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Based on review of medical records, policies and procedures, and interviews with staff, it was determined that the facility's nursing services failed to ensure that nursing care was delivered in accordance to facility policy and procedures, physician orders, and standards of care when:

1. Vital signs and nursing reassessments were not conducted per policy for 15 (P#3, P#4, P#5, P#6, P#8, P#9, P#10, P#11, P#13, P#14, P#15, P#16, P#17, P#19, P#20) of 20 (P#1, P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11,P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20) sampled emergency department (ED) records.

2. Medication was not prepared and administered per physcian order and facility policy for one (P#11) of 20 (P#1, P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11,P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20) sampled ED records.

Cross-refer A- 0398 as it related to the facility's failure to ensure that nursing staff followed policies and procedures related to patient assessments/reassessments.

Cross-refer A-405 as it related to the facility's failure to ensure that nursing staff administered medications per a physician order and facility policy.

Based on review of medical records, interview with staff, and review of policy and procedures, it was determined that the facility failed to ensure that nursing staff adhered to policies, practices, and procedures for re-assessments and vital signs of patients in the Emergency Department. Specifically, a review of medical records revealed that 15 (P#3, P#4, P#5, P#6, P#8, P#9, P#10, P#11, P#13, P#14, P#15, P#16, P#17, P#19, P#20) of 20 records failed to reveal documentation of vital signs and re-assessments according to the facility's policies and procedures.

Findings included:

A review of the emergency department (ED) Electronic Central Log revealed that P#3 arrived at the ED on 4/9/22 at 3:23 p.m. with low blood pressure, diaphoresis (sweating), nausea, and vomiting.

A review of P#3 medical record (MR) revealed that he presented to the ED via Emergency Medical Services (EMS) on 4/9/22 at 3:23 p.m. with chief complaints of abdominal pain, nausea, vomiting, diaphoresis, and near syncope (fainting).

Vital signs at 3:25 p.m. were:
Temperature (T): 97.6 degrees (normal was 98.6 degrees)
Heart rate (HR): 96 beats per minute (normal was 60-100 beats per minute)
Respiratory Rate (RR): 20 breaths per minute (normal was 12-20 breaths per minute)
Blood pressure (BP): 86/68 (normal was 120/80-139/89)
Pulse oximeter (O2): 98% (normal was 92-100%) on room air.

An acuity level (level denoting the severity of a patient's complaint) of two (emergent) was assigned to P#3 at triage.

A medical screening exam (MSE) was initiated at 3:31 p.m.

A nurse's note written at 5:51 p.m. on 4/9/22 revealed that at 5:22 p.m., P#3's daughter requested assistance and that P#3 was having bad abdominal pain. P#3 had agonal (very slow, irregular) breathing with a rhythm on the monitor. RN BB requested assistance from DO PP, who instructed her to find MD OO. RN BB informed DO PP of P#11's agonal breathing. RN BB found P#3 with no heart rhythm on the monitor when she returned to P#3's room. A code blue was called, and cardiopulmonary resuscitation (CPR) was initiated. P#3 was intubated (a plastic tube inserted into the respiratory tract to assist breathing) and placed on a ventilator at 5:40 p.m.

Vital signs as documented included:

At 7:13 p.m. HR: 122 BP: 67/49.
At 7:30 p.m. HR: 119 BP: 71/40
At 7:50 p.m. HR: 108 BP: 92/67
At 7:55 p.m. HR: 105 RR: 18 BP: 103/87
At 8:10 p.m. BP: 64/37
At 8:15 p.m. HR: 63 BP: 40/19
At 8:22 p.m. HR: 62 BP: 73/16
At 8:26 p.m. HR: 60 BP: 60/37
At 8:31 p.m. HR: 66 BP: 87/70
At 8:39 p.m. HR: 62 BP: 82/67
At 8:44 p.m. HR: 100 BP: 41/26
At 8:45 p.m. HR: 110 BP: 50/32
At 8:49 p.m. HR: 100 BP: 50/32
At 8:53 p.m. HR: 118 RR: 18 BP: 92/39
At 8:57 p.m. HR: 98 BP: 45/25
At 9:00 p.m. HR: 108 BP: 50/34
At 9:06 p.m. HR: 112 BP: 58/34
At 9:19 p.m. HR: 107 BP: 40/29
At 9:20 p.m. HR: 107 BP: 69/30
At 9:23 p.m. HR: 102 BP: 72/40
Repeated at 9:23 p.m. HR: 106 BP: 97/65
At 9:24 p.m. HR: 104 BP: 97/65
At 9:29 p.m. HR: 101 BP: 44/31
At 9:31 p.m. HR: 106 BP: 44/31
At 9:35 p.m. HR: 101 BP: 37/28
At 9:41 p.m. HR: 80 BP: 82/70
At 9:52 p.m. HR: 79 BP: 50/31
At 9:53 p.m. HR: 72 BP: 50/31
At 10:02 p.m. HR: 68 BP: 39/30
At 10:12 p.m. HR: 67 BP: 48/34
At 10:16 p.m. HR: 70 BP: 42/30
At 10:21 p.m. HR: 64 BP: 37/27
At 10:33 p.m. HR: 76 BP: 33/20
At 10:45 p.m. HR: 70 BP: 42/30
At 10:55 p.m. HR: 88 BP: 78/59
At 11:05 p.m. HR: 48 BP: 33/23
At 11:16 p.m. HR: 41
At 11:26 p.m. HR: 38

