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An Immediate Jeopardy (IJ) situation was identified during the survey at A115 Patient Rights. On March 4, 2022 at 1:11 PM, the Chief Executive Officer of HCA Florida West Marion Hospital, an affiliated hospital, was informed of the determination of IJ and given the IJ Template. The immediate jeopardy began on February 2, 2022, with the lack of continuous cardiac telemetry monitoring and unwitnessed fall with injuries. The patient suffered an unwitnessed fall, cardiac arrest, nasal fracture and periorbital hematoma, and died on 02/06/2022. The immediate jeopardy was determined to be ongoing.

The hospital failed to ensure patient rights were honored for care in a safe setting for 1 of 3 patients, Patient #1. The hospital failed to follow current standards of practice when the patient experienced an unwitnessed fall, was found without vital signs, and was unresponsive in emergency department on 2/22/2022. The failure to implement the physician's order and hospital's cardiac telemetry monitoring protocol resulted in the patient being left in an unsafe situation while in the hospital setting. This systemic failure constitutes an Immediate Jeopardy situation.

HCA Florida Ocala Hospital was not in compliance with the Condition of Participation for 42 CFR 482.13 Patient Rights, Requirements for Hospitals and Code of Federal Regulations (CFR) 42, Part 482 Conditions of Participation for Hospitals.

Refer to A144 - Patient Rights-Care in a Safe Setting.

Based on medical record review, interview, and policy and procedure review, the hospital failed to ensure patient rights were honored for care in a safe setting for 1 of 3 patients, Patient #1; the hospital failed to follow current standards of practice when the patient experienced an unwitnessed fall, was found without vital signs, and was unresponsive. The failure to implement the hospital's cardiac telemetry monitoring protocol resulted in the patient being left in an unsafe situation while in the hospital setting. This systemic failure constitutes an Immediate Jeopardy situation.

Findings:

Review of the medical record for Patient #1 revealed the patient presented to the Emergency Department (ED) on 2/2/2022 at 6:30 AM with a past medical history of congestive heart failure (a condition where the heart does not pump blood as well as it should), hypertension (high blood pressure), coronary artery disease (the major blood vessels of the heart are damaged or diseased), coronary artery bypass grafting (open heart surgery), atrial fibrillation (an irregular heartbeat), and chronic obstructive pulmonary disease (a chronic lung disease).

Review of the order record for [Patient #1's name] reads "Procedure - Cardiac Monitor, Order No. 0202-0141, Pri (Priority) Stat (immediately), Date 2/2/2022, Time 0632 (6:32 AM), Signed by [Physician's Name] 2/02/22 0632.

Review of the Emergency Screening note dated 2/2/2022 at 6:39 AM reads, "Per pt. [patient] family pt. was found wondering the house with acute AMS [altered mental status], pt. was sleeping at 0430 [4:30 AM] when family left, and they returned at 0530[5:30AM] the pt. was up and walking around confused. Family states this is her usual way of acting when she gets a UTI [Urinary tract infection], which she gets frequently." Focused physical exam under general/const [Constitutional] reads, "Awake, alert. No acute distress. Well appearing. Neurologic: mental status read Confused."

Review of the labs collected dated 2/2/2022 at 6:59 AM reported Potassium 2.9 as a critical low.

Review of Patient #1's records revealed the patient was admitted to the hospital on 2/2/2022 at 10:14 AM and remained in the emergency department awaiting bed placement.

Review of the nursing documentation dated 2/2/2022 at 7:55 AM authored by Staff A, Registered Nurse (RN), reads, "Patient arrived back from CT [CAT Scan]. Tech states the patient was thrashing around while trying to be placed on CT causing a skin tear on right lower forearm and pulled out IV."

Review of the nursing documentation on 2/2/2022 at 8:50 AM authored by Staff A, RN, reads, "Unable to get urine as patient is too confused and not following commands."

Review of the nursing documentation dated 2/22/2022 at 9:35 AM authored by Staff A, RN, reads, "Unsuccessful IV attempts x 2 without assistance and x 1 with assistance. Veins keep blowing. Requested assistance for a line."

Review of the nursing documentation dated 2/22/2022 at 11:30 AM authored by Staff A, RN, reads, "Another nurse attempted IV again to get potassium started. Unsuccessful x 3. Contact provider. Awaiting orders."

Review of the nursing documentation dated 2/2/2022 at 12:15 PM authored by Staff A, RN, reads, "Still not urinating. Bladder scan performed and retaining 526 mls [milliliters]."

Review of the nursing documentation dated 2/2/2022 at 1:10 PM authored by Staff B, RN, reads, "This RN assisted RN [Staff A name] with pt. who was noted to be on the ground unresponsive. Pt bleeding from her face. Pt noted to not have a pulse. This RN held C spine while [Staff A' name] RN started CPR [Cardiopulmonary Resuscitation]. Code Blue called immediately."

Review of the physician progress note dated 2/2/2022 authored by APRN (Advanced Practice Registered Nurse) reads, "Event: I found the patient on the floor with blood over her face, called the nurse who checked the patient, no pulse, compression started. Code Blue called and trauma team came on site and took over care."

Review of telemetry strips provided by the facility showed no ECG (Electrocardiogram) strips available within the medical record until 2/2/2022 at 12:55 PM. The next strip provided was on 2/2/2022 at 12:57 when there was no cardiac rhythm and then at 1:06 PM when the telemetry strip showed ventricular tachycardia. No additional telemetry monitoring strips were provided by the facility.

