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 March 8, 2011
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview, record and document review, the facility's Governing Body failed to provide a safe environment for 2 sampled patients (1,2), which may have contributed to the unexpected cardio-pulmonary arrest of Patient 1 outside the Emergency Department of Hospital A; and failed to provide a safe environment for Patient 2 in the ED of Hospital B, which may have contributed to the suicide of Patient 2. The Governing Body also failed to maintain full oversight for the thorough investigation of these two adverse events, and failed to maintain full oversight for the implementation of an effective action plan to ensure that the above events did not recur.

The facility had 546 licensed beds.
The facility was comprised of two acute care campuses, Hospital A and Hospital B. Hospital A was the main hospital with 360 acute care beds. Hospital B had 119 acute care beds. The combined acute care patient census between the two campuses during day one of the complaint validation survey was 404 with 288 acute care patients at Hospital A and 116 acute care patients at Hospital B.

Findings:

1. The Governing Body failed to ensure that the hospital provided a safe environment during the discharge process of Patient 1 outside the Emergency Department of Hospital A; and failed to ensure that the hospital provided a safe environment for Patient 2 while being treated in the ED of Hospital B.
(A tag 144 #1, #2)

2. The Governing Body failed to ensure that an effective quality assessment and performance improvement program (QAPI) was implemented when a thorough and credible Root Cause Analysis was not conducted following the suicide of Patient 2 while a patient in the Emergency Department of Hospital B.
(A tag 287 #1, A tag 290)

3. The Governing Body failed to maintain full oversight and responsibility for the management of a thorough and complete investigation of the events surrounding the cardio-pulmonary arrest of Patient 1 outside of the Emergency Department of Hospital A.
(A tags 287 #2, A tag 1103 #2)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Governing Body.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observation, interview and record review, the hospital failed to provide an emotionally and physically safe environment for two sampled patients (1, 2). The hospital also failed to adequately train the security agents, who were occasionally assigned to monitor suicidal patients in the waiting rooms of the Emergency Departments. In addition, the protected health information of three non-sampled patients (21,22,23), was not safeguarded. And, the hospital did not ensure that their policy and procedures related to the safe use of restraints were implemented for five sampled patients (31,41,42,43,44) in restraints.

Findings:

1. Hospital A failed to provide an emotionally and physically safe environment for Patient 1 during the discharge process from the Emergency Department (ED), which may have contributed to Patient 1 sustaining a cardio-pulmonary arrest outside of the ED.
(A tag 144 #1)

2. Hospital B's Emergency Department (ED) failed to establish and implement an increased level of observation for Patient 2 who was admitted to the ED following a suicide attempt, which may have contributed to Patient 2's suicide while a patient in the ED.
(A tag 144 #2)

3. Hospital A and Hospital B failed to adequately train the security agents who were occasionally assigned to monitor suicidal patients in the waiting rooms of both Emergency Departments.
(Tag 144 #4)

4. Hospital A failed to safeguard the protected health information of three patients (21, 22, 23).
(A tag 147)

5. Hospital A failed to ensure that the hospital's policy and procedures on the safe use of restraints were implemented for five patients (31, 41, 42, 43, 44).
(A tag 166)
(A tag 167 #1, #2, #3)
(A tag 168 #1, #2)
(A tag 175 #1, #2, #3)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Patient Rights.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on observation, interview and record review, a Registered Nurse (RN) in the Emergency Department (ED) at Hospital A failed to perform and document a focused assessment within the 2 hour time frame established by the ED Standards of Patient Care, for Patient 24 who was admitted to the ED verbalizing depression and suicidal intent. In addition, RNs in the ED of Hospital A failed to reassess the needs of a patient during the discharge process (Patient 1). And, the ED RN Manager failed to implement the hospital's policy and procedure pertaining to employee corrective action.

Findings:

1. On 2/22/11 at 2:30 P.M., a tour of Hospital A's ED was conducted. Per Medical Doctor (MD) 21, there were 2 patients in the ED at that time with diagnoses of suicidal ideation.

On 2/22/11 at 2:45 P.M. a review of Patient 24's record revealed that he was triaged on 2/22/11 at 12:10 P.M. The patient verbalized depression and suicidal intent and was determined to be a triage acuity level 1. According to the ED triage policy, a triage acuity level 1 was defined as "critical, an illness or injury where there is potential for loss of life or limb; and requires immediate medical intervention to prevent death or permanent disability."