A review of a note by MD QQ on 4/10/22 at 12:49 a.m. revealed that he evaluated P#3 at the request of the ED provider. At the time of the evaluation, P#3 was intubated and sedated. P#3 had been hemodynamically unstable (abnormal or unstable blood pressure, which could lead to inadequate blood flow to organs) in the ED with severe metabolic acidosis (a condition where there was too much acid in the body). P#3 had been started on vasopressors (medications that raise blood pressure) and monitored closely afterward. A bedside Focused Assessment with Sonography for Trauma (FAST) (ultrasound examination screening to test for blood around the heart and abdominal organs) exam showed fluid in the abdomen, and an evaluation of the anatomy revealed severely dilated abdominal aorta (large artery in the abdominal cavity). The suspicion of a ruptured abdominal aortic aneurysm (AAA- massive spontaneous internal bleeding from aortic artery) could not be excluded. A focused abdominal ultrasound was ordered as P#3 was deemed too unstable for an emergent CTA (CT scan of the abdomen). Impression was discussed with P#3's family. P#3 was made a Do Not Resuscitate (DNR). P#3 was not suitable for the hospitalist service due to the critical state and emergent surgical need to address a possible AAA rupture. Around 12:00 a.m., P#3 went into asystole (no heartbeat) and expired at 12:12 a.m.

A review of a MR for P#3's revealed that vital signs and re-assessments were not completed from 3:25 p.m. until 7:13 p.m.

A review of a MR for P#4 revealed that he arrived at the ED on 3/15/22 at 8:28 a.m. with complaints of nausea and vomiting. P#4 was triaged at 8:34 a.m. and was assigned an acuity score of level three (urgent). Vital signs were taken at triage. P#4 was discharged home at 11:56 a.m. A review of the record failed to reveal that vital signs or a re-assessment were completed prior to discharge.

A review of a MR for P#5 revealed that he arrived at the ED on 3/15/22 at 10:31 a.m. with heart palpitations (a sensation that the heart is racing, fluttering, or skipping a beat). P#5 had been sent from his doctor's office. A triage assessment was performed at 10:45 a.m., and he was assigned a level two (emergent) acuity. P#5's vital signs were reassessed at 11:55 a.m. and 1:46 p.m. P#5 was admitted to the facility's Intensive Care Unit (ICU) at 3:10 p.m. A review of the record failed to reveal vital signs or re-assessment from 1:46 p.m. until 3:10 p.m.

A review of a MR for P#6 revealed that she arrived at the ED on 4/6/22 at 2:07 a.m. with weakness. At triage, she had a blood pressure of 75/49 and was assigned an acuity level of two. P#6 was admitted to the facility at 7:00 a.m. with a diagnosis of severe anemia (a condition where the body has a lack of red blood cells). A review of the record failed to reveal vital signs or re-assessments from 2:07 a.m. until 7:00 a.m.

A MR review revealed that P#8 presented to the ED on 4/8/22 at 10:21 a.m. with a chief complaint of nausea, vomiting, and diarrhea. P#8 was seven weeks pregnant. She was triaged at 10:31 a.m. and given an acuity level of three. Her vital signs were reassessed at 2:37 p.m. P#8 was discharged home at 2:38 p.m. with a final diagnosis of threatened abortion. A review of the record revealed that vital signs and re-assessment was not completed from 10:21 a.m. to 2:37 p.m.

A MR review revealed that P#9 presented to the ED via EMS on 4/9/22 at 10:10 a.m. with a chief complaint of chest pain. P#9's MSE began at 10:12 a.m. He was triaged at 10:12 a.m. and given an acuity level of two. His vital signs were reassessed at 1:21 p.m. P#9's vital signs were assessed again at 5:54 p.m., prior to his transfer to another facility. P#9's final diagnosis was subdural hemorrhage (bleeding in the brain). A review of the record revealed that vital signs were assessed 3 hours 10 minutes after triage and again in approximately 4 hours 30 minutes.

A MR review revealed that P#10 presented to the ED on 4/9/22 at 10:12 p.m. with a chief complaint of dizziness. P#10 was triaged at 10:23 p.m. and given an acuity level of three. P#10 had a set of orthostatic blood pressures (blood pressure assessed while lying down and then retaken while standing up) taken on 4/10/22 at 2:58 a.m. P#10 was discharged on 4/10/22 at 3:20 a.m. with a final diagnosis of vertigo (the sensation that your environment is spinning). A record review revealed that P#10's blood pressure was taken approximately 4 hours 30 minutes after triage.

A review of the ED Electronic Central Log revealed that P#11 arrived at the ED on 3/23/22 at 6:37 p.m. with complaints of shortness of breath. Triage was started at 7:47 p.m. by RN BB. P#11 was assigned a level two acuity. A triage note revealed that P#11 complained of shortness of breath that started two days prior. P#11 was breathing quickly, P#11's skin was cool and clammy, and P#11 was sweating. P#11 was alert and oriented. P#11 was intubated due to severe respiratory distress at 10:40 p.m. and placed on a ventilator. A Levophed (used to increase blood pressure) infusion was started at 11:03 p.m.