During an observation on 3/2/2022 at 9:50 AM through 10:20 AM, there were four staff members present in the nurse's station, three registered nurses and one unit secretary. The telemetry bank of monitors was present at the nurse's station. There were four patients on telemetry monitoring with one patient's telemetry ringing with an audible alarm. No staff attended to the monitor until 10:16 AM.

During an interview on 3/2/2022 at 9:50 AM, the Patient Safety Director stated, "We have had several meetings related to this event and did an SEA [serious event analysis]. We have not finished our analysis of the event and fully implemented the corrective actions. We are still meeting to complete the process. We are looking into having centralized telemetry monitor for the patients but that will take time. We do not have a dedicated monitor technician in the ED [Emergency Department] as of right now. We did discuss doing this, but neither telemetry nor the ED could provide the resources. There has been no initiation of telemetry boxes in the emergency department. There has been training related to falls and fall precautions, the use of bed alarms and completing assessments and hourly rounding. There has been no additional training related to telemetry monitoring for the ED staff. They are all trained yearly. I see that we may not have removed the potential of this happening again. I can see where you might think that. No, we did not implement any changes immediately to prevent this for happening again."

During an interview on 3/2/2022 at 10:05 AM, the Emergency Department Director stated, "We have been meeting ever since this event occurred to come up with a solution to this. They are working on telemetry, but currently nothing has been put into place. We do not currently have a staff assigned to watch telemetry. The nurses are responsible to make sure that they watch telemetry. The nurses continue to provide telemetry monitoring for any patients that require it. We don't currently have the process in place. I understand that does mean we have not implemented any changes beyond training on fall alarms and checking telemetry. It is possible that this could happen again if the day were busy. I have no good answer in place as to why we have not implemented any changes related to telemetry monitoring. We have not had any major events prior to this related to monitoring patients. On that day, we were over ratios for staffing. I couldn't dedicate a nurse to do the job of a telemetry tech. We simply don't have the resources. We needed a telemetry monitor technician to do the job as we have staffing for patient care to be concerned about. Additional training was provided of a refresher of fall precautions and hourly rounding. A secretary is always at the desk. They are not trained on telemetry monitoring. I was involved in the meeting related to this. It was discussed to have dedicated telemetry monitoring and that the ED is not part of the centralized monitoring for the hospital. We do have a telemetry monitoring policy for the hospital, and it does apply to the ED also. I don't really know how long the patient was off telemetry. We were having trouble printing any data after the event. I did take photographs, but we did not have the company come and retrieve the strips from the monitor. I did not review the chart for any problems."

During an interview on 3/2/2022 at 11:10 AM, The Chief Nursing Officer (CNO) stated, "We have had several meetings to discuss the event and come up with solutions to the problem. Additional telemetry is not an option at this time. We did not implement any new process in the ED to prevent this from occurring again. The nurses continue to watch the monitors in the ED. We have not fully conducted our root cause analysis to determine what needs to be implemented to make sure this does not occur in the future. This is not who we are. Our investigation was not complete. There were details that were not completed during the investigation. We do not have any details related to the cardiac monitoring and we should have. There was some difficulty retrieving the data from the monitor. I'm not sure if the company representative was called to retrieve the data."

During an interview on 3/2/2022 at 12:12 PM, Staff C, RN, stated, "The patient ratios are higher than normal and that really does impact our staffing and what we can do as ED nurses. We are all competent to read telemetry. We're all ACLS [Advanced Cardiac Life Support] certified, but with ratios above average, it can be impossible to watch a monitor and care for the patients if we are in other rooms doing other things. We never are assigned a monitor tech to watch the monitors and there is not a nurse sitting at the desk all the time. It is a group effort to review the monitor alarms. You hope someone else can respond to the alarms. It is impossible to watch the monitor at all times. I was on that day that [Patient #1's name] fell and coded. All the halls were full that day. We had multiple trauma and stroke alerts and ED hold patients that day. I was in her room several times that day. The patient was very restless, but not trying to get out of bed. We were having a hard time getting a line in her and I attempted to get an IV [Intravenous]. While I was in there, she never gave me concerns that she would fall. She was very weak and was on the monitor when I saw her. This is a problem. We need to be able to give care and we need a monitor tech all the time. I cannot say that we are able to safely monitor telemetry patients every day when we are overcapacity. They did tell us that we would be getting a monitor tech but that did not happen yet."

During an interview on 3/2/2022 at 2:16 PM, Staff E, RN, stated, "I was on the day that this happen. It was a very busy day with traumas. We were understaffed for the volume of patients that we had. You can't watch monitors when you have multiple other responsibilities, or if you are having difficulty with another patient. It is really not safe for us to be responsible for the volume of patients we are taking care of and be responsible for watching the telemetry. We can't have eyes on it all the time. Alarm monitors are set to go off and alarm with certain rhythms. If we are busy, we have to count on our coworkers to respond to them and let us know if there is a problem."

