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Based on observation, interview, record review and policy review, the hospital failed to ensure a safe environment when 15 minute safety rounds were not completed for one discharged patient (#38) of three patients reviewed. This failure resulted in a patient's death and placed all patients on 15 minute safety rounding at risk for their safety.

This failed practice resulted in a systemic failure and noncompliance with 42 CFR 482.13 Condition of Participation: Patient's Rights. The hospital census was 520.

The severity and cumulative effect of this practice had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

As of 09/21/23, the hospital had provided an immediate action plan sufficient to remove the IJ when the hospital implemented corrective actions that included all current and oncoming nursing staff were educated on the nursing rounding policy, expected procedures and documentation standards. All remaining staff were educated prior to the start of their next shift. All nursing staff were directed to complete a computer-based training module to demonstrate competency in the education provided.

Please refer to A-0144


47504

Based on observation, interview, record review and policy review, the hospital failed to ensure a safe environment when 15 minute safety rounds were not completed for one discharged patient (#38) of three patients reviewed. This failure resulted in a patient's death and placed all patients on 15 minute safety rounding at risk for their safety.

Findings included:

Review of the hospital's policy titled, "Patient Observation Rounds," dated 05/16/22, showed:
- All behavioral health patients were to be rounded on every 15 minutes at irregular intervals, not to exceed 16 minutes.
- All rounds are documented in real time.
- Patient observation rounds include the visualization of the patient and their surrounding environment.
- Patient observation rounds are made by a nurse at least every two hours throughout the duration of the shift.
- Psychiatric technicians and PCTs also complete safety rounds as ordered.
- The RN is responsible for ensuring that all rounds are completed.
(This policy applies to inpatient and ED behavioral health patients per hospital management)

Review of Patient #38's medical record showed the following:
- She was a 48 year-old female who arrived in the ED on 04/21/23 at 11:44 AM via Emergency Medical Services (EMS, emergency response personnel, such as paramedics, first responders, etc.) for a psychiatric evaluation.
- She had a history of schizophrenia bipolar disorder (a mental disorder that causes unusual shifts in mood by alternating periods of emotional highs and lows), depression (extreme sadness that doesn't go away), anxiety (a feeling of fear or worry experienced intermittently) and substance abuse (misuse of alcohol and/or other drugs).
- Fifteen minute patient safety observation rounds were initiated on 04/21/23 at 11:50 AM by Staff EEE, RN.
- Staff AAA, PCT, was assigned to Patient #38 to perform 15 minute safety rounds from 04/21/23 at 11:00 PM through 04/22/23 at 7:00 AM.
- There was no documentation of PCT 15 minute patient safety rounds on 04/22/23 at 5:45 AM, 6:00 AM, 6:15 AM, 6:30 AM, and 6:45 AM.
- On 04/22/23 at 3:59 AM, 5:49 AM and 6:30 AM, Staff BBB, RN, documented that Patient #38 was resting in bed and respirations were even and unlabored.
- At 6:58 AM, Staff BBB, RN, documented "EMS arrives to transport for inpatient admission. Patient was found to be cool to touch, not breathing and no pulse. Advanced Cardiac Life Support (ACLS, specific life saving measures taken by certified health professionals when a patient's heartbeat or breathing stops) immediately initiated."
- At 7:19 AM, Staff CCC, MD, documented they were called to Patient #38's bedside after Cardiopulmonary Resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped) was initiated at approximately 7:00 AM. The patient was pulseless, gray, cold to the touch and had swelling to her back. Two rounds (doses of 1 milligram [mg, a measure of dosage strength] each) of epinephrine (a hormone and medication used along with emergency medical treatment to treat life-threatening conditions) were administered. The patient had no heart activity identified throughout ACLS efforts. Patient #38 was pronounced dead at 7:07 AM.

During an interview on 09/20/23 at 7:50 AM, Staff AAA, PCT, stated the following:
- On 04/21/23 from 11:00 PM through 04/22/23 at 7:00 AM, he was assigned as the PCT for Patient #38.
- He did not have direct interaction with Patient #38 during his shift and never entered her room while making patient safety rounds. He used the video monitor or looked through a window into her room to document patient safety rounds.
- His last 15 minute patient safety round was done at 5:30 AM and he was unsure who made rounds on Patient #38 for the remainder of his shift.
- Staff BBB, RN, was the assigned nurse and was aware he was busy with another patient.
- He heard a code blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond to attempt to restore the heartbeat or breathing) called to Room 60 (Patient #38's room).
- He entered Patient #38's room to assist with the code blue and saw that she was unresponsive, gray in color and stiff.

During an interview and concurrent medical record review on 09/20/23, at 8:30 AM, Staff BBB, RN, stated the following:
- She assumed care as the primary nurse for Patient #38 on 04/21/23 at 11:00 PM.
- Patient #38 was on 15 minute rounding while awaiting a transfer to an outside BHU.
- She documented on 04/22/23 at 2:11 AM that the patient was resting in bed, had no acute distress (NAD) at that time, and respirations were even and unlabored.
- On 04/22/23 at 6:57 AM, EMS arrived to transfer the patient to the outside BHU.
- When EMS arrived and they went into Patient #38's room, the patient was found pale, cool to the touch, and had no pulse.
- A code blue was activated and she began to do chest compressions.
- The nurse was responsible to ensure that 15 minute rounds were completed and she was unaware that there had not been 15 minute observation rounds completed on Patient #38 since 5:30 AM.
- At times in the ED, patients awaiting transfer were overlooked and not assessed.
- She had used the preset choices for documentation by clicking a box.
- She did not go into the room of Patient #38 during her shift to assess the patient, and stated, "Clearly I was wrong, Patient #38 did not have respirations that were even and unlabored."
- She did not know how long Patient #38 had been unresponsive prior to the arrival of EMS.