Per the Triage Record, Patient 24 was moved to the hallway bed/gurney at 12:18 P.M.

On 2/22/11 at 3:00 P.M., Patient 24 was observed lying on a gurney in the ED's hallway. According to the ED Nurse Manager (NM), Patient 24 was assigned to RN 21.

On 2/22/11 at 3:00 P.M., approximately 2 hours and 45 minutes after the patient was placed in an ED hallway bed, there was no evidence in the record that RN 21's assessment of Patient 24 had been conducted.

The Director of Emergency Services (DES) stated, on 2/22/11 at 3:05 P.M., that RNs were required to complete a focused assessment of a patient within 2 hours.

The Emergency Department Standards of Patient Care dated 2010, documented that "The patient focused assessment will be completed within 2 hours of the patient being placed in a patient care delivery area." The patient focused assessment was to include as appropriate: "physical findings, psychological status, educational needs and barriers, and discharge planning needs."

On 2/22/11 at 3:05 P.M., an interview was conducted with RN 21. Per RN 21, she was very busy with her other patients and had not had a chance to complete a focused assessment on Patient 24. According to RN 21 she was unaware if Patient 24 had been assessed or cleared by psychiatry as of that time, and was unaware of the plan for the patient. RN 21 acknowledged that the focused assessment of the patient should have been completed within 2 hours per the ED policy and procedure.





2. A review of Patient 1's medical record was conducted on 1/6/11 at 4:00 P.M. Patient 1 was admitted to Hospital A's ED on 3/24/10 for the treatment of a hard palate superficial ulceration after sustaining a burn to the roof of her mouth according to the ED MD notes.

According to a nursing note written by Registered Nurse (RN 2), dated 3/24/10 and timed at 2:20 P.M., Patient 1 "refused to leave initially and to sign paperwork...was escorted from ED w (with) security, walking w out assistance." However, there was no documentation in the ED nursing notes in regards to why Patient 1 did not want to leave the ED.

A telephone interview was conducted with Patient 1's home health caregiver on 1/7/11 at 10:55 A.M. The caregiver stated that Patient 1 told her that she did not want to leave the ED because she could not breathe. Patient 1 further stated that she did not want to go home because she did not feel well.

On 2/17/11 at 4:05 P.M. an interview was conducted with RN 1 who was the ED discharge RN for Patient 1 on 3/24/10. RN 1 did not remember if Patient 1 told her why she did not want to leave the ED However, RN 1 did state that she thought that Patient 1 had significant lung problems. RN 1 believed that Patient 1 had COPD (Chronic Obstructive Lung Disease). A review of Patient 1's medical records from four previous hospitalization s at Hospital A verified that Patient 1 had been diagnosed with COPD and obesity hypoventilation (inadequate ventilation).

An interview was conducted with the ED Charge RN (ECRN 1) on 2/23/11 at 1:47 P.M. The ECRN 1 thought that the Security Agents, EDT 1, and he escorted Patient 1 out of the ED. Patient 1 walked 30 to 50 yards to the bench at the loop (an area outside the ED for taxi cabs to pull up). When the taxi cab arrived Patient 1 resisted being placed in the cab. ECRN 1 stated that he made the decision to take Patient 1 out of the taxi cab. ECRN 1, EDT 1, and Security Agent 1 carried Patient 1 prone (face down) halfway to the bench and placed the patient on the cement on her stomach. ECRN 1 then got on the phone and called the ED Nurse Manager (EDNM). When the EDNM arrived she assessed the patient. Patient 1 was not breathing and had no detectable pulse. CPR was initiated.

A security surveillance video tape scanning the loop area at the time of the incident was observed with the Director of Regulatory Affairs (DRA) and the Director of Emergency Services (DES) on 2/17/11 at 3:00 P.M. According to the timer on the video screen, Patient 1 was lying prone on the cement sidewalk for approximately 3 1/2 to 4 minutes. The DRA and DES verified the calculated time that the patient was prone. There was no evidence on the video tape that any attempt was made to evaluate or assess Patient 1 until the ED Case Manager and ED RN Manager arrived.