During an interview on 3/2/2022 at 2:33 PM, Staff A, Registered Nurse (RN), stated, "We were very very busy that day. I was assigned to the back hallway where she [Patient #1] was. She was a very confused altered patient, who was very sick. She lost her IV access in CT [Computerized Tomography] scan when it was pulled out by the patient. I knew she needed an IV. She had critical labs and needed potassium, and she had elevated ammonia levels. I did not administer any potassium orally or IV to her. I contacted the ED physician to do a US [Ultrasound Guided] IV, but they were too busy. I tried twice and then another coworker who is an expert with IVs tried, but we couldn't get a line on her. I think she was admitted around 10:30 AM. I had been in there numerous times that morning and other nurses also were in there. She mostly stayed curled up. I did a bladder scan on her and I think that is the last time that I saw her. I was taking care of another patient when the admitting physicians Nurse Practitioner came by and didn't see her in the bed and found her on the floor. I went into the room, and she was on the floor, face down next to the bed and bleeding. She had no pulse. I called for help, got on a C [cervical] collar and backboard and then called a trauma alert/code blue. I don't recall hearing or seeing any alarms when I entered the room. The patient was not on the monitor when I entered the room and when we got her on the monitor. She was in VTach [Ventricular Tachycardia]. I don't know how long she was off the monitor when she fell or when we got to her room. The alarms were not ringing at the monitor at the nurse's station when I was sitting at it. I was speaking with the APRN [Advanced Practice Registered Nurse] and there were no alarms going off at all. It is a struggle to have a critical or sick patient. We cannot always see the monitored patients when we are in another room. There is no good answer to this. We cannot effectively view the monitors when we are caring for other patients that may take up to an hour of our time to get what they need done. We are always short on staff when there are more patients coming into the ED."

During a telephone interview on 3/2/2022 at 4:15 PM, Staff B, RN, stated, "I was the nurse that took over care of [Patient #1 name] after she coded. I was assigned for trauma and stroke alerts that day. I responded to the room and [Patient #1 name] was face down on the floor and bleeding. She was not on telemetry when I entered the room. I do not know if she pulled it off or it became disconnected when she fell. I don't remember hearing any alarms ringing when I entered the room. I don't know how long she had been off the monitor. We stabilized her neck and moved her to her back, and she was not breathing. So, we checked her pulse and started CPR [Cardiopulmonary Resuscitation] and called a code/trauma alert to her room. We placed her on a backboard and moved her to the trauma room. It was very busy that day with multiple patients and trauma alerts. We usually have 4-6 patients when we work. It can be hard to make sure that patients are watched when they are in the ED on the monitor. If you get busy you won't be able to see the telemetry and have to hope that other nurses will follow up on any alarms. We really aren't able to view patients monitors when we are working on others. We can't see what is happening at all times. I would say that we do need additional monitor tech in the ED all the time based on how busy we always are."

Review of Policy #9925285 titled "Telemetry, Care of Patient, Monitoring", approved on 6/16/2021, reads, "Scope: All HCA Health-care staff and providers involved in providing care, treatment or services to patients requiring cardiac telemetry monitoring at Ocala Health. Purpose: I. To provide guidelines for telemetry monitoring of patients. IV. Identify cardiac rhythms changes requiring provider notification. Policy: Patients being monitored on continuous telemetry will be observed by a Telemetry Technician or Nurse who is competent in cardiac rhythm interpretation & arrythmia detection. Rhythm changes, life threatening arrythmias, and/or loss of signal will be responded to in an immediate manner. Loss of signal interrupts monitoring, placing the telemetry patient at risk. I. Is available 24 hours a day, 7 days a week, based on physician order for cardiac telemetry monitoring in accordance with the guidelines described in this policy. II. Patients requiring telemetry will have their cardiac rhythm continuously monitored and documented at predetermined intervals as described below. III. The Registered Nurse (RN) assumes responsibility for the initiation and management of cardiac monitoring to include placement of the leads, assessment of the patient including the validation of capture of cardiac rhythm and rhythm interpretation and patient education related to cardiac monitoring. Telemetry Initiation Guidelines: a. A provider order is required for telemetry monitoring. When ordering telemetry monitoring the documented indication for telemetry monitoring should align with American heart association (AHA) guidelines for cardiac telemetry monitoring. Patient population Indication: Potassium or magnesium imbalances documented as a: Class I (should be performed) until normalization of electrolytes."

An Immediate Jeopardy (IJ) situation was identified during the survey at A263 QAPI. On March 4, 2022, at 1:11 PM, the Chief Executive Officer of HCA Florida West Marion Hospital, an affiliated hospital, was informed of the determination of IJ and given the IJ Template. The immediate jeopardy began on February 2, 2022, with the lack of continuous cardiac telemetry monitoring and unwitnessed fall with injuries. The patient suffered an unwitnessed fall, cardiac arrest, nasal fracture and periorbital hematoma, and died on 02/06/2022. The immediate jeopardy was determined to be ongoing.

The hospital failed to ensure an effective and acceptable plan of correction was developed and fully implemented for a high-risk, high-volume and problem prone area when the facility failed to ensure actions were taken to provide continuous observation of cardiac telemetry monitoring for 1 out of 3 patients reviewed (Patient #1).

HCA Florida Ocala Hospital was not in compliance with the Condition of Participation for 42 CFR 482.21 Quality Assessment and Program Improvement, Requirements for Hospitals and Code of Federal Regulations (CFR) 42, Part 482 Conditions of Participation for Hospitals.

Refer to A283 Quality Improvement Activities.

Based on observation, interview, and serious event analysis review, the facility failed to ensure an effective and acceptable plan of correction was developed and fully implemented for a high-risk, high-volume and problem prone area when the facility failed to ensure actions were taken to provide continuous observation of cardiac telemetry monitoring for 1 out of 3 patients reviewed. (Patient #1).

Findings include:

Review of the medical record revealed Patient #1 presented to the Emergency Department (ED) on 2/2/2022 at 6:30 AM with a past medical history of congestive heart failure (a condition where the heart does not pump blood as well as it should), hypertension (high blood pressure), coronary artery disease (the major blood vessels of the heart are damaged or diseased), coronary artery bypass grafting (open heart surgery), atrial fibrillation (an irregular heartbeat), and chronic obstructive pulmonary disease (a chronic lung disease).