During an interview and concurrent medical record review on 09/20/23 at 8:45 AM, Staff CCC, ED Physician, stated the following:
- On 04/22/23, she was working the 7:00 AM to 3:00 PM shift.
- She had just arrived and was reviewing her assigned patient records when a nurse told her that there was a code blue.
- She had not been assigned Patient #38 and was not aware of why the patient was in the ED.
- She arrived in Room 60 (Patient #38's room) and found the patient was cold, had mottled (when the skin had a red or purple marbled appearance, can indicate impending death) skin and blood pooling on her back.
- She directed the code blue and pronounced Patient #38 dead at 7:07 AM.
- Based on her observations, Patient #38 could have been dead for at least one hour and up to four hours.
- She expected that 15 minute patient safety rounds were completed by the assigned PCT or RN.
- She expected PCTs and RNs to walk into the patient room to do patient assessments and observations.
- She was not aware that 15 minute patient safety rounds were not documented on 04/22/23 from 5:45 AM through 6:57 AM, at which time the patient was found unresponsive.

During an interview and concurrent medical record review on 09/20/23 at 9:00 AM, Staff DDD, RN, Charge Nurse, stated the following:
- On 04/22/23 she was called to a code blue in room 60. EMS personnel and Staff BBB, RN, were doing chest compressions on Patient #38.
- She had no direct contact with Patient #38 prior to the code blue.
- Patient #38 had mottled skin and her body was cold and stiff.
- She was not aware that Patient #38's 15 minute safety rounds had not been completed since 5:30 AM.
- The expectation was that the 15 minute patient safety rounds were completed in real time.
- The expectation of the staff performing the 15 minute safety rounds were to physically walk into a room and make the assessment. If patients were sleeping, they were still expected to walk into a patient's room to ensure the patient was safe.

During an interview on 09/20/23 at 11:30 AM, Staff A, Vice President of Quality, stated the following:
- Her expectation was that 15 minute patient safety rounds were performed by physically walking into that patient's room to make the observation. Assessments and observations were not to have been completed using video monitors or looking through a window.
- It was the responsibility of the RN to ensure that the patient safety rounds were completed. If the nurse was busy, there was always a charge nurse who could assist.
- She was unaware that Patient #38 did not have 15 minute patient safety rounds from 5:30 AM until she was found unresponsive at 6:57 AM.
- She was aware that Staff BBB, RN, documented respirations were even and unlabored at 6:30 AM. In her opinion, this was not possible based on Patient #38's documented appearance at 6:57 AM.
- It takes time for the body to become cool to touch.
- "I am not an expert in estimating the time of a patient death, but I feel that she had been deceased for at least one to two hours based on what was documented."

During an interview on 09/20/23 at 3:30 PM, Staff SSS, ED Medical Director, stated the following:
- Patient safety rounds were to have been completed every 15 minutes for all psychiatric patients in the ED.
- His expectation was for the PCT to have gone into a room and make observations. Patient safety rounding should not have been done utilizing the video monitoring system or by looking through a window.
- The patient's assigned nurse was responsible to ensure that all patient safety rounds were completed.
- A nursing assessment should have been done at the patient's bedside. The ED physicians rely on accurate nursing assessments and expected they were notified if there were any changes.

During an interview on 09/20/23 at 4:00 PM, Staff N, ED Director, stated the following:
- Her expectation of patient safety rounds was the PCT or RN went into the patient room when they made observations. Observations and assessments were not to have been done solely using the video monitors and by looking through a window.
- The RN was responsible for ensuring that the patient safety rounds were completed.
- She reviewed the events and the documentation in Patient #38's medical record. She believed Staff BBB, RN's documentation of observations and assessments were inaccurate. There was an option when documenting within the electronic health record that prefills documentation when a specific box was selected. In her opinion, she felt that was what was done with documentation in Patient #38's record.

During an interview on 09/20/23 at 4:30 PM, Staff RRR, ED Clinical Nurse Manager, stated the following:
- Her expectation of patient safety rounds was for the PCT or RN to have gone into that room to make their observations. Observations and assessments were not to have been done solely using the video monitors and by looking through a window.
- The RN was responsible for ensuring that the patient safety rounds were completed.
- She met with Staff BBB, RN, and discussed in an informal meeting that prefilled selections could be utilized when documenting however, staff must also include details specific to the patient. That tool within their system was not meant to be the only documentation done.

During an interview and concurrent observation on 09/21/23 at 11:30 AM, with Staff N, ED Director, showed the following:
- Room 60 was located in a BHU within the ED, the room Patient #38 was assigned.
- There was a window on the door and a window on the wall that was also the back wall of the nurses' station where nursing staff completed their documentation. A nurse could stand up and look through the window if the blinds were open.
- There was video monitoring that was monitored by a security guard.
- At the time room 60 was observed, a patient was in the room sleeping with the lights out; the patient's respirations were unable to be assessed through the window.
- She agreed that if the lights were out, staff could not have accurately seen that the patient's respirations were even and unlabored.

During an interview on 09/21/23 at 12:08 PM, Staff QQQQ, Chief Nursing Officer (CNO), stated that:
- Her expectation of 15 minute patient safety rounding was that staff went into a patient's room to make the observation.
- Observations were not to be done using the video monitor or by looking through a window.
- The RN was responsible to ensure that the 15 minute patient safety rounds were completed. If the nurse removed the assigned technician for another task, the nurse was expected to find another staff member to complete safety rounds or completed rounds themselves.