Vital Signs as documented included:

3/23/22 7:47 p.m.
T: 28.6 degrees Celsius Normal was 36-38 degrees Celsius
HR: 57 RR: 45 BP: 108/72 Oxygen saturation (O2 Sat): 98

3/23/22 8:00 p.m.
HR: 69 RR: 33 BP: 111/95 O2 Sat: 90

3/23/22 8:25 p.m.
T: 34.2 degrees Celsius

3/23/22 8:55 p.m.
HR: 63 RR: 13 BP: 123/84 O2 Sat: 100

3/23/22 9:43 p.m.
HR: 132

3/23/22 10:50 p.m.
HR: 116 RR: 18 BP: 59/18 O2 Sat: 92

3/23/22 10:55 p.m.
HR: 63 RR: 18 BP: 134/86 O2 Sat: 100

3/23/22 11:10 p.m.
HR: 124 RR: 19 BP: 98/84 O2 Sat: 100


A general nurse's note by RN RR revealed that on 3/24/22 at 2:16 a.m., P#11 was received (in ICU) on a ventilator with sodium bicarbonate drip at 100 milliliters (ml) per (/) hour. Levophed drip 8 milligrams (mg)/250 ml was hanging at 999 ml/hour. The drip was paused, and Levophed was reprogrammed to hospital protocol. P#11's fingers and legs were blue and cold. Mottled (patchy irregular colors) was noted from P#11's feet up to the chest. There was no palpable pedal (foot area) or radial (wrist area) pulses. Femoral (area between the hip and pubic bone) pulse was obtained using a doppler. A Nasogastric (NG) tube was connected to suction, and dark red drainage was noted. Pink frothy sputum was noted from the endotracheal (ET) tube. P#11's rectal temperature was 34.7 degrees Celsius, and a blanket warmer was applied to P#11. Fentanyl (narcotic) and Versed (sedative) drips were discontinued on arrival to the ICU. A continued review of the nurse's note revealed that a code was called on 3/24/22 at 3:00 a.m. P#11's heart rate was 34 beats per minute, and no pulse could be obtained. P #11 was in pulseless electrical activity (PEA). At 3:14 a.m., MD QQ pronounced P#11 deceased.

A review of P#11's MR revealed that vital signs and re-assessments were not completed from 3/23/22 at 11:10 p.m. until transfer at 2:16 a.m. or approximately 3 hours.

A review of P#13's MR revealed that she arrived at the ED on 5/13/22 at 9:46 a.m. with complaints of chest pain. P#13 was assigned an acuity level of two. P#13 left Against Medical Advice (AMA) at 1:00 p.m. A continued review of the MR revealed that vital signs were not reassessed after triage. The record failed to reveal vital signs or a re-assessment from 9:46 a.m. until P#13 left AMA at 1:00 p.m.

A review of P#14's MR revealed that he arrived at the ED on 5/13/22 at 3:10 p.m. with complaints of inability to sleep. P#14 was assigned a level three acuity. P#14 eloped from the ED at 7:59 p.m. The record revealed that vital signs were not assessed from 3:10 p.m. until the patient eloped at 7:59 p.m.

A review of P#15's MR revealed that she arrived at the ED on 5/13/22 at 8:23 p.m. and was triaged at 8:34 p.m. with complaints of hand bruising and swelling. She was assigned an acuity level of four. P#15 was discharged home at 11:02 p.m. The record failed to reveal that vital signs were reassessed prior to discharge.

A review of P#16's MR revealed that he was transferred from another hospital via EMS on 5/16/22 and arrived at 6:31 a.m. P#16 was triaged and assigned an acuity level two. A review of the record revealed that vital signs were reassessed at 5:15 p.m. and 6:00 p.m. P#16 was admitted to the ICU at 8:21 p.m. The record failed to reveal vital signs or re-assessments from triage at 6:31 a.m. until 5:15 p.m.

A review of P#17's MR revealed that she arrived at the ED at 3:01 p.m. on 5/16/22. P#17 was triaged and assigned a level three acuity. P#17 was discharged to home at 5:40 p.m. Review of the record failed to reveal vital signs or re-assessment prior to discharge.

A review of P#19's MR revealed that he arrived at the facility on 5/18/22 at 5:53 a.m. he was assigned a level three acuity during triage at 6:10 a.m. A review of the record revealed that P#19's blood pressure was reassessed at 1:05 p.m., and he was discharged to home at 1:10 p.m. Review of the record failed to reveal vital signs or a re-assessment from triage at 5:53 a.m. until 1:05 p.m.

A review of P#20's MR revealed that she arrived on 5/18/22 at 8:37 a.m. and was assigned an acuity level of three at 8:42 a.m. She was discharged home at 3:59 p.m. Review of the record failed to reveal that vital signs or a re-assessment were conducted from triage at 8:42 a.m. to discharge at 3:59 p.m.

A review of the facility's policy titled, "Assessment/Re-assessment, Patient," policy #10634684, last revised 2/17/22, revealed that the purpose of the policy was to clearly define the scope of assessment/re-assessment and the documentation of such data for patient care services to meet the patient's needs/changing needs throughout the organization.

1. All patients would have a full assessment each shift and appropriate re-assessments based on their individual needs. Patients were reassessed throughout their stay and upon any significant change in condition.

2. The scope of assessment and re-assessment was determined by the patient's diagnosis, the treatment setting, the patient's desire for treatment, and the patient's response to the treatment.

3. Diagnostic testing for determining the patient's health care needs was performed in a timely manner. When a test result required clinical interpretation, any relevant clinical information was provided with request.

