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Based on policy review, observation, interview, cardiac monitor default settings, closed record review, equipment work order review, manufacturer alarm analysis report, historical cardiac monitor alarm log review and staffing assignment review, the hospital leadership failed to provide oversight and have systems in place to ensure the protection of patients' rights and an organized nursing service to ensure that patients on cardiac monitors were evaluated and assessed when cardiac monitor alarms activate.

The findings include:

1. The hospital's nursing staff failed to protect and promote patients' rights for a safe environment for patients on cardiac monitors as evidence by failing to monitor, evaluate and assess cardiac and respiratory status when cardiac monitor alarms activated signaling changes outside set parameters for the patient's cardiac and respiratory status.

~cross refer to 482.13 Patient Rights' Condition: Tag A0115

2. The hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations by failing to ensure patients on cardiac monitors were monitored, evaluated and assessed for changes in cardiac and respiratory status when cardiac monitor alarms were activated warning of changes in cardiac and respiratory status.

~cross refer to 482.23 Nursing Services Condition: Tag A0385

Based on policy review, observation, interview, cardiac monitor default settings, closed record review, equipment work order review, manufacturer alarm analysis report, historical cardiac monitor alarm log review and staffing assignment review, the hospital's nursing staff failed to protect and promote patients' rights for a safe environment for patients on cardiac monitors as evidence by failing to monitor, evaluate and assess cardiac and respiratory status when cardiac monitor alarms activated signaling changes outside set parameters for the patient's cardiac and respiratory status.

The findings include:

The hospital failed to ensure a safe environment for the delivery of care to patients on cardiac monitors as evidenced by failing to ensure continuous supervision of cardiac monitors, response to cardiac monitor alarms and assessment of a patient when a cardiac alarm warned of a change in the patient's cardiac and respiratory status.

~cross refer to 482.13(c)(2) Patients' Rights Standard: Tag A0144

Based on policy review, observation, interview, cardiac monitor default settings, closed record review, equipment work order review, manufacturer alarm analysis report, historical cardiac monitor alarm log review and staffing assignment review, the hospital failed to ensure a safe environment for the delivery of care to patients on cardiac monitors as evidenced by failing to ensure continuous supervision of cardiac monitors, response to cardiac monitor alarms and assessment of a patient when a cardiac alarm warned of a change in the patient's cardiac and respiratory status for 1 of 6 sampled patients on a cardiac monitor (#3).

The findings include:

Review of the hospital's "Clinical Alarms" policy reviewed/revised February 2010 revealed "A clinical alarm should be audible and staff should respond when it sounds under reasonable predictable extremes of environmental conditions, including normal ambient noise levels....It is the responsibility of the user to ensure that alarm systems are used appropriately and safely, and that sound levels are sufficient to notify staff in the event of an alarm. For alarms that are an integral part of a patient-care device (infusion pump, ventilator, physiological monitor, etc.), the user must ensure that the alarms are set appropriately (alarm turned on, volume set to appropriate level, alarm parameters set appropriately for the patient, etc.) and functioning correctly before each use."

Observation during tour of IMU1 and IMU2 (intermediate care units) on 07/08/2010 at 1330 through 1500 revealed each unit was set up identical and had the same floor plan. Interview with administrative staff during the tour revealed that nursing staff were assigned to both units interchangeably. Interview with administrative staff revealed that IMU1 and IMU2 are staffed with one registered nurse for three patients. Observation revealed each unit had 10 patient rooms with a nursing station located in the middle of the unit. Observation revealed a central cardiac monitor screen located on the desk at the nursing station. Observation revealed cardiac monitors alarming at the central monitoring station and a unit secretary sitting at the desk. Interview with the unit secretary during the tour revealed she did not "do anything" with the cardiac monitor. The staff member stated "Nursing staff take care of that." Interview with administrative staff during the tour revealed unit secretaries are assigned to IMU1 and IMU2 sometimes, not always, but they do not have anything to do with the monitors or alarms because they are not trained or qualified to view and interpret the monitors. Interview revealed nursing staff were responsible for monitoring and responding to alarms. Interview revealed that IMU1 and IMU2 are not set up for centralized monitoring in the hospital's centralized telemetry area. Observation further revealed that each of the 10 patient rooms had bedside cardiac monitors and every two rooms had a cardiac monitor screen located between the two rooms (total of 5 monitors). Interview with staff during tour revealed the monitor screens located outside of the rooms were limited to viewing two patients at a time. Interview further revealed that these monitors did not have audible alarms and only had visual alarms. Observation and interview revealed that audible alarms sounded at the central monitor at the nursing station and inside each patient's room. Observation revealed a red visual alarm message that appeared on the screen of the five monitors outside patient's rooms when patient parameters have exceeded set limits. Interview during the tour with biomedical engineering staff revealed there are three different audible alarms defined as "advisory, warning and crisis." Interview revealed all alarms are set at the factory default of 80% volume and maintain the same volume until silenced. Interview revealed the crisis alarm has to be manually silenced at the bedside (push a button on the monitor) and the advisory and warning alarms will silence automatically upon return to normal parameters (default settings).