During an interview on 09/26/23 at 3:30 PM, Staff RRRR, Physician, stated that:
- She had received a verbal report on Patient #38 from Staff CCC, Physician, during her shift on 04/21/23 from 3:00 PM until 11:00 PM.
- She had not seen Patient #38 during her shift.
- She had reviewed the lab work and signed the transfer order for Patient #38 to be transferred to a BHU.
- She was not aware that 15 minute patient safety rounds had not been completed.
- Her expectation of 15 minute patient safety rounding was that staff went into a patient's room to make the observation.
- The RN was responsible for ensuring that the patient safety rounds were completed.
- Her expectation was for staff to go in and assess the patient at bedside and not visualize through a window or by using a video monitor.
- She gave report to Staff TTTT, Physician, at the end of her shift.

During an interview on 09/29/23 at 3:40 PM, Staff TTTT, Physician, stated that:
- He worked as one of the ED physicians on 04/21/23 from 11:00 PM through 04/22/23 7:00 AM.
- He did not remember receiving report on Patient #38 and did not know that he had been assigned that patient.
- Due to staffing issues, they do not routinely see patients after they had been seen by another ED physician unless they were alerted by the nurse there was a problem.
- He was not aware that Patient #38 did not receive 15 minute patient safety rounds on 04/22/23 from 5:30 AM until the patient was found unresponsive at 6:57 AM.
- He was not aware that the nurse or the PCT never went into the room of Patient #38 for any of the observations or assessments.
- He expected staff to go into patient rooms and not make observations looking through a window or by looking at a video monitor.
- He was in a procedure during the code blue.
- He was not aware that the nurse had documented at 6:40 AM that Patient #38's respirations were even and unlabored and that the body had been found cold and gray at 6:57 AM. He had not seen the body, but stated he had heard about the situation that morning; "That's not good if she documented that at 6:40 AM and the body was cold and gray 20 minutes later."

Based on interview, record review and policy review, the hospital failed to have systemic practices in place to ensure the Quality Assurance and Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) program properly investigated and effectively monitored an unexpected death in the hospital's Emergency Department (ED). These failures had the potential to adversely affect the quality of care, safety and care outcomes of all patients in the hospital. The hospital census was 520.

The severity and cumulative effects of these systemic practices resulted in the hospital's non-compliance with 42 CFR 482.21 Condition of Participation: QAPI Program and resulted in the hospital's failure to ensure quality health care and safety.

Please refer to A-0309

Based on interview, record review and policy review, the hospital failed to have systemic practices in place to ensure the Quality Assurance and Performance Improvement (QAPI, process for reporting and/or identifying adverse events, near misses or review of high risk, problem prone areas for patient safety) program properly investigated and effectively monitored an unexpected death of Patient #38 in the hospital's Emergency Department (ED). These failures had the potential to adversely affect the quality of care, safety and care outcomes of all patients in the hospital.

Findings included:

Review of the hospital's policy titled, "Mercy Wide Unanticipated Outcomes (including unintended adverse medical events, sentinel events [actual events that could or did cause patient harm], serious reportable events) Policy," dated 08/16/23, showed:
- An unanticipated outcome means a result that occurs during the course of care that was reasonably unexpected by the patient and may be clinically significant to patient's health now or in the future.
- An "unanticipated outcome" is determined based upon the result to the patient, not the cause of the outcome; analyzing the cause of an "unanticipated outcome" may be performed in accordance with other Mercy policies relating to patient safety and quality.
- The appropriate setting to engage should be one that facilitates a face-to-face meeting with the patient/family.
- The purpose of the engagement with the patient/family is to promptly communicate the patient's clinical circumstances as a result of the "unanticipated outcome."
- If questions require follow-up, provide the patient/family with a timeframe in which their questions will be answered.
- A physician or designee shall document in the patient's medical record with a short statement containing the facts communicated to the patient or his/her family.

Review of the hospital's policy titled, "St. Louis Administration Patient or Patient Representative Complaints and Grievance Policy," dated 06/01/20 showed a complaint/grievance is defined as:
- A situation where the patient, family member, or a patient representative expresses displeasure with a process, person, or some aspect of care and is not resolved by the staff present or within the same day by another co-worker.
- Issues with real or perceived violations of patient rights or a serious complaint in which the intent is to improve the clinical process related to care.
- Any formal expression of dissatisfaction that is received by the Patient Relations Department.
No complaint or grievance was completed after the family called the Patient Relations Department requesting medical information regarding the death of their family member.

Review of the hospital's policy titled, "St. Louis Administration Safety Event Reporting Policy," dated 11/17/22, showed a Safety Accountability and Feedback for Everyone (SAFE) tool is used for patient events that involve a specific patient. The reporter is to complete all required fields in the narrative section, which includes, a comprehensive, factual description of what happened, who was involved, the degree of injury, and what was done after the event.

Review of the hospital's document titled, "Mercy Safety Event Review/Approval Form," dated 04/22/23, showed:
- Patient #38 had an unanticipated event.
- Staff RRR, ED Clinical Nurse Manager, reported the event on 04/22/23 at 9:16 AM and it was then forwarded to Staff M, Patient Safety Lead, to review.
- The event was classified as a "patient event," that occurred on 04/22/23 at 6:57 AM.
- It was determined that there were no contributing factors.
- The outcome was documented as a "Safety Event."
- There was an autopsy reviewed which reportedly showed that the cause of death was related to an underlying medical disease.
- After the review of the autopsy in 07/2023, three months after the event, the report was closed with no further investigation or education provided to staff.