3. A review of Patient 1's medical record was conducted on 1/6/11 at 4:00 P.M. Patient 1 was admitted to Hospital A's ED on 3/24/10 for the treatment of a hard palate superficial ulceration after sustaining a burn to the roof of her mouth according to the ED MD notes.

According to a nursing note, dated 3/24 and timed at 2:20 P.M., Patient 1 "refused to leave initially and to sign paperwork...was escorted from ED w (with) security, walking w out assistance."

An interview was conducted with the ED Charge RN (ECRN 1) on 2/23/11 at 1:47 P.M. The ECRN 1 thought that the Security Agents, EDT 1, and he escorted Patient 1 out of the ED. Patient 1 walked 30 to 50 yards to the bench at the loop (an area outside the ED for taxi cabs to pull up). When the taxi cab arrived, Patient 1 resisted being placed in the cab. ECRN 1 stated that he made the decision to take Patient 1 out of the taxi cab. ECRN 1, EDT 1, and Security Agent 1 carried Patient 1 prone (face down) halfway to the bench and placed the patient on the cement on her stomach. ECRN 1 then got on the phone and called the ED Nurse Manager (EDNM). When the EDNM arrived she assessed the patient. Patient 1 was not breathing and had no detectable pulse. CPR was initiated.

On 1/14/11 at 2:45 P.M., an interview was conducted with the EDNM. The EDNM stated that she had no involvement with Patient 1 prior to being called by ECRN 1. When she arrived at the loop area she saw two security agents, EDT 1, and the ECRN 1. Patient 1 was lying face down. The ED RN Manager stated that she was a little surprised and upset to see Patient 1 lying prone on the sidewalk outside the ED. After the incident the EDNM spoke to ECRN 1. ECRN 1 was counseled by being told that the prone position was not a safe position for an obese person to be placed in due to the potential for respiratory compromise.

According to the hospital's policy and procedure entitled "Corrective Action, Discipline, and Discharge," "a counseling memorandum shall be placed in the nurse's personnel record."

Another interview was conducted with the EDNM on 2/23/11 at 2:35 P.M. The EDNM again stated that she discussed the incident with ECRN 1 that same day regarding the possibility that the respiratory arrest may have occurred because of Patient 1 being in the prone position which could cause respiratory compromise. The EDNM was aware that the hospital policy and procedure was to document verbal counseling in the employees personnel file. A review of ECRN 1's personnel file revealed no evidence of verbal counseling on 3/24/10.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure effective continuum of care occurred when Patient (2) arrived at Hospital B's Emergency Department (ED) after she attempted suicide but was not assigned an RN for 1 hour and 32 minutes after her arrival. In addition, the hospital failed to ensure that effective nursing communication occurred when a handoff report did not take place between two RNs regarding the management of Patient 2.

Findings:

1. A review of Patient 2's medical record was conducted on 2/4/11 at 4:30 P.M. Patient 2 was admitted on [DATE] after having attempted suicide by cutting her wrists according to the ED Triage Record.

Patient 2 arrived at the ED of Hospital B via ambulance at 5:28 P.M. Patient 2 was placed on gurney T-16 upon arrival. T-16 is a gurney located in the hallway. Patient 2's initial nursing assessment was conducted by Registered Nurse (RN 2) at 6:12 P.M. It was documented in the initial nursing assessment that Patient 2 had expressed suicidal ideation/intent. RN 2 also documented in the nursing notes that "pt states to me 'I just want to die'...placed in front of nursing station for continuous monitoring. assure pt. (patient) that she is in a safe place. will continue to observe."

An interview was conducted with RN 2 on 2/11/11 at 2:10 P.M. RN 2 stated that she worked 11:00 A.M. to 11:00 P.M. on 2/2/11. RN 2 was assigned to patients in ED Rooms 8, 9, 10, 11. At 7:00 P.M. RN 2's assignment changed to patients in ED Rooms 8, 9, 10, 15. RN 2 stated that she was not assigned to Patient 2 who was on gurney 16 in the hallway. However, RN 2 did acknowledge that she conducted the initial nursing assessment on 2/2/11 at 6:12 P.M. Patient 2 was admitted to the ED at 5:28 P.M. RN 2 thought that the ED Charge RN (ECRN 2) may have been assigned to care for Patient 2.

