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Tag No.: A0115
A hospital must protect and promote each patient's rights.
This CONDITION is not met as evidenced by: An Immediate Jeopardy (IJ) was identified beginning on 07/31/2022.
Based on review of medical records, review of hospital policy and procedures, and staff interviews, it was determined the facility failed to provide patient care in a safe setting for two (P#1 and #4) of six patients reviewed for incidents of serious life-threatening events. Two patients with physician ordered continuous telemetry cardiac monitoring/oxygen saturation monitoring, experienced cardiac arrest when they were not being monitored by hospital staff as required. Both patients died. (see A0144)
The cumulative effect of these systemic problems resulted in the facility's inability to protect and promote each patient's rights as required by the CFR 482.13, Patient Rights.
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Tag No.: A0144
Based on review of medical records, review of hospital policy and procedures, and staff interviews, it was determined the facility failed to provide patient care in a safe setting for two (P#1 and #4) of six patients reviewed for incidents of serious life-threatening events. Two patients with physician ordered continuous telemetry cardiac monitoring/oxygen saturation monitoring, experienced cardiac arrest when they were not being monitored by hospital staff as required. Both patients died.
The findings include:
1) A Record Review (RR) of the medical record for Patient #1 revealed the patient presented to the Emergency Department (ED) via ambulance on 01/30/23 at 1:02 AM for a stroke alert. On 01/30/23 at 1:33 AM a Computerized Tomography (CT) of the head without contrast revealed no evidence of a Cerebrovascular Accident (CVA). She was admitted to the Clinical Decision Unit with continuous telemetry/oxygen saturation monitoring orders on 01/30/23 at 4:20 PM. She required a higher level of care and was transferred to the Progressive Care Unit (PCU) on 01/30/23 at 6:45 PM. On 02/04/23 P#1 was diagnosed as COVID-19 positive. Facility protocol was to keep the patient door closed for all COVID-19 positive patients. On 02/04/23 at 4:46 PM, P#4 had an oxygen saturation of 100%. On 02/04/23 at 7:16 PM, P#4 oxygen saturation dropped to 79%. Review of documentation revealed the low oxygenation was not addressed with a medical provider. Additional review of P#1's Vital Signs (VS) revealed 72 critical vital signs (one heart rate, four respiratory rates, seven oxygen saturations, and 53 blood pressures) between 02/03/23 at 7:00 AM and 02/04/23 at 8:16 PM, when the patient coded. Review of documentation revealed the critical VS were not address with a medical provider and the critical vital signs were not reassessed. On 02/04/23 at 8:16 PM, Employee A, Registered Nurse, went into P#1's room to conduct an initial assessment. She discovered respiratory therapy in the room and the patient was unresponsive. Employee A, Registered Nurse, checked for a pulse, called a code blue, and initiated Cardiopulmonary Resuscitation (CPR). Efforts to resuscitate Patient #1 were unsuccessful. Patient #1 expired on 02/04/23 at 10:02 PM. An adverse event was submitted to the Agency for Health Care Administration on 02/17/23. The facility developed an initial plan of correction related to incident. The facility discovered that the monitor technician silenced the oxygen saturation alarm, 13 times, prior to P#1 coding. Patient #1's room door was closed and prevented staff from visually observing P#1, while she was in respiratory distress, prior to the code blue. Employee A, Registered Nurse, stated and staff were unable to hear the alarm and unable to observe P#1 behind the closed door. The Plan of Correction (PoC) was to contact the monitor manufacturer regarding software upgrade and configuration, Individual monitor technician was suspended pending further investigation. Education to telemetry monitor technicians related to telemetry alarms and escalation. The facility had a similar event (P#4) involving telemetry/oxygen saturation monitors approximately six months prior to P#1's event. The facility Plan of Correction was in process during the survey.