Review of the hospital's policy titled, "St. Louis Procedure for Performing a Root Cause Analysis, Intensive Analysis, or Swarm Investigation Policy," dated 08/17/23, showed:
- The purpose of a Root Cause Analysis (RCA) is to identify factors that led to and caused a serious preventable adverse event, or near miss. The preventable adverse event is, very often, the result of a larger process or system failure.
- On the "Standard List of Events" that would prompt a RCA would be an event that resulted in unanticipated death or major permanent loss of function, not related to natural course of patient's illness or underlying condition.
- On the "Standard List of Root Causes" was patient observation procedures and the failure by any caregiver to monitor adequately any patient, which may include rounding on patients and one to one interaction.

The hospital allowed three months to lapse without a RCA performed. During that time period, they awaited the autopsy results and determined that no RCA was required. Due to this determination, no plan of correction, thorough investigation or education was completed.

Review of the undated document, "4th Quarter Fiscal Year 2023 Root Cause Analysis Activity," showed events that occurred from 02/02/23 to 05/25/23. Patient #38's unexpected death event that occurred on 04/22/23 was not included for review.

During an interview on 09/20/23, at 7:50 AM, Staff AAA, Patient Care Technician (PCT), stated that he cared for Patient #38 and no one had contacted him regarding this event prior to the interview with a state surveyor.

During concurrent interview and medical record review on 09/20/23, at 8:30 AM, Staff BBB, Registered Nurse (RN), stated that she cared for Patient #38 and no one from Quality or Administration had spoken with her regarding a sentinel event investigation.

During a concurrent interview and medical record review on 09/20/23 at 9:00 AM, Staff DDD, RN Charge Nurse, stated the following:
- She was called to a code blue in room 60.
- She had no direct contact with Patient #38 prior to the code blue.
- She filed a SAFE report following this sentinel event.
- She spoke directly with Staff N, ED Director, about the events.
- No one from Quality or Risk Management contacted her for any type of investigation.

During an interview on 09/20/23 at 4:00 PM, Staff N, ED Director, stated that she had not participated in or was not asked any questions as part of a sentinel event.

During an interview on 09/20/23 at 3:30 PM, Staff SSS, ED Medical Director, stated the following:
- He was new to this position, therefore he was not aware of Patient #38's sentinel event until state surveyors arrived at the hospital.
- He oversees all investigations but did not participate in any investigation.
- Patient #38 was never presented at the Sentinel Event Committee meeting.
- "Hindsight, I should have asked more questions and this case should have been presented to the sentinel event committee for review."

During an interview on 09/26/23 at 3:30 PM, Staff RRRR, MD, stated that:
- She had received a verbal report on Patient #38 from Staff CCC, MD, during her shift on 04/21/23 from 3:00 PM until 11:00 PM.
- She had not seen Patient #38 during her shift.
- She had not been contacted for any investigation prior to being interviewed by a state surveyor.

During an interview on 09/29/23 at 3:40 PM, Staff TTTT, MD, stated that:
- He worked as one of the ED physicians on 04/21/23 from 11:00 PM through 04/22/23 7:00 AM.
- Due to staffing issues, they do not routinely see patients after they had been seen by another ED physician unless they were alerted by the nurse there was a problem.
- No one had contacted him about an investigation prior to being interviewed by the state surveyor.

During an interview on 09/19/23 at 10:30 AM and 09/20/23 at 11:30 AM, Staff A, Quality Vice President stated the following:
- Once a safety event was created, it was discussed in a weekly meeting with patient relations and safety.
- During the weekly meeting, they discussed the investigation.
- An operational leader assigned to the investigation, would then assign a department/discipline to facilitate that particular investigation.
- The case remained on the weekly agenda until the investigation was completed.
- Once a case was deemed as fully investigated it was then sent to the hospital president to review and sign off the case.
- She was not directly involved in the investigation, the only information she had was from her team.
- She knew after the fact that this should have been escalated to a serious event and a RCA should have been done.
- She was aware that once the hospital received the coroner's report, the SAFE event was closed.

During concurrent interview and medical record review on 09/19/23 at 3:40 PM, Staff L, Patient Safety Specialist, stated the following:
- She had worked with Staff M, Patient Safety Lead, on the investigation of this case.
- Based on the outcome of the investigation, the patient died from natural causes and an underlying medical condition.
- The clinical outcome of the investigation was based on the autopsy report.
- She had not interviewed any personnel that had been directly involved with Patient #38.
- She was not aware that 15 minute patient safety rounds had not been completed on Patient #38.
- She completed the chart review of Patient #38.
- She did not interview the leadership from that particular department.
- She did not know what physician had been assigned to care for the patient on 04/21/23 during the 3:00 PM to 11:00 PM shift or the 11:00 PM to 7:00 AM shift for Patient #38. .
- The medical record did not reflect a physician being assigned during these two shifts, "so I have no idea who took care of Patient #38."
- She did not follow-up with leadership to determine what physician had been assigned to Patient #38 or if one had been assigned.
- She did not know if the chart had been reviewed by the two physicians that were assigned.
- "Upon review of Staff BBB, RN's documentation for Patient #38, we trust our nurses and if she documented the respirations were even and unlabored then we did not question that."
- I felt that we fully investigated this case and when we got the autopsy result back we closed this case. No further review was done.