On 2/11/11 an interview was conducted with RN 4 at 4:15 P.M. RN 4 stated that Patient 2 asked her for a phone to call her friend. RN 4 gave Patient 2 a cordless phone to call her friend. RN 4 stated that she was not assigned to care for Patient 2. It was documented in the ED nursing notes that RN 4 gave a verbal report to ECRN 2 at 7:09 P.M. on 2/2/11.

An interview was conducted with ECRN 2 on 3/2/11 at 11:20 A.M. ECRN 2 stated that she conducted the triage for Patient 2 upon her arrival to the ED. She stated that RN 2 did the initial nursing assessment and RN 4 was also involved in Patient 2's care. ECRN 2 stated that she thought that at 7:00 P.M. on 2/2/11 she officially became Patient 2's nurse. Patient 2 arrived in the ED at 5:28 P.M. but was not assigned an RN for 1 hour and 32 minutes after her arrival. Therefore, there was no means to ensure that Patient 2 actually had continuous monitoring without having been assigned to a specific RN. There was no RN assigned to Patient 2 to implement her plan of care or to officially assume the responsibility for her care until 7:00 P.M. on 2/2/11.

2. A review of Patient 2's medical record was conducted on 2/4/11 at 4:30 P.M. Patient 2 was admitted on [DATE] after having attempted suicide by cutting her wrists according to the ED Triage Record.

Patient 2 arrived at the ED of Hospital B via ambulance at 5:28 P.M. Patient 2 was placed on gurney T-16 upon arrival. T-16 is a gurney located in the hallway. There was a nursing note present , dated 2/2/11 and timed 7:19 P.M., that a verbal report was given to ECRN 2 by RN 4 when ECRN 2 assumed the care of Patient 2. Another nursing note written by RN 5, on 2/2/11 at 8:25 P.M., indicated that RN 5 assumed the care of Patient 2 when ECRN 2 moved Patient 2 to Room 7.

A review of the hospital's policy and procedure entitled "Patient Handoff Communication" revealed that the definition of Patient Handoff is a "transfer of responsibility between one caregiver and another caregiver." And that the "primary objective of patient handoff communication is to provide up-to-date, accurate information about a patient's care, treatment and services, current condition and any recent or anticipated changes."

An interview was conducted with RN 5 on 2/11/11 at 1:55 P.M. RN 5 stated that usually there is a report or handoff that occurs when a patient is moved from a hallway gurney to an ED room. RN 5 further stated that she did not receive any report or hand-off from ECRN 2 when she moved Patient 2 from the hallway gurney 16 to room 7.

On 3/2/11 at 11:20 A.M. an interview was conducted with ECRN 2. ECRN 2 stated that she could not remember if she gave a report or handoff regarding Patient 2 to RN 5 when she assumed the care of Patient 2.

During the interview with RN 5, RN 5 stated that she never went into room 7 between the time that Patient 2 was moved (at 8:25 P.M.) and the time that Patient 2 was discovered not breathing, with no pulse, on the floor of room 7 with her oxygen tubing and temperature probe tubing wrapped tightly around her neck (at 8:42 P.M.).
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to provide an emotionally and physically safe environment for 2 of 2 sampled patients (1,2). Patient 1 sustained a cardio-pulmonary arrest while being escorted from the Emergency Department (ED) of Hospital A; and, Patient 2 committed suicide while a patient in the ED of Hospital B. In addition, the hospital failed to develop consistent, clear, and thorough procedures and guidelines pertaining to the management of suicide risk patients.

Findings:

1. A review of Patient 1's medical record was conducted on 1/6/11, at 4:00 P.M. Patient 1 was admitted to Hospital A's ED on 3/24/10 for the treatment of a hard palate superficial ulceration after sustaining a burn to the roof of her mouth according to the ED physician notes.

According to a nursing note, written by Registered Nurse 1 (RN 1), dated 3/24/10 and timed at 2:20 P.M., Patient 1 "refused to leave initially and to sign paperwork...was escorted from ED w (with) security, walking w out assistance."

A telephone interview was conducted with Patient 1's home health caregiver on 1/7/11, at 10:55 A.M., regarding Patient 1's visit to the ED on 3/24/10. The caregiver stated that Patient 1 told her that she did not want to leave the ED because she could not breathe. Patient 1 further stated that she did not want to go home because she did not feel well.

