The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

UC SAN DIEGO HEALTH HILLCREST - HILLCREST MED CTR 200 WEST ARBOR DRIVE SAN DIEGO, CA 92103 Oct. 29, 2013
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation, interview and record review, Hospital A failed to ensure care was provided in a safe setting, for 1 of 14 sampled patients (1). Patient 1 presented to the hospital's Emergency Department (ED) with a chief complaint of chest pain and had a physician's order for cardiac monitoring. Patient 1 was found unresponsive and pulseless with no evidence of cardiac monitoring in place. A code blue (a medical emergency in which a team of medical personnel work to revive an individual in cardiac arrest) was called on 10/19/13 at 4:30 P.M. and resuscitative measures were initiated but unsuccessful. Patient 1's death was pronounced on 10/19/13 at 5:00 P.M. The medical treatment plan and physician's orders for Patient 1 were not implemented in the ED. The lack of cardiac monitoring prevented ED staff from being alerted to the patient's deteriorating condition, which in turn led to a delayed response for the implementation of resuscitative efforts, to ensure that care in the ED was provided in a safe and effective manner.

Findings:

On 10/23/13 at 3:00 P.M., a tour of Hospital A's ED was conducted with Quality Compliance Specialist (QCS 1) and the charge nurse (CRN 1). Multiple doors were closed and curtains pulled as patient care and treatments were in progress.

A review of Patient 1's medical record was conducted on 10/23/13 beginning at 4:31 P.M. with QCS 1. Patient 1 was admitted to Hospital A's ED on 10/19/13 per the Admission Face Sheet. According to a Patient Care Timeline in the ED, dated 10/19/13 at 11:35 A.M. to 10/19/13 at 9:20 P.M., there was a physician's order that read "cardiac monitoring - ED patient." The order was prescribed on 10/19/13 at 11:49 A.M. Per the same timeline, on 10/19/13 at 2:40 P.M., Registered Nurse (RN 1) documented that Patient 1 was on a cardiac monitor with normal sinus rhythm (a normal heart rhythm).

Per RN 2's documentation, on 10/19/13 at 4:27 P.M., Patient 1 was found unresponsive and pulseless and, not on a telemetry or blood pressure monitor and oxygen probe. From 10/19/13 at 2:45 P.M. to 4:27 P.M., there was no documented evidence found in the medical record to demonstrate that Patient 1 was on a cardiac monitor per the physician's order.

According to a Death Note dated 10/19/13 at 6:07 P.M., Physician 1 documented that a code blue was called on Patient 1 at 4:30 P.M. who was found to be in PEA (pulseless electrical activity - a heart rhythm is observed on the monitor but is not producing a pulse). Per the same note, Patient 1 expired despite resuscitative efforts. Patient 1's death was pronounced on 10/19/13 at 5:00 P.M.

An interview with RN 1 was conducted on 10/25/13 at 9:35 A.M. RN 1 stated that she recalled caring for Patient 1, as his primary ED nurse on 10/19/13. She remembered talking to Patient 1 before she went on her afternoon break which was at "a little after 4:00 P.M." She referred to her documentation at 3:55 P.M. and said that at this time, she knew that Patient 1 was not on a cardiac monitor, the monitor was not on, the cables that connect the patient to the cardiac monitors were on the mayo stand (a metal table) and the room was dark. She confirmed that there was a cardiac monitoring order by the physician for Patient 1. She acknowledged that she did not follow the physician's orders when she did not place Patient 1 back on his cardiac monitor when she identified that he was not connected and the cardiac monitoring for the patient was not in place.

A telephone interview with the attending physician (Physician 2) was conducted on 10/25/13 at 1:30 P.M. Physician 2 stated that the first time he had seen Patient 1 was when the code blue was called. He stated that when he arrived to the room, Patient 1 was actively being placed on monitors. He stated that this was very concerning, a "horrible case" and that it "greatly disturbed" him that Patient 1 was not on a cardiac monitor. He said that ideally, if Patient 1 was on a cardiac monitor, the ED staff may have been alerted sooner of the patient's deterioration which could have led to a better chance of resuscitating the patient.

An interview with RN 2 was conducted on 10/28/13 at 9:07 A.M. RN 2 stated that she was the break nurse who cared for Patient 1 on 10/19/13. She stated that she had received a verbal report (handoff communication) from RN 1. According to RN 2, RN 1 had told her that there was a central line placement in progress in room 8A, the rest of her patients were stable and to look out for orders from ED physicians. RN 1 had left for her break at 4:25 P.M. RN 2 stated that at 4:26 P.M., she noted new physician's orders that indicated that Patient 1 was going to be admitted . She stated that she looked at the central telemetry monitoring at the nurse's station and noted that there were no readings found on Patient 1. She explained that she went into room 8B, the lights were dim, Patient 1 was not interacting even after introductions, the patient's body was shifted to the left side, his eyes were open but he was unresponsive. She stated that she performed a sternal stimuli and still did not get a response. She checked his pulse and found him pulseless but the patient was still warm. RN 2 recalled that Patient 1's cardiac monitor was on, but on standby and not connected to the patient. She said that the cables that connected Patient 1 to the cardiac monitor were located on the hooks beneath the base of the monitor.

On 10/28/13 at 10:54 A.M., an observation in the ED was made with the Director of Emergency Services (DED) and QCS 1. Room 8 was divided into two bedsides: 8A and 8B. Patient 1 had been admitted into room 8B. The bed was located on the right hand side of the room (when facing room from doorway). The cardiac monitor was located on the upper left side of the bed (at the head of the bed) with hooks beneath the base of the monitor. There was no mayo table noted in the room during this time.