During an interview on 09/19/23 at 3:10 PM, Staff M, Patient Safety Lead, stated the following:
- She participated in the investigation of Patient #38's sentinel event that had occurred on 04/22/23.
- A Mercy Safety Event Review should have been done on all sentinel events; the initial narrative should have been entered by the staff member and then it would have been assigned to a Patient Safety Lead to investigate.
- She had been assigned to investigate Patient #38's sentinel event.
- During the review of Patient #38's case, she was not aware if the medical care provided had been reviewed by the hospital President or the Medical Chair physicians.
- She was aware an email was sent to them to do the review but she did not have documentation that showed they reviewed the documentation. She stated it was informal and she had assumed they had done the review.
- A family member of Patient #38 called to inquire about the care and spoke to the social worker. She requested information on the death of her family member.
- A grievance was not filed following the patient's family member calling the hospital.
- There was no documentation that showed a physician had followed up with the family after the autopsy results but, "I assumed he did."
- Everything in the investigation had been documented.
- She had not interviewed the PCT, the RN or the medical physicians regarding this sentinel event.
- They waited on the autopsy report and upon review of the autopsy, the patient died from an underlying medical condition, therefore no RCA was completed.
- If the nurse documented that she saw the chest rise and fall at 6:40 AM, she saw the chest rise and fall. We trust our nurses' documentation and it was "end of case."
- We believed that we had completed the investigation, completed chart review, and reviewed the autopsy report of Patient #38; the case was closed.

During an interview on 09/21/23 at 12:08 PM, Staff QQQQ, Chief Nursing Officer (CNO), stated that:
- She was directly involved with the OAPI program and the collaboration with all areas of the hospital.
- She was not involved in the investigation process because it was not brought to her.
- When the incident was reviewed initially, the hospital felt they had not done anything wrong.
- Hindsight was 20/20 and she felt that it was a sentinel event.
- Staff should have slowed down and investigated more thoroughly.
- She was not involved in the initial conversation regarding this event.
- This incident was not discussed in any Sentinel Event Meeting that she attended because it was not classified as a sentinel event.



47504

Based on observation, interview, record review and policy review, the hospital failed to ensure that staff followed hospital policies when they failed to appropriately perform thorough safety rounds for one discharged patient (#38) of four discharged patients reviewed.

The lack of appropriate safety rounds created an unsafe environment with the potential to place all patients at risk for their health and safety, also known as an Immediate Jeopardy (IJ). The hospital census was 520.

The severity and cumulative effects of these practices resulted in the overall non-compliance with 42 CFR §482.23, Condition of Participation (CoP): Nursing Services.

As of 09/21/23, the hospital had provided an immediate action plan sufficient to remove the IJ when the hospital implemented corrective actions that included all current and oncoming nursing staff were educated on the nursing rounding policy, expected procedures and documentation standards. All remaining staff were educated prior to the start of their next shift. All nursing staff were directed to complete a computer-based training module to demonstrate competency in the education provided.

Please refer to A-0395.

Based on observation, interview, record review and policy review, the hospital failed to appropriately perform thorough safety rounds for one discharged patient (#38) out of four discharged patient records reviewed.

The lack of appropriate safety rounds had the potential to put all patients who required frequent monitoring for safety at risk.
Findings included:

1. Review of the hospital's policy titled, "Patient Observation Rounds," dated 05/16/22, showed:
- All behavioral health patients were rounded on every 15 minutes at irregular intervals, not to exceed 16 minutes.
- All rounds are documented in real time.
- Patient observation rounds include the visualization of the patient and their surrounding environment.
- Patients in their bed are observed for respirations, breathing and safe position.
- Patient observation rounds are made by a nurse at least every two hours throughout the duration of the shift.
- Psychiatric technicians and patient care technicians (PCT) also complete safety rounds as ordered.
- The Registered Nurse (RN) is responsible for ensuring that all rounds are completed.
(This policy applies to inpatient and ED behavioral health patients per hospital management)

Review of Patient #38's medical record showed the following:
- She was a 48 year old female who arrived in the ED on 04/21/23 at 11:44 AM via Emergency Medical Services (EMS, emergency response personnel, such as paramedics, first responders, etc.) for a psychological (relating to mental illness) evaluation.
- She had a history of schizophrenia bipolar disorder (a mental disorder that causes unusual shifts in mood by alternating periods of emotional highs and lows), depression (extreme sadness that doesn't go away), anxiety (a feeling of fear or worry experienced intermittently) and substance abuse (misuse of alcohol and/or other drugs).
- Fifteen minute patient safety observation rounds were initiated on 04/21/23 at 11:50 AM by Staff EEE, RN.
- Staff AAA, PCT, was assigned Patient #38's 15 minute safety rounds from 04/21/23 at 11:00 PM through 04/22/23 at 7:00 AM.
- There was no documentation for 15 minute patient safety rounds on 04/22/23 at 5:45 AM, 6:00 AM, 6:15 AM, 6:30 AM, and 6:45 AM.
- Staff BBB, RN, documented on 04/22/23 at 3:59 AM, 5:49 AM and 6:30 AM that Patient #38 was resting in bed and respirations were even and unlabored.
- At 6:58 AM, Staff BBB, RN, documented "EMS arrives to transport for inpatient admission. Patient was found to be cool to touch, not breathing and no pulse. Advanced Cardiac Life Support (ACLS, specific life saving measures taken by certified health professionals when a patient's heartbeat or breathing stops) immediately initiated."
- At 7:19 AM, Staff CCC, ED Physician, documented they were called to Patient #38's bedside after CPR was initiated at approximately 7:00 AM. The patient was pulseless, gray, cold to touch and had swelling to her back. Two rounds (doses of 1 milligram [mg, a measure of dosage strength] each) of epinephrine (a hormone and medication used along with emergency medical treatment to treat life-threatening conditions) were administered. The patient had no cardiac activity identified throughout ACLS efforts. Patient #38 was pronounced dead at 7:07 AM.