On 1/14/11, an interview was conducted with ED Technician (EDT 1) at 4:45 P.M. EDT 1 stated that after returning from lunch, he went outside of the ED to make a phone call. That's when he saw two security agents (SA) escorting Patient 1 out of the ED. Patient 1 was walking. The ED Charge Registered Nurse (ECRN 1) was present, as well. ECRN 1 told EDT 1 that the plan was to put Patient 1 in a cab to go home. When the two security agents, the ECRN 1, and EDT 1 tried to put Patient 1 in the cab she went limp and put up a fight. The ECRN 1 decided to take Patient 1 out of the cab. Patient 1 was then carried toward a bench and placed prone (lying with the front or face downward) on the sidewalk in front of the bench. EDT 1 stated that this was not the best position for Patient 1 to be in given her anatomy. EDT 1 further explained that by "anatomy" he meant that she was morbidly obese (a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health). EDT 1 stated that Patient 1 was prone for a couple of minutes until they turned Patient 1 over and it was established that she was not breathing.

An interview was conducted with Security Agent 1 on 2/17/11 at 2:15 P.M. SA 1 stated that he was called to ED Room 12 B shortly after 2:00 P.M. When he arrived at Room 12 B in the ED, Patient 1 was refusing to get off of the gurney. Patient 1 said that she was not going to leave. SA 1 never heard Patient 1 say why she did not want to leave. Eventually, Patient 1 got off the gurney and she was escorted by himself and SA 2 to the "loop" which is an area outside the ED where taxi-cabs pull up. SA 1 further stated that a male staff member told the patient that if she did not leave the premises they were going to call the police for trespassing. That statement was repeated to the patient by both of the security agents. SA 1 then explained that Patient 1 sat on the bench at the loop waiting for the taxi cab to arrive. When the taxi cab arrived, they opened the back passenger door. He stated Patient 1 went limp on purpose. They were joined by EDT 1. They were not successful in getting Patient 1 into the taxi cab. The taxi cab driver did not want to take the patient home if she could not help herself. SA 1 recalled Patient 1 saying that she was not leaving but the words were broken because she was short of breath. Patient 1 was hanging half way out of the taxi. It took three people to carry the patient: ECRN 1, EDT 1, and SA 1. Patient 1 was carried face down and placed face down on the cement in front of the bench. About 5 minutes later, the ED Case Manager arrived and suggested that they turn Patient 1 over. When they turned her over, Patient 1's lips were observed to be purple. Cardio-Pulmonary Resuscitation (CPR) was initiated. Patient 1 was then placed on a back board, raised to a gurney and taken back in to the ED.

On 2/17/11, an interview was conducted with RN 1 who was the ED discharge RN for Patient 1 on 3/24/10. RN 1 did not remember if Patient 1 told her why she did not want to leave the ED. However, RN 1 did state that she thought that Patient 1 had significant lung problems. RN 1 believed that Patient 1 had COPD (Chronic Obstructive Lung Disease). A review of Patient 1's medical records from four previous hospitalization s at Hospital A verified that Patient 1 had been diagnosed with COPD and obesity hypoventilation (inadequate ventilation).

A security surveillance video tape scanning the loop area at the time of the incident was observed on 2/23/11, at 10:30 A.M. The video tape supported the details of the incident as described by both EDT 1 and Security Agent 1.

An interview was conducted with the ECRN 1 on 2/23/11 at 1:47 P.M. The ECRN 1 thought that the security agents, EDT 1, and he escorted Patient 1 out of the ED. Patient 1 walked 30 to 50 yards to the bench at the loop. When the taxi cab arrived Patient 1 resisted being placed in the cab. ECRN 1 stated that he made the decision to take Patient 1 out of the taxi cab. ECRN 1, EDT 1, and Security Agent 1 carried Patient 1 prone (face down) halfway to the bench and placed the patient on the cement on her stomach. ECRN 1 then got on the phone and called the ED Nurse Manager (EDNM). When the EDNM arrived she assessed the patient. Patient 1 was not breathing and had no detectable pulse. CPR was initiated.

