, not answering questions, her lower extremities were mottled (uneven discolored patches occurring in low blood flow to the skin) and cold with no pulses.

The 10/29/23 note further indicated MD 1 was concerned that Patient 1 was suffering from a possible aortic dissection/thrombus (tearing or clotting of the heart's main artery that prevents blood flow to organs and can be fatal) and arterial occlusions (a blockage in the artery that prevents blood flow). Patient 1 was taken emergently to the Computed Tomography scan (CT scan) for an aortic angiogram and run off (CT scan where dye is injected and x-rays are taken of the abdomen and leg arteries).

Further review of MD 1 note indicated Patient 1 tolerated the CT scan of the abdomen but attempted to "jump off table" during the lower extremity CT scan. MD 1 ordered "Versed [midazolam] 5 milligrams (mg, unit of measurement) IV to facilitate the LE (lower extremity) ..." for CT scan procedure.

MD 1's 10/29/23 note indicated that after the CT was completed, Patient 1 was found not breathing and unresponsive. Cardiopulmonary Resuscitation (CPR, reviving heartbeat and breathing) was initiated. Patient 1 was revived after 20 minutes of CPR and placed on multiple medications to maintain a life sustaining blood pressure. Approximately 1 ½ hours later, Patient 1's heart stopped again. CPR was reinitiated, but unsuccessful, and Patient 1 was pronounced dead.

During a review of Patient 1's CT scan orders on 1/2/24 at 11:15 a.m., the order indicated a CT scan of the abdomen with runoff was ordered and started on 10/29/23 at 5:35 p.m. The order further indicated a CT scan of the lower extremities was ordered and started on 10/29/23 at 5:58 p.m.

During a review of Patient 1's medication order, written by Medical Doctor Resident (MDR), dated 10/29/23 at 5:53 p.m., the order indicated midazolam 5 mg IV one time use was ordered. The order did not include parameters for how long, or the time, the midazolam should have been administered via IV push to Patient 1 or the monitoring requirements or administration.

Review of Patient 1's Medication Administration Record (MAR, electronic record of ordered medications administered by nursing) for 10/29/23, the MAR indicated midazolam 5 mg was administered IV at 5:56 p.m. by RN 3.

Review of Patient 1's first CPR record, dated 10/29/23, indicated CPR was initiated at 6:06 p.m. Patient 1 was not breathing, and her heart had stopped. Patient 1 was revived with a heartbeat at 6:22 p.m. while on multiple medications to sustain blood pressure and heartbeat.

Review of Patient 1's second CPR record, dated 10/29/23, indicated CPR was reinitiated on at 7:59 p.m. when the heart rate became slow. Patient 1 was pronounced dead at 8:24 p.m.

During an interview with Registered Nurse (RN) 4 on 1/2/24 at 1:35 p.m., RN 4 stated that Patient 1 was in the hallway and placed on the monitor (machine that monitors breathing and heart rate, blood pressure, and oxygen saturation [percentage of oxygen in the blood]) waiting to be seen by a physician. RN 4 stated Patient was disconnected from the monitor by MD 1 and taken for a CT scan. RN 4 stated Patient 1 became restless in CT scan, and midazolam 5 mg IV dose was administered by RN 3 to help with restlessness. RN 4 stated the facility had a policy on how to give the midazolam and it's use required breathing and body oxygen level monitoring but not every situation required this type of monitoring.

During an interview with RN 3 on 1/2/24 at 2:45 p.m., RN 3 stated that he administered midazolam 5 mg IV to Patient 1, per order. RN 3 further stated that he administered the medication over 30 to 60 seconds, which was approximately two times faster than recommended per policy and standard of practice. RN 3 confirmed Patient 1 should have been on the monitor when he administered the medication.

During a telephone interview with MD 1 on 1/3/24 at 2:15 p.m., the MD 1 stated Patient 1 needed monitoring, and MD 1 stated "not being monitored was a fail [neglect to do something]." MD 1 further stated midazolam was not a poor choice for Patient 1's restless and anxious behavior but acknowledged a lower dose could have been ordered.

During an interview on 1/4/24, at 10:56 a.m. with RN 4, RN 4 stated midazolam IV push (intravenous - drug given through the vein) should have been administered over 2-3 minutes and the patient needed to be on a monitor to assess for the respiratory depression (shallow breathing) and/or adverse effects (harmful) of the medication.