Review of the Emergency Screening note dated 2/2/2022 at 6:39 AM reads, "Per pt [patient] family pt was found wondering the house with acute AMS [altered mental status], pt was sleeping at 0430 [4:30 AM] when family left, and they returned at 0530[5:30AM] the pt was up and walking around confused. Family states this is her usual way of acting when she gets a UTI [Urinary tract infection], which she gets frequently." Focused physical exam under general/const [Constitutional] reads, "Awake, alert. No acute distress. Well appearing. Neurologic: mental status read Confused."

Review of the labs collected dated 2/2/2022 at 6:59 AM reported Potassium 2.9 as a critical low.

Review of Patient #1's records revealed the patient was admitted to the hospital on 2/2/2022 at 10:14 AM and remained in the emergency department awaiting bed placement.

Review of the nursing documentation dated 2/2/2022 at 7:55 AM authored by Staff A, Registered Nurse (RN), reads, "Patient arrived back from CT [CAT Scan]. Tech states the patient was thrashing around while trying to be placed on CT causing a skin tear on right lower forearm and pulled out IV."

Review of the nursing documentation on 2/2/2022 at 8:50 AM authored by Staff A, RN, reads, "Unable to get urine as patient is too confused and not following commands."

Review of the nursing documentation dated 2/22/2022 at 9:35 AM authored by Staff A, RN, reads, "Unsuccessful IV attempts x 2 without assistance and x 1 with assistance. Veins keep blowing. Requested assistance for a line."

Review of the nursing documentation dated 2/22/2022 at 11:30 AM authored by Staff A, RN, reads, "Another nurse attempted IV again to get potassium started. Unsuccessful x 3. Contact provider. Awaiting orders."

Review of the nursing documentation dated 2/2/2022 at 12:15 PM authored by Staff A, RN, reads, "Still not urinating. Bladder scan performed and retaining 526 mls [milliliters]."

Review of the nursing documentation dated 2/2/2022 at 1:10 PM authored by Staff B, RN, reads, "This RN assisted RN [Staff A name] with pt who was noted to be on the ground unresponsive. Pt bleeding from her face. Pt noted to not have a pulse. This RN held C spine while [Staff A' name] RN started CPR [Cardiopulmonary Resuscitation]. Code Blue called immediately."

Review of the physician progress note dated 2/2/2022 authored by APRN (Advanced Practice Registered Nurse) reads, "Event: I found the patient on the floor with blood over her face, called the nurse who checked the patient, no pulse, compression started. Code Blue called and trauma team came on site and took over care."

Review of telemetry strips provided by the facility showed no ECG (Electrocardiogram) strips available within the medical record until 2/2/2022 at 12:55 PM. The next strip provided was on 2/2/2022 at 12:57 when there was no cardiac rhythm and then at 1:06 PM when the telemetry strip showed ventricular tachycardia. No additional telemetry monitoring strips were provided by the facility.

During an observation on 3/2/2022 at 9:50 AM through 10:20 AM, there were four staff members present in the nurse's station, three registered nurses and one unit secretary. The telemetry bank of monitors was present at the nurse's station. There were four patients on telemetry monitoring with one patient's telemetry ringing with an audible alarm. No staff attended to the monitor until 10:16 AM.

Review of an untitled document provided by the facility on 3/2/2022 at 3:10 PM reads, "Dates of review for 88735. Incident fall occurred on 02/02/2022. 1. PSD [Patient Safety Director] met in the ED with the director immediately after the fall to briefly discuss the occurrence of a fall patient in CT scan. Director to collect additional information. 2. 2/8/2022, RCA with team, including RN involved. The event reviewed timeline, nursing documentation, staffing, possible cardiac event/monitoring. Action Plan discussed. 3.Team met again 2/15/2022 to discuss Action Planning for the event. 4.Team met again to discuss options for telemetry monitoring in the ED. Additional members included the Admit Director, Telemetry Director, IT director, and biomed. Performance improvement team formed. Meetings are scheduled biweekly as ongoing tele process improvement."

Review of the Serious Event Analysis (SEA) provided by the facility on 3/3/2022 at 4:30 PM reads, "Identified system or process failure: Staff did not recognize the risk: The staff did not recognize the risk of patient falling, the staff did not complete the fall risk evaluation as per policy, the patient was not attempting to exit the bed before the fall. Implementation date 2/15/2022. Risk Mitigation strategies: Education will be provided to all ED staff members on the expectations of completing a fall assessment for patients and the proper use and location of all equipment. Education will also include the expectation that hourly rounding and inpatient assessment is completed and documented in the medical record within the policy timeframe.
Thirty random chart audits will be conducted on documentation of fall assessment, application of precautions and hourly rounding. The expected compliance is 100%. Implementation date 3/2/2022. Equipment, alarms or safety mechanisms were bypassed: The equipment alarms and safety mechanisms were bypassed by staff. The staff did not assess the patient as a fall risk. Staff did not identify the need for bed alarm. Risk Mitigation Strategies: The appropriate use of bed alarms in the ED will be audited 30 random charts Implementation date 3/2/2022. Telemetry box was unavailable: The telemetry box for central monitor was not available, the telemetry monitor in use was not centrally monitored. The equipment in the ED does not connect with the central monitors. The monitors at the nursing station did not have designated staff observing it. Risk Mitigation Strategies: The monitoring of telemetry patients will be moved to a centralized monitoring system. This project will include the addition of telemonitoring licensing, addition of tele boxes and the addition of FTE [Full Time Equivalent] for monitoring. Implementation date: 2/18/2022. Staffing was not adequate compared to staffing grid/census: Staffing was not adequate compared to staffing grid/census, the hospital was full, and the ED was holding admitted patients, COVID-19 surge led to additional patients in the ED. Established policies and procedures were not followed: Established policies preventing falls was not followed, the staff did not complete the falls risk assessment and place interventions such as bed alarms as indicated. The staff did not consider the patient a fall risk. Risk Mitigation Strategies: Education will be provided to all ED staff members on the expectations of completing a fall assessment for patients and the proper use and location of all equipment utilized for fall prevention. Education will also include the expectation that hourly rounding and inpatient assessment is completed and documented in the medical record within the policy timeframe. Implementation date: 2/15/20223."