Observation at 1410 of a biomedical engineering staff revealed the staff member connected an electronic rhythm simulator to the bedside cardiac monitor of a vacant patient room (#154 - the most distal room from the central monitor at the nursing station on IMU1). Further observation revealed the simulator was used to test the monitoring system's alarms. The electronic simulator was used to simulate a Tachycardia (rapid heart rate) rhythm, a bradycardia (low heart rate) rhythm, and an asystole (absent heart rate) rhythm. Observation revealed when the tachycardia rhythm and bradycardia rhythm were detected by the monitoring system, respectively, a warning alarm (double beep) sounded at the bedside and when the asystole rhythm (life threatening) was detected by the monitoring system a crisis alarm (loud triple+ beep) sounded at the bedside. Observation revealed the monitoring systems alarm volume parameters were set at 80% (default) during each test. Interview with the biomedical engineering staff member present revealed all alarms except for the crisis alarm can be silenced at the bedside or at the central monitoring station. Interview revealed crisis alarms can only be silenced at the bedside. Continued observation revealed when the tachycardia and bradycardia warning alarms sounded at the bed side, respectively, and were silenced no audible warning alarms were heard in the adjacent hallways. Observation revealed the monitors located at the adjacent "pods" did not produce an audible alarm during the tests. Observation revealed when tested, the tachycardia and bradycardia warning alarms remained active while the surveyor, accompanied by administrative nursing staff walked from room 154 to the central monitoring station at the nurses station. Observation confirmed the central monitoring station sounded a warning alarm for the tachycardia and bradycardia rhythm, respectively, when tested. Observation upon return to room 154, revealed the central monitoring station's audible tachycardia and bradycardia warning alarms could not be easily identified from within the room nor outside in the hallway in front of room 154. Observations revealed ambient noise (i.e. television volumes, infusion pump alarms sounding, and ventilator/nebulizer machine noise) in adjacent occupied patient rooms and in the hallway created an inability to distinctly hear and identify the audible warning alarms from the central monitoring station at the nursing station. Observation revealed when the asystole crisis alarm sounded at the bed side and was silenced, the monitors located at the adjacent "pods" did not produce an audible alarms during the tests, however the crisis alarm could be heard (distally) from the central monitoring station. Observation revealed the bedside monitor alarms were able to be heard from the "pod" located in between Room 154 and 155. Observation revealed the alarms became increasingly distant as the surveyor walked down the hall away from room 154. Observation revealed during the unannounced tests, a staff nurse responded to the simulated crisis alarm in room 154, however, no staff nurse responded to the tachycardia or bradycardia warning alarms. Observation of the pulse oximetry monitor (a component of the bedside cardiac monitor) revealed when oxygen saturation levels register outside of the default parameters (89% to 101%), an alarm sounds at the bedside and at the central monitor station. Further observation revealed the saturation level flashes on the bedside monitor and central monitor screen. Observations revealed the visual and auditory pulse oximetry alarms are not visible or audible from all locations of the unit. Interview with administrative nursing staff during tour of the IMU1 confirmed the observations made during the cardiac monitor alarm tests.

Review of a printout of cardiac monitor alarm default settings received from biomedical engineering staff revealed asystole, ventricular fibrillation and ventricular tachycardia would activate a crisis alarm. Heart rate (outside set parameters), no breath and ventricular bradycardia would activate a warning alarm, and SPO2 (oxygen saturation) and respiratory rate (outside set parameters) would activate an advisory alarm. Further review revealed default settings for heart rate were 50 to 140, SPO2 89% to 101% and respiratory rate 5 to 30 per minute with apnea defined as greater than 20 seconds.

