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Based on observations, interviews, and record reviews the facility failed to provide consistent cardiac monitoring for one patient (#2) in the Intensive Care Unit (ICU) on telemetry (a screen-type monitor that receives the transmissions of signals from one electronic unit to another by radio waves using a device that provides real time measurement of a patient's cardiac rhythm and rate). Patient #2 was found unresponsive and cold with no pulse. A Code Blue (an emergency situation announced in which a patient is in cardiopulmonary arrest, requiring a team of providers to rush in and begin immediate resuscitation efforts) was announced, but the patient had been without telemetry monitoring for two hours and 20 minutes. Patient #2 was resuscitated successfully, but the follow-up neurological examination (an assessment of sensory neuron and motor responses to determine whether the nervous system is impaired) and an electroencephalography (EEG), (a method to record electrical activity of the brain) showed significant brain injury due to hypoxia (deficiency in the amount of oxygen reaching the tissues). Patient #2 was removed from life support and expired.

This failure created an unsafe environment and had the potential to place all patients admitted to ICU at risk for their safety and resulted in the overall non-compliance with 42 CFR 482.23 Condition of Participation: Nursing Services that resulted in a condition of Immediate Jeopardy (IJ). The ICU census was 14.

The facility was notified of the IJ on 08/28/18 and as of 08/29/18, at the time of the survey exit, the facility had provided an immediate action plan sufficient to remove the IJ by implementing the following:
- ICU cardiac monitor alerts were changed from an advisory level alert to a warning level alarm which will continuously sound until addressed.
- Cardiothoracic Unit (CTU) cardiac monitor alerts were changed from an advisory level alert to a warning level alarm which will continuously sound until addressed.
- ICU/CTU staff were educated on the anticipated alarm alert process change and documentation changes at the combined staff meeting.
- The policy "Patient Safety Events" was reviewed and revised as follows: "Added Risk Mitigation section to the existing policy that should an event occur that meets the definition of a sentinel event, the administrative chain of command will be implemented to determine the need for immediate mitigating steps."
- Leaders from Critical Care, Cardiac Progressive Care, Medical-Telemetry, Surgical Progressive Care/Oncology, Neurology, Nursing and Hospital Administration, Radiology, Laboratory, Emergency Services, Respiratory Therapy, Inpatient Rehabilitation Services, and Unit, Pharmacy, Dietary, Surgical Services, Women's Services, Information Technology, Educational Services and Biomed were educated about the findings from the investigation of the serious patient safety event and the solutions to prevent further occurrences.
- Education regarding telemetry monitoring and alarm response will continue until 100% compliance is achieved.
- Education will occur prior to the next shift worked and will continue until 100% of Leadership and staff has been educated utilizing:
a. Face to Face training with sign in sheets for leaders and staff.
b. Mock drills with scenario completed by administration daily, all shifts until 100% compliance, then weekly, all shifts, until return revisit survey.
c. Printed material for staff review related to electrocardiogram (ECG), (a noninvasive procedure where electrodes are placed on the skin in a specific order and connected to a machine that measures the electrical activity of the heart) ECG monitoring and alarms, validated with sign in sheets.
d. The use of Learning Management System to track completion of drills and education.
e. To create an awareness of policy/process changes Information Technology was notified to add verbiage alerting staff on the computer on the home page of the hospital intranet of process changes.
- From this point forward critical care ECG tracings will be monitored 24/7 by designated trained personnel until tracings are projected into the central bank.
- ICU/CTU (cardiothoracic critical care unit) staff were educated per printed documentation called Lessons Learned addressing appropriate response to telemetry alarms.
- Documentation labels in the Electronic Medical Record (EMR) was changed from generic label of the heart rate to label the heart rate from the ECG monitor and the Pulse Oximetry monitor (monitors the oxygen saturation of a patient's blood and changes in blood volume in the skin) separately.

Based on observations, interviews, and record reviews the facility failed to provide consistent cardiac monitoring for one patient (#2) in the Intensive Care Unit (ICU) on telemetry (a screen-type monitor that receives the transmissions of signals from one electronic unit to another by radio waves using a device that provides real time measurement of a patient's cardiac rhythm and rate). Patient #2 was found unresponsive and cold with no pulse. A Code Blue (an emergency situation announced in which a patient is in cardiopulmonary arrest, requiring a team of providers to rush in and begin immediate resuscitation efforts) was announced, but the patient had been without telemetry monitoring for two hours and 20 minutes. Patient #2 was resuscitated successfully, but the follow-up neurological examination (an assessment of sensory neuron and motor responses to determine whether the nervous system is impaired) and an electroencephalography (EEG. a method to record electrical activity of the brain) showed significant brain injury due to hypoxia (deficiency in the amount of oxygen reaching the tissues). Patient #2 was removed from life support and expired.
These failures had the potential to affect all patients admitted to the ICU. The total facility census was 138. The ICU census was 14.