4. Information generated by a patient's assessment would be integrated into the medical record via documentation on forms and/or on-line; included, but not limited to:

Physician History and Physical
Consultation Records
Triage Records
Episodic Area Specific Forms
Department-specific Assessment/Re-assessment forms

5.Each discipline would define their scope assessment/re-assessment.

Emergency Department/Express Care
Assessment:
1. The Registered Nurse (RN) or Qualified Paramedic (QP) performed a triage assessment for all patients within the shortest time possible after arrival to the ED.
Patient Reception: Patient identification, stated complaint, chief complaint (any staff could perform this)

Rapid Initial Assessment: First point of contact, allergies, mode of arrival, pain level, vital signs, ESI triage level

Based on the triage findings and the emergent status, the patient was either brought immediately to the room for care or placed in priority of triage and bed availability. Once placed in a room for care, the detailed assessment for Triage level 1-3, as well as the focused chief complaint assessment, was completed within 1 hour. Triage level 4/5 patients needed only a focused chief complaint assessment, focusing on the body system affected. A pediatric assessment would be age-appropriate, detailed, and based on the triage level.

Re-assessment:
1. The RN would reassess the patient's condition based on status and chief complaint; and, as a minimum, when a change in condition occurred and immediately prior to discharge or transfer.
Level 1- hourly with continuous monitoring
Level 2- every two hours with continuous monitoring
Level 3- every three hours and as condition warranted
Level 4- every four hours
Level 5- prior to discharge

2. All ED patients waiting for a medical screening by a physician or physician mid-level would have a re-assessment to determine if a change in condition had occurred. This re-assessment should be performed approximately every two hours after initial triage and based on the severity of the illness.

Documentation:

1. All assessments and re-assessment data should be documented in the ED patient record. Re-assessments would be documented for the following acuity levels:
Level 1- every one hour
Level 2- every two hours
Level 3- every three hours
Level 4- every four hours
Level 5- at discharge
All levels would be documented upon discharge and transfer.

A follow-up interview with DON CC and DED FF occurred in the conference room on 5/24/22 at 12:30 p.m. DON CC explained that recent chart audits had revealed deficiencies with nursing re-assessments and vital signs frequency. As a result, re-education and reminders had been implemented recently for all ED staff.

A follow-up interview with DED FF and ED Manager (EDM) UU took place on 5/25/22 at 10:30 a.m. in the conference room. DED FF explained that the policy for assessment and re-assessment had just been revised in the past couple of weeks. Vital signs in the ED were to be done at triage, for a change in condition and prior to discharge. EDM UU explained that she had focused on the revision of the policy on nursing assessments and re-assessments.

Based on a review of medical records, policy and procedures, and interviews with staff, it was determined that the facility failed to ensure that medications were prepared and administered in accordance with provider orders, facility policies, and accepted standards of practice when one (P#11) of 20 patients reviewed were administered the incorrect dose of Levophed and the patient eventually expired.

Findings included:

A review of the Emergency Department (ED) Electronic Central Log revealed that P#11 arrived at the ED on 3/23/22 at 6:37 p.m. with complaints of shortness of breath.

Triage was started at 7:47 p.m. by RN BB. P#11 was assigned a level two (emergent) acuity. A triage note revealed that P#11 complained of shortness of breath that started two days prior. P#11 was breathing quickly, skin was cool and clammy, and P#11 was sweating. P#11 was alert and oriented.
Vital signs at triage were:

Temperature: 28.6 degrees Celsius (normal was 36-38 degrees Celsius)
Heartrate: 57 (normal was 60-100 beats per minute)
Respiratory Rate: 45 (normal was 12-20 breaths per minute)
Blood Pressure:108/72 (normal was 120/80-139/89)
Oxygen Saturation: 98% (normal was 92-100%) on room air

An electrocardiogram (EKG) (recording of the electrical signals in the heart) was ordered at 8:06 p.m. by MD SS. A review of an EKG at 8:10 p.m. showed atrial fibrillation (an irregular, often rapid heart rate) with a rate of 146 beats per minute.

A review of the 'ED Physician Record' signed on 3/23/22 at 8:54 p.m. revealed that P#11 had a medical history of high blood pressure, mechanical mitral valve (one of the valves in the heart) repair (MVR), and aortic valve (one of the valves in the heart) replacement (AVR), coronary artery disease (damage or disease in the heart's major blood vessels), atrial fibrillation (A-fib), and tobacco use. She presented to the ED with complaints of sudden onset dyspnea (shortness of breath). P#11 was in atrial fibrillation and tachypneic (rapid breathing) on arrival with no complaints of fever, chills, chest pain, nausea, or vomiting.

A review of the 'Basic Physical Exam' included:
Skin: no rashes, warm/dry; extremities: no gross abnormality and Neuro: alert and oriented, gross movement normal

A review of 'General/Constitutional' included:
awake, alert, and in distress

Breath Sounds: equal bilaterally, no stridor, retractions, or wheezing; mild/moderate respiratory distress Cardiovascular: rapid atrial fibrillation (150's to 160s)

Skin: cold, pale, clammy; pulses equal in all extremities.

