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Based on the manner and degree of the standard-level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 PATIENT RIGHTS was out of compliance.

A0144- The patient has the right to receive care in a safe setting. Based on document reviews and interviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure telemetry and continuous pulse oximetry monitoring were provided in accordance with physician's orders and facility policies in one of three medical records reviewed. (Patient #2)

Based on document reviews and interviews, the facility failed to ensure patients received care in a safe setting. Specifically, the facility failed to ensure telemetry and continuous pulse oximetry monitoring were provided in accordance with the physician's orders and facility policies in one of three medical records reviewed. (Patient #2)

Findings include:

Facility policies:

The Telemetry Monitoring policy read, its purpose was to provide guidelines for telemetry monitoring (electrode pads attached to the patient's chest and connected to leads attached to a portable monitor transmitter providing wireless electrocardiogram (ECG) transmission to a remote or centralized monitoring station), to outline the process for notification and documentation of cardiac rhythm changes, to identify cardiac rhythm changes requiring provider notification, and to assess patients for appropriate discontinuation of cardiac telemetry monitoring. The registered nurse (RN) assumes responsibility for the initiation and management of cardiac monitoring including verification of an order. A provider order is required for telemetry monitoring. A telemetry discontinue order should be entered when telemetry monitoring is no longer indicated for patient care.

The Telemetry Monitoring policy also read, the telemetry escalation process, in the event that a non-lethal arrhythmia is detected, the telemetry technician (tech) will initiate a multi-level escalation process, requiring loop closure/alarm resolution within five minutes. If resolution is not reached within five minutes, the telemetry technician will initiate a call to the house supervisor and initiate a telemetry alert on the unit. When a telemetry alert is initiated, all available personnel on the unit are expected to respond to the patient's bedside to ensure the patient is assessed. The house supervisor will ensure the nurse responding to the patient notifies the telemetry tech once the patient has been assessed and provides an update on patient status and/or ensures the patient's rhythm is being transmitted. The nurse will notify the provider in the event the changes are an abnormal rhythm. In the event the telemetry tech is unable to contact anyone within the multilevel escalation within five minutes a rapid response will be initiated. The telemetry technician will record the notifications via the approved notification log.

The Pulse Oximetry policy read, its purpose was to define guidelines and limitations of pulse oximetry and how it should be utilized in making clinical decisions. Continuous pulse oximetry (SpO2, a non-invasive method used to measure the percentage of hemoglobin in the blood that is saturated with oxygen) is initiated by provider order. The criteria for discontinuation is per provider order.

References:

The facility's Olanzapine (Zyprexa) intravenous (IV) Formulary document, dated September 2023, Pharmacy and Therapeutics committee read, olanzapine was Food and Drug Administration (FDA) approved for the treatment of agitation (bipolar one disorder or schizophrenia). Off-label FDA uses included acute agitation. The medication is only FDA-approved for oral or intramuscular (IM) use. Some of the adverse effects include: orthostatic hypotension (low blood pressure with position change), QT prolongation (longer than usual time it takes for the heart to recharge between beats), sedation, and neuroleptic malignant syndrome (NMS) (NMS can be fatal; symptoms include fevers, excessive sweating, rigid muscles, confusion, changes in breathing, heartbeat, and blood pressure). Available as 10 milligram (mg) powder for IM injection, oral tablets, and oral disintegrating tablets. Approved for use in head trauma or traumatic brain injury (TBI) patients only. Will use the IM formulary IV.

The Chain of Command Algorithm read, the RN will assess the patient, recognize an issue, and then contact the appropriate provider regarding the concern. If the issue persists, the RN will notify the charge nurse or nurse manager of the concern, and the charge nurse will perform an independent assessment. If the issue persists, the charge nurse or nurse manager will notify the unit director or house supervisor regarding the concern. If the issue persists, the House Supervisor or Chief Nursing Officer (CNO) will notify the chief medical officer (CMO) of the issue. The CMO contacts the appropriate medical staff leadership until the issue is resolved, including, but not limited to, the medical staff president, department chairman, attending, risk director, and/or vice president of quality, legal counsel, until the concern is addressed and the patient is stable. During all steps, the nurse/healthcare provider must maintain the duty of care, retain accountability for the patient, and continue to monitor and call a rapid response when indicated. Documentation of each step is essential; the nurse should keep good documentation records and enter all necessary information in a nursing note and occurrence report.