Findings included:

1. Record review of the facility's policy titled, "Centralized Telemetry Monitoring (CTM) and Patient Telemetry," dated 04/01/2008 and reviewed 08/28/2018, showed the following directives for telemetry monitoring:
- The nurse must trouble shoot and respond to a patient's needs in regards to changes in abnormality in the patient's rhythm.
- Patients in ICU will be monitored as part of the specialty standard.
- Upon detection of a lethal arrhythmia (a condition in which the heart beats with an irregular or abnormal rhythm) or leads off alarm the nurse will immediately assess the patient.
- Arrhythmia alarms occur when arrhythmia analysis is enabled in the electrocardiogram (ECG, the process of recording the electrical activity of the heart over a period of time) monitoring system.
- Suggested master unit default arrhythmia alarm is set to ON in reorder setup for each patient as follows:
1. Asystole (a cardiac flatline indicating the cessation of electrical activity of the heart) greater than (>) 3.10
seconds with no QRS (a combination of three of the graphical deflections seen on a typical ECG).
2. Ventricular fibrillation (the heart beats with rapid, erratic electrical impulses).
3. Ventricular tachycardia (a very fast heart rhythm >100 beats per minute) with four or more consecutive premature ventricular contractions (PVCs, extra heartbeats that begin in one of the heart's two lower pumping chambers).
4. Tachycardia reaching in the upper heart rate (HR) limit of 50 beats per minute.
5. Bradycardia reaching the lower HR limit of 50 beats per minute.
6. The Registered Nurse (RN) may change the Tachycardia and Bradycardia arrhythmia parameter in accordance with the patient's cardiac history.

Review of the Patient's History and Physical (H&P) showed:
- On 07/11/18 at 7:04 PM the patient, a 58 year old male presented to the Emergency Department with severe abdominal pain, malaise (a general feeling of discomfort or uneasiness), blood in his urine and low blood pressure (the pressure of circulating blood on the walls of blood vessels).
- History of Coarctation of Aorta (a narrowing of the main large blood vessel that carries oxygen-rich-blood from the heart to all the organs in the body), non-ischemic cardiomyopathy (disease of the heart muscle that causes the heart muscle to thicken making it hard to pump blood through the body), atrial fibrillation (an irregular heart rate that commonly causes poor blood flow), and high blood pressure.
- His blood pressure (BP) was 86 systolic and 36 diastolic (normal BP is 120 systolic and 80 diastolic).
- Current radiology report was interpreted as probable perforated sigmoid diverticulitis (small bulging pouches that form in the large intestine that have ruptured).
- He was experiencing septic shock (a widespread infection causing organ failure and dangerously low blood pressure), and acute kidney failure.
- He was taken to the operating room for repair or removal of the perforated intestine.
- Following surgery he remained intubated (during surgery, a tube placed through the mouth and into the airway), was transferred to ICU and placed on telemetry and cardiac monitoring.

Review of Physician progress notes showed:
- On 07/13/18 the patient went into Atrial Fibrillation and was given IV (catheter in the vein used to introduce fluids and medication directly into the blood) medications to convert his heart rate back to a normal sinus rhythm.
- On 07/16/18 the patient was extubated (removal of the endotracheal tube from the patients airway) and placed on the BiPAP (Bi-level Positive Airway Pressure where a machine provides pressurized air through a mask into the patient's airways to keep them open) machine.
- On 07/17/18 the patient was taken off BiPAP and was doing well.
- On 07/18/18 the patient was awake, alert and in no distress. No new specific events of note.
- On 07/19/18 at 2:30 AM the patient went into cardiac arrest. He was found unresponsive. When the leads (individual wires connected from the patient to the telemetry monitor by a cable so the cardiac rhythm is displayed) on the cardiac monitor were re-adjusted the patient's heart was in Ventricular Fibrillation. Advanced Cardiac Life Support (ACLS) protocol was followed for 30 minutes prior to return of cardiac activity. The patient was placed on therapeutic hypothermia protocol (reduction of the core body temperature in an attempt to decrease further brain injury) and remained on a ventilator (a machine that provides artificial respirations for someone who cannot breath on their own).

Observation on 08/28/18 at 10:40 AM with Staff I, RN, and Director Intensive Care Units showed:
- In each room there were two cardiac monitors for the patient displaying the vital signs and cardiac activity.
- One monitor was at the bedside and the second monitor was easily visible from outside the patient's room.
- Both monitors showed, in bold letters, the statement "Check Leads" when the cable (attaching the leads from the patient to the monitor) is disconnected.
- Both monitors showed the patient did not have a cardiac wave form (the electrical activity of the heart produced from the heart and creates a readable pattern that can be interpreted) only a straight line.