A review of the Patient Order Summary revealed that MD SS entered an order on 3/23/22 at 9:45 p.m.:

-Levophed (used to increase blood pressure) 8 milligrams (mg) per (/) /250 milliliters (ml) STAT (as soon as possible)
-Start at a rate of 0.05 microgram (mcg)/kilogram (kg)/minute (min), then titrate by 0.05 mcg/kg/min every 10 minutes to maintain systolic blood pressure between 90-110 millimeters of mercury (mmHg), mean arterial pressure (MAP) greater than 60 mmHg, and HR between 60-70 beats per minute (BPM). Maximum rate of 1 mcg/kg/min

A respiratory therapy note at 11:01 p.m. revealed that P#11 was intubated by MD SS at 10:40 p.m.

A review of the Medication Discharge Summary Report revealed that a Levophed infusion was started at 11:03 p.m. at 0.05 mcg/kg/min for a rate of 5.741 ml/hr.

A continued review of the Medication Discharge Summary Report revealed that 250 milliliter (ml) bags of Levophed were dispensed at 12:30 a.m., 12:54 a.m., and 1:54 a.m. on 3/24/22.

A review of 'Re-Evaluation and MDM,' time not documented, revealed that P#11 had a cardiac monitor applied that revealed rapid A-fib with oxygen saturation of 90% on room air. P#11 was placed on oxygen, and saturations improved. The sepsis protocol was initiated. P#11's blood pressure was 108/72, and intravenous (IV) fluids were initiated per the sepsis protocol. Cardizem (heart medication) IV was administered for the management of A-fib with rapid ventricular response (RVR). Vital signs temporarily improved, and consultation was requested for evaluation and admission to the ICU. MD QQ was at the bedside evaluating P#11, and a decision was made to intubate P#11 to protect the airway. Levophed drip was ordered. P#11 was successfully intubated, and a post-intubation x-ray confirmed appropriate intubation. After intubation, care was transferred to MD QQ.


A review of 'Patient Care Notes' revealed a note by RN TT, signed at 5:18 a.m. on 3/24/22:
Nextrone (treats heart rhythm problems) 150 mg/100 ml at 12:13 a.m.
Levophed 8 mg/250 ml at 12:27 a.m.
Lasix (treats fluid retention) 60 mg in 500 Normal Saline IV at 12:44 a.m.
Levophed 8 mg/250 ml at 12:51 a.m.
Sodium Bicarb 8.4 150 in D5 at 1:00 a.m.
Primacor (supports blood pressure)20 mg/100 ml at 1:31 a.m.
Levophed 8 mg/250 at 1:52 a.m.
Levophed 8 mg/250 ml at 2:31 a.m.

A general nurse's note by RN RR revealed that on 3/24/22 at 2:16 a.m., P#11 was received (in ICU) on a ventilator with sodium bicarbonate drip at 100 milliliters (ml) per (/) hour. Levophed drip 8 milligrams (mg)/250 ml was hanging at 999 ml/hour. The drip was paused, and Levophed was reprogrammed to hospital protocol. P#11's fingers and legs were blue and cold. Mottled (patchy irregular colors) was noted from P#11's feet up to the chest. There was no palpable pedal (foot area) or radial (wrist area) pulses. Using a doppler, a pulse was located at the femoral (area between the hip and pubic bone). A Nasogastric (NG) tube was connected to suction, and dark red drainage was noted. Pink frothy sputum was noted from the endotracheal (ET) tube. P#11's rectal temperature was 34.7 degrees Celsius, and a blanket warmer was applied to P#11. Fentanyl (narcotic) and Versed (sedative) drips were discontinued on arrival to the ICU. A continued review of the nurse's note revealed that a code was called on 3/24/22 at 3:00 a.m. P#11's heart rate was 34 beats per minute, and no pulse could be obtained. P #11 was in pulseless electrical activity (PEA). At 3:14 a.m., MD QQ pronounced P#11 deceased.

A review of a 'History of Present Illness' electronically signed by MD QQ on 3/24/22 at 6:46 a.m. revealed that P#11 presented to the ED for severe dyspnea and change in mental status. The history was unable to be obtained from P#11 as she had difficulty breathing and could not communicate in full sentences at the time of the evaluation. P#11 was severely hypoxic (not enough oxygen) at the time of the evaluation and was immediately intubated and sedated for worsening hypoxemia. She was initially treated with a sepsis protocol with blood cultures drawn, IV antibiotics, and IV fluids per protocol. P#11 was dyspneic and tachypneic at the bedside and required emergent intubation. IV access was established via a central line placed by MD QQ, and Levophed was started. Arterial blood gases were drawn after intubation.

A review of a note signed by MD QQ on 3/24/22 at 6:58 a.m. revealed that P#11 was seen and evaluated post initial intervention, acute decompensated heart failure with cardiogenic shock (heart suddenly cannot pump enough blood to meet the body's needs). Examination findings were consistent: cold and clammy, bilateral crackles and wheezes. P#11 was intubated, sedated, and started on Levophed after a central line insertion. A urinary catheter was placed to monitor P#11's urine output. P#11 was re-evaluated on multiple occasions, and continuous deterioration in clinical status was noted. Unresponsiveness to resuscitative efforts was noted. No urine output was recorded one-hour post-intervention. Orders for IV Levophed for vasopressor support was given. However, P#11 was administered boluses of Levophed at a rate of 999 ml/hour. P#11 was started on an amino drip concurrently and eventually transferred to ICU. Minutes after arrival at the ICU, P#11 went into bradycardia (low heart rate) and subsequently had a cardiac arrest. Advanced Cardiac Life Support (ACLS) protocol was initiated, but no pulses were achieved after four rounds of epinephrine. A physical exam showed persistent cold, clammy, and purplish extremities. P#11 was eventually pronounced dead during the early hours of 3/24/22.