Observation and concurrent interview on 09/21/23 at 11:30 AM with Staff N, ED Director, showed the following:
- Room 60 was located in a Behavioral Health Unit (BHU) within the ED.
- There was a window on the door and a window on the wall that was also the back wall of the nurses' station. A nurse could stand up and look through the window if the blinds were open.
- At the time of the observation on 09/21/23, a patient was sleeping in Room 60 with the lights out. The patient's respirations were unable to be assessed by looking through the window.
- Staff N stated that if the lights were out, staff could not accurately assess that a patient's respirations were even and unlabored.

During an interview on 09/20/23 at 7:50 AM, Staff AAA, PCT, stated the following:
- On 04/21/23 from 11:00 PM through 04/22/23 at 7:00 AM, he was assigned as the PCT for Patient #38.
- He did not have direct interaction with Patient #38 during his shift and never entered her room while making patient safety rounds. He used the video monitor or looked through a window into her room to document patient safety rounds.
- His last 15 minute patient safety round was done at 5:30 AM and he was unsure who made rounds on Patient #38 for the remainder of his shift.
- Staff BBB, RN, was the assigned nurse and was aware he was busy with another patient.
- He heard a code blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond to attempt to restore the heartbeat or breathing) called to Room 60 (Patient #38's room).
- He entered Patient #38's room to assist with the code blue and saw that she was unresponsive, gray in color and stiff.

During an interview and concurrent medical record review on 09/20/23, at 8:30 AM, Staff BBB, RN, stated the following:
- She assumed care as the primary nurse for Patient # 38 on 04/21/23 at 11:00 PM.
- Patient #38 was on 15 minute rounding while awaiting a transfer to an outside BHU.
- She documented on 04/22/23 at 2:11 AM that the patient was resting in bed, had no acute distress (NAD) at that time, and respirations were even and unlabored.
- On 04/22/23 at 6:57 AM, EMS arrived to transfer the patient to the outside BHU.
- When EMS arrived and they went into Patient # 38's room, the patient was found pale, cool to the touch, and had no pulse.
- A code blue was activated and she began to do chest compressions.
- The nurse was responsible to ensure that 15 minute rounds were completed and she was unaware that there had not been 15 minute observation rounds completed on Patient #38 since 5:30 AM.
- At times in the ED, patients awaiting transfer were overlooked and not assessed.
- She had used the preset choices for documentation by clicking a box.
- She did not go into the room of Patient #38 during her shift to assess the patient, and stated, "Clearly I was wrong, Patient #38 did not have respirations that were even and unlabored."
- She did not know how long Patient #38 had been unresponsive prior to the arrival of EMS.

During an interview and concurrent medical record review on 09/20/23 at 8:45 AM, Staff CCC, ED Physician, stated the following:
- On 04/22/23, she was working the 7:00 AM to 3:00 PM shift.
- She had not been assigned Patient #38 and was not aware of why the patient was in the ED.
- She arrived in Room 60 (Patient #38's room) and found the patient was cold, had mottled (when the skin had a red or purple marbled appearance, can indicate impending death) skin and blood pooling on her back.
- She directed the code blue and pronounced Patient #38 dead at 7:07 AM.
- Based on her observations, Patient #38 could have been dead for at least one hour and up to four hours.
- She expected that 15 minute patient safety rounds were completed by the assigned PCT or RN.
- She expected PCTs and RNs to walk into the patient room to do patient assessments and observations.
- She was not aware that 15 minute patient safety rounds were not documented on 04/22/23 from 5:45 AM through 6:57 AM, at which time the patient was found unresponsive.

During an interview and concurrent medical record review on 09/20/23 at 9:00 AM, Staff DDD, RN, Charge Nurse, stated the following:
- On 04/22/23 she was called to a code blue in room 60. EMS personnel and Staff BBB, RN, were doing chest compressions on Patient #38.
- She had no direct contact with Patient #38 prior to the code blue.
- Patient #38 had mottled skin and her body was cold and stiff.
- She was not aware that Patient #38 did not have 15 minute patient safety rounds completed since 5:30 AM.
- The expectation was that the 15 minute patient safety rounds were completed in real time.
- The expectation of the staff performing the 15 minute safety rounds were to physically walk into a room and make the assessment. If patients were sleeping, they were still expected to walk into a patient's room to ensure it was safe.

During an interview on 09/20/23 at 4:00 PM, Staff N, ED Director, stated the following:
- Her expectation of patient safety rounds was the PCT or RN went into the patient room when they made observations. Observations and assessments were not to have been done solely using the video monitors and by looking through a window.
- The RN was responsible for ensuring that the patient safety rounds were completed.
- She reviewed the events and the documentation in Patient #38's medical record. She believed Staff BBB, RN's documentation of observations and assessments were inaccurate. There was an option when documenting within the electronic health record that prefills documentation when a specific box was selected. In her opinion, she felt that was what was done with documentation in Patient #38's record.

During an interview on 09/20/23 at 4:30 PM, Staff RRR, ED Clinical Nurse Manager, stated the following:
- Her expectation of patient safety rounds was for the PCT or RN to have gone into that room to make their observations.
- Observations and assessments were not to have been done solely using the video monitors and by looking through a window.
- The RN was responsible for ensuring that the patient safety rounds were completed.

During an interview on 09/20/23 at 3:30 PM, Staff SSS, ED Medical Director, stated the following:
- Patient safety rounds were to have been completed every 15 minutes for all psychiatric patients in the ED.
- His expectation was for the PCT to have gone into a room and make observations. Patient safety rounding should not have been done utilizing the video monitoring system or by looking through a window.
- The patient's assigned nurse was responsible to ensure that all patient safety rounds were completed.
- A nursing assessment should have been done at the patient's bedside. The ED physicians rely on accurate nursing assessments and expected they were notified if there were any changes.