Closed record review on 07/08/2010 of Patient #3 revealed a 78 year-old female admitted to the hospital's Intensive Care Unit on 04/20/2010 with respiratory failure and pneumonia. Review revealed the patient was transferred from another hospital where the patient was intubated and placed on a mechanical ventilator on 04/10/2010. Review revealed the patient was weaned from the mechanical ventilator and placed on a trach collar with 30% oxygen on 04/29/2010. Physician's orders dated 04/30/2010 at 1012 revealed an order to transfer the patient to IMU (intermediate care unit) vent bed. Physician's orders on 04/30/2010 at 1015 revealed an order for pulse oximetry and routine vital signs per unit protocol. The orders further stated "Titrate oxygen to keep O2 Sat (oxygen saturation) greater than 90%." Review of nursing notes dated 05/01/2010 at 0010 recorded the patient was received on IMU2, room 160. Notes recorded the patient was following simple commands and mouthing words. Notes revealed the patient was in a sinus tachycardia rhythm, on 30% trach collar and had oxygen saturation of 90 to 100%. Review of respiratory therapy notes recorded suctioning, trach care and nebulizer treatment were provided at 0740 and 1140. Review of nursing flowsheet documentation revealed a nursing assessment was recorded at 0800 and 1200. Review of the flowsheet recorded "EKG alarms audible" with heart rate alarm settings at "50 to 140." Vital signs were recorded at 1200 as blood pressure 126/70, pulse 119, temperature 97.4, respiratory rate 24 and oxygen saturation 100%. Review revealed nursing notes dated 05/01/2010 at 1530 recorded "At 1438 nurse heard monitor beep asystole (no heart rate) and immediately responded to patient's room. Noticed patient was unresponsive without carotid pulse. Code Blue called. Patient status was Intubate Only. Respiratory bagged patient as attending MD was paged. MD gave order for two RNs to pronounce expiration. At 1450 code ended..." Review of a Code Blue record revealed the event was recognized at 1437 when the patient was found asystole. Review revealed the code team arrived at 1438, the patient had no blood pressure or heart rate and the code was ended at 1450 when the patient was pronounced dead. Review revealed a cardiac monitor strip at 1434:36 that recorded "ALARM SAVED *HR LO 48* ICU-16001 (patient name) ALM VOL 80% HR 48 BRADY (bradycardia, low heart rate) SPO2 PULSE SEARCH RR APNEA (unable to measure oxygen saturation, respiratory distress)." Review revealed a cardiac monitor strip at 1440:08 (six minutes after the prior strip recording a low heart rate) that recorded "ALARM *ASYSTOLE* ICU-16001 (patient name) ALM VOL 80% HR 0 ASYSTOLE SPO2 PULSE SEARCH RR APNEA." Review of the record revealed no documentation that a nurse evaluated or assessed the patient at 1434 (six minutes before the asystole alarm) when the cardiac monitor alarmed warning of a low heart rate and inability to measure the patient's respiratory rate and oxygen saturation.

Review of staffing assignments for IMU2 on 05/01/2010 for the 0700 shift revealed that four registered nurses (RNs) were assigned to ten patients with a team leader RN (#2) who was also covering IMU1. Review of the assignments revealed RN #1 was the charge nurse and assigned to Patient #3 in room 160 and another patient in room 169. RN #3 was assigned to 2 patients, RN #4 was assigned to 3 patients and RN #5 was assigned to 3 patients. Review of the staffing sheet revealed no unit secretary or nursing assistants were assigned to IMU2.

Interview with RN #1 (assigned to Patient #3) on 07/09/2010 at 1350 revealed she was the charge nurse that day and was assigned to two patients with rooms located such that the nursing station was between the two rooms. The staff member stated that she was not able to see both patient's simultaneously, but that she placed both patient cardiac monitor readings on the monitor screen outside of one of the rooms. Interview revealed audible alarms sounded in the patients rooms and at the central monitor at the nursing station. The interview revealed that a "red" message alarm appears at the bottom of the monitor screen for all 10 patients whenever an alarm is activated. Interview revealed RN #1 was making rounds for other patients on the unit (performing charge nurse duties) when she heard a critical heart rate alarm sound at the nursing station. The nurse stated "(RN #2) was yelling my name, come in here. I assessed her (Patient #3) pulse. Someone else called the code....when I heard the alarm, I went to her room. I didn't check the monitor." The nurse stated that after the code ended, she and RN #2 were trying to figure out what happened and were reviewing the strips. The nurse stated that she had not torn off a strip from the monitor from earlier in the day and saw a new strip had automatically printed showing a heart rate of 40 about a minute before the asystole rhythm. The staff member stated "A heart rate of 40 should have alarmed. If I am in the back and an alarm is going off, it is difficult to hear. If you are in a room, you can't hear the alarm. The alarm would blink visually on the patient's monitor in the room and I would look." Interview revealed if a patient had a sinus tachycardia (rapid heart rate) and went into a sinus bradycardia (slow heart rate), it would be a significant change and the patient should be assessed, leads checked and the physician notified. The nurse stated "I didn't see warning signs of anything pending." RN #1 reviewed the patient's record and cardiac monitor strips. The nurse confirmed the last documented nursing assessment was at 1200 and the heart rate of 48 was six minutes prior to the asystole alarm. Interview revealed that when an alarm activates, the nurse should assess the patient and check the leads. Interview revealed the nurse had not notified the physician about a change in the patient's condition because she was not aware the heart rate had slowed to 48 until after the patient coded and she found the monitor strips that had printed automatically. The interview revealed the nurse had gone to lunch around 1330 and all five nurses were on the unit when the asystole alarm sounded. The interview revealed that each nurse has five patients to monitor when a nurse goes to lunch. Interview revealed the staff cannot visualize all five cardiac monitors on the pod monitor (monitor screen outside the patient's room) because it is limited to two patients. RN #1 stated "If I heard an alarm, I would have assessed the patient and called the doctor. I didn't know the patient had decreased heart rate and apnea. I saw the strips after the code had started. (RN #2) and I tried to figure out what happened. We went to the monitor and all the settings were correct. We concluded it should have alarmed or we didn't hear it. We were trying to understand why we didn't hear this. I didn't know there were different levels and sounds of alarms at that time. I know that now."