On 1/14/11, at 2:45 P.M., an interview was conducted with the EDNM. The EDNM stated that she had no involvement with Patient 1 prior to being called by ECRN 1. When she arrived at the loop area she saw two security agents, EDT 1, and the ECRN 1. Patient 1 was lying face down. The EDNM stated that she was a little surprised and upset to see Patient 1 lying prone on the sidewalk outside the ED. After the incident the EDNM spoke to ECRN 1. ECRN 1 was counseled by being told that the prone position was not a safe position for an obese person to be placed in due to the potential for respiratory compromise.

According to Patient 1's medical record, Patient 1 was resuscitated, intubated (passage of a tube through the mouth into the trachea for the maintenance of the airway) and admitted to the intensive care unit (ICU). During Patient 1's 28 day hospital stay she required the insertion of a tracheostomy (surgical operation that creates an opening into the trachea with a tube inserted to provide a passage for air). Patient 1 was discharged on [DATE], with a tracheostomy stent (a device used to support the trachea) in place.

2. A review of Patient 2's medical record was conducted on 2/4/11, at 4:30 P.M. Patient 2 was admitted on [DATE] after having attempted suicide by cutting her wrists at a healthcare facility, according to the ED Triage Record.

Patient 2 arrived at the ED of Hospital B via ambulance on 2/2/11, at 5:28 P.M. Patient 2 was placed on T-16 upon arrival. T-16 is a gurney located in the hallway. Patient 2's initial nursing assessment was conducted by Registered Nurse (RN 2) at 6:12 P.M. It was documented in the initial nursing assessment that Patient 2 had expressed suicidal ideation/intent. RN 2 also documented in the nursing notes that "pt states to me 'I just want to die'...placed in front of nursing station for continuous monitoring. assure pt. (patient) that she is in a safe place. will continue to observe." At 7:25 P.M. a Psychologist arrived in the ED to interview and assess Patient 2. According to his psychology note "At interview, Patient was mentally competent and expressed her desire not to live and her desire not to be a burden to her daughter. She stated that she wanted to die and that she would do everything possible to die. She then stated that she 'just wanted a room in which she could sleep' and I requested of one of the nurses that she be moved into a room when possible, from the noisy and busy hallway where I interviewed her."

On 2/4/11 at 4:35 P.M., a review of the hospital policy entitled "Suicide Risk Management" was reviewed. According to the policy, if a patient is identified as a possible risk for suicide "The RN will inform the charge RN of the possible risk. The charge RN will assist with initiating appropriate precautions to ensure the patient's safety while in the emergency department according to the "ED Psychiatric Standards of Care." These Standards of Care indicated to "CONSIDER a sitter (continuous one-to-one monitoring) for the following situations only...If unable to place patient in room where patient is easily observable...rooms 8, 9, and 10" at Hospital B.

An interview was conducted with the Assistant (Asst.) ED Nurse Manager on 2/11/11, at 1:20 P.M. The Asst. Manager acknowledged that the best beds for constant observation from the nursing station in the ED at Hospital B were rooms 8, 9, 10.

On 2/25/11 an interview was conducted with Patient 2's Psychologist. He stated that he saw Patient 2 in the ED at about 8:00 P.M. on 2/2/11. The Psychologist stated that Patient 2 was an elderly female who was determined to die. He interviewed Patient 2 but he did not complete his assessment. The patient asked to be moved to a quiet place to sleep. The Psychologist spoke to an ED RN and asked that Patient 2 be placed in a room. The Psychologist was going to continue his assessment in a private area. Patient 2's Psychologist stated that it was absolutely his intention for Patient 2 to remain on constant observation. According to the hospital policy entitled "Constant Observation" the definition is an increased level of observation and supervision in which continuous one-to-one monitoring techniques are used to assure the safety and well being of an individual patient. His intention was to place Patient 2 on a 5150 (involuntary 72 hour psychiatric hold for patients who are either a danger to themselves or others).