During an interview on 3/2/2022 at 9:50 AM, the Patient Safety Director stated, "We have had several meetings related to this event and did an SEA [serious event analysis]. We have not finished our analysis of the event and fully implemented the corrective actions. We are still meeting to complete the process. We are looking into having centralized telemetry monitor for the patients but that will take time. We do not have a dedicated monitor technician in the ED [Emergency Department] as of right now. We did discuss doing this, but neither telemetry nor the ED could provide the resources. There has been no initiation of telemetry boxes in the emergency department. There has been training related to falls and fall precautions, the use of bed alarms and completing assessments and hourly rounding. There has been no additional training related to telemetry monitoring for the ED staff. They are all trained yearly. I see that we may not have removed the potential of this happening again. I can see where you might think that. No, we did not implement any changes immediately to prevent this for happening again."

During an interview on 3/2/2022 at 10:05 AM, the Emergency Department Director stated, "We have been meeting ever since this event occurred to come up with a solution to this. They are working on telemetry, but currently nothing has been put into place. We do not currently have a staff assigned to watch telemetry. The nurses are responsible to make sure that they watch telemetry. The nurses continue to provide telemetry monitoring for any patients that require it. We don't currently have the process in place. I understand that does mean we have not implemented any changes beyond training on fall alarms and checking telemetry. It is possible that this could happen again if the day were busy. I have no good answer in place as to why we have not implemented any changes related to telemetry monitoring. We have not had any major events prior to this related to monitoring patients. On that day, we were over ratios for staffing. I couldn't dedicate a nurse to do the job of a telemetry tech. We simply don't have the resources. We needed a telemetry monitor technician to do the job as we have staffing for patient care to be concerned about. Additional training was provided of a refresher of fall precautions and hourly rounding. A secretary is always at the desk. They are not trained on telemetry monitoring. I was involved in the meeting related to this. It was discussed to have dedicated telemetry monitoring and that the ED is not part of the centralized monitoring for the hospital. We do have a telemetry monitoring policy for the hospital, and it does apply to the ED also. I don't really know how long the patient was off telemetry. We were having trouble printing any data after the event. I did take photographs, but we did not have the company come and retrieve the strips from the monitor. I did not review the chart for any problems."

During an interview on 3/3/2022 at 3:10 PM, The Vice President of Quality stated, "We did not do a thorough SEA to determine what the exact cause of the patients fall was. We were initially told that it was a fall. We were told that no one knew what precipitated the fall or the cardiac arrhythmia. It was after the fact that we found out there was a cardiac event also. We should have obtained the rhythm strips. I did not review the patient's chart for any other concerns. Our initial meetings focused on fall prevention while in the Emergency Department. I know that we discussed the lack of continuous telemetry monitoring as part of the problem. We did discuss additional resources for centralized monitoring but that takes time to develop. We did not place a monitor technician or a nurse to watch monitors in the ED after this event. The investigation into the events was not completed, so we were not completely aware of all of the details involved in the incident with the patient. We should have completed a more thorough investigation. We were meeting weekly or every other week to work through the analysis. I am not sure why or how this happened that we were not completely aware of all the details. We should have thoroughly reviewed the medical record. If we could not get the cardiac telemetry strips, we should have had the companies technical support assist us in getting them."

During an interview on 3/4/2022 at 8:10 AM, the Chief Nursing Officer (CNO) stated, "We did not complete a thorough SEA. We were not aware of some key factors in the patients stay. I was unaware that there was any problem getting the telemetry strips printed out and we did not investigate that aspect fully. We did consider the fact that there was not a dedicated telemetry technician as part of the cause, but failed to follow thorough and place staff in that position until we could get an alternative means to monitor patients while in the ED. We should have implemented these safety measure and we didn't. This is not us as an organization."

During an interview on 3/4/2022 at 8:30 AM, the Chief Medical Officer (CMO) stated, "I was actively involved in the serious event analysis. I fully understand your concern. We did look at and review the event, but we failed to have an immediacy to put a fix in place, so this would not happen again. I looked at the plan and I failed to see where the holes were. I was not aware that we did not have a thorough investigation and that falls on all of us. I am not sure how we missed this. We are patient centered and safety focused. Patient safety is our first priority. Although I am responsible for the Medical Staff, I also partner with [CNO's name] in all aspects of care delivery."