Interview with RN #2 on 07/09/2010 at 1205 revealed she was the team leader on 05/01/2010 and did not have a patient assignment. The nurse stated she was covering IMU1 and IMU2 and was in IMU2 assisting another nurse with medication at the nursing station when she heard an alarm. The nurse stated "I immediately saw on the central monitor room 160 asystole. I went into the room and asked her (Patient #3) two times if she was okay. The patient was dusky. I yelled to call a code....I had been on the unit around 10 minutes before the asystole alarm sounded. I did not hear any alarms before the asystole alarm sounded." Interview revealed the patient should be assessed when alarms are activated.

Interview with RN #3 on 07/09/2010 at 1220 revealed she remembered the patient. The nurse stated it had been a good day, everybody had gone to lunch and she had gone to the medication area just behind the nursing station to get some medication for her patient when she heard the central cardiac monitor alarm. The staff member stated she looked at the monitor and it was asystole room 160. RN #2 was assisting her with wasting medication when the alarm sounded. The interview revealed she and RN #2 responded to the alarm and a code was called. The interview revealed RN #3 and RN #2 were "the only ones at the front of the unit (by the central monitor) when this happened." The nurse stated "I am not sure if all alarms can be heard on the unit. No I didn't hear an alarm for room 160 prior to the asystole alarm."

Interview with RN #4 on 07/09/2010 at 1250 revealed it had been a slow day with everything caught up. Interview revealed the nurse had gone into a patient room when she heard RN #2 and someone up front call a code. The nurse stated she could not remember if she heard alarms at that time. The staff member stated "Sometimes alarms, you get so used to hearing them. The amount of alarms going off is a concern. I heard no alarms prior to the code."

Interview with RN #5 on 07/09/2010 at 1325 revealed she remembered the patient. Interview revealed the nurse was assigned three patients that were located in rooms 161, 162 and 163 (closest rooms to 160 where Patient #3 was located). The nurse stated she heard the asystole alarm and stated "I don't remember hearing any alarms prior." The staff member stated there are different sounds to the alarms and "you can hear the life threatening alarms anywhere." Interview further revealed that an oxygen saturation of 70% would be life threatening and that the alarms for the oxygen saturation are different, not as loud and obnoxious as some of the other life threatening rhythm alarm sounds. The staff member stated "I would not have heard SAO2 (oxygen saturation) alarms on my assigned patients during the code."

Review of a work order form revealed the IMU2 unit manager had requested biomedical engineering staff to evaluate the cardiac monitor on 05/17/2010 for possible equipment failure. Review of the model/serial numbers on the form matches the model/serial numbers on the cardiac monitor in IMU2, room 160. Interview on 07/09/2010 at 1115 with a biomedical engineering staff member revealed the cardiac monitor was checked and found to be working appropriately. Interview further revealed that the IMU2 nursing manager had requested the cardiac monitor historical logs from IMU2 room 160 on 04/30/2010 at 2100 through 05/01/2010 at 1515 due to an incident related to the monitor alarms being silenced. Interview revealed the file from the monitor was downloaded and sent to the manufacturer for interpretation. Review of documentation from the manufacturer representative dated 06/07/2010 revealed the following summary: Log files indicate that IMU2, bed 160 "was in a constant state of ADVISORY alarm for SPO2 between 1330 and 1434 (1 hour and 4 minutes). At 1434 a HR LO alarm was indicated at WARNING level. At 1440 the monitor alarmed for ASYSTOLE at CRISIS level. See attachment for complete list of alarms from IMU2 room 160 between 1330 and 1500. Alarm volume at the CIC (central monitor at IMU2 nursing station) was set to 80%. The bedside alarm was confirmed to be 80% based on the graph strip provided."

Review of the cardiac monitor historical log for IMU2, room 160 from 05/01/2010 at 1330 through 1500 was conducted on 07/09/2010 at 0740 with a hospital risk management staff member who had discussed the interpretation of the log with the manufacturer representative. The staff member explained the codes defining different levels of audible alarms. Review of the log revealed at 1330:04 an audible advisory alarm was issued for a SPO2 of 73 and the alarm continued without being silenced until 1432:20 when an audible warning alarm was issued for a low heart rate of 48. The alarm continued without being silenced until 1433:12 when an audible advisory alarm was issued for an SPO2 of 51. The alarm continued without being silenced until 1434:18 when an audible warning alarm was issued for a low heart rate of 49. The alarm continued without being silenced until 1440:06 when an audible critical alarm was issued for asystole. Review of the log revealed the alarm was silenced at 1443:20. Review of the log revealed SPO2 levels recorded as low as 44% (life threatening) and ongoing recordings during this time frame of oxygen saturation readings at critical levels.