A review of the Hospital's ED Standards of Patient Care, dated fiscal year (FY) 2012/2013, was conducted on 12/28/13. The ED Standards entitled "Cardiovascular Assessment Standard" under assessment/data, indicated that "Cardiac rhythms will be assessed and documented via bedside cardiac monitors on patients, regardless of age, as indicated by the patient's chief compliant or clinical presentation including: a. chest pain ...." Per this same section, it stipulated to assess cardiac pain, conduct rhythm analysis and rate. Within the interventions and documentation section, it stipulated to "Place patient on cardiac monitoring, assess and document heart rate and rhythm. Alarms will be set, on and audible." According to the Cardiovascular: Hemodynamics and ECG (electrocardiogram - records of electrical signals as they travel through the heart) Monitoring Standard, patients "will be diagnosed and treated according to accurate analysis of ECG and hemodynamic indices." Per the same section, it read "The patient will be free of complications related to hemodynamic monitoring."

An interview with the ED Nurse Manager (EDNM) was conducted on 10/28/13 at 2:08 P.M. The EDNM stated that the nursing staff in the ED were expected to follow physician's orders and the Hospital's ED Standards of Patient Care. She acknowledged that RN 1 did not follow Patient 1's physician's orders, nor did she implement the Hospital's ED Standards, after she identified that the patient was no longer connected to the cardiac monitor.

A review of the hospital's policy entitled "Patient's Rights and Responsibilities", dated 4/18/13, was conducted on 10/29/13. The policy indicated that "Patients have the right to: ... 12. Receive care in a safe setting...."

Patient 1 did not receive care in a safe setting when ED staff did not ensure that the patient was being monitored in accordance with physician's orders and ED Standards of Care.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on observation, interview and record review, Hospital A failed to ensure that their performance improvement activities included the implementation of early response strategies to an adverse patient event, in accordance with the hospital's Sentinel Event and Significant Adverse Event policy, for 1 of 14 sampled patients (1). The failure to implement early response strategies or preventive actions had the potential to impede the hospital's ability to ensure that appropriate patient safety measures and monitoring were put into place, in an effort to provide safe and effective patient care in the ED.

Hospital A's initial action plan in response to Patient 1 being found unresponsive and pulseless with no evidence of cardiac monitoring in the ED on 10/19/13, was implemented on 10/23/13, five days after the incident.

Findings:

On 10/23/13 at 2:50 P.M., a complaint investigation related to the quality of care and treatment in the ED was initiated at Hospital A.

On 10/23/13 at 3:00 P.M., a tour of the ED was conducted with Quality Compliance Specialist (QCS 1) and the charge nurse (CRN 1). Multiple doors were closed and curtains pulled as patient care and treatments were in progress.

A review of Patient 1's medical record was conducted on 10/23/13 beginning at 4:31 P.M. with QCS 1. Patient 1 was admitted to Hospital A's ED on 10/19/13 per the Admission Face Sheet. According to a Patient Care Timeline in the ED, dated 10/19/13 at 11:35 A.M. to 10/19/13 at 9:20 P.M., there was a physician's order that read "cardiac monitoring - ED patient." The order was prescribed on 10/19/13 at 11:49 A.M. Per the same timeline, on 10/19/13 at 2:40 P.M., Registered Nurse (RN 1) documented that Patient 1 was on a cardiac monitor with normal sinus rhythm (a normal heart rhythm).

Per RN 2's documentation, on 10/19/13 at 4:27 P.M., Patient 1 was found unresponsive and pulseless and, not on a telemetry or blood pressure monitor and oxygen probe. From 10/19/13 at 2:45 P.M. to 4:27 P.M., there was no documented evidence found in the medical record to demonstrate that Patient 1 was on a cardiac monitor per the physician's order.

According to a Death Note dated 10/19/13 at 6:07 P.M., Physician 1 documented that a code blue was called on Patient 1 at 4:30 P.M. and was found to be in PEA (pulseless electrical activity - a heart rhythm is observed on the monitor but is not producing a pulse). Per the same note, Patient 1 expired despite resuscitative efforts. Patient 1's death was pronounced on 10/19/13 at 5:00 P.M.

On 10/23/13 at 5:24 P.M., a group interview was conducted with the Chief Nursing Officer (CNO), Chief Medical Officer (CMO), the Director of Performance Improvement (DPI), the Director of Regulatory Affairs (DRA), and QCS 1. According to the DPI, there were a total of 3 EQVRs (Electronic Quality Variance Report - web based event reporting system used by the hospital; the event reporting process supports a data-driven patient safety program) that were generated with regards to what had happened to Patient 1 in the ED. The CMO stated that the hospital's immediate action plan, in response to Patient 1 being found unresponsive and pulseless with no evidence of cardiac monitoring, was being implemented that afternoon on 10/23/13 which was 5 days after the patient death. When the group was asked about any additional action plans that had been implemented as they investigated Patient 1's incident, in an effort to ensure patient safety in the ED, the CMO stated that, on 10/21/13, they determined which ED staff needed to be interviewed to immediately begin the hospital's internal investigation of what may have happened to Patient 1. The CMO acknowledged that the implementation of an immediate action plan occurred on 10/23/13, 5 days after the incident.

According to the hospital's policy entitled "Sentinel Event and Significant Adverse Events", dated 8/15/13, was conducted on 10/25/13. The policy indicated that the hospital "... will identify and respond appropriately to all Sentinel Events and Significant Adverse Events occurring in the organization or associated with services the organization provides." Per the same policy, it stipulated that "Appropriate response includes:

1. Early response strategies
2. Identification and timely notification
3. Thorough investigation
4. Action plan development to reduce risk of reoccurrence
5. Implementation of improvements
6. Monitoring the effectiveness of those improvements; and
7. Reporting to required agencies"

On 10/23/13 at 9:11 P.M., the Department was notified in writing via a facsimile (fax) from the DRA that the hospital may have identified an adverse event. The DRA documented that on 10/19/13 at 4:27 P.M., Patient 1 "was found lying on the gurney unresponsive, pulseless and not breathing." Per the DRA, code blue was called, initiated but at 5:07 P.M., Patient 1 had expired.