A review of the facility's policy entitled "High-Alert Medications," policy #11160303, last revised 2/8/22, revealed that the facility identified a critical drip as a high alert medication.

Procedure:

1. High alert medications were stored in a manner to decrease the risk of errors.
a. The high-alert list was prominently displayed in medication areas.

2. Specific tools and systems were utilized to decrease the frequency of medication errors at the administration level.
a. Bedside barcoding systems are available and implemented for the administration of all medications.
b. Smart pump utilization for infusion of high-alert medications, including independent double-check and documentation of pump rate by a second nurse, is recommended.

3. Independent Double Checks were incorporated, as deemed by the organization, as a strategy to minimize risks with high-alert medications. Independent Double-Checks could also be leveraged as a strategy to minimize protentional error with designated high-alert medications.

4. All staff members/clinicians were educated about high-alert medications specific to their area, and risk reduction strategies were taken to prevent errors. This should be part of the usual orientation process for all newly hired staff as well as an ongoing education process for all involved staff.

Definitions:

High-Alert Medications: High-alert medications are those drugs that, when involved in a medication error, carry a risk of causing significant patient harm. While mistakes may or may not happen more frequently with these medications, when errors do occur, they typically have more detrimental effects to patients.

Independent Double-Checks: An independent double-check of a High-Alert medication was a procedure in which two licensed clinicians separately check (alone and apart from each other, then compare results) each component of prescribing, dispensing, and verifying the high-alert medication before administering it to the patient. Independent double checks, if implemented, were recommended to be done before administration of all High-Alert medications. In addition, for smart pump infusions, an independent double-check was recommended, and documentation of pump rate settings by a second RN or licensed health care provider.

A review of the facility's policy entitled "IV Therapy," policy #10197146, last revised 11/9/21, revealed that the policy applied to Registered Nurses (RN), Licensed Practical Nurses (LPN), Paramedics, Respiratory Therapists, Radiology Technologist, and Anesthesia Personnel who inserted, maintained, or discontinued intravenous therapy (IV).

IV Additive/Secondary IV Infusion:
1. Mix admixtures as prepared by the Pharmacy.
2. Medications to be prepared and administered as intermittent infusions should be mixed in a compatible IV solution.
3. Standard concentrations were used for medications administered via IV infusions. Information concerning these concentrations was included in the library developed and maintained in the Department of Pharmacy.

IV Administration by patient care area:
Intravenous admixtures were appropriate to a given patient care area based on their safety for monitoring. Medications approved to be administered by areas were listed in a chart. This list was consistent with Alaris Guardrails and should be consulted to confirm the appropriateness of administration of a drug in each area.

IV Administration by area: Vasopressin should be administered in a Critical Care area.

A review of the facility's policy entitled "Medication Management," Policy #10195421, last revised 8/5/21, revealed that the policy was to establish clinical guidelines for safe medication administration, accurate documentation of medications, storage, and quality control, and ordering of medications. This policy applied to all Facility staff, including Medical Staff, who order, dispense, or administer medications.

Procedure:
1. Medication Orders
a. The ordering provider would enter the order into the electronic record. Verbal or telephone orders must be read back and verified by the physician.
b. Electronic medication orders were entered directly by the physician and would be available immediately by the bedside clinician for use. Verbal and telephone orders had to be verified by a pharmacist prior to being released for administration.
c. Physicians were to call the nurse taking care of the patient if STAT (administer as soon as possible) orders were entered directly into the electronic record.
d. The pharmacist assessed for appropriateness of the drug, dose, frequency, and route.

The patient's profile would be reviewed for therapeutic duplications, and the ordering provider would be contacted if necessary. Medications ordered were screened for interactions with other drugs, foods, and lab values where applicable. The medication was scheduled according to the administration standard times. The pharmacist also assessed medications for approved restrictions to make sure the restrictions were followed.

2. Automatic Stop orders would include a date or time to discontinue the medication.
3. Titrating orders (dose increased/decreased in response to a patient's status)
a. Must clearly state the parameter to be controlled by the titration to assure that the prescriber ' s intent was known. The prescriber had to be contacted to clarify unclear orders before initiating the therapy.
b. Taper is not a frequency in the electronic medical record (EMR).