In summary, review of the log confirmed a continuous audible alarm that started at 1330 was not silenced until 1443 (1 hour and 13 minutes). Interview with the staff member that was assisting with the log review confirmed the crisis alarm has to be manually silenced (push a button on the monitor) and the advisory and warning alarms will silence automatically upon return to normal parameters (default settings). Interview confirmed the cardiac monitor alarms continued to sound for 1 hour and 13 minutes without nursing staff intervening to silence the alarm. Interview confirmed the alarm did not auto correct during the 1 hour and 13 minutes and that the alarm was activated. Interview with the staff member revealed "We have a problem with desensitization."

Interview with administrative staff on 07/09/2010 at 1610 revealed the hospital's risk management staff were notified of Patient #3's death on 05/02/2010 at 1430 by the IMU2 nurse manager. Interview revealed an investigation was conducted by risk management staff that included staff interviews. The investigation was concluded on 05/03/2010. Interview revealed the risk management staff member "did not find anything at risk clinically. The patient was ventilator only for DNR (do not resuscitate). The patient was already trached and vented. All alarms were on." Interview revealed the code blue (emergency response) procedures were followed appropriately. Interview revealed around two weeks later risk management received an anonymous report of a "concern between two staff members." Interview revealed the concern was an allegation that cardiac monitor alarms were turned off prior to the code blue occurring on Patient #3 on 05/01/2010. Interview revealed staff were interviewed again and the cardiac monitor logs from Patient #3's monitor were obtained and sent to the manufacturer for review. Interview revealed the manufacturer review of the logs was completed 06/07/2010 and revealed the alarms were not turned off. The staff member stated "From a risk perspective, we considered the case closed. There were no concerns."

Consequently, nursing staff failed to ensure a safe environment for the delivery of care to patients placed on cardiac monitors as evidenced by failing to ensure continuous supervision of the cardiac monitors, failing to evaluate and respond to cardiac monitor alarms and failing to assess Patient #3 after the cardiac monitor alarms warned of a change in the patient's cardiac and respiratory status.

Based on policy review, observation, interview, cardiac monitor default settings, closed record review, equipment work order review, manufacturer alarm analysis report, historical cardiac monitor alarm log review and staffing assignment review, the hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations by failing to ensure patients on cardiac monitors were monitored, evaluated and assessed for changes in cardiac and respiratory status when cardiac monitor alarms were activated warning of changes in cardiac and respiratory status.

The findings include:

Nursing staff failed to evaluate and assess a patient when cardiac monitoring warning alarms sounded indicating a change in the patient's cardiac and respiratory status.

~cross refer to 482.23(b)(4) Nursing Services Standard: Tag A0395

Based on policy review, observation, interview, cardiac monitor default settings, closed record review, equipment work order review, manufacturer alarm analysis report, historical cardiac monitor alarm log review and staffing assignment review, nursing staff failed to evaluate and assess a patient when cardiac monitoring warning alarms sounded indicating a change in the patient's cardiac and respiratory status for 1 of 6 sampled patient's on a cardiac monitor (#3).

The findings include:

Review of the hospital's "Clinical Alarms" policy reviewed/revised February 2010 revealed "A clinical alarm should be audible and staff should respond when it sounds under reasonable predictable extremes of environmental conditions, including normal ambient noise levels....It is the responsibility of the user to ensure that alarm systems are used appropriately and safely, and that sound levels are sufficient to notify staff in the event of an alarm. For alarms that are an integral part of a patient-care device (infusion pump, ventilator, physiological monitor, etc.), the user must ensure that the alarms are set appropriately (alarm turned on, volume set to appropriate level, alarm parameters set appropriately for the patient, etc.) and functioning correctly before each use."

Review of "IMU2 Standard of Care Guidelines and Flowsheet Documentation" revealed "C. Pulmonary Assessment 1. Assess and document pulse oximeter every 4 hours and prn (as needed). Continuous pulse oximetry of ventilated patients, ... and if condition warrants.... 3. Assess respiratory status (rate, effort, skin color, orientation) every 4 hours and prn for significant changes in respiratory status.... 6. Notify physician of deterioration in SaO2 (oxygen saturation) consistently < [less than] 90%.... D. Cardiovascular Assessment 1. Continuously monitor cardiac rhythm in (1) lead with alarm limits set between 50 and 140 and turned on at all times. Parameters may be individualized for each patient's condition. If the parameters are set less than (<) 50 or greater than (>) 140, a physician's order is needed for these limits.... 4. Alarm limits should always be on and audible for BP, P, RR, A-line, and SaO2 (blood pressure, pulse, respiratory rate, arterial line and oxygen saturation). Assess and document a cardiac strip for EKG pattern, ... every (12) twelve hours and prn for rhythm changes. Documentation of each strip should include PR, QRS, and QT on each strip and interpret the rhythm."

Review of the "Assessment/Reassessment of Patient and Referral Criteria" revised May 2010 revealed "Patients will be reassessed: 1. At regular intervals and in a timely manner so as to meet the patient's ongoing needs. 2. when significant changes in the patient's condition, patient diagnosis, or change in the patient's level of care occur.... Physician's are appropriately notified of changes in a patient's condition."