The hospital did not implement early response strategies to this patient's death in the ED per it's own Sentinel Event and Significant Adverse Event Policy to ensure appropriate patient safety measures were in place, and to prevent a recurrence.
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
Based on interview and record review, Hospital A and B failed to ensure that a printed version of cardiac rhythm strips (a graphic tracing of the electrical activity of the heart) were retained in the medical records of 3 of 6 sampled patient's (17, 19, 20) who had presented to the Emergency Department (ED) with cardio-pulmonary resuscitation (CPR - an emergency lifesaving procedure that is done when someone's breathing or heart beat has stopped) in progress. Failure to print and retain a cardiac rhythm strip resulted in incomplete medical records for three patients.

Findings:

1. Patient 17 presented to Hospital B's Emergency Department (ED) on 5/26/13 via ambulance and paramedics with cardiopulmonary resuscitation (CPR) in progress according to the Admission Face Sheet.
An interview was conducted with the Assistant RN Manager of the ED (ARNM) on 10/28/13 at 3:45 P.M. The ARNM stated that, during CPR in the ED, an electrocardiogram (EKG) rhythm strip should be printed from the patient's cardiac monitor when:
1. The ED Staff begins CPR
2. There is any change in the patient's cardiac rhythm
3. CPR has ended.
A review of Patient 17's medical record was conducted on 10/28/13 at 4:00 P.M. According to Patient 17's ED record, "pt. (patient) awoke out of sleep with crushing chest pain. When medics arrived, at Patient 17's residence, a 12 lead ECG showed "anterior STEMI" (anterior myocardial infarction or heart attack.) It was documented, in the ED record, that the ED staff started to continue CPR at 2:23 A.M. At 2:30 A.M., the patient was in a "fine v-fib" rhythm (the heart muscle quivers rather than contracts). At 2:33 A.M., "Pt. in PEA (pulseless electrical activity - a heart rhythm is observed on the monitor but is not producing a pulse) on monitors." And, at 3:18 P.M., "ASYSTOLE (absence of heart beat) on monitor." Patient 17 was pronounced dead, at that time, and CPR was stopped However, there was no documented evidence in Patient 17's medical record that any cardiac rhythm strips had been printed and retained as part of his medical record.
On 10/29/13 at 11:00 A.M., an interview was conducted with the Director of the ED (DED). The DED stated the hospital did not have a policy and procedure specific to Code Blue (a medical emergency in which a team of medical personnel work to revive an individual in cardiac arrest) in the ED. The DED further explained that the hospital wide policy and procedure related to Code Blue did not contain specific information regarding the role of the responders for a Code Blue in the ED. The DED stated that it was her expectation that the primary nurse or code nurse would make sure that cardiac rhythm strips were printed, at the appropriate times during a Code Blue, and go with the patient's paper chart to medical records.
A review of the hospital wide policy and procedure, entitled Code Blue - Adult/Pediatric" and dated 6/20/13, indicated that "Role Responsibilities:...Code Blue RN...Attaches patient to monitor...Identifies rhythm and all changes in rhythm. Obtains rhythm strip for the code and places it in the hard copy chart."
2. Patient 19 presented to Hospital A's Emergency Department (ED) on 4/23/13 via ambulance and paramedics with cardio-pulmonary resuscitation (CPR) in progress according to the Admission Face Sheet.
An interview was conducted with the Assistant RN Manager of the ED (ARNM) on 10/28/13 at 3:45 P.M. The ARNM stated that, during CPR in the ED, an electrocardiogram (EKG) rhythm strip should be printed from the patient's cardiac monitor when:
1. The ED Staff begins CPR
2. There is any change in the patient's cardiac rhythm
3. CPR has ended.
A review of Patient 19's medical record was conducted on 10/28/13 at 4:15 P.M. According to Patient 19's medical record, Patient 19 collapsed after lunch and suffered a cardiac arrest. Patient 19 arrived in the ED of Hospital A at 3:39 P.M. and the ED staff continued cardio-pulmonary resuscitation (CPR). At 3:44 P.M., Pt (patient) in Vtach..." (the heart muscle quivers rather than contracts). At 4:00 P.M., it was documented "no pulse, PEA in 120's...(pulseless electrical activity - a heart rhythm is observed on the monitor but is not producing a pulse). At 4:16 P.M. "a-systole (absence of heart beat) now, no pulse..." Patient 19 was pronounced dead at 4:23 P.M. and CPR was stopped. However, there was no documented evidence in Patient 19's medical record that any cardiac rhythm strips had been printed and retained as part of his medical record.
On 10/29/13 at 11:00 A.M., an interview was conducted with the Director of the ED (DED). The DED stated the hospital did not have a policy and procedure specific to Code Blue (a medical emergency in which a team of medical personnel work to revive an individual in cardiac arrest) in the ED. The DED further explained that the hospital wide policy and procedure related to Code Blue did not contain specific information regarding the role of the responders for a Code Blue in the ED. The DED stated that it was her expectation that the primary nurse or code nurse would make sure that cardiac rhythm strips were printed, at the appropriate times during a Code Blue, and go with the patient's paper chart to medical records.
A review of the hospital wide policy and procedure, entitled Code Blue - Adult/Pediatric" and dated 6/20/13, indicated that "Role Responsibilities:...Code Blue RN...Attaches patient to monitor...Identifies rhythm and all changes in rhythm. Obtains rhythm strip for the code and places it in the hard copy chart."
3. Patient 20 presented to the Emergency Department (ED) of Hospital A on 5/14/13 via ambulance and paramedics with cardio-pulmonary resuscitation in progress according to the Admission Face Sheet.
An interview was conducted with the Assistant RN Manager of the ED (ARNM) on 10/28/13 at 3:45 P.M. The ARNM stated that, during CPR in the ED, an electrocardiogram (EKG) rhythm strip should be printed from the patient's cardiac monitor when:
1. The ED Staff begins CPR
2. There is any change in the patient's cardiac rhythm
3. CPR has ended.
A review of Patient 20's medical record was conducted on 10/28/13 at 4:15 P.M. Patient 20's husband reported that Patient 20 complained of feeling dizzy before sliding down to the floor at home. When the paramedics arrived, Patient 20 did not have a pulse. At 9:13 P.M., Patient 20 arrived in the ED and the ED staff continued CPR. At 9:27 P.M., Patient 20 had "PEA on the monitor" (pulseless electrical activity - a heart rhythm is observed on the monitor but is not producing a pulse). By 9:35 P.M. there was "Asystole (absence of heart beat) on the monitor, no pulse." Patient 20 was pronounced dead at 9:49 P.M. and CPR was stopped. However, there was no documented evidence in Patient 20's medical record that any cardiac rhythm strips had been printed and retained as part of her medical record.
On 10/29/13 at 11:00 A.M., an interview was conducted with the Director of the ED (DED). The DED stated the hospital did not have a policy and procedure specific to Code Blue (a medical emergency in which a team of medical personnel work to revive an individual in cardiac arrest) in the ED. The DED further explained that the hospital wide policy and procedure related to Code Blue did not contain specific information regarding the role of the responders for a Code Blue in the ED. The DED stated that it was her expectation that the primary nurse or code nurse would make sure that cardiac rhythm strips were printed, at the appropriate times during a Code Blue, and go with the patient's paper chart to medical records.
A review of the hospital wide policy and procedure, entitled "Code Blue - Adult/Pediatric" and dated 6/20/13, indicated that "Role Responsibilities:...Code Blue RN...Attaches patient to monitor...Identifies rhythm and all changes in rhythm. Obtains rhythm strip for the code and places it in the hard copy chart."
VIOLATION: EMERGENCY SERVICES Tag No: A1100
Based on observation, interview and record review, Hospital A failed to ensure that Registered Nurses (RNs) in the Emergency Department (ED) followed physician's orders in accordance with the Hospital's ED Standards of Patient Care, for 2 of 14 sampled patients (1, 2). Patient 1 had a physician's order for cardiac monitoring. Patient 1 was found unresponsive and pulseless with no evidence of cardiac monitoring in the ED. A code blue (a medical emergency in which a team of medical personnel work to revive an individual in cardiac arrest) was called on 10/19/13 at 4:30 P.M. and resuscitative measures were initiated but unsuccessful. Patient 1's death was pronounced on 10/19/13 at 5:00 P.M. The medical treatment plan and physician's orders for Patient 1 were not implemented in the ED. The lack of cardiac monitoring prevented ED staff from being alerted to the patient's deteriorating condition, which in turn led to a delayed response for the implementation of resuscitative efforts, to ensure that care in the ED was provided in a safe and effective manner.