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2) A record review of Patient #4's medical record revealed the patient presented to the Emergency Department on 7/18/22 with chest pain, nausea, emesis, and fatigue. A Computed Tomography scan (CT) indicated small bowel obstruction which was discussed with the surgeon. Patient #4 was admitted on 7/18/22 at 8:31 PM and moved to the Medical Surgical (M/S) unit after midnight. Continuous Pulse Oximetry and telemetry monitoring was ordered on 7/18/22. On 7/25/22 at 12:24 AM, Patient #4 was moved to the Progressive Care Unit for a higher level of care. A nurse's note was reviewed and dated 7/31/22 at 9:21 AM. The nurse noted a call was received from telemetry technician due to patient heart rate had decreased into the 20's, and he responded to the room which revealed patient presented apneic with no pulse detected. A Code Blue was called, and CPR was initiated at 9:21 AM. Patient was found with abdominal distention, drooling brown emesis and suction was started. After patient was revived, he was transferred to the Intensive Care Unit (ICU). The telemetry log dated 7/31/22 was reviewed which noted Patient #4 had a heart rate change to 31, oxygen saturation of 70% and pulse oximetry was turned off. The monitor tech turned the pulse oximetry back on at 9:21 AM per the log. A code blue was called at 9:22 AM. A review of the cardiac monitoring strips noted on 7/31/22 the 8:00 AM strip was attached at 9:55 AM (after a code). The last cardiac monitoring strip was at 4:00 AM on 7/31/22 with a pulse oximetry of 86. Pulse oximetry flow sheets were reviewed from 7/29/22-8/1/22 with multiple blanks and low pulse oximetry readings On 7/31/22 at 9:17 AM is blank with other times also blank. Patient expired on 8/1/22 at 3:05 AM. The facility developed a plan of correction related to the incident on 8/4/22. Staff were educated regarding bedside monitor alarms not being turned off and recognizing alarm off icons. Staff were to submit event reports for any alarms turned off, monitor manufacturer technicians were called to assess equipment, run reports, and verify no malfunction, monitor manufacturer representative to educate Progressive Care Unit (PCU) staff on bedside monitors and train superusers. Competencies and training provided by superusers were initiated for new staff, monitor manufacturer was contacted to upgrade monitor software to not allow pulse oximetry to be turned off. The software is projected to be available in 6 months to one year. Seven months after the event occurred, the facility failed to complete their action plan which included having a report from the monitor manufacturer on the equipment assessment, and any auditing or data collection of monitoring telemetry alarms.
On 2/23/23 at 12:00 p.m. an interview was conducted with the Risk Manager (RM) RN. Audits from the Plan of Correction (POC) were requested for the event for Patient #4. The RM asked what exactly we needed, and it was explained about the data collection with audits, and if the audits revealed improvement or not after items implemented in POC. The RM was unable to produce any audit or data collection conducted related to Patient #4's event.
An interview was conducted with the Regional Executive Director of Clinical Operations, RN on 2/23/23 at 1:00 p.m. via Zoom. The Executive Director reported the alarms for cardiac monitoring for Patient #4 was never turned on when he arrived and was never turned on during his stay. The pulse oximetry was turned off. The Executive Director reported and confirmed the alarm for oxygen saturation for Patient #1 was silenced 13 times prior to his coding and expiring.
A review of the facility policy titled "Telemetry Cardiac and Continuous Pulse Oximetry Monitoring" with a last reviewed date of 10/2022 was conducted. Page 1 stated the purpose as "to delineate requirements in monitoring patients for cardiac arrhythmia, continuous pulse oximetry monitoring and to initiate proper treatment of life threatening dysrhythmias of patients." Also on page 1, V1, A2 the policy stated, "Telemetry ECG tracings and continuous pulse oximetry shall be monitored continuously by qualified staff." Alarms are not to be turned off or silenced.
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Tag No.: A0263
The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program.
This CONDITION is not met as evidenced by: An Immediate Jeopardy (IJ) was identified beginning on 07/31/2022.
Based on review of medical records, review of hospital policy and procedures, and staff interviews, it was determined the facility failed to ensure the established facility committee analyzed patient mortality, identified a potential cause or delay in care (P#1, P#4) and failed to implement two of six corrective actions as a result of Patient #4's death. (See A0286)
The cumulative effect of these systemic problems resulted in the facility's inability to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program as required by the CFR 482.21, QAPI.