Review of Policy #10186067 titled "Organizational Performance Improvement Plan", approved on 7/29/2021, reads, "Accountability for Performance Improvement and Patient Safety: The governing body and the hospital and medical staff leaders are accountable for the development, implementation, monitoring and evaluation of the performance improvement and patient safety plan and the initiatives that support it. The leaders will: Establish a planned, systematic, organization wide approach to process design redesign, performance measurement, analysis and improvement to affect health outcomes, patient safety and quality of care; Ensure performance improvement activities address priorities for quality and patient safety, and that improvement activities are evaluated; Develop specific, measurable goals, objectives and targets for performance improvement, clinical outcomes and patient safety; Establish process to assure immediate response to medical/healthcare errors, including care of the affected patients, containment of risk, and preservation of factual information for subsequent analysis; Assign high priority for patient safety in the design or redesign of processes, functions or services; Define mechanisms for responding to the various types of occurrences, e.g. serious event analysis, in response to a sentinel event or for conducting proactive risk reduction activities; Use the findings of error analysis to establish and support changes in processes, functions and services in order to prevent or reduce the probability of the reoccurrence of errors; Measure and track subsequent performance to ensure improvements are sustained; Provide care, treatment, services and an environment that pose no risk of an immediate threat to health or safety to our patients."

Based on medical record review, interview, and policy and procedure review, the hospital failed to have adequate numbers of licensed registered nurses and other personnel to provide nursing care in a safe setting for 1 out of 3 patients (Patient #1). The hospital failed to follow current standards of practice when the patient experienced an unwitnessed fall, was found without vital signs and was unresponsive. The failure to implement the hospital's cardiac telemetry monitoring protocol resulted in the patient being left in an unsafe situation while in the hospital setting. The hospital failed to ensure the adequate numbers of licensed registered nurses and other qualified personnel to provide nursing care in a safe setting for 1 out of 3 patients (Patient #1). This systemic failure constitutes an Immediate Jeopardy situation.

Refer to A 0392 Staffing and delivery of care

Based on medical record review, interview, and policy and procedure review, the hospital failed to have adequate numbers of licensed registered nurses and other personnel to provide nursing care in a safe setting for 1 out of 3 patients (Patient #1).

Findings include:

Review of the medical record for Patient #1 revealed the patient presented to the Emergency Department (ED) on 2/2/2022 at 6:30 AM with a past medical history of congestive heart failure (a condition where the heart does not pump blood as well as it should), hypertension (high blood pressure), coronary artery disease (the major blood vessels of the heart are damaged or diseased), coronary artery bypass grafting (open heart surgery), atrial fibrillation (an irregular heartbeat), and chronic obstructive pulmonary disease (a chronic lung disease).

Review of the order record for [Patient #1's name] reads "Procedure - Cardiac Monitor, Order No. 0202-0141, Pri (Priority) Stat (immediately), Date 2/2/2022, Time 0632 (6:32 AM), Signed by [Physician's Name] 2/02/22 0632.

Review of the Emergency Screening note dated 2/2/2022 at 6:39 AM reads, "Per pt [patient] family pt was found wondering the house with acute AMS [altered mental status], pt was sleeping at 0430 [4:30 AM] when family left, and they returned at 0530[5:30AM] the pt was up and walking around confused. Family states this is her usual way of acting when she gets a UTI [Urinary tract infection], which she gets frequently." Focused physical exam under general/const [Constitutional] reads, "Awake, alert. No acute distress. Well appearing. Neurologic: mental status read Confused."

Review of the labs collected dated 2/2/2022 at 6:59 AM reported Potassium 2.9 as a critical low. Normally, your blood potassium level is 3.6 to 5.2 millimoles per liter (mmol/L). A very low potassium level (less than 2.5 mmol/L) can be life-threatening and requires urgent medical attention. (https://www.mayoclinic.org/symptoms/low-potassium/basics/definition/sym-20050632#:~:text=Normally%2C%20your%20blood%20potassium%20level,and%20requires%20urgent%20medical%20attention.)

Review of Patient #1's records revealed the patient was admitted to the hospital on 2/2/2022 at 10:14 AM and remained in the emergency department awaiting bed placement.

Review of the nursing documentation dated 2/2/2022 at 7:55 AM authored by Staff A, Registered Nurse (RN), reads, "Patient arrived back from CT [CAT Scan]. Tech states the patient was thrashing around while trying to be placed on CT causing a skin tear on right lower forearm and pulled out IV."

Review of the nursing documentation on 2/2/2022 at 8:50 AM authored by Staff A, RN, reads, "Unable to get urine as patient is too confused and not following commands."

Review of the nursing documentation dated 2/22/2022 at 9:35 AM authored by Staff A, RN, reads, "Unsuccessful IV attempts x 2 without assistance and x 1 with assistance. Veins keep blowing. Requested assistance for a line."

Review of the nursing documentation dated 2/22/2022 at 11:30 AM authored by Staff A, RN, reads, "Another nurse attempted IV again to get potassium started. Unsuccessful x 3. Contact provider. Awaiting orders."

Review of the nursing documentation dated 2/2/2022 at 12:15 PM authored by Staff A, RN, reads, "Still not urinating. Bladder scan performed and retaining 526 mls [milliliters]."

Review of the nursing documentation dated 2/2/2022 at 1:10 PM authored by Staff B, RN, reads, "This RN assisted RN [Staff A name] with pt who was noted to be on the ground unresponsive. Pt bleeding from her face. Pt noted to not have a pulse. This RN held C spine while [Staff A' name] RN started CPR [Cardiopulmonary Resuscitation]. Code Blue called immediately."

Review of the physician progress note dated 2/2/2022 authored by APRN (Advanced Practice Registered Nurse) reads, "Event: I found the patient on the floor with blood over her face, called the nurse who checked the patient, no pulse, compression started. Code Blue called and trauma team came on site and took over care."