During an interview on 08/27/18 at 3:00 PM, Staff A, Executive Director of Quality stated that:
- Census in the ICU the morning of 07/19/18 was 14.
- The RN responsible for the patient had two total patients assigned to him at the beginning of his shift that began on 07/18/18 at 7:00 PM.
- The policy calls for the RN to complete a full assessment of the patient at midnight, 4:00 AM, and make hourly rounds.
- The Code Blue documentation was reviewed and it was noticed per this documentation that the last cardiac rhythm was at 12:22 AM then the monitor cable came apart and the lack of a heart rhythm was not recognized by the nurse in charge of this patient for two hours and 20 minutes.
- During the facilities investigation of Patient #2's death it was discovered the monitor only alarmed with a onetime beep when the cable was disconnected. This was a factory default setting.
- During the facilities investigation of Patient #2's death discussion with staff from the ICU (Intensive Care Unit) they learned the staff just assumed the alarm would not stop until the problem was corrected.
- The patient was on a pulse oximetry monitor (a noninvasive method for monitoring a person's oxygen saturation in the blood) and so the heart rate was showing and automatically being documented in the patient's electronic medical record but there was no rhythm strip (tracings of the electrical activity of the heart that show on the monitor and can also be printed on paper).
- Staff did not notice the rhythm strip was not on the monitor until the BiPAP machine alarmed that the patient's oxygen level was dropping.
- The RN went into the room to check the oxygen level and found the patient unresponsive. He reconnected the cable and called a Code Blue.
- At the time of the incident the staff documented the heart rate from the pulse oximetry machine without looking at the cardiac rhythm strip on the monitor.
- The nurses in the Intensive Care Unit monitor the patient's cardiac status. The ICU was not monitored by a telemetry bank (a unit where an RN and a Monitor Tech watch the patient's cardiac activity on a bank of monitors 24 hours a day, seven days a week).

During an interview on 08/28/18 at 10:40 AM, Staff I, RN, and Director of ICU stated that:
- Nursing in ICU should document the cardiac rhythm strip one time every shift.
- Staff T had two patients with minimum acuity level (the measurement of the intensity of nursing care required to take care of a patient).
- Investigation of the patient's medical record showed on 07/19/18 at 12:22 AM the ECG stopped working. The staff did not notice the monitor had stopped working until Staff T went into the room, after hearing the alarm from the BiPAP machine that the patient's oxygen saturation had dropped.
- He could not arouse the patient. He reconnected the cable and called a Code Blue.
- There are two monitors in each patient room and one at the main nursing station. No one watches the monitor at the main nursing station.
- Staff T did not notice the wave form was not visible on the monitor.

During an interview on 08/28/18 at 4:45 PM, Staff E, RN stated that:
- She and an Orientee RN took care of the patient on the day shift prior to his cardiac arrest.
- During her shift the patient was doing well and would have been moved out of the ICU the next day.
- She thought if cables were removed the monitor would continue to alarm.
- She does not rely on the alarms to know her patient's status.
- An ICU nurse should have known there was something wrong when the rhythm strip was not on the monitor.

During an interview on 08/28/18 at 4:30 PM, Staff C, Director of Biomedical, stated that the telemetry monitors have been in the hospital since 2003. He stated each monitor has an Advisory alarm (a single alarm) a Warning alarm (a continuous repetitive alarm), and a Crises alarm (a fast and repetitive alarm). The telemetry monitors had been set to Advisory mode as the default setting which has only one alarm sound rather than the continuous sound the staff had expected.

Review of the Patient's Nursing Progress notes showed that:
- On 07/19/18 at 12:00 AM the monitor was recording the patient's blood pressure, heart rate, respirations, and pulse oximetry readings but the cardiac waveform was not working.
- According to his documentation Staff T had been in the patient's room on seven separate occasions during the two hours and 20 minutes the monitor was disconnected which gave him the opportunity each of these times to notice the telemetry was not connected and the opportunity to re-connect.
- On 07/19/18 at 12:00 AM, 12:30 AM, 12:45 AM, 1:00 AM, 1:30 AM, 2:00 AM, and 2:15 AM Staff T documented:
- A peripheral pulse (the heart rate that is taken while touching the patient, usually at the wrist or feet).
- A pain scale which requires the patient talks to you and tell you how much pain they are in.
- At 1:17 AM he began infusing (allow a liquid to flow into the patient's vein) an IV antibiotic.
- At 2:30 AM a Code Blue was called.

Review of Physician Statement following the patient's death showed:
- On 07/19/18, the day prior to transfer out of the intensive care unit, the patient suffered an apparent respiratory and cardiac arrest.
- He was resuscitated aggressively and placed on hypothermia protocol.
- When he was re-warmed and evaluated it was obvious that he had suffered a significant cerebral brain injury that was felt to be anoxic (total depletion of oxygen) in nature.
- On 07/21/18, after consultation with the family they elected to perform a terminal wean from the ventilator.
- On 07/22/19 at 9:58 AM the Patient's son stated that each family member wanted 1:1 time with the patient and then they wanted to withdraw care.
- On 07/22/19 at 11:29 PM the patient's assessment completed. He was unresponsive to forms of stimuli, his pupils fixed and dilated, asystole in all leads per monitor, heart tones absent and peripheral pulses absent. All signs of life appear to have ceased.












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