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Tag No.: A0286
Based on review of medical records, review of hospital policy and procedures, and staff interviews, it was determined the facility failed to ensure an established facility committee that analyzed patient mortality, identified a potential cause or delay in care (P#1, P#4) and failed to implement two of six corrective actions as a result of Patient #4's death.
The findings include:
1) Record review of the medical record for Patient #1 revealed the patient presented to the Emergency Department (ED) via ambulance on 01/30/23 at 1:02 AM for a stroke alert. On 01/30/23 at 1:33 AM a Computerized Tomography (CT) of the head without contrast revealed no evidence of a Cerebrovascular Accident (CVA). She was admitted to the Clinical Decision Unit with continuous telemetry/oxygen saturation monitoring orders on 01/30/23 at 4:20 PM. She required a higher level of care and was transferred to the Progressive Care Unit (PCU) on 01/30/23 at 6:45 PM. On 02/04/23 P#1 was diagnosed as COVID-19 positive. Facility protocol was to keep the patient door closed for all COVID-19 positive patients. On 02/04/23 at 4:46 PM, P#4 had an oxygen saturation of 100%. On 02/04/23 at 7:16 PM, P#4 oxygen saturation dropped to 79%. Review of documentation revealed the low oxygenation was not addressed with a medical provider. Additional review of P#1's Vital Signs (VS) revealed 72 critical vital signs (one heart rate, four respiratory rates, seven oxygen saturations, and 53 blood pressures) between 02/03/23 at 7:00 AM and 02/04/23 at 8:16 PM, when the patient coded. Review of documentation revealed the critical VS were not address with a medical provider and the critical vital signs were not reassessed. On 02/04/23 at 8:16 PM, Employee A, Registered Nurse, went into P#1's room to conduct an initial assessment. She discovered respiratory therapy in the room and the patient was unresponsive. Employee A, Registered Nurse, checked for a pulse, called a code blue, and initiated Cardiopulmonary Resuscitation (CPR). Efforts to resuscitate Patient #1 were unsuccessful. Patient #1 expired on 02/04/23 at 10:02 PM. An adverse event was submitted to the Agency for Health Care Administration on 02/17/23. The facility developed an initial plan of correction related to incident. The facility discovered that the monitor technician silenced the oxygen saturation alarm, 13 times, prior to P#1 coding. Patient #1's room door was closed and prevented staff from visually observing P#1, while she was in respiratory distress, prior to the code blue. Employee A, Registered Nurse, stated staff were unable to hear the alarm and unable to observe P#1 behind the closed door. The Plan of Correction (PoC) was to contact the monitor manufacturer regarding software upgrade and configuration, Individual monitor technician was suspended pending further investigation. Education to telemetry monitor technicians related to telemetry alarms and escalation. The facility had a similar event (P#4) involving telemetry/oxygen saturation monitors approximately six months prior to P#1's event. The facility Plan of Correction for P#1 was in process during the survey.