During an interview on 1/4/24 at 11:10 a.m. with the ED Manager (EDM), the EDM stated midazolam 4 to 5 mg IV push had frequently been given in the Emergency Department. EDM stated, midazolam caused respiratory depression and therefore the patient needed to have their oxygen saturation and respiratory rate (per minute) monitored during medication administration. EDM stated, midazolam should have been given over at least two minutes and given slowly. EDM stated, the ED had been short on transport monitors (portable monitors that display current heart rate and respiratory rate per minute, blood pressure, and oxygen saturation).

During an interview with RN 5 on 1/4/24 at 11:35 a.m., RN 5 stated midazolam should be given over five minutes and the patient needed to be on a monitor to be able to assess for respiratory depression.

During a joint interview with the Chief Nursing Officer (CNO) and the Director of Quality (DOQ) on 1/3/24 at 10 a.m., CNO stated midazolam should have been given 1 to 2 mg at a time, and not 5 mg at once. CNO and DOQ both confirmed Patient 1 should have received the medication slowly and while on a monitor.

In an interview with Chief Nursing Officer (CNO), on 1/3/24, at 11:26 AM, the CNO stated midazolam was not a first line drug for treatment of agitation and anxiety related to medical environment. The CNO stated there were safer drugs to use. The CNO stated the facility's policy on "Procedural Sedation" (a policy that ensured safe medication use and monitoring for moderate or deep sedation) did not apply to midazolam use in the CT scan for agitation.

Review of the Food and Drug Administration (FDA, a federal agency responsible for protecting the public health by assuring the safe and effective medication use) Black Box Warning (or BBW, the FDA ' s most stringent warning for drugs which alerts healthcare providers to serious side effects, such as injury or death), last accessed on 1/10/24 via https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e8c021b-6f4e-4164-be7f-eb5e033718fe , the BBW indicated "Adults and Pediatrics: Intravenous midazolam... has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy [brain damage caused by lack of oxygen] has resulted. Intravenous midazolam... should be used only in hospital or ambulatory care settings ... that provide for continuous monitoring of respiratory and cardiac function, e.g., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation [tube used for oxygenation and ventilation], and personnel trained in their use and skilled in airway management should be assured ... The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult ... The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect..."

Review of the facility's guidelines titled, "Medications Given By IV Push or Rapid Administrations in Adults," approved by the facility's Pharmacy and Therapeutics Committee and last revised 3/8/23, indicated that midazolam was only to be given in Intensive Care Units, ED, and procedural areas. It stipulated for "anxiolysis (reduction or treatment for anxiety): give over minimum of 2 minutes". The guideline instructs, "Monitoring Considerations, respiratory depression, airway obstruction, and/or arrest, CNS (Central Nervous System) depression. Monitoring: Respiratory status (e.g. oxygen saturation). The document included comments, "Use the 1 mg/ml strength for better titration (dose gradually increased until effective). Wait at least 2 minutes after does to fully evaluate the effect ..."

Review of the facility's policy titled "Medication Administration", last revised on 11/2023, section 8 indicated, "The nurse will not administer any medication without the knowledge of adverse reactions, appropriate dosing, and expected pharmacological response."

2. A review of Patient 1's Face Sheet, dated 10/29/23, indicated Patient 1 was triaged at the facility's ED on 10/29/23 at 4:55 p.m.

During a concurrent record review of Patient 1's Triage Note and interview with the Emergency Department Clinical Educator (EDCE) on 1/4/24 at 11:24 a.m., the note indicated Patient 1 was triaged with an ESI of 3, and then placed in an ED hallway to be seen by a physician and assessed by a nurse. The medical record did not indicate an initial nursing assessment and/or shift nursing assessment. EDCE stated that a patient with an ESI of 3 is required to have a nursing assessment. EDCE acknowledged Patient 1's initial nursing assessment and/or the following shift's nursing assessment were not completed.