Hospital A also failed to ensure that the ED Nurse Manager (EDNM) followed her chain of command when she was notified of a patient who presented to the ED with a chief complaint of chest pain and had cardiac monitor orders, was found unresponsive and pulseless with no evidence of cardiac monitoring in accordance with the Hospital's policy. The EDNM's failure to contact her immediate supervisor to alert her of a potential or actual patient safety issue related to nursing care practices in the ED, impeded or had the potential to cause a delay in the hospital's process to implement early response strategies, identification, timely notification, investigation and action plan development to reduce risk of reoccurrence. A delay in the implementation of an immediate action plan was identified at Hospital A, when the hospital's initial action plan in response to their awareness that a patient who presented to the ED with a chief complaint of chest pain and had cardiac monitor orders, was found unresponsive and pulseless with no evidence of cardiac monitoring, was implemented on 10/23/13, 5 days after the incident.

Patient 2 had a physician's order to be discharged to home. However, rather than being discharged to home, Patient 2 was discharged from Hospital A's ED and transported to another facility via ambulance.

In addition, Hospital A failed to ensure that RNs in the ED performed handoff communication with all the required elements to ensure patient safety and continuity of care, in accordance with the Hospital's Handoff Communication policy. The failure to perform handoff communication with the required elements may impede the interactive process of passing patient-specific information from one caregiver to another, for the purpose of ensuring patient safety and continuity. Hospital A also failed to ensure that patient's pre-code rhythm strips and rhythm strips for the code were retained and placed in the medical record, for 1 of 6 sampled patients (1). Failure to print and retain a cardiac rhythm strip prior to and during a code blue prevents the ED staff from reviewing and analyzing patient data to determine diagnosis, treatment and intervention in accordance with cardiac rhythm findings and hemodynamic (the study of blood flow or the circulation) indices.

Lastly, Hospital A failed to ensure that a physician's order was obtained when a patient's medical record contained documentation that oxygen therapy had been administered, for 1 of 14 sampled patients (1) in accordance with the Hospital's ED Standards of Patient Care. There was documentation found in Patient 1's medical record that oxygen therapy was administered without a physician's order. Lack of a physician's order made it difficult to determine whether or not the physician actually prescribed the documented medical treatment plan.

Findings:

1. On 10/23/13 at 3:00 P.M., a tour of Hospital A's ED was conducted with Quality Compliance Specialist (QCS 1) and the charge nurse (CRN 1). Multiple doors were closed and curtains pulled as patient care and treatments were in progress.

A review of Patient 1's medical record was conducted on 10/23/13 beginning at 4:31 P.M. with QCS 1. Patient 1 was admitted to Hospital A's ED on 10/19/13 per the Admission Face Sheet. According to a Patient Care Timeline in the ED, dated 10/19/13 at 11:35 A.M. to 10/19/13 at 9:20 P.M., there was a physician's order that read "cardiac monitoring - ED patient." The order was prescribed on 10/19/13 at 11:49 A.M. Per the same timeline, on 10/19/13 at 2:40 P.M., Registered Nurse (RN 1) documented that Patient 1 was on a cardiac monitor with normal sinus rhythm (a normal heart rhythm).

Per RN 2's documentation, on 10/19/13 at 4:27 P.M., Patient 1 was found unresponsive and pulseless and, not on a telemetry or blood pressure monitor and oxygen probe. From 10/19/13 at 2:45 P.M. to 4:27 P.M., there was no documented evidence found in the medical record to demonstrate that Patient 1 was on a cardiac monitor per the physician's order.

According to a Death Note dated 10/19/13 at 6:07 P.M., Physician 1 documented that a code blue was called on Patient 1 at 4:30 P.M. and was found to be in PEA (pulseless electrical activity - a heart rhythm is observed on the monitor but is not producing a pulse). Per the same note, Patient 1 expired despite resuscitative efforts. Patient 1's death was pronounced on 10/19/13 at 5:00 P.M.