1. The facility failed to ensure telemetry and continuous pulse oximetry monitoring were provided in accordance with the physician's orders and facility policies to detect changes in a patient's condition.

A. Document Review

i. Patient #2's medical record was reviewed and revealed Patient #2 was a 37-year-old admitted to the facility on 10/6/24 after weeks of mental status deterioration and increased agitation. During hospitalization, Patient #2 had episodes of violent agitation, which presented a safety risk to the patient and the staff. A patient safety attendant (PSA) had been stationed at the bedside for 1:1 observation to keep Patient #2 safe.

The medical record also revealed Patient #2 was diagnosed and treated for autoimmune encephalitis (the body's immune system attacked healthy tissue, which inflamed brain tissue and caused swelling and abnormal brain function). In addition to the PSA, Patient #2 required frequent chemical and mechanical restraints for safety.

On 10/8/24, Patient #2 was evaluated by a psychiatrist who recommended Zyprexa (medication used to regulate mood, thoughts, and behavior) for acute safety concerns. The psychiatrist had also recommended close cardiac monitoring of the QT interval (portion of the heartbeat, if prolonged could cause dangerous heart rhythms) and of potassium and magnesium levels (could cause dangerous heart rhythms if too low or too high). Patient #2 had been ordered Zyprexa 5 mg IV as needed every 24 hours.

Additionally, medical record review revealed on 10/17/24 at 12:53 p.m., Patient #2's physician ordered continuous pulse oximetry and telemetry monitoring for arrhythmia and electrolyte imbalance. Patient #2 received a one-time dose of Zyprexa 10 mg IV at 1:11 p.m. for sedation. At 7:00 p.m., the virtual telemetry tech posted a shift assessment ECG strip, which showed Patient #2 had a heart rate of 102 (normal 60 - 100 beats per minute), heart rhythm sinus tachycardia (heart beats greater than 100 beats per minute), QTc (QT interval) 0.43 (normal less than 0.45), and SpO2 92% (level of oxygen in the blood, normal 95 - 100%). At 8:00 p.m., Patient #2 was placed on two liters of oxygen by nasal cannula.

Review of the Telemetry Notification Log revealed, on 10/18/24 at 6:18 a.m., the telemetry tech called the RN to notify them the telemetry leads were off. The RN directed the telemetry tech to keep the telemetry monitoring paused due to Patient #2's agitation.

This was in contrast to the Telemetry Monitoring policy, which read, a provider order was required to discontinue telemetry monitoring. This was also in contrast to the physician's orders, which read Patient #2 should have been on continuous telemetry monitoring. Also, there was no evidence in the medical record or in the Tele Notification Log that telemetry monitoring had been resumed.

The Protective Observation Tool documentation by the PSA read, at 7:30 a.m. Patient #2 kept jumping out of bed. At 7:45 a.m., the RN documented they had notified the physician of Patient #2's increased agitation and requested an order for restraints; however, no order to restrain was received. At 7:49 a.m., the physician was at the bedside to assess Patient #2. The record revealed Patient #2's vital signs at 7:52 a.m. had been a temperature of 98.1 Fahrenheit (F), a heart rate of 99, a respiratory rate of 15, a blood pressure of 129/86, and a SpO2 of 89% on room air.

There was no evidence in the medical record that oxygen had been provided for Patient #2 until nursing documentation over an hour later at 9:00 a.m. revealed Patient #2 had been placed on heated humidified high flow oxygen by nasal cannula at 40 liters per minute.

At 8:18 a.m., the Protective Observation Tool documentation read, the patient was hallucinating, and the RN and patient care technician (PCT) were at the bedside. At 8:45 a.m., the record revealed Patient #2 was administered Zyprexa 5 mg IV. The PSA documentation read, at 9:05 a.m. Patient #2 was yelling and hallucinating. At 9:15 a.m., the PSA documented Patient #2 was agitated and anxious. At 9:30 a.m., the PSA documented Patient #2 was awake, quiet, sleeping, or resting. At 9:45 a.m., the PSA documentation read, Patient #2 was sleeping or resting. The medical record revealed at 9:52 a.m., a code blue (medical emergency where the patient has stopped breathing or their heart has stopped) was called. The medical record revealed Patient #2 was resuscitated by the code blue team and transferred to the intensive care unit (ICU).