Review of telemetry strips provided by the facility showed no ECG (Electrocardiogram) strips available within the medical record until 2/2/2022 at 12:55 PM. The next strip provided was on 2/2/2022 at 12:57 when there was no cardiac rhythm and then at 1:06 PM when the telemetry strip showed ventricular tachycardia. No additional telemetry monitoring strips were provided by the facility.

During an observation on 3/2/2022 at 9:50 AM through 10:20 AM, there were four staff members present in the nurse's station, three registered nurses and one unit secretary. The telemetry bank of monitors was present at the nurse's station. There were four patients on telemetry monitoring with one patient's telemetry ringing with an audible alarm. No staff attended to the monitor until 10:16 AM.

During an interview on 3/2/2022 at 9:50 AM, the Patient Safety Director stated, "We have had several meetings related to this event and did an SEA [serious event analysis]. We have not finished our analysis of the event and fully implemented the corrective actions. We are still meeting to complete the process. We are looking into having centralized telemetry monitor for the patients but that will take time. We do not have a dedicated monitor technician in the ED [Emergency Department] as of right now. We did discuss doing this, but neither telemetry nor the ED could provide the resources. There has been no initiation of telemetry boxes in the emergency department. There has been training related to falls and fall precautions, the use of bed alarms and completing assessments and hourly rounding. There has been no additional training related to telemetry monitoring for the ED staff. They are all trained yearly. I see that we may not have removed the potential of this happening again. I can see where you might think that. No, we did not implement any changes immediately to prevent this for happening again."

During an interview on 3/2/2022 at 10:05 AM, the Emergency Department Director stated, "We have been meeting ever since this event occurred to come up with a solution to this. They are working on telemetry, but currently nothing has been put into place. We do not currently have a staff assigned to watch telemetry. The nurses are responsible to make sure that they watch telemetry. The nurses continue to provide telemetry monitoring for any patients that require it. We don't currently have the process in place. I understand that does mean we have not implemented any changes beyond training on fall alarms and checking telemetry. It is possible that this could happen again if the day were busy. I have no good answer in place as to why we have not implemented any changes related to telemetry monitoring. We have not had any major events prior to this related to monitoring patients. On that day, we were over ratios for staffing. I couldn't dedicate a nurse to do the job of a telemetry tech. We simply don't have the resources. We needed a telemetry monitor technician to do the job as we have staffing for patient care to be concerned about. Additional training was provided of a refresher of fall precautions and hourly rounding. A secretary is always at the desk. They are not trained on telemetry monitoring. I was involved in the meeting related to this. It was discussed to have dedicated telemetry monitoring and that the ED is not part of the centralized monitoring for the hospital. We do have a telemetry monitoring policy for the hospital, and it does apply to the ED also. I don't really know how long the patient was off telemetry. We were having trouble printing any data after the event. I did take photographs, but we did not have the company come and retrieve the strips from the monitor. I did not review the chart for any problems."

During an interview on 3/2/2022 at 11:10 AM, The Chief Nursing Officer (CNO) stated, "We have had several meetings to discuss the event and come up with solutions to the problem. Additional telemetry is not an option at this time. We did not implement any new process in the ED to prevent this from occurring again. The nurses continue to watch the monitors in the ED. We have not fully conducted our root cause analysis to determine what needs to be implemented to make sure this does not occur in the future."

During an interview on 3/2/2022 at 12:12 PM, Staff C, RN, stated, "The patient ratios are higher than normal and that really does impact our staffing and what we can do as ED nurses. We are all competent to read telemetry. We're all ACLS [Advanced Cardiac Life Support] certified, but with ratios above average, it can be impossible to watch a monitor and care for the patients if we are in other rooms doing other things. We never are assigned a monitor tech to watch the monitors and there is not a nurse sitting at the desk all the time. It is a group effort to review the monitor alarms. You hope someone else can respond to the alarms. It is impossible to watch the monitor at all times. I was on that day that [Patient #1's name] fell and coded. All the halls were full that day. We had multiple trauma and stroke alerts and ED hold patients that day. I was in her room several times that day. The patient was very restless, but not trying to get out of bed. We were having a hard time getting a line in her and I attempted to get an IV [Intravenous]. While I was in there, she never gave me concerns that she would fall. She was very weak and was on the monitor when I saw her. This is a problem. We need to be able to give care and we need a monitor tech all the time. I cannot say that we are able to safely monitor telemetry patients every day when we are overcapacity. They did tell us that we would be getting a monitor tech but that did not happen yet."

During an interview on 3/2/2022 at 2:16 PM, Staff E, RN, stated, "I was on the day that this happen. It was a very busy day with traumas. We were understaffed for the volume of patients that we had. You can't watch monitors when you have multiple other responsibilities, or if you are having difficulty with another patient. It is really not safe for us to be responsible for the volume of patients we are taking care of and be responsible for watching the telemetry. We can't have eyes on it all the time. Alarm monitors are set to go off and alarm with certain rhythms. If we are busy, we have to count on our coworkers to respond to them and let us know if there is a problem."