Medication Administration:
1. The nurse reviewed the schedule for the medication by using the patient electronic Medication Administration Record.
a. Medications should be obtained from the automated dispensing cabinet/machine (ADM or ADC) one patient at a time using the Five Rights.
b. The Five Rights were defined as #1 Right Patient, #2 Right Drug, #3, Right Dose, #4 Right Time, and #5 Right Route.
c. If the medication was not available in the ADC, the medication should be obtained from the Pharmacy. ADCs were used to securely house medications house-wide. The Pharmacy used the ADC as a delivery point. Medications that were not immediately used, and sent from the Pharmacy, were to be placed in the patient Specific "Other Meds" bin in the ADC.
2. Medication Turnaround Standard:
a. Routine Orders: Under normal working conditions, the expected routine order processing time within the Pharmacy (measured from the time the order enters the work queue until it leaves the Pharmacy on its way back to the Nursing Unit or was accessible under the system) was one hour.
b. STAT Orders: Under normal working conditions, the expected STAT order processing time within the Pharmacy (measured from the time the order enters the work queue until it leaves the Pharmacy on its way back to the Nursing Unit or was accessible under the system) was 15 minutes.
c. Time-critical scheduled medications were those where early or delayed administration of maintenance doses of greater than 30 minutes may cause harm or result in substantial sub-optimal therapy or pharmacological effect.
d. Order Process: Prescribers should indicate through the medication order when a specific medication was needed.
3. Compare the patient's name and date of birth (DOB) on the identification band to the medication record and ask the patient to state his/her name and DOB or scan the patient's armband.
a. Advise the patient or, if appropriate, the patient's family about any potential clinically significant adverse reaction or other concerns about administering a new medication.
b. Discuss any resolved, significant concerns about the medication with the patient's physician or relevant staff involved with the patient's care.
c. Verify that the medication being administered is given at the proper time, in the prescribed dose, by the correct route and product label.
d. Scan each medication to be administered via the barcode on its packing prior to removing the medication from the package.
e. Scan the patient's identification armband again after scanning medications to identify the correct patient was receiving the scanned medication.
f. Administer medications as ordered. In order for a medication administration to be considered "timely," any medication, except insulin, must be administered within a two-hour window (one hour before the scheduled time and up to one hour after).

4. Document all scheduled, and PRN (as needed) medications administered in the Medication Administration Record.
a. Document patient response to all PRN medications and any adverse reactions. Include nursing observations and patient perception of effects of medications.
b. Remain with the patient for the first few minutes and monitor the patient as appropriate for first-time medications.

Emergency Medications:
1. When ordering emergency medications, pharmacy staff should consider unit-dose, age-specific, and ready-to-administer packaging whenever possible.
2. Pharmacists should be available in emergency situations to assist with calculations for proper dosage.

A review of the Urgent and Emergent Medication Guide, Job Aid #3, revealed the following:

Vasopressin (Pitressin)
Indication: Hypotension (low blood pressure), shock
Dose: 0-0.04 units/minute (min)
How to compound: 20 units vasopressin in 250 milliliters (ml) D5W
How to administer: 0.03 microgram(mcg)/min for cardiac patient, 0.04 mcg/min
Acuity Level: Life-threatening (needed in minutes)

An interview with the Director of Quality Improvement/Medical Management (DOQ) DD was conducted on 5/23/22 at 1:30 p.m. in the conference room. DOQ DD recalled that she was notified of a serious adverse event that involved P#11 in the early morning of 3/24/22. The serious adverse event had been a medication error that had occurred in the ED. P#11 had been transferred to the ICU and eventually expired. Within a day, a team consisting of the ED staff, ED leadership and physicians met to review the medication error event. During the serious event analysis meeting, it was learned that the nurse involved was an ED nurse who was contracted. P#11 arrived in critical condition and was intubated soon after arrival. Verbal orders were given to the nurse involved for medications, including a Levophed drip. It was learned that the Hospitalist that gave the order (MD QQ) asked if the medication was maxed out, to which the nurse replied 'no.' The nurse then bypassed the parameters in the IV pump and ran the Levophed at the maximum allowed rate per the pump at 999 ml/hour. DOQ DD recalled that since P#11 had been admitted to the ICU, a team of staff met on the following Monday to discuss the events that took place. An 'off cycle' peer review meeting was held, and the event was sent to the next regular peer review meeting. It was determined that the medical care had been appropriate. The consensus of the peer review committee was that P#11 would not have survived regardless.
DOQ DD recalled that RN BB had triaged P#11 and stated that the patient had been cold on arrival and her temperature was 83.6 degrees. RN BB immediately escorted P#11 back to an exam room and notified the physician. MD QQ came to the ED to assess P#11 and gave verbal orders for her care. DOQ DD explained that during the serious event analysis, she ascertained nurses of all experience and skill levels were aware that Levophed was a weight-based medication that always was given by an IV pump. The term 'maxed' out was not interpreted by the nurse caring for P#11 the same as the provider giving the verbal orders.
As a result of the event, the facility sent an email to 'All Staff' reminding them not to over-ride the IV pump guardrails. In addition, leadership staff made rounds to the ED and ICU, verbally giving the same reminders and medication updates. Since the event, weekly audits had been conducted to ensure staff was not overriding medication guardrails in the pumps. The contracted nurse involved with the error was no longer working at the facility.