During an interview on 09/20/23 at 11:30 AM, Staff A, Vice President of Quality, stated the following:
- Her expectation was that 15 minute patient safety rounds were performed by physically walking into that patient's room to make the observation. Assessments and observations were not to have been completed using video monitors or looking through a window.
- It was the responsibility of the RN to ensure that the patient safety rounds were completed. If the nurse was busy, there was always a charge nurse who could assist.
- She was not aware that Patient #38 did not have 15 minute patient safety rounds from 5:30 AM until she was found unresponsive at 6:57 AM.

During an interview on 09/21/23 at 12:08 PM, Staff QQQQ, Chief Nursing Officer (CNO), stated that:
- Her expectation of 15 minute patient safety rounding was that staff went into a patient's room to make the observation.
- Observations were not to be done using the video monitor or by looking through a window.
- The RN was responsible to ensure that the 15 minute patient safety rounds were completed. If the nurse removed the assigned technician for another task, the nurse was expected to find another staff member to complete safety rounds or completed rounds themselves.

During an interview on 09/19/23 at 2:20 PM, Staff SS, Interim Manager Inpatient BHU, stated the following:
- Every 15 minute monitoring was primarily carried out by behavioral health technicians (BHT).
- The nurse was responsible for rounding at least every two hours on every patient.
- If a patient was in their room during rounds, the BHT went into the patient's room and ensured that they visualized part of the patient's body above the bed linens and that they were not in distress.
- All rounding documentation was entered into the electronic health record.





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Based on observation, interview, record review and policy review, the hospital failed to:
- Document the date on intravenous (IV, small flexible tube inserted into a vein to deliver medications and fluids into the blood stream) dressings and IV tubing for 17 patients (#2, #4, #5, #7, #13, #14, #17, #18, #19, #23, #34, #35, #36, #44, #61, #62 and #63) of 29 patients observed.
- Perform hand hygiene (wash hands with soap and water or use hand sanitizer) and change gloves after touching inanimate objects (not alive, for example computer keyboard, medical equipment, medical bed, etc.) and before performing patient care for seven patients (#5, #9, #10, #16, #33, #43 and #63) of 25 patients observed.
- Clean or place a clean barrier prior to laying supplies or medications on surfaces for two patients (#13 and #14) of two patients observed.

The lack of dated IV dressings and IV tubing, hand hygiene and creating a clean barrier had the potential to increase the risk of preventable hospital acquired infection (HAI, infection that was transmitted to the patient while in the hospital). The hospital census was 520.

Findings included:

1. Review of the hospital's policy titled, "IV Care and Maintenance Policy," dated 05/19/23, showed:
- IV administrations sets (tubing) were labeled with the date of initiation.
- Pre-hospital IVs were defined as inserted outside of the medical facility or with an unknown history of insertion and were removed within 24 hours of a patient's admission.
- Nurses were directed to refer to Lippincott procedure standards for IV insertion, IV dressing changes and IV tubing changes.

Review of the hospital-provided document titled, "Lippincott Procedures-IV catheter insertion," revised 08/21/23 showed staff were directed to discontinue/change IVs that were placed in emergent situations within 24 hours. After insertion of an IV, the site was covered with a transparent dressing and labeled with the current date.

Review of the hospital-provided document titled, "Lippincott Procedures-IV dressing changes," revised 08/21/23 showed the following:
- Staff were directed to change IV dressings at least every seven days.
- The IV dressing was changed immediately if it was assessed as soiled, loosened or any skin integrity (refers to skin health, to be free of wounds or irritation) beneath the dressing was compromised.
- After changing a transparent IV dressing in an aseptic manner (process that is intended to minimize contamination from pathogens), the new transparent dressing was labeled with the date.

Review of the hospital-provided document titled, "Lippincott Procedures-IV administration set (tubing) changes," revised 08/21/23 showed the following:
- Staff were directed to change primary and secondary continuous administration IV tubing at least every seven days, unless otherwise directed according to the solution or medication being administered.
- Tubing was also changed if the integrity of the tubing was breached or contamination was suspected.
- Secondary medication administration tubing that was detached from primary administration tubing was replaced every 24 hours.
- The tubing was labeled with the date of initiation or date when change was needed.

Observation and concurrent interview on 09/18/23 at 3:25 PM, showed Patient #2 had two IV dressings which were not dated. The IV dressing on the back of his right hand was peeling away at all four corners. Patient #2 stated that the IV on his right hand was begun by the Emergency Medical Technicians (EMT) at his place of employment immediately after his accident and prior to his transport to the hospital on 09/13/23. The IV on his left hand was started by the hospital's Emergency Department (ED) staff.

Observation on 09/18/23 at 3:10 PM, showed Patient #4's IV dressing and IV tubing were not dated.

Observation on 09/18/23 at 3:15 PM, showed Patient #5's IV dressing was not dated.

Observation on 09/18/23 at 3:20 PM, showed Patient #7's IV dressing was not dated.

Observation on 09/18/23 at 3:35 PM, showed Patient #13's IV dressing was not dated.

Observation on 09/18/23 at 3:20 PM, showed Patient #14's IV dressing and IV tubing were not dated.

Observation on 09/19/23 at 9:10 AM, showed Patient #17's IV dressing was not dated.

Observation on 09/19/23 at 10:55 AM, showed Patient #18's IV dressing was not dated.

Observation on 09/19/23 at 12:45 PM, showed Patient #19's IV dressing was not dated.