ICU physician documentation revealed Patient #2 was not on telemetry or pulse oximetry at the time of the code blue. This was in contrast to the physician's orders, which stated Patient #2 should have been on continuous pulse oximetry and telemetry monitoring for arrhythmia and electrolyte imbalance to detect any change in condition. This was also in contrast to the Pulse Oximetry and Telemetry Monitoring policies, which read an order was required to discontinue monitoring.

The physician's documentation also revealed Patient #2's PSA reported Patient #2 had curled up in a ball on their side, and after several minutes, was found to be unresponsive by the nurse who had been called to the bedside. Finally, the medical record revealed on 10/21/24 at 3:58 p.m., Patient #2 died of anoxic brain injury (lack of oxygen to brain cells) after cardiac arrest.

ii. An event report for Patient #2's code blue and unanticipated transfer to the ICU was reviewed. Follow-up actions from the event analysis included a peer review of Patient #2's medical record, a care concern escalation pathway had been developed for clinical staff, and education had been provided to all staff.

The Chain of Command Policy and Algorithm were provided to the surveyor as evidence of the facility's actions taken in response to the event.

iii. On 5/28/25 at 10:37 a.m., upon request, the facility was unable to provide evidence of education provided to staff in response to Patient #2's event. This was in contrast to the event analysis follow-up actions which read, education had been provided to all staff.

B. Interviews

i. On 5/29/25 at 1:20 p.m., an interview was conducted with telemetry technician (Tech) #1. Tech #1 stated telemetry would have been paused or discontinued only at the direction of the RN.

ii. On 5/29/25 at 1:59 p.m., an interview was conducted with clinical nurse coordinator (CNC) #2. CNC #2 stated Patient #2 had been sweaty and agitated, and the staff were not able to keep the telemetry monitor on the patient. CNC #2 stated they had been in Patient #2's room with the PCT before Patient #2's code blue. CNC #2 stated they had been trying to fix Patient #2's telemetry, and the nurse had received a medication order to help calm the patient down. CNC #2 stated they had asked the PSA at the bedside to notify them when Patient #2 had calmed down. CNC #2 stated the nurses and physicians had discussed the situation and had been in and out of Patient #2's room several times. CNC #2 stated the physicians wanted Patient #2 to be monitored, and Patient #2 needed to be monitored, and there had been no physician order to discontinue the monitoring.

Additionally, CNC #2 stated physician orders were important to follow for patient safety. CNC #2 stated telemetry monitoring could have detected a cardiac arrhythmia, and pulse oximetry could have detected a drop in Patient #2's oxygen level. CNC #2 stated if Patient #2 had been on telemetry or pulse oximetry monitors, staff would have been able to detect a change in Patient #2's condition. CNC #2 stated it was important to follow the physician's orders to ensure a change in patient condition was not missed.

iii. On 5/29/25 at 2:41 p.m., an interview was conducted with clinical pharmacist (Pharmacist) #3. Pharmacist #3 stated the total maximum dose of Zyprexa administered in 24 hours should have been 10 mg IV. This was in contrast to Patient #2's medical record, which revealed Patient #2 had received a total of 15 mg of Zyprexa IV in 18 hours.

Also, Pharmacist #3 stated Zyprexa could have caused positional low blood pressure, increased sleepiness, or dangerous heart rhythms. Pharmacist #3 stated Patient #2 should have been monitored closely. This was in contrast to Patient #2's medical record, which revealed Patient #2 was not on continuous telemetry and pulse oximetry monitors as ordered on the morning of 10/18/24 when Patient #2 became unresponsive.

iv. On 6/2/25 at 1:59 p.m., an interview was conducted with critical care intensivist (Physician) #4. Physician #4 stated they had been the physician who responded to Patient #2's code blue event on 10/18/24 and cared for Patient #2 in the ICU. Physician #4 stated Patient #2 had not been on telemetry or continuous pulse oximetry at the time of the code blue. Physician #4 stated they did not know why Patient #2 was unmonitored at the time of the event. Physician #4 stated patients who received Zyprexa should have been monitored for QT prolongation and seizures. Physician #4 stated Patient #2 died of anoxic brain injury caused by the cardiorespiratory arrest.

v. On 5/28/25 at 11:51 a.m., an interview was conducted with director of patient safety (Director) #5. Director #5 stated they participated in the review of Patient #2's event. Director #5 stated the event follow-up included reeducation of staff on the chain of command policy and improved documentation. Director #5 stated this reeducation had occurred in discussions at team huddles.

Upon request, the facility was unable to provide evidence of education provided to staff in response to Patient #2's event.