During a phone interview with nocturnist (MD) QQ on 5/23/22 at 3:00 p.m., he explained that he was a hospitalist on the night shift. He had been at the facility since October of last year. He explained that he evaluated patients in the ED when the ED physician felt that the patient should be admitted. He received a text from the ED physician with P#11's name. MD QQ explained that he proceeded directly to the ED to assess P#11. When he walked into P#11's room, she was in the room alone and in respiratory distress. MD QQ was unsure how long P#11 had been in the room. He recalled that P#11 was unable to answer any questions or speak due to her distress. He immediately called for assistance, and the ED physician arrived at the patient's room. The ED physician intubated P#11 and left the room. MD QQ recalled that he inserted a central venous line. He recalled that P#11's nurse was not around, and when she came into P#11's room, it was a quick in and out. He recalled that the ED physician had placed orders, and none had been implemented. The nurse practitioner that accompanied MD QQ from the hospitalist service placed a urinary catheter. MD QQ recalled that he went to the desk and began documenting in the record and entering an order to transfer P#11 to the ICU. MD QQ recalled that he questioned P#11's nurse several times about starting the Levophed infusion. At one point, she told MD QQ that she had to go to the pharmacy to pick the Levophed up. During this time, he and his nurse practitioner waited at the bedside for about 30 minutes for the nurse to return. Later, he returned to P#11's room and noted P#11's blood pressure to be low. He asked the nurse if the Levophed 'was maxed out.' He instructed the nurse to 'crank it up and max it out.' MD QQ explained that the medication was already in the computer to titrate to a maximum dose. MD QQ recalled that P#11 continued to deteriorate despite ventilation support. Just after P#11 was transferred to the ICU, MD QQ received a call from the ICU nurse reporting that she had received the patient from the ED with the Levophed infusing at the incorrect rate. P#11 continued to deteriorate quickly and coded within a few minutes. ACLS was followed but was unsuccessful, and P#11 was pronounced deceased about 15 minutes later.

An interview with RN BB was conducted on 5/24/22 at 9:35 a.m. in the conference room. RN BB recalled that she was working when P#11 arrived at the ED. RN BB recalled that she triaged the patient and immediately took her to a main ED room. P#11 was tachypneic, alert, and talking in triage. Patient #11 was cold to the touch, and RN BB could not obtain an oral temperature. A temporal scan was done, and P#11 was extremely cold. At the time of triage, an ED physician had not seen P#11. After P#11 was moved to a main ED room, RN BB recalled RN TT walking into the room. RN BB did not observe P#11 being put on monitors or other care as she returned to the triage area. RN BB did not recall the time of the triage but knows that it was toward the end of her shift which was 8:45 p.m. RN BB did not observe a physician go into P#11's main ED room.

A phone interview with ICU nurse (RN) RR was conducted on 5/24/22 at 10:00 a.m. RN RR explained that she had worked at the facility for over 25 years. She stated she had worked in the ICU since January of this year. She had experience in the ED as well. RN RR recalled that the ED nurse did not call report on P#11 and just 'showed up.' She recalled that multiple IV bags were hanging, some infusing, some were not. The IV lines were such 'a mess' that she decided to discard all the bags and start over. P#11 was intubated and on a ventilator on arrival. Another ICU nurse assisted RN RR and noted that the pump infusing Levophed was running at 999 ml/hr. She immediately turned the pump off and noted that Levophed had been programmed in, but the guardrails had been overridden. She was unsure how long the Levophed had been infusing, but she 'heard' that the ED nurse had infused two to three bags over two to three hours. The ED nurse was still at the bedside, and when asked about the rate, her response was, 'that's what the doctor told me to put it at.'

A phone interview with ED physician (MD) SS occurred on 5/24/22 at 10:30 a.m. MD SS explained that he had been on staff in the ED for a little over three years. He recalled that P#11 had arrived at the ED in respiratory distress with atrial fibrillation in the 150s. P#11 was determined to have severe sepsis with a history of multiple comorbidities. He immediately recognized that she would require immediate interventions and initiated the sepsis protocol. MD SS recalled that he asked MD QQ to come and evaluate P#11 for admission, and MD QQ assumed P#11's care after that decision was made. P#11 required intubation and multiple 'drips' soon after arriving in an ED room. MD SS explained that he had multiple ED patients that were high acuity and MD QQ also had multiple higher acuity patients while P#11 was in the ED.

A follow-up interview with DOQ DD took place on 5/24/22 at 11:30 a.m. DOQ DD explained that the ED charge nurse on duty when P#11 was in the ED could not be reached as she was out of the country. DOQ DD recalled that the ED nurse caring for P#11 (RN TT) had been a contracted nurse. After the adverse medication event, the staffing agency confirmed that RN TT had completed competencies and all required employment information. DOQ TT explained that RN TT had not worked at the facility since the adverse event. DOQ DD explained that house-wide re-education on IV pump guardrails and medication administration had been sent out. She explained that the pharmacy had determined that RN TT had infused four bags of Levophed to P#11. One of the performance measures initiated was collecting the number of instances in that guardrails were overridden. The goal was 90% compliance. The pharmacy just began collecting data going forward to determine the top two most frequent medications overridden
.
A follow-up interview with DED FF and ED Manager (EDM) UU took place on 5/25/22 at 10:30 a.m. in the conference room. DED FF explained that the policy for assessment and re-assessment had just been revised in the past couple of weeks. Vital signs in the ED were to be done at triage, for a change in condition and prior to discharge. EDM UU explained that she had focused on the revision of the policy on nursing assessments and re-assessments. DED FF explained that contract nurses that had worked in a facility owned by the same cooperation received four hours of orientation to the ED. Nurses that had not worked in a facility owned by the same cooperation received 12 hours of orientation in the ED. The contracting agency trained nurses on the facility's cooperate policies and IV pumps and assessed them for medication administration competency. DED FF recalled that RN TT had received 12 hours of ED orientation. RN TT had worked in the ED for approximately six weeks when the error occurred with P#11. DED FF confirmed that RN TT began on 1/31/22 and had 7.25 hours of ED orientation. EDM UU had just transferred from the ICU to be the ED manager.

A review of four (RN AA, RN BB, DED FF, and RN TT) personnel files revealed that all contained current professional licensure, competency training, updated EMTALA training, and compliant vaccine mandate.