An interview with RN 1 was conducted on 10/25/13 at 9:35 A.M. RN 1 stated that she recalled caring for Patient 1, as his primary ED nurse on 10/19/13. She remembered talking to Patient 1 before she went on her afternoon break which was at a little after 4:00 P.M. She referred to her documentation at 3:55 P.M. and said that at this time, she knew that Patient 1 was not on a cardiac monitor, the monitor was not on, the cables that connect the patient to the cardiac monitors were on the mayo stand (a metal table) and the room was dark. She confirmed that there was a cardiac monitoring order by the physician for Patient 1. She acknowledged that she did not follow the physician's orders when she did not place Patient 1 back on his cardiac monitor when she identified that he was not connected and the cardiac monitoring for the patient was not in place.

A telephone interview with the attending physician (Physician 2) was conducted on 10/25/13 at 1:30 P.M. Physician 2 stated that the first time he had seen Patient 1 was when the code blue was called. He stated that when he arrived to the room, Patient 1 was actively being placed on monitors. He stated that this was very concerning, a "horrible case" and that it "greatly disturbed" him that Patient 1 was not on a cardiac monitor. He said that ideally, if Patient 1 was on a cardiac monitor, the ED staff may have been alerted sooner of the patient's deterioration which could have led to a better chance of resuscitating the patient.

An interview with RN 2 was conducted on 10/28/13 at 9:07 A.M. RN 2 stated that she was the break nurse who was caring for Patient 1 on 10/19/13. She stated that she had received a verbal report (handoff communication) from RN 1. According to RN 2, RN 1 had told her that there was a central line placement in progress in room 8A, the rest of her patients were stable and to look out for orders from ED physicians. RN 1 had left for her break at 4:25 P.M. RN 2 stated that at 4:26 P.M., she noted new physician's orders that indicated that Patient 1 was going to be admitted . She stated that she looked at the central telemetry monitoring at the nurse's station and noted that there were no readings found on Patient 1. She explained that she went into room 8B, the lights were dim, Patient 1 was not interacting even after introductions, the patient's body was shifted to the left side, his eyes were open but he was unresponsive. She stated that she performed a sternal stimuli and still did not get a response. She checked his pulse and found him pulseless but the patient was still warm. RN 2 recalled that Patient 1's cardiac monitor was on, but on standby and not connected to the patient. She said that the cables that connected Patient 1 to the cardiac monitor were located on the hooks beneath the base of the monitor.

On 10/28/13 at 10:54 A.M., an observation in the ED was made with the Director of Emergency Services (DED) and QCS 1. Room 8 was divided into two bedsides: 8A and 8B. Patient 1 had been admitted into room 8B. The bed was located on the right hand side of the room (when facing room from doorway). The cardiac monitor was located on the upper left side of the bed (at the head of the bed) with hooks beneath the base of the monitor. There was no mayo table noted in the room during this time.

A review of the Hospital's ED Standards of Patient Care, dated fiscal year (FY) 2012/2013, was conducted on 12/28/13. The ED Standards entitled "Cardiovascular Assessment Standard" under assessment/data, indicated that "Cardiac rhythms will be assessed and documented via bedside cardiac monitors on patients, regardless of age, as indicated by the patient's chief compliant or clinical presentation including: a. chest pain ...." Per this same section, it stipulated to assess cardiac pain, conduct rhythm analysis and rate. Within the interventions and documentation section, it stipulated to "Place patient on cardiac monitoring, assess and document heart rate and rhythm. Alarms will be set, on and audible." According to the Cardiovascular: Hemodynamics and ECG (electrocardiogram - records of electrical signals as they travel through the heart) Monitoring Standard, patients "will be diagnosed and treated according to accurate analysis of ECG and hemodynamic indices." Per the same section, it read "The patient will be free of complications related to hemodynamic monitoring."

An interview with the ED Nurse Manager (EDNM) was conducted on 10/28/13 at 2:08 P.M. The EDNM stated that the nursing staff in the ED were expected to follow physician's orders and the Hospital's ED Standards of Patient Care. She acknowledged that RN 1 did not follow Patient 1's physician's orders nor did she implement the Hospital's ED Standards, after she identified that the patient was no longer connected to the cardiac monitor.

Patient 1 did not receive care in a safe setting when ED staff did not ensure that the patient was being monitored in accordance with physician's orders and ED Standards of Patient Care.
2. A review of Patient 2's medical record was conducted on 10/23/13 at 8:50 A.M. Patient 2 was admitted to Hospital A's ED on 10/20/13 for medical clearance from another facility per the ED Note dated 10/20/13 at 5:28 A.M. According to Progress Notes dated 10/20/13 at 1:57 P.M., Patient 2 "was seen and no longer meets criteria for a legal hold". Per the same note, Patient 2 "will be discharged to home".

A physician order dated 10/20/13 at 1:38 P.M., read "Remove all peripheral IV (intravenous - in the vein) lines prior to discharge; discharge patient to home".

According to Patient 2's Patient Care Timeline in the ED dated 10/20/13, there was documentation that Registered Nurse (RN 3) acknowledged the physician's orders that read "discharge patient to home" on 10/20/13 at 1:39 P.M. However, per the same Timeline, Patient 2 was transported via ambulance to another facility on 10/20/13 at 2:01 P.M. rather than being discharged to home.

An interview with RN 3 was conducted on 10/25/13 at 10:40 A.M. RN 3 stated that she acknowledged the physician's order that instructed her to discharge Patient 2 to home; however, she made a mistake, and had the patient transported via ambulance to another facility.

A review of the Hospital's Emergency Department Standards of Patient Care dated fiscal year (FY) 2012/2013 was conducted on 10/25/13. The ED Standards of Care indicated that "Prior to patient discharge from the Emergency Department, the nurse will check all physicians' orders and instructions, making certain they have been completed and signed off."