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2) A record review of Patient #4's medical record revealed the patient presented to the Emergency Department on 7/18/22 with chest pain, nausea, emesis, and fatigue. A Computed Tomography scan (CT) indicated small bowel obstruction which was discussed with the surgeon. Patient #4 was admitted on 7/18/22 at 8:31 PM and moved to the Medical Surgical (M/S) unit after midnight. Continuous Pulse Oximetry and telemetry monitoring was ordered on 7/18/22. On 7/25/22 at 12:24 AM, patient #4 was moved to the Progressive Care Unit for a higher level of care. A nurse's note was reviewed and dated 7/31/22 at 9:21 AM. The nurse noted a call was received from telemetry technician due to patient heart rate had decreased into the 20's, and he responded to the room which revealed patient presented apneic with no pulse detected. A Code Blue was called, and CPR was initiated at 9:21 AM. Patient was found with abdominal distention, drooling brown emesis and suction was started. After patient was revived, he was transferred to the Intensive Care Unit (ICU). The telemetry log dated 7/31/22 was reviewed which noted Patient #4 had a heart rate change to 31, oxygen saturation of 70% and pulse oximetry was turned off. The monitor tech turned the pulse oximetry back on at 9:21 AM per the log. A code blue was called at 9:22 AM. A review of the cardiac monitoring strips noted on 7/31/22 the 8:00 AM strip was attached at 9:55 AM (after a code). The last cardiac monitoring strip was at 4:00 AM on 7/31/22 with a pulse oximetry of 86. Pulse oximetry flow sheets were reviewed from 7/29/22-8/1/22 with multiple blanks and low pulse oximetry readings On 7/31/22 at 9:17 AM is blank with other times also blank. Patient expired on 8/1/22 at 3:05 AM. The facility developed a plan of correction related to the incident on 8/4/22. Staff were educated regarding bedside monitor alarms not being turned off and recognizing alarm off icons. Staff were to submit event reports for any alarms turned off, monitor manufacturer technicians were called to assess equipment, run reports, and verify no malfunction, monitor manufacturer representative to educate Progressive Care Unit (PCU) staff on bedside monitors and train superusers. Competencies and training provided by superusers were initiated for new staff. monitor manufacturer was contacted to upgrade monitor software to not allow pulse oximetry to be turned off. The software is projected to be available in 6 months to one year. Seven months after the event occurred, the facility failed to complete their action plan which included having a report from the monitor manufacturer on the equipment assessment, and any auditing or data collection of monitoring telemetry alarms.
On 02/23/23 at 12:00 PM an interview was conducted with the the Risk Manager, RN. Audits were requested for the July event for Patient #4. The RM asked what exactly we needed, and it was explained about the data collection with audits, and if the audits revealed improvement or not after items were implemented in the plan of correction. Event reporting documentation was also requested. The Risk Manager was unable to produce any audit or data collection conducted related to Patient #4's event showing improvement or decline.
On 02/23/23 at 1:00 PM an interview was conducted with the Regional Executive Director of Clinical Operations, RN, via Zoom. She reported reaching out to the monitor manufacturer for a report generated for August and February after the two events occurred. The facility was unable to produce an official monitor manufacturer's report.
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Tag No.: A0385
The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse.
This CONDITION is not met as evidenced by: An Immediate Jeopardy (IJ) was identified beginning on 07/31/2022.
Based on review of medical records, review of hospital policy and procedures, and staff interviews, it was determined the facility failed to evaluate patients on an ongoing basis in accordance with accepted standards of nursing practice and failed to ensure the Monitor Technicians (MT) responsible for monitoring patients on continuous cardiac telemetry/Pulse oximetry monitoring were supervised appropriately for 2 (P#1, P#4) out of 6 sampled patients. (see A0395)
The cumulative effect of these systemic problems resulted in the facility's inability to provide care in accordance with accepted standards of nursing practice as required by the CFR 482.23, Nursing Services.
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Tag No.: A0395
Based on review of medical records, review of hospital policy and procedures, and staff interviews, it was determined the facility failed to evaluate patients on an ongoing basis in accordance with accepted standards of nursing practice and failed to ensure the Monitor Technicians (MT) responsible for monitoring patients on continuous cardiac telemetry/Pulse oximetry monitoring were supervised appropriately for 2 (P#1, P#4) out of 6 sampled patients.