A review of the facility's policy titled, "Assessment/Reassessment of Patients in the Emergency Department", last revised on 4/22, indicated, "All patients who present to this facility requesting to see a provider will receive an initial assessment by a registered nurse [RN] ...." The policy further indicated the ED staff will assess and reassess each patient and document the data collected. A nursing assessment is to be performed at the beginning of each shift and a reassessment for the ongoing problem at least every 2 hours. ESI Level 3 patients reassessments included the patient ' s vital signs (blood pressure, heartbeat, temperature, respirations, blood oxygen saturation level and pain) as frequent as necessary (minimum of every 4 hours), behavioral concerns, and the chief complaint performed on each nursing shift. In addition, re-assessments and/or the need for more frequent assessments may be necessary with a patient ' s response to nursing/medical intervention (including medication administration(s) and diagnostic testing), pain, recovery from sedation, and/or change in condition (condition improving or deteriorating).


3. During a review of Patient 22's clinical record titled, "History and Physical", dated 1/2/24 at 3:29 p.m., written by the Medical Doctor (MD 2), indicated Patient 22 presented to the Emergency Department (ED) with complaints of abdominal pain, fever, and nausea for approximately three days. Patient 22 had a past medical history of chronic (long term) pain.

A review of Patient 22's clinical record titled, "Order Information for Morphine [narcotic medication used to treat severe pain]", dated 1/2/24 at 3:00 p.m., by MD 3, indicated Morphine 4 milligrams (mg- unit of measurement) IV Push (intravenous - medication given through the vein) was ordered to treat Patient 22's pain.

During a review of Patient 22's clinical record titled, "Pain Intensity Flowsheet", dated 1/2/24, during the time frame of 5:00 p.m.-5:59 p.m., indicated Patient 22 was assessed to have 10/10 pain (pain scale assessment tool - 0=no pain and 10=the worst pain).

A review of Patient 22's clinical record titled, "MEDICATION ADMINISTRATION RECORD (MAR) Summary", dated 1/2/24 at 5:08 p.m., indicated Registered Nurse (RN 5) administered Morphine 4 mg IV Push to Patient 22.

A second review of Patient 22's clinical record titled, "Pain Intensity Flowsheet", dated 1/2/24, indicated Patient 22's pain was reassessed during the time frame of 11:00 p.m.-11:59 p.m.

During an interview with on 1/3/24 at 1:12 p.m., with the Quality Patient Safety Program Manager (QPSPM), stated pain assessments and vital signs (blood pressure, heart rate per minute, respiratory rate per minute, temperature, and oxygen saturation [amount of oxygen in the blood]) should have been completed every four hours.

During a concurrent interview with RN 5 on 1/4/24 at 10:56 AM and clinical record review of Patient 22's "MAR Summary", dated 1/2/24, the MAR Summary indicated Patient 22 did not have a pain reassessment for approximately six hours after Morphine was given. RN 5 stated Patient 22's pain should have been reassessed 30 minutes after IV pain medication was administered to ensure the pain medication was effective.

During an interview on 1/4/24 at 11:10 a.m., with the ED Manager (EDM), stated Patient 22's pain reassessment should have been conducted within 30 minutes after the administration of IV pain medication.

During an interview on 1/4/24 at 11:35 a.m., with RN 6, stated Patient 22's pain should have been reassessed within 30 minutes of receiving IV pain medication to evaluate the effectiveness of the pain medication.

During an interview on 1/4/24 at 3:30 p.m., with the Chief Nursing Officer (CNO), stated the nurse should have reassessed the patient's pain level according to Policy and Procedure (P&P) and at least within two hours after administering pain relieving medication. The CNO stated reassessments were necessary to ensure the pain medication was effective in reducing the patient's pain to an acceptable level.

A review of the facility's P&P titled, "[HOSPITAL NAME] Medical Management Policy and Procedure SUBJECT: Pain Management", dated 11/21, indicated, " ... Pain Assessment and Reassessment ... A measure of pain intensity and personal pain relief will be assessed as follows: ...Routinely every 4 hours while awake ... After each pain management intervention (not greater than one hour after interventions) ..."

A review of the facility's P&P titled, "Assessment/Reassessment of Patients in the Emergency Department", dated 3/23, indicated, " ... To evaluate the patient's response to treatment ... Reassessments and vital signs will be performed as frequently as necessary based on patient's clinical condition and medical treatments. The standard minimum of documentation ... will be every 4 hours ... Many conditions could occur that require more frequent assessment and/or the need for re-assessment. These may include: ... Response to nursing/medical interventions (e.g.; Medication administration) ... Pain ...".