An interview with Physician 4 was conducted on 10/25/13 at 11:02 A.M. Physician 4 stated that when it was determined that Patient 2 no longer met the criteria for a legal hold and was medically cleared, she wrote an order to discharge the patient to home. However, she acknowledged that RN 3 discharged Patient 2 from Hospital A's ED and had him transported via an ambulance to another facility.

An interview with the ED Nurse Manager (EDNM) was conducted on 10/28/13 at 2:08 P.M. The EDNM stated that the nurses in the ED were expected to follow physician's orders in accordance with the Hospital's ED Standards of Care. She acknowledged that RN 3 made a mistake when she had Patient 2 transported via ambulance to another facility, and did not follow the physician's order when it instructed her to discharge patient to home.

3. On 10/23/13 at 3:00 P.M., a tour of Hospital A's ED was conducted with Quality Compliance Specialist (QCS 1) and the charge nurse (CRN 1).

A review of Patient 1's medical record was conducted on 10/23/13 beginning at 4:31 P.M. with QCS 1. Patient 1 was admitted to Hospital A's ED on 10/19/13 per the Admission Face Sheet. According to a Patient Care Timeline in the ED, dated 10/19/13 at 11:35 A.M. to 10/19/13 at 9:20 P.M., there was a physician's order that read "cardiac monitoring - ED patient." The order was prescribed on 10/19/13 at 11:49 A.M. Per the same timeline, on 10/19/13 at 2:40 P.M., Registered Nurse (RN 1) documented that Patient 1 was on a cardiac monitor with normal sinus rhythm (a normal heart rhythm).

Per RN 2's documentation, on 10/19/13 at 4:27 P.M., Patient 1 was found unresponsive and pulseless and, not on a telemetry or blood pressure monitor and oxygen probe. From 10/19/13 at 2:45 P.M. to 4:27 P.M., there was no documented evidence found in the medical record to demonstrate that Patient 1 was on a cardiac monitor per the physician's order.

On 10/23/13 at 9:11 P.M., the Department was notified in writing via a facsimile (fax) from the Director of Regulatory Affairs (DRA) that the hospital may have identified an adverse event. The DRA documented that on 10/19/13 at 4:27 P.M., Patient 1 "was found lying on the gurney unresponsive, pulseless and not breathing." Per the DRA, code blue was called, initiated but at 5:07 P.M., Patient 1 had expired.

An interview with the ED Nurse Manager (EDNM) was conducted on 10/25/13 at 2:28 P.M. The EDNM stated that she had received a phone call from the ED charge nurse (RN 4) on 10/19/13 between 5:00 P.M. and 6:00 P.M. about Patient 1 who presented to the ED with a chief complaint of chest pain, was found unresponsive and pulseless with no evidence of cardiac monitoring by the break nurse. She stated that RN 4 informed her that a code blue was called, initiated and even after resuscitative efforts, Patient 1 had expired. She stated that she knew that an EQVR (Electronic Quality Variance Report - web based event reporting system used by the hospital; the event reporting process supports a data-driven patient safety program) had been generated, an email sent to her regarding this subject matter and decided that she would "look into" what happened to Patient 1 on 10/21/13. The EDNM stated that she did not notify her supervisor, the Director of Emergency Services (DED). She acknowledged that she did not follow the hospital's Chain of Command policy when she did not notify the DED about a patient in the ED who was found unresponsive and pulseless without evidence of cardiac monitoring as ordered by the physician.

A review of the hospital's policy entitled "Chain of Command", dated 10/17/13, was conducted on 10/25/13. The policy defined Chain of Command as "... in healthcare refers to an authoritative structure established to resolve administrative, clinical, or other patient safety issue by allowing healthcare staff and physicians to present an issue(s) of concern through the line of authority until resolution is reached." Per the same policy, it stipulated that "When a team member is aware of a potential or actual issue, the team member is accountable for:

* Making attempts to prevent or resolve the issue (within their scope
of responsibility.)
* If unresolved, the team member shall contact their immediate
supervisor to alert them to the potential or actual issue.
* If still unresolved, the team member should notify the next level
of command and/or the Administrator-On-Call.
* If still unresolved, the team members should notify successively
higher levels of command until a satisfactory resolution is
achieved...."

According to the hospital's policy entitled "Sentinel Event and Significant Adverse Events", dated 8/15/13, was conducted on 10/25/13. The policy indicated that the hospital "... will identify and respond appropriately to all Sentinel Events and Significant Adverse Events occurring in the organization or associated with services the organization provides." Per the same policy, it stipulated that "Appropriate response includes:

1. Early response strategies
2. Identification and timely notification
3. Thorough investigation
4. Action plan development to reduce risk of reoccurrence
5. Implementation of improvements
6. Monitoring the effectiveness of those improvements; and
7. Reporting to required agencies"

An interview with the Director of Emergency Services (DED) was conducted on 10/28/13 at 9:44 A.M. The DED stated that she was notified on 10/21/13 about had happened to Patient 1, the patient who presented to the ED with a chief complaint of chest pain, was found unresponsive and pulseless with no evidence of cardiac monitoring. She stated she had also spoken to the EDNM "late Monday" (10/21/13), the EDNM had said to her "I made a mistake, I should have used the chain of command." The DED stated that the EDNM should have used her chain of command which was to notify her of the ED incident involving Patient 1, in accordance with the hospital's policy. She stated that the purpose of using one's chain of command was to seek further guidance or direction from supervisors who may identify a need to "implement something to ensure patient safety."

The EDNM did not implement the hospital's Chain of Command policy to ensure that required levels of leadership were notified and aware of the events surrounding Patient 1's death, in an effort to ensure that appropriate response strategies and monitoring were put into place for patient safety in the ED.

4. On 10/23/13 at 2:50 P.M., a complaint investigation related to the quality of care and treatment in the ED was initiated at Hospital A.

On 10/23/13 at 3:00 P.M., a tour of the ED was conducted with Quality Compliance Specialist (QCS 1) and the charge nurse (CRN 1). Multiple doors were closed and curtains pulled as patient care and treatments were in progress.