Observation during tour of IMU1 and IMU2 (intermediate care units) on 07/08/2010 at 1330 through 1500 revealed each unit was set up identical and had the same floor plan. Interview with administrative staff during the tour revealed the nursing staff were assigned to both units interchangeably. Interview with administrative staff revealed that IMU1 and IMU2 are staffed with one registered nurse for three patients. Observation revealed each unit had 10 patient rooms with a nursing station located in the middle of the unit. Observation revealed a central cardiac monitor screen located on the desk at the nursing station. Observation revealed cardiac monitors alarming at the central monitoring station and a unit secretary sitting at the desk. Interview with the unit secretary during the tour revealed she did not "do anything" with the cardiac monitor. The staff member stated "Nursing staff take care of that." Interview with administrative staff during the tour revealed that unit secretaries are assigned to IMU1 and IMU2 sometimes, not always, but they do not have anything to do with the monitors or alarms because they are not trained or qualified to view and interpret the monitors. Interview revealed nursing staff were responsible for monitoring and responding to alarms. Observation further revealed that each of the 10 patient rooms had bedside cardiac monitors and every two rooms had a cardiac monitor screen located between the two rooms (total of 5 monitors). Interview with staff during tour revealed the monitor screens located outside of the rooms were limited to viewing two patients at a time. Interview further revealed that these monitors did not have audible alarms and only had visual alarms. Observation and interview revealed that audible alarms sounded at the central monitor at the nursing station and inside each patient's room. Observation revealed a red visual message alarm that appeared on the screen of the five monitors outside patient's rooms when patient parameters have exceeded set limits. Interview during the tour with biomedical engineering staff revealed there are three different audible alarms defined as "advisory, warning and crisis." Interview revealed all three alarms have different sounds and all are set at 80% volume (factory default). Interview further revealed the crisis alarm has to be manually silenced at bedside (push a button on the monitor) and the advisory and warning alarms will silence automatically upon return to normal parameters (default settings).

Review of a printout of cardiac monitor alarm default settings received from biomedical engineering staff revealed asystole, ventricular fibrillation and ventricular tachycardia would activate a crisis alarm. Heart rate (outside set parameters), no breath and ventricular bradycardia would activate a warning alarm, and SPO2 (oxygen saturation) and respiratory rate (outside set parameters) would activate an advisory alarm. Further review revealed default settings for heart rate were 50 to 140, SPO2 89% to 101% and respiratory rate 5 to 30 per minute with apnea defined as greater than 20 seconds.

Closed record review on 07/08/2010 of Patient #3 revealed a 78 year-old female admitted on 04/20/2010 with respiratory failure and pneumonia. Review revealed the patient had a previous admission to the hospital on 02/24/2010 for respiratory failure and required mechanical ventilation, was weaned from the ventilator and placed on a trach collar, then transferred to another hospital for continued care. Record review revealed the patient subsequently developed pneumonia, was reintubated and placed back on mechanical ventilation on 04/10/2010 prior to arrival for admission to the Intensive Care Unit on 04/20/2010. Review revealed the patient was weaned from the mechanical ventilator and placed on a trach collar with 30% oxygen on 04/29/2010. Physician's orders dated 04/30/2010 at 1012 revealed an order to transfer the patient to IMU (intermediate care unit) vent bed. Orders on 04/30/2010 at 1015 revealed an order for pulse oximetry and routine vital signs per unit protocol. The orders further stated "Titrate oxygen to keep O2 Sat (oxygen saturation) greater than 90%." Review of nursing notes dated 05/01/2010 at 0010 recorded the patient was received on IMU2, room 160. Notes recorded the patient was following simple commands and mouthing words. Notes revealed the patient was in a sinus tachycardia rhythm, on 30% trach collar and had oxygen saturation of 90 to 100%. Nursing notes at 0645 revealed the patient was restless and agitated most of the shift and was given medication with minimal relief. Review of respiratory therapy notes recorded suctioning, trach care and nebulizer treatment were provided at 0740 and 1140. Review of nursing flowsheet documentation revealed a nursing assessment was recorded at 0800 and 1200. Review of the flowsheet recorded "EKG alarms audible" with heart rate alarm settings at "50 to 140." Vital signs were recorded at 1200 as blood pressure 126/70, pulse 119, temperature 97.4, respiratory rate 24 and oxygen saturation 100%. Review revealed nursing notes dated 05/01/2010 at 1530 recorded "At 1438 nurse heard monitor beep asystole (no heart rate) and immediately responded to patient's room. Noticed patient was unresponsive without carotid pulse. Code Blue called. Patient status was Intubate Only. Respiratory bagged patient as attending MD was paged. MD gave order for two RNs to pronounce expiration. At 1450 code ended..." Review of a Code Blue record revealed the event was recognized at 1437 when the patient was found asystole. Review revealed the code team arrived at 1438, the patient had no blood pressure or heart rate and the code was ended at 1450 when the patient was pronounced dead. Review of a cardiac monitor strip dated 05/01/2010 at 0017 recorded a HR (heart rate) of 104, SPO2 (oxygen saturation) 100% and RR (respiratory rate) 13. Review of a monitor strip at 0703 recorded HR 119, SPO2 100%, RR 27. Review revealed a cardiac monitor strip at 1434:36 that recorded "ALARM SAVED *HR LO 48* ICU-16001 (patient name) ALM VOL 80% HR 48 BRADY (bradycardia, low heart rate) SPO2 PULSE SEARCH RR APNEA (unable to measure oxygen saturation, respiratory distress)." Review revealed a cardiac monitor strip at 1440:08 (six minutes after the prior strip recording a low heart rate) that recorded "ALARM *ASYSTOLE* ICU-16001 (patient name) ALM VOL 80% HR 0 ASYSTOLE SPO2 PULSE SEARCH RR APNEA." Review of the record revealed no documentation that a nurse evaluated or assessed the patient at 1434 when the cardiac monitor alarmed warning of a low heart rate and inability to measure the patient's respiratory rate and oxygen saturation. Review of the patient's record revealed no evidence of an assessment after 1200 on 05/01/2010 until the patient was coded on 05/01/2010 at 1440 (six minutes after the cardiac monitor warning alarm).