A review of the facility's document titled, "NURSE II STAFF JOB DESCRIPTION", not dated, indicated, " ... Job Standards ... Performs reassessments/care at intervals as required or appropriate to the patient's specific needs ... Assesses and manages the patient's pain ... Evaluating the effectiveness of measures and ... Documenting according to hospital policy ...".


43943

Based on interview, clinical record review and facility policy review, the facility failed to ensure a medication was administered in accordance with facility policy for one of 35 sampled Emergency Department (ED) patients (Patient 1) when midazolam (a medication that is used to help a patient relax or sleep during a medical procedure) was not administered based on facility's policy.

This failure may have contributed to Patient 1's respiratory depression and subsequent death.

Findings:

1. Review of Patient 1's ED Triage (preliminary assessment) Note upon arrival, indicated Patient 1 arrived in the ED on 10/29/23 at 4:55 p.m. by ambulance from home. The note further indicated Patient 1 had weakness, slurred speech, and a history of Congestive Heart Failure (CHF, a chronic condition where the heart is weak and unable to pump blood effectively to the body). Patient 1 was triaged with an emergency severity index of 3 (ESI, a tool used in the emergency department for triage, 3 was considered urgent).

Review of Medical Doctor (MD) 1's note, titled "ED Physician Notes", dated 10/29/23 at 9:53 p.m. (after Patient 1's death at 8:24 p.m.) included the following:

Patient 1 had a history CHF, ischemic myopathy (heart damage) with an ejection fraction of 28% (amount of blood that pumps out of the heart with normal percentage between 50-70) and daily alcohol ingestion. The note further indicated MD 1's initial assessment indicated Patient 1 appeared tired, not answering questions, her lower extremities were mottled (uneven discolored patches occurring in low blood flow to the skin) and cold with no pulses.

The 10/29/23 note further indicated MD 1 was concerned that Patient 1 was suffering from a possible aortic dissection/thrombus (tearing or clotting of the heart's main artery that prevents blood flow to organs and can be fatal) and arterial occlusions (a blockage in the artery that prevents blood flow). Patient 1 was taken emergently to the Computed Tomography scan (CT scan) for an aortic angiogram and run off (CT scan where dye is injected and x-rays are taken of the abdomen and leg arteries).

Further review of MD 1 note indicated Patient 1 tolerated the CT scan of the abdomen but attempted to "jump off table" during the lower extremity CT scan. MD 1 ordered "Versed [midazolam] 5 milligrams (mg, unit of measurement) IV to facilitate the LE (lower extremity) ..." for CT scan procedure.

MD 1's 10/29/23 note indicated that after the CT was completed, Patient 1 was found not breathing and unresponsive. Cardiopulmonary Resuscitation (CPR, reviving heartbeat and breathing) was initiated. Patient 1 was revived after 20 minutes of CPR and placed on multiple medications to maintain a life sustaining blood pressure. Approximately 1 ½ hours later, Patient 1's heart stopped again. CPR was reinitiated, but unsuccessful, and Patient 1 was pronounced dead.

During a review of Patient 1's CT scan orders on 1/2/24 at 11:15 a.m., the order indicated a CT scan of the abdomen with runoff was ordered and started on 10/29/23 at 5:35 p.m. The order further indicated a CT scan of the lower extremities was ordered and started on 10/29/23 at 5:58 p.m.

During a review of Patient 1's medication order, written by Medical Doctor Resident (MDR), dated 10/29/23 at 5:53 p.m., the order indicated midazolam 5 mg IV one time use was ordered. The order did not include parameters for how long, or the time, the midazolam should have been administered via IV push to Patient 1 or the monitoring requirements or administration.

Review of Patient 1's Medication Administration Record (MAR, electronic record of ordered medications administered by nursing) for 10/29/23, the MAR indicated midazolam 5 mg was administered IV at 5:56 p.m. by RN 3.

Review of Patient 1's first CPR record, dated 10/29/23, indicated CPR was initiated at 6:06 p.m. Patient 1 was not breathing, and her heart had stopped. Patient 1 was revived with a heartbeat at 6:22 p.m. while on multiple medications to sustain blood pressure and heartbeat.

Review of Patient 1's second CPR record, dated 10/29/23, indicated CPR was reinitiated on at 7:59 p.m. when the heart rate became slow. Patient 1 was pronounced dead at 8:24 p.m.