A review of Patient 1's medical record was conducted on 10/23/13 beginning at 4:31 P.M. with QCS 1. Patient 1 was admitted to Hospital A's ED on 10/19/13 per the Admission Face Sheet. According to a Patient Care Timeline in the ED, dated 10/19/13 at 11:35 A.M. to 10/19/13 at 9:20 P.M., there was a physician's order that read "cardiac monitoring - ED patient." The order was prescribed on 10/19/13 at 11:49 A.M. Per the same timeline, on 10/19/13 at 2:40 P.M., Registered Nurse (RN 1) documented that Patient 1 was on a cardiac monitor with normal sinus rhythm (a normal heart rhythm).

Per RN 2's documentation, on 10/19/13 at 4:27 P.M., Patient 1 was found unresponsive and pulseless and, not on a telemetry or blood pressure monitor and oxygen probe. From 10/19/13 at 2:45 P.M. to 4:27 P.M., there was no documented evidence found in the medical record to demonstrate that Patient 1 was on a cardiac monitor per the physician's order.

According to a Death Note dated 10/19/13 at 6:07 P.M., Physician 1 documented that a code blue was called on Patient 1 at 4:30 P.M. and was found to be in PEA (pulseless electrical activity - a heart rhythm is observed on the monitor but is not producing a pulse). Per the same note, Patient 1 expired despite resuscitative efforts. Patient 1's death was pronounced on 10/19/13 at 5:00 P.M.

On 10/23/13 at 5:24 P.M., a group interview was conducted with the Chief Nursing Officer (CNO), Chief Medical Officer (CMO), the Director of Performance Improvement (DPI), the Director of Regulatory Affairs (DRA), and QCS 1. According to the DPI, there were a total of 3 EQVRs (Electronic Quality Variance Report - web based event reporting system used by the hospital; the event reporting process supports a data-driven patient safety program) that were generated with regards to what had happened to Patient 1 in the ED. The CMO stated that the hospital's immediate action plan, in response to Patient 1 being found unresponsive and pulseless with no evidence of cardiac monitoring, was being implemented that afternoon on 10/23/13 which was 5 days after the patient death. When the group was asked about any additional action plans that had been implemented as they investigated Patient 1's incident, in an effort to ensure patient safety in the ED, the CMO stated that, on 10/21/13, they determined which ED staff needed to be interviewed to immediately begin the hospital's internal investigation of what may have happened to Patient 1. The CMO acknowledged that the implementation of an immediate action plan occurred on 10/23/13, 5 days after the incident.

According to the hospital's policy entitled "Sentinel Event and Significant Adverse Events", dated 8/15/13, was conducted on 10/25/13. The policy indicated that the hospital "... will identify and respond appropriately to all Sentinel Events and Significant Adverse Events occurring in the organization or associated with services the organization provides." Per the same policy, it stipulated that "Appropriate response includes:

1. Early response strategies
2. Identification and timely notification
3. Thorough investigation
4. Action plan development to reduce risk of reoccurrence
5. Implementation of improvements
6. Monitoring the effectiveness of those improvements; and
7. Reporting to required agencies"

On 10/23/13 at 9:11 P.M., the Department was notified in writing via a facsimile (fax) from the DRA that the hospital may have identified an adverse event. The DRA documented that on 10/19/13 at 4:27 P.M., Patient 1 "was found lying on the gurney unresponsive, pulseless and not breathing." Per the DRA, code blue was called, initiated but at 5:07 P.M., Patient 1 had expired.

The hospital did not implement early response strategies to this patient's death in the ED per it's own Sentinel Event and Significant Adverse Event Policy to ensure appropriate patient safety measures were in place, and to prevent a recurrence.

5. On 10/23/13 at 3:00 P.M., a tour of Hospital A's ED was conducted with Quality Compliance Specialist (QCS 1) and the charge nurse (CRN 1). Multiple doors were closed and curtains pulled as patient care and treatments were in progress.

A review of Patient 1's medical record was conducted on 10/23/13 beginning at 4:31 P.M. with QCS 1. Patient 1 was admitted to Hospital A's ED on 10/19/13 per the Admission Face Sheet. According to a Patient Care Timeline in the ED, dated 10/19/13 at 11:35 A.M. to 10/19/13 at 9:20 P.M., there was a physician's order that read "cardiac monitoring - ED patient." The order was prescribed on 10/19/13 at 11:49 A.M. Per the same timeline, on 10/19/13 at 2:40 P.M., Registered Nurse (RN 1) documented that Patient 1 was on a cardiac monitor with normal sinus rhythm (a normal heart rhythm).

Per RN 2's documentation, on 10/19/13 at 4:27 P.M., Patient 1 was found unresponsive and pulseless and, not on a telemetry or blood pressure monitor and oxygen probe. From 10/19/13 at 2:45 P.M. to 4:27 P.M., there was no documented evidence found in the medical record to demonstrate that Patient 1 was on a cardiac monitor per the physician's order.

An interview with RN 1 was conducted on 10/25/13 at 9:35 A.M. RN 1 stated that she recalled caring for Patient 1, as his primary ED nurse on 10/19/13. She remembered talking to Patient 1 before she went on her afternoon break which was at "a little after 4:00 P.M." She referred to her documentation at 3:55 P.M. and said that at this time, she knew that Patient 1 was not on a cardiac monitor, the monitor was not on, the cables that connect the patient to the cardiac monitors were on the mayo stand (a metal table) and the room was dark. She stated that she had given RN 2 (the break nurse) a verbal report (handoff communication) regarding her 4 patients.

A review of the hospital's policy entitled "Patient Handoff Communication", dated 10/17/13, was conducted on 10/28/13. The policy defined handoff communication as "A contemporaneous, interactive process of passing patient-specific information from one caregiver to another or from a team of caregivers to another for the purpose of ensuring the continuity and safety of the patient's care." Per the policy, it instructed that "... handoff communications must provide accurate information about the patient, patient care, treatment and services, current condition and any recent or anticipated changes." According to the policy, there were standard elements which were always required and included in all handoff communications, whether the handoff was direct (person-to-person), telephonic or written. The handoff stand elements were as follows:

1) Patient Name and date of birth or health record number.
2) Responsible physician name and managing service.
3) Pertinent medical history including:
a. Diagnosis.
b. Current condition.
c. Anticipated changes in condition or treatment.
d. What to watch for in the next interval of care.
e. Collaborative review of medications.