Review of a work order form revealed the IMU2 unit manager had requested biomedical engineering staff to evaluate the cardiac monitor on 05/17/2010 for possible equipment failure. Review of the model/serial numbers on the form matches the model/serial numbers on the cardiac monitor in IMU2, room 160. Interview on 07/09/2010 at 1115 with a biomedical engineering staff member revealed the cardiac monitor was checked and found to be working appropriately. Interview further revealed that the IMU2 nursing manager had requested the cardiac monitor historical logs from IMU2 room 160 on 04/30/2010 at 2100 through 05/01/2010 at 1515 due to an incident related to the monitor alarms being silenced. Interview revealed the file from the monitor was downloaded and sent to the manufacturer for interpretation. Review of documentation from the manufacturer representative dated 06/07/2010 revealed the following summary: Log files indicate that IMU2, bed 160 "was in a constant state of ADVISORY alarm for SPO2 between 1330 and 1434 (1 hour and 4 minutes). At 1434 a HR LO alarm was indicated at WARNING level. At 1440 the monitor alarmed for ASYSTOLE at CRISIS level. See attachment for complete list of alarms from IMU2 room 160 between 1330 and 1500. Alarm volume at the CIC (central monitor at IMU2 nursing station) was set to 80%. The bedside alarm was confirmed to be 80% based on the graph strip provided."

Review of the cardiac monitor historical log for IMU2, room 160 from 05/01/2010 at 1330 through 1500 was conducted on 07/09/2010 at 0740 with a hospital risk management staff member who had discussed the interpretation of the log with the manufacturer representative. The staff member explained the codes defining different levels of audible alarms. Review of the log revealed at 1330:04 an audible advisory alarm was issued for a SPO2 of 73 and the alarm continued without being silenced until 1432:20 when an audible warning alarm was issued for a low heart rate of 48. The alarm continued without being silenced until 1433:12 when an audible advisory alarm was issued for an SPO2 of 51. The alarm continued without being silenced until 1434:18 when an audible warning alarm was issued for a low heart rate of 49. The alarm continued without being silenced until 1440:06 when an audible critical alarm was issued for asystole. Review of the log revealed the alarm was silenced at 1443:20. Review of the log revealed SPO2 levels recorded as low as 44% (life threatening) and ongoing recordings during this time frame of oxygen saturation readings at critical levels. In summary, review of the log confirmed a continuous audible alarm that started at 1330 and continued alarming was not silenced until 1443 (1 hour and 13 minutes). Interview with the staff member that was assisting with the log review confirmed the crisis alarm has to be manually silenced (push a button on the monitor) and the advisory and warning alarms will silence automatically upon return to normal parameters (default settings). Interview confirmed the cardiac monitor alarms continued to sound for 1 hour and 13 minutes without nursing staff intervening to silence the alarm. Interview confirmed the alarm did not auto correct during the 1 hour and 13 minutes and that the alarm was activated. Interview with the staff member revealed "We have a problem with desensitization."

Review of staffing assignments for IMU2 on 05/01/2010 for the 0700 shift revealed that four registered nurses (RNs) were assigned to ten patients with a team leader RN (#2) who was also covering IMU1. Review of the assignments revealed RN #1 was the charge nurse and assigned to Patient #3 in room 160 and another patient in room 169. RN #3 was assigned to 2 patients, RN #4 was assigned to 3 patients and RN #5 was assigned to 3 patients. Review of the staff ing sheet revealed no unit secretary or nursing assistants were assigned to IMU2.