During an interview with Registered Nurse (RN) 4 on 1/2/24 at 1:35 p.m., RN 4 stated that Patient 1 was in the hallway and placed on the monitor (machine that monitors breathing and heart rate, blood pressure, and oxygen saturation [percentage of oxygen in the blood]) waiting to be seen by a physician. RN 4 stated Patient was disconnected from the monitor by MD 1 and taken for a CT scan. RN 4 stated Patient 1 became restless in CT scan, and midazolam 5 mg IV dose was administered by RN 3 to help with restlessness. RN 4 stated the facility had a policy on how to give the midazolam and it's use required breathing and body oxygen level monitoring but not every situation required this type of monitoring.

During an interview with RN 3 on 1/2/24 at 2:45 p.m., RN 3 stated that he administered midazolam 5 mg IV to Patient 1, per order. RN 3 further stated that he administered the medication over 30 to 60 seconds, which was approximately two times faster than recommended per policy and standard of practice. RN 3 confirmed Patient 1 should have been on the monitor when he administered the medication.

During a telephone interview with MD 1 on 1/3/24 at 2:15 p.m., the MD 1 stated Patient 1 needed monitoring, and MD 1 stated "not being monitored was a fail [neglect to do something]." MD 1 further stated midazolam was not a poor choice for Patient 1's restless and anxious behavior but acknowledged a lower dose could have been ordered.

During an interview on 1/4/24, at 10:56 a.m. with RN 4, RN 4 stated midazolam IV push (intravenous - drug given through the vein) should have been administered over 2-3 minutes and the patient needed to be on a monitor to assess for the respiratory depression (shallow breathing) and/or adverse effects (harmful) of the medication.

During an interview on 1/4/24 at 11:10 a.m. with the ED Manager (EDM), the EDM stated midazolam 4 to 5 mg IV push had frequently been given in the Emergency Department. EDM stated, midazolam caused respiratory depression and therefore the patient needed to have their oxygen saturation and respiratory rate (per minute) monitored during medication administration. EDM stated, midazolam should have been given over at least two minutes and given slowly. EDM stated, the ED had been short on transport monitors (portable monitors that display current heart rate and respiratory rate per minute, blood pressure, and oxygen saturation).

During an interview with RN 5 on 1/4/24 at 11:35 a.m., RN 5 stated midazolam should be given over five minutes and the patient needed to be on a monitor to be able to assess for respiratory depression.

During a joint interview with the Chief Nursing Officer (CNO) and the Director of Quality (DOQ) on 1/3/24 at 10 a.m., CNO stated midazolam should have been given 1 to 2 mg at a time, and not 5 mg at once. CNO and DOQ both confirmed Patient 1 should have received the medication slowly and while on a monitor.

In an interview with Chief Nursing Officer (CNO), on 1/3/24, at 11:26 AM, the CNO stated midazolam was not a first line drug for treatment of agitation and anxiety related to medical environment. The CNO stated there were safer drugs to use. The CNO stated the facility's policy on "Procedural Sedation" (a policy that ensured safe medication use and monitoring for moderate or deep sedation) did not apply to midazolam use in the CT scan for agitation.

Review of the Food and Drug Administration (FDA, a federal agency responsible for protecting the public health by assuring the safe and effective medication use) Black Box Warning (or BBW, the FDA ' s most stringent warning for drugs which alerts healthcare providers to serious side effects, such as injury or death), last accessed on 1/10/24 via https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e8c021b-6f4e-4164-be7f-eb5e033718fe , the BBW indicated "Adults and Pediatrics: Intravenous midazolam... has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy [brain damage caused by lack of oxygen] has resulted. Intravenous midazolam... should be used only in hospital or ambulatory care settings ... that provide for continuous monitoring of respiratory and cardiac function, e.g., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation [tube used for oxygenation and ventilation], and personnel trained in their use and skilled in airway management should be assured ... The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult ... The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect..."

Review of the facility's guidelines titled, "Medications Given By IV Push or Rapid Administrations in Adults," approved by the facility's Pharmacy and Therapeutics Committee and last revised 3/8/23, indicated that midazolam was only to be given in Intensive Care Units, ED, and procedural areas. It stipulated for "anxiolysis (reduction or treatment for anxiety): give over minimum of 2 minutes". The guideline instructs, "Monitoring Considerations, respiratory depression, airway obstruction, and/or arrest, CNS (Central Nervous System) depression. Monitoring: Respiratory status (e.g. oxygen saturation). The document included comments, "Use the 1 mg/ml strength for better titration (dose gradually increased until effective). Wait at least 2 minutes after does to fully evaluate the effect ..."