The policy indicated that this was an interactive process that allowed caregivers (staff) the ability to ask questions and have questions answered. Per the same policy, it described how handoff communication responsibilites were performed during but not limited to the following:

1) Admissions
2) Shift-to-shift reports
3) Relief of staff for breaks
4) Transports for diagnostic tests
5) Unit-to-unit transports
6) Physician/resident transferring responsibility of care
7) Transfers to the ED from ambulatory care areas, excluding 911,
ambulance and paramedic transports.

An interview with RN 2 was conducted on 10/28/13 at 9:07 A.M. RN 2 stated that she was the break nurse who cared for Patient 1 on 10/19/13. She stated that she had received a verbal report (handoff communication) from RN 1. According to RN 2, RN 1 had told her that there was a central line placement in progress in room 8A, the rest of her patients were stable and to look out for orders from ED physicians. RN 1 left for her break at 4:25 P.M. RN 2 acknowledged that the verbal report (handoff communication) that she had received from RN 1 did not contain all the required elements of handoff communication in accordance with the hospital policy. In addition, RN 2 failed to ask further questions of RN 1 to ensure that she received a complete report on Patient 1's status.

On 10/29/13 at 2:08 P.M., the Director of Emergency Services (DED) acknowledged that the hospital's policy was not followed when a verbal report of 4 patients in the ED, inclusive of Patient 1 was given by RN 1 to RN 2, did not contain all the required elements of a handoff communication.

6. A review of Patient 1's medical record was conducted on 10/23/13 beginning at 4:31 P.M. with QCS 1. Patient 1 was admitted to Hospital A's ED on 10/19/13 per the Admission Face Sheet. According to a Patient Care Timeline in the ED, dated 10/19/13 at 11:35 A.M. to 10/19/13 at 9:20 P.M., there was a physician's order that read "cardiac monitoring - ED patient". The order was prescribed on 10/19/13 at 11:49 A.M. Per the same timeline, on 10/19/13 at 2:40 P.M., Registered Nurse (RN 1) documented that Patient 1 was on a cardiac monitor with normal sinus rhythm (a normal heart rhythm).

Per RN 2's documentation, on 10/19/13 at 4:27 P.M., Patient 1 was found unresponsive and pulseless and, not on a telemetry or blood pressure monitor and oxygen probe. From 10/19/13 at 2:45 P.M. to 4:27 P.M., there was no documented evidence found in the medical record to demonstrate that Patient 1 was on a cardiac monitor per the physician's order. There was also no documented evidence that rhythm strips before and during the code were printed and attached to Patient 1's medical record.

According to a Death Note dated 10/19/13 at 6:07 P.M., Physician 1 documented that a code blue was called on Patient 1 at 4:30 P.M. who was found to be in PEA (pulseless electrical activity - a heart rhythm is observed on the monitor but is not producing a pulse). Per the same note, Patient 1 expired despite resuscitative efforts. Patient 1's death was pronounced on 10/19/13 at 5:00 P.M.

An interview with RN 2 was conducted on 10/28/13 at 9:07 A.M. RN 2 stated that she was the break nurse who cared for Patient 1 on 10/19/13. She stated that she found Patient 1 unresponsive, pulseless and not on a telemetry monitor, blood pressure monitoring and an oxygen probe on 10/19/13 at 4:27 P.M. She stated that she called for help and a code blue was initiated. During a code, she explained that the ED staff ran their own internal codes within in their department. She stated that the Attending Physician ran the code, unless another physician had been designated for the role. She explained that all the staff involved in the code, had a role to perform and was clearly designated and announced. She stated that typically the primary nurse or the charge nurse will take the lead during a code to ensure that roles where assigned and designated accordingly. She stated that the ED staff followed their ART (Advanced Resuscitation Training - the hospital's equivalent to advanced cardiac life support training for their healthcare providers in the ED; a set of clinical interventions for the urgent treatent of cardiac arrest and other life threatening medical emergencies, as well as the knowledge and skills to deploy those interventions) Training. RN 2 stated that as the nurse responsible for Patient 1 during the code, it was her responsibility to ensure that rhythm strips were printed and attached to Patient 1's medical record.

A review of the hospital wide policy entitled "Code Blue -- Adult/Pediatric", dated 6/20/13, was conducted 10/28/13. The policy indicated that "Role Responsibilities:...Code Blue RN...Attaches patient to monitor...Identifies rhythm and all changes in rhythn. Obtains rhythm strip for the code and places it in the hard copy chart." Per the same policy, it also indicated that "In telemetry monitored units documents pre-code ECG rhythm strip in the patient's medical record."

An interview was conducted with the Director of Emergency Services (DED) on 10/29/13 at 11:40 A.M. The DED stated that the hospital did not have a written process like a policy and procedure specific to the code blue process in the ED. She stated that the ED staff ran their own internal code blues within the department. She explained that ED staff who participated in code blues in the ED were trained with the hospital's ART and BART (basic advanced resuscitation training) Training, which was the equivalent to advanced cardiac life support and basic life support. She explained that the hospital wide policy related to code blue did not contain specific information regarding the role of the responders for the code blue in the ED. She stated that it was her expectation that the primary nurse or code nurse was responsible for ensuring that the cardiac rhythm strips after a code were printed and attached with the patient's hard copy medical record. She acknowledged that there was no evidence found in the Patient 1's medical record that cardiac rhythm strips were printed and attached after his code on 10/19/13.

7. A review of Patient 1's medical record was conducted on 10/23/13 beginning at 4:31 P.M. with QCS 1. Patient 1 was admitted to Hospital A's ED on 10/19/13 per the Admission Face Sheet. According to a Patient Care Timeline in the ED, dated 10/19/13 at 11:35 A.M. to 10/19/13 at 9:20 P.M., there was was documentation