The findings include:
1) Record review of the medical record for Patient #1 revealed the patient presented to the Emergency Department (ED) via ambulance on 01/30/23 at 1:02 AM for a stroke alert. On 01/30/23 at 1:33 AM a Computerized Tomography (CT) of the head without contrast revealed no evidence of a Cerebrovascular Accident (CVA). She was admitted to the Clinical Decision Unit with continuous telemetry/oxygen saturation monitoring orders on 01/30/23 at 4:20 PM. She required a higher level of care and was transferred to the Progressive Care Unit (PCU) on 01/30/23 at 6:45 PM. On 02/04/23 P#1 was diagnosed as COVID-19 positive. Facility protocol was to keep the patient door closed for all COVID-19 positive patients. On 02/04/23 at 4:46 PM, P#4 had an oxygen saturation of 100%. On 02/04/23 at 7:16 PM, P#4 oxygen saturation dropped to 79%. Review of documentation revealed the low oxygenation was not addressed with a medical provider. Additional review of P#1's Vital Signs (VS) revealed 72 critical vital signs (one heart rate, four respiratory rates, seven oxygen saturations, and 53 blood pressures) between 02/03/23 at 7:00 AM and 02/04/23 at 8:16 PM, when the patient coded. Review of documentation revealed the critical VS were not address with a medical provider and the critical vital signs were not reassessed. On 02/04/23 at 8:16 PM, Employee A, Registered Nurse, went into P#1's room to conduct an initial assessment. She and the respiratory therapist entered the room and discovered the patient was unresponsive. Employee A, Registered Nurse, checked for a pulse, called a code blue, and initiated Cardiopulmonary Resuscitation (CPR). Efforts to resuscitate Patient #1 were unsuccessful. Patient #1 expired on 02/04/23 at 10:02 PM. An adverse event was submitted to the Agency for Health Care Administration on 02/17/23. The facility developed an initial plan of correction related to incident. The facility discovered that the monitor technician silenced the oxygen saturation alarm, 13 times, prior to P#1 coding. Patient #1's room door was closed and prevented staff from visually observing P#1, while she was in respiratory distress, prior to the code blue. Employee A, Registered Nurse, stated staff were unable to hear the alarm and unable to observe P#1 behind the closed door. She stated the closed door was per protocol for COVID positive patients. The Plan of Correction (POC) was to contact the monitor manufacturer regarding software upgrade and configuration. The individual monitor technician was suspended pending further investigation. Education to telemetry monitor technicians related to telemetry alarms and escalation. The facility had a similar event (P#4) involving telemetry/oxygen saturation monitors approximately six months prior to P#1's event. The facility Plan of Correction was in process during the survey.
On 02/23/23 at 3:00 PM an interview was conducted with Employee A, Registered Nurse, Progressive Care Unit. She confirmed that the critical vital signs are to be reported to the ordering medical provider and reassessments are to be competed. She confirmed the telemetry alarm/oxygen saturation alarm was not audible at the time of P#1 coding. She also confirmed P#1's room door was closed at the time P#1 was discovered unresponsive.
On 02/22/23 at 3:00 PM an interview with the Risk Manager confirmed that there were abnormal vital signs without provider notification and without reassessments. She confirmed the telemetry/oxygen saturation monitor alarm was silenced 13 times prior to the patient being found unresponsive on 02/04/23. The Risk Manager was not aware of any audits for monitoring staff compliance with the prior POC.
On 2/23/23 at 2:30 PM an interview was conducted with the Medical Director. He was familiar with Patient #1 and Patient #4. He confired his expectations were to follow physician's orders as directed. He expected any variences to be discussed with the ordering physician.
A review of the facility's Policy and Procedure titled "Telemetry Cardiac and Continuous Pulse Oximetry Monitoring" with a last review date of 10/2022 stated on page 1, VI, A-2, stated "Telemetry Electrocardiogram (ECG) tracings and continuous pulse oximetry shall be monitored continuously by qualified staff.
A review of the facility's Policy and Procedure titled "Nursing Documentation" with a last revised date of 09/2022, page 7, 13-a-i, stated physician notification required for changes in patient condition or clinical findings.