Interview with RN #1 (assigned to Patient #3) on 07/09/2010 at 1350 revealed she was the charge nurse that day and was assigned to two patients with rooms located such that the nursing station was between the two rooms. The staff member stated that she was not able to see both patient's simultaneously, but that she placed both patient cardiac monitor readings on the monitor screen outside of one of the rooms. Interview revealed audible alarms sounded in the patients rooms and at the central monitor at the nursing station. The interview revealed that a "red" alarm appears at the bottom of the monitor screen for all 10 patients whenever an alarm is activated. Interview revealed RN #1 was making rounds for other patients on the unit (performing charge nurse duties) when she heard a critical heart rate alarm sound at the nursing station. The nurse stated "(RN #2) was yelling my name, come in here. I assessed her (Patient #3) pulse. Someone else called the code....when I heard the alarm, I went to her room. I didn't check the monitor." The nurse stated that after the code ended, she and RN #2 were trying to figure out what happened and were reviewing the strips. The nurse stated that she had not torn off a strip from the monitor from earlier in the day and saw a new strip had automatically printed showing a heart rate of 40 about a minute before the asystole rhythm. The staff member stated "A heart rate of 40 should have alarmed. If I am in the back and an alarm is going off, it is difficult to hear. If you are in a room, you can't hear the alarm. The alarm would blink visually on the patient's monitor in the room and I would look." Interview revealed if a patient had a sinus tachycardia (rapid heart rate) and went into a sinus bradycardia (slow heart rate), it would be a significant change and the patient should be assessed, leads checked and the physician notified. The nurse stated "I didn't see warning signs of anything pending." RN #1 reviewed the patient's record and cardiac monitor strips. The nurse confirmed the last documented nursing assessment was at 1200 and the heart rate of 48 was six minutes prior to the asystole alarm. Interview revealed that when an alarm activates, the nurse should assess the patient and check the leads. Interview revealed the nurse had not notified the physician about a change in the patient's condition because she was not aware the heart rate had slowed to 48 until after the patient coded and she found the monitor strips that had printed automatically. The interview revealed the nurse had gone to lunch around 1330 and all five nurses were on the unit when the asystole alarm sounded. The interview revealed that each nurse has five patients to monitor when a nurse goes to lunch. Interview revealed the staff cannot visualize all five cardiac monitors on the pod monitor (monitor screen outside the patient's room) because it is limited to two patients. RN #1 stated "If I heard an alarm, I would have assessed the patient and called the doctor. I didn't know the patient had decreased heart rate and apnea. I saw the strips after the code had started. (RN #2) and I tried to figure out what happened. We went to the monitor and all the settings were correct. We concluded it should have alarmed or we didn't hear it. We were trying to understand why we didn't hear this. I didn't know there were different levels and sounds of alarms at that time. I know that now."

Interview with RN #2 on 07/09/2010 at 1205 revealed she was the team leader on 05/01/2010 and did not have a patient assignment. The nurse stated she was covering IMU1 and IMU2 and was in IMU2 assisting another nurse with medication at the nursing station when she heard an alarm. The nurse stated "I immediately saw on the central monitor room 160 asystole. I went into the room and asked her (Patient #3) two times if she was okay. The patient was dusky. I yelled to call a code....I had been on the unit around 10 minutes before the asystole alarm sounded. I did not hear any alarms before the asystole alarm sounded." Interview revealed the patient should be assessed when alarms are activated.

Interview with RN #3 on 07/09/2010 at 1220 revealed she remembered the patient. The nurse stated it had been a good day, everybody had gone to lunch and she had gone to the medication area just behind the nursing station to get some medication for her patient when she heard the central cardiac monitor alarm. The staff member stated she looked at the monitor and it was asystole room 160. RN #2 was assisting her with wasting medication when the alarm sounded. The interview revealed she and RN #2 responded to the alarm and a code was called. The interview revealed RN #3 and RN #2 were "the only ones at the front of the unit (by the central monitor) when this happened." The nurse stated "I am not sure if all alarms can be heard on the unit. No I didn't hear an alarm for room 160 prior to the asystole alarm."

Interview with RN #4 on 07/09/2010 at 1250 revealed it had been a slow day with everything caught up. Interview revealed the nurse had gone into a patient room when she heard RN #2 and someone up front call a code. The nurse stated she could not remember if she heard alarms at that time. The staff member stated "Sometimes alarms, you get so used to hearing them. The amount of alarms going off is a concern. I heard no alarms prior to the code."

Interview with RN #5 on 07/09/2010 at 1325 revealed she remembered the patient. Interview revealed the nurse was assigned three patients that were located in rooms 161, 162 and 163 (closest rooms to 160 where Patient #3 was located). The nurse stated she heard the asystole alarm and stated "I don't remember hearing any alarms prior." The staff member stated there are different sounds to the alarms and "you can hear the life threatening alarms anywhere." Interview further revealed that an oxygen saturation of 70% would be life threatening and that the alarms for the oxygen saturation are different, not as loud and obnoxious as some of the other life threatening rhythm alarm sounds. The staff member stated "I would not have heard SAO2 (oxygen saturation) alarms on my assigned patients during the code."

Consequently, nursing staff failed to evaluate and respond to patients with cardiac monitor alarms and failed to assess Patient #3 after cardiac monitor alarms warned of a change in the patient's cardiac and respiratory status.