Review of the facility's policy titled "Medication Administration", last revised on 11/2023, section 8 indicated, "The nurse will not administer any medication without the knowledge of adverse reactions, appropriate dosing, and expected pharmacological response."

Based on observation, interview, and record review, the facility failed to ensure safe medication use and storage practices for a census of 109 patients in the Emergency Department (ED) when:

1. Expired IV (IntraVenous- into the vein) saline bags (sterile salt solution) were stored in the Computerized Tomography Scan (CT scan combines a series of images taken from different angles inside the body to identify disease or injury) room 3, and

2. Spiked (tubing was attached to the bag) IV saline bags and opened contrast agents called Isovue-370 (IV contrast materials injected into a vein and used to enhance CT images inside body) were in active patient care area of the CT scan room 3 with no label or marking for open date or time.

These failures may contribute to unsafe medication use and improper storage with the potential to cause patient harm.

Findings:

1. During a concurrent observation and interview, on 1/2/24, at 10:25 AM, in the facility's CT scan room 3, accompanied by Radiology Technician 1 (RadT-1), the cabinet next to CT scan machine stored more than seven 1000 mL ("mL" is measure of volume) saline bags with expiration dates ranging from July 2023 to November 2023. RadT-1 acknowledged the findings and stated the products were not used frequently and should have been thrown away.

2a. During a concurrent observation and interview, on 1/2/24, at 10:32 AM, inside facility's CT scan room 3, accompanied by RadT-1, the IV pole (a rolling hanger used to hold the IV medications) next to CT scan bed was holding two spiked bags of saline 1000 mL without any marking on when or what time it was spiked. RadT-1 acknowledged the findings and stated they didn't label the bag or tubing with date or time when they first opened them. RadT-1 stated the partial bag of saline was used on a previous case (patient) and they had pre-spiked bags ready for use to speed up the workflow.

2b. During a concurrent observation and interview, on 1/2/24, at 10:32 AM, inside facility's CT scan room 3, accompanied by RadT-1, two opened vials of Isovue-370 was on the cabinet counter inside the CT scan room 3 without any marking for date/time opened. RadT-1 acknowledged the findings. RadT-1 then quickly tossed one vial in the waste bin as it was almost empty and kept the partially used vial with spiked pin and green cap. RadT-1 stated the Isovue-370 were retrieved from the Automated Dispensing Machine (or ADM, a computerized medication handling system that used for secure drug storage, and accurate dispensing, with drug traceability at various points of care within a hospital) per doctor's order for each patient.

In an interview with Radiology Technician 2 (RadT-2), on 1/4/24, at 10:43 AM, RadT-2 stated once they opened and spiked a bottle of contrast, it was good for 4-6 hours and if not used it was important to label it.

In an interview with Pharmacy Clinical Manager (PCM), on 1/4/23, at 10:56 AM, the PCM stated pharmacy inspected all patient care areas that stocked medications including the CT scan's department central stock area and discrepancies reported to the leadership. The PCM stated the CT scan room 3 was not an area for inspection as it should not have had any stock or stash of IV products.

In an interview with Imaging Director (ID), on 1/4/24, at 11:09 AM, in his office, the ID stated CT scan room should not have stored unmonitored supply of IV bags. The ID stated the main supply room stocked IV products and was monitored for outdated medications. The ID stated the department followed hospital policy and labeling with date and time should have been followed.

Review of the facility's policy titled "Medication Storage and Handling", last revised on 4/2023, the policy indicated "Medications are to be removed from their designated storage area just prior to the time needed for administration to the patient. Only those medications require to meet the immediate needs of the individual patient will be accessed. Medications are not to be removed in anticipation of administration of the medication at a later time and must be for only one patient at a time." The policy further indicated "Medications prepared for administration during a planned procedure are to be labeled appropriately with ... and beyond use date ...".

Review of the facility's policy titled "Floor Stock; Medication Management", last revised on 11/2018, the policy indicated "multi-dose vials used on the nursing units should be discarded after initial use ... ".

Review of the facility's policy titled "IV therapy; Medication Management", last revised on 10/2020, the policy indicated "tubing on all IVs will be labeled with expiration date and time."