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2) A record review of Patient #4's medical record revealed the patient presented to the Emergency Department on 7/18/22 with chest pain, nausea, emesis, and fatigue. A Computed Tomography scan (CT) indicated small bowel obstruction which was discussed with the surgeon. Patient #4 was admitted on 7/18/22 at 8:31 PM and moved to the Medical Surgical (M/S) unit after midnight. Continuous Pulse Oximetry and telemetry monitoring was ordered on 7/18/22. On 7/25/22 at 12:24 AM, patient #4 was moved to the Progressive Care Unit for a higher level of care. A nurse's note was reviewed and dated 7/31/22 at 9:21 AM. The nurse noted a call was received from telemetry technician due to patient heart rate had decreased into the 20's, and he responded to the room which revealed patient presented apneic with no pulse detected. A Code Blue was called, and CPR was initiated at 9:21 AM. Patient was found with abdominal distention, drooling brown emesis and suction was started. After patient was revived, he was transferred to the Intensive Care Unit (ICU). The telemetry log dated 7/31/22 was reviewed which noted Patient #4 had a heart rate change to 31, oxygen saturation of 70% and pulse oximetry was turned off. The monitor tech turned the pulse oximetry back on at 9:21 AM per the log. A code blue was called at 9:22 AM. A review of the cardiac monitoring strips noted on 7/31/22 the 8:00 AM strip was attached at 9:55 AM (after a code). The last cardiac monitoring strip was at 4:00 AM on 7/31/22 with a pulse oximetry of 86. Pulse oximetry flow sheets were reviewed from 7/29/22-8/1/22 with multiple blanks and low pulse oximetry readings On 7/31/22 at 9:17 AM is blank with other times also blank. Patient expired on 8/1/22 at 3:05 AM. The facility developed a plan of correction related to the incident on 8/4/22. Staff were educated regarding bedside monitor alarms not being turned off and recognizing alarm off icons. Staff were to submit event reports for any alarms turned off, monitor manufacturer technicians were called to assess equipment, run reports, and verify no malfunction, monitor manufacturer representative to educate Progressive Care Unit (PCU) staff on bedside monitors and train superusers. Competencies and training provided by superusers were initiated for new staff. monitor manufacturer was contacted to upgrade monitor software to not allow pulse oximetry to be turned off. The software is projected to be available in 6 months to one year. Seven months after the event occurred, the facility failed to complete their action plan which included having a report from the monitor manufacturer on the equipment assessment, and any auditing or data collection of monitoring telemetry alarms.
A review of a physician progress note for Patient #4 dated 07/31/22 at 9:54 PM noted reviewing critical labs, and patient is status post respiratory arrests with severe multisystem organ failure including severe metabolic acidosis and is on maximal ventilator support with oxygen at 100%. The prognosis is noted as very poor at this point and code status is now Do Not Resuscitate.
On 02/21/23 at 2:20 PM an interview was conducted with the Quality Manager, RN. She reported there is a central monitoring room for telemetry where telemetry technicians monitor and watch alarms. The RN reported the Nurse in PCU received a call from the central monitoring that patients heart rate decreased into the 20's and responded to Patient #4's room. There is an alarm at the PCU nurses' station, which can be heard if in nurse's station. No one is dedicated to watch the monitors, alarms are also in the room at bedside. Alarms can be turned off at the nurse's station, in telemetry room or bedside monitors. It was turned off at bedside in patient's room. It had been turned off for days, unable to find out who cut it off. The nurse did not recognize the alarm was cut off. No one was checking to see if the alarms were working.
On 02/23/23 at 1:00 PM an interview was conducted with the Regional Executive Director of Clinical Operations, RN, via Zoom. The Executive Director reported the alarms for cardiac monitoring for Patient #4 was never turned on when he arrived and was never turned on during his stay. The RN reported if the alarm for cardiac monitoring is turned off in one location, it is turned off at all locations. The facility could never find out who turned off the alarm. The pulse oximetry was turned off. The monitor requires a distinct action to turn the alarm back on.
On 02/23/23 at 9:15 AM an interview was conducted with the Quality Manager, RN. She reported the monitor technicians have one hour to print cardiac monitoring strips within required times. Monitoring strips are to be printed for Midnight 12:00 AM, 4:00 AM, 8:00 AM, 12:00 PM, 4:00 PM and 8:00 PM. The RN confirmed one cardiac monitoring strip was two hours late which was printed on 7/31 at 9:55 AM for 8:00 AM, after a code was initiated. She confirmed the last cardiac monitoring strip was printed at 4:00 AM on 7/31/22.
On 02/24/23 at 1:01 PM a review of the pulse oximetry flow sheet with multiple blanks noted was shown to the Quality Manager. She confirmed there were multiple blanks in the flow sheet for pulse oximetry.
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