During an interview on 3/2/2022 at 2:33 PM, Staff A, Registered Nurse (RN), stated, "We were very very busy that day. I was assigned to the back hallway where she [Patient #1] was. She was a very confused altered patient, who was very sick. She lost her IV access in CT [Computerized Tomography] scan when it was pulled out by the patient. I knew she needed an IV. She had critical labs and needed potassium, and she had elevated ammonia levels. I did not administer any potassium orally or IV to her. I contacted the ED physician to do a US [Ultrasound Guided] IV, but they were too busy. I tried twice and then another coworker who is an expert with IVs tried, but we couldn't get a line on her. I think she was admitted around 10:30 AM. I had been in there numerous times that morning and other nurses also were in there. She mostly stayed curled up. I did a bladder scan on her and I think that is the last time that I saw her. I was taking care of another patient when the admitting physicians Nurse Practitioner came by and didn't see her in the bed and found her on the floor. I went into the room, and she was on the floor, face down next to the bed and bleeding. She had no pulse. I called for help, got on a C [cervical] collar and backboard and then called a trauma alert/code blue. I don't recall hearing or seeing any alarms when I entered the room. The patient was not on the monitor when I entered the room and when we got her on the monitor. She was in VTach [Ventricular Tachycardia]. I don't know how long she was off the monitor when she fell or when we got to her room. The alarms were not ringing at the monitor at the nurse's station when I was sitting at it. I was speaking with the APRN [Advanced Practice Registered Nurse] and there were no alarms going off at all. It is a struggle to have a critical or sick patient. We cannot always see the monitored patients when we are in another room. There is no good answer to this. We cannot effectively view the monitors when we are caring for other patients that may take up to an hour of our time to get what they need done. We are always short on staff when there are more patients coming into the ED."

During a telephone interview on 3/2/2022 at 4:15 PM, Staff B, RN, stated, "I was the nurse that took over care of [Patient #1 name] after she coded. I was assigned for trauma and stroke alerts that day. I responded to the room and [Patient #1 name] was face down on the floor and bleeding. She was not on telemetry when I entered the room. I do not know if she pulled it off or it became disconnected when she fell. I don't remember hearing any alarms ringing when I entered the room. I don't know how long she had been off the monitor. We stabilized her neck and moved her to her back, and she was not breathing. So, we checked her pulse and started CPR [Cardiopulmonary Resuscitation] and called a code/trauma alert to her room. We placed her on a backboard and moved her to the trauma room. It was very busy that day with multiple patients and trauma alerts. We usually have 4-6 patients when we work. It can be hard to make sure that patients are watched when they are in the ED on the monitor. If you get busy you won't be able to see the telemetry and have to hope that other nurses will follow up on any alarms. We really aren't able to view patients monitors when we are working on others. We can't see what is happening at all times. I would say that we do need additional monitor tech in the ED all the time based on how busy we always are."

During an interview on 3/3/2022 at 3:10 PM, The Vice President of Quality stated, "We did not do a thorough SEA to determine what the exact cause of the patients fall was. We were initially told that it was a fall. We were told that no one knew what precipitated the fall or the cardiac arrhythmia. It was after the fact that we found out there was a cardiac event also. We should have obtained the rhythm strips. I did not review the patient's chart for any other concerns. Our initial meetings focused on fall prevention while in the Emergency Department. I know that we discussed the lack of continuous telemetry monitoring as part of the problem. We did discuss additional resources for centralized monitoring but that takes time to develop. We did not place a monitor technician or a nurse to watch monitors in the ED after this event. The investigation into the events was not completed, so we were not completely aware of all of the details involved in the incident with the patient. We should have completed a more thorough investigation."

During an interview on 3/4/2022 at 8:10 AM, the Chief Nursing Officer (CNO) stated, "We did not complete a thorough SEA. We were not aware of some key factors in the patients stay. I was unaware that there was any problem getting the telemetry strips printed out and we did not investigate that aspect fully. We did consider the fact that there was not a dedicated telemetry technician as part of the cause, but failed to follow thorough and place staff in that position until we could get an alternative means to monitor patients while in the ED. We should have implemented these safety measure and we didn't. This is not us as an organization."

During an interview on 3/3/2022 at 3:25 PM, the Vice-President of Emergency Services stated, "On the day this happened on 2/2/2022, we were at 109% capacity with 314 in patients and had 60 patients in the emergency department. By the next day, we were at 118% capacity. We were down 5 nurses and 1 medic on that day of the event. Staffing did play a role in this as well as the staff not completing expected documentation for fall risk assessments and for placing a bed alarm on the patient's stretcher while in the ED."

Review of Policy #9925285 titled "Telemetry, Care of Patient, Monitoring", approved on 6/16/2021, reads, "Scope: All HCA Health-care staff and providers involved in providing care, treatment or services to patients requiring cardiac telemetry monitoring at Ocala Health. Purpose: I. To provide guidelines for telemetry monitoring of patients. IV. Identify cardiac rhythms changes requiring provider notification. Policy: Patients being monitored on continuous telemetry will be observed by a Telemetry Technician or Nurse who is competent in cardiac rhythm interpretation & arrythmia detection. Rhythm changes, life threatening arrythmias, and/or loss of signal will be responded to in an immediate manner. Loss of signal interrupts monitoring, placing the telemetry patient at risk. I. Is available 24 hours a day, 7 days a week, based on physician order for cardiac telemetry monitoring in accordance with the guidelines described in this policy. II. Patients requiring telemetry will have their cardiac rhythm continuously monitored and documented at predetermined intervals as described below. III. The Registered Nurse (RN) assumes responsibility for the initiation and management of cardiac monitoring to include placement of the leads, assessment of the patient including the validation of capture of cardiac rhythm and rhythm interpretation and patient education related to cardiac monitoring. Telemetry Initiation Guidelines: a. A provider order is required for telemetry monitoring. When ordering telemetry monitoring the documented indication for telemetry monitoring should align with American heart association (AHA) guidelines for cardiac telemetry monitoring. Patient population Indication: Potassium or magnesium imbalances documented as a: Class I (should be performed) until normalization of electrolytes."