Observation on 09/19/23 at 10:35 AM, showed Patient #23's IV tubing was not dated.

Observation on 09/19/23 at 2:46 PM, showed Patient #34's IV dressing was not dated.

Observation on 09/19/23 at 2:50 PM, showed Patient #35's IV dressing was not dated.

Observation on 09/19/23 at 3:05 PM, showed Patient #36 had two IV dressings which were not dated.

Observation on 09/20/23 at 1:26 PM, showed Patient #44's IV dressing was not dated.

Observation on 09/21/23 at 8:55 AM, showed Patient #61's two IV dressings and IV tubing were not dated.

Observation on 09/21/23 at 9:30 AM, showed Patient #62's IV dressing was not dated.

Observation on 09/21/23 at 9:15 AM, showed Patient #63's three IV dressings were not dated.

During an interview on 09/18/23 at 3:45 PM, Staff J, Registered Nurse (RN), stated that IV dressings were to have been dated.

During an interview on 09/18/23 at 3:20 PM, Staff K, RN, stated that IV dressings were to have been dated.

During an interview on 09/19/23 at 12:45 PM, Staff AA, RN, stated that IV dressings were changed every three days or sooner if they were dirty or thought at risk of infection. IV dressings were labeled with the date they were placed.

During an interview on 09/20/23 at 9:55 AM, Staff GGG, RN, stated that IV dressings were changed weekly. IV dressings were changed sooner if soiled or they were felt compromised or an infection risk.

2. Review of the hospital's policy titled, "Infection Prevention Hand Hygiene Policy," dated 02/24/23, showed staff were directed to use alcohol-based hand rub (ABHR) before and after touching a patient, after contact with inanimate surfaces and objects in the immediate vicinity of the patient and before and after removing sterile and non-sterile gloves. Gloves were changed when they became damaged, soiled or when working from a contaminated body part to another site on the same patient.

Observation on 09/18/23 at 3:15 PM, showed Staff P, RN, did not perform hand hygiene when she exited the room after she started an IV for Patient #5.

Observation on 09/18/23 at 3:45 PM, showed Staff S, RN, did not perform hand hygiene after reaching into his pocket while doing bedside care for Patient #9.

Observation on 09/18/23 at 4:00 PM, showed Staff T, RN, did not perform hand hygiene when she exited the room after providing beside care on Patient #10.

Observation on 09/19/23 at 9:35 AM, showed Staff W, RN, changed Patient #16's wound vacuum assisted closure (wound VAC, a device that decreases air pressure on a wound to help it heal more quickly) dressing and changed gloves three times without performing hand hygiene between glove changes. Staff W used a cell phone camera device to take pictures of Patient #16's wounds, put the device in her pocket with her gloved hand after touching the wound area and wound marker, did not clean the device before leaving the patient's room and removed the device from her pocket with her ungloved hand in the hallway.

Observation on 09/19/23 at 2:15 PM, showed that Staff JJ, RN, touched Patient #33's computer and the scanner with gloved hands, then proceeded to touch the patient and started the blood transfusion without performing hand hygiene and changing gloves.

Observation on 09/20/23 at 10:36 AM, showed that Staff MMM, RN, placed a new dressing on Patient #43's port (a small medical appliance installed beneath the skin in the chest region and connects the port to a vein and is used to administer medications and draw blood), then placed her gloved hand in her dirty pocket to retrieve a marker and proceeded to date the clean dressing, then placed the dirty marker back in her pocket when finished.

Observation on 09/21/23 at 9:30 AM showed Staff CCCC, RN, picked up Patient #63's ink pen off of the floor and then dispensed their oral medications without performing hand hygiene.

During an interview on 09/19/23 at 9:50 AM Staff W, RN, stated that she was unsure of the hospital's policy on performing hand hygiene between glove changes. She stated that the cell phone device remained in her pocket except when removed to take pictures of patient wounds.

During an interview on 09/19/23 at 2:35 PM, Staff II, Nurse Manager, stated that she expected nurses to have performed hand hygiene and change gloves after they touched inanimate objects in the patient's room and prior to providing any care.

During an interview on 09/20/23 at 10:51 AM, Staff MMM, RN, stated that gloves should have been removed and hand hygiene performed prior to placing hands in a pocket, and then again before the dressing was dated.

3. Although requested, a policy on the use of barriers or a clean work surface was not provided.

Observation on 9/18/23 at 3:15 PM, showed that Staff K, RN, failed to use a barrier when she placed chest tube dressing supplies on Patient #14's bed.

Observation on 9/18/23 at 3:35 PM, showed that Staff J, RN, failed to clean or use a barrier when she placed IV supplies on Patient #13's dirty chair arm to remove two IVs.

During an interview on 09/18/23 at 3:20 PM, Staff K, RN, stated that a chest tube dressing change was not a sterile procedure, therefore a barrier was not used.

During an interview on 9/18/23 at 3:45 AM, Staff J, RN, stated that taking out an IV was not a sterile procedure and the chair arm did not need a barrier or cleaned prior to use.

During an interview on 09/19/23 at 3:30 PM, Staff H, Infection Preventionist, stated that IV dressings were to have been dated and timed. He stated that it was expected that supplies were placed on a barrier or on a clean work surface.

During an interview on 09/21/23 at 12:08 PM, Staff QQQQ, Chief Nursing Officer, stated that it was expected that nurses dated IV dressings and IV tubing on every unit. It was expected that staff perform hand hygiene between glove changes and any time that an inanimate object was touched before care was provided. She expected that the bedside table was cleaned or a barrier was placed on any surface before placing clean supplies to perform patient care tasks.