An interview was conducted with the ED Charge RN (ECRN 2) on 3/2/11, at 11:20 A.M. The ECRN 2 stated that when Patient 2 arrived in the ED, via ambulance, she instructed the Emergency Medical Technicians to put Patient 2 on gurney T-16 so she could be constantly observed. The ECRN 2 conducted the triage for Patient 2 and RN 2 conducted the initial nursing assessment. ECRN 2 thought that the psychologist came to see Patient 2 at about 7:25 P.M. RN 2 and a unit secretary told the ECRN 2 that the Psychologist wanted Patient 2 moved to a private room. ECRN 2 stated that she just assumed that the psychologist had cleared Patient 2 from a psychiatric standpoint. ECRN 2 moved Patient 2 to room 7 at 8:25 P.M. The ECRN 2 thought that Patient 2 no longer required constant observation. She acknowledged that the Psychologist never verified that Patient 2 had been cleared psychiatrically. The ECRN 2 chose room 7 because it was the first available room. The ECRN 2 was never told that Patient 2 was being placed on a 5150.

According to the ED Psychiatric Standards of Care when a patient is placed on a 5150 hold "A SITTER must be assigned to the patient."

A nursing note entry written by RN 5 documented that at 8:42 P.M. "...pt. (patient) found lying on floor on lt. (left) side. Pt. found to have thermometer probe cord around her neck along with her oxygen tubing. Pt. unresponsive, no spont. (spontaneous) resp. (respirations) or pulse. Code blue called. cpr (cardio-pulmonary resuscitation) started.

Patient 2 was resuscitated, intubated (breathing tube placed in the throat) and transferred to the Intensive Care Unit (ICU) where she eventually expired on [DATE]. According to the Discharge Summary, dated 2/3/11, Patient 2 expired on [DATE] at 7:49 P.M. The discharge diagnosis was "suicide by hanging."

During the interview conducted with the Assistant ED Nurse Manager, the Assistant Manager stated that it was his expectation that, if a patient was on constant observation on gurney T-16 in the hallway, constant observation of the patient would continue in room 7, by assigning a trauma technician to be one-on-one which means the patient is never left alone. The Assistant Manager acknowledged that constant observation of Patient 2 did not occur in this case.

3. A general observation tour of the Emergency Department (ED) of Hospital A was conducted on 2/22/11 at 2:40 P.M. At that time there were two patients in the ED with suicidal ideation, Patient 3 and Patient 24. Patient 3 was in room 12 bed A and Patient 24 was on hallway gurney. Certified Nursing Assistant (CNA 3) was assigned as a "constant observer" for both Patient 3 and Patient 24.

An interview was conducted with CNA 3 on 2/22/11 at 3:05 P.M. CNA 3 verified that she was a "constant observer" for both Patient 3 and Patient 24. She explained that she monitored the suicidal patients' behaviors.

An interview was conducted with Patient 3's ED Registered Nurse (RN 3) on 2/22/11, at 3:20 P.M. RN 3 stated that patients that present to the ED who are suicidal are assigned a 1:1 "sitter" or "constant observer."

On 2/22/11, a review of the following facility documents, and policies and procedures, was conducted: "Care of Psychiatric Patients in the ED," "Suicide Risk Management" dated 12/16/10, "Constant Observation" dated 8/08, and the Checklist for Patients Presenting to the ED with Suicide Ideation (SI, no date).

The policies and procedures, along with the checklist, provided unclear and conflicting information and guidelines to staff, with regards to monitoring requirements and required documentation for patients with suicide ideation or other psychiatric diagnoses. Various monitoring terms were used by facility staff to include "sitter," "constant observation attendant," "patient care attendant," and "direct observation." Facility policies and procedures did not clearly define the difference between direct observation and constant observation. The facility's Suicide Risk Management Policy dated 12/10, referred to the use of a "constant observation attendant" for 1:1 monitoring, or a "patient care attendant" for 2:1 or 3:1 monitoring. A policy entitled "Care of Psychiatric Patients in the ED" (no date), instructed staff to use a sitter in a specific situation and "adhere to the patient care attendant policy (MCP 300.3)." However, policy # MCP 300.3 was the "Constant Observation" policy and procedure which pertained to 1:1 monitoring, not 2:1 or 3:1. In addition, per the "Care of Psychiatric Patients in the ED" policy, psychiatric patients who were determined to be a danger to self or others were managed differently at each hospital when no beds were immediately available in the ED.





4. An interview with security agent (SA) 31 was conducted on 3/1/11 at 10:45 A.M. at Hospital B. SA 31 stated he did not recall having any formal training regarding the management of a suicidal patient. SA 31 stated that their department had monthly briefings which may include training.

An interview with SA 32 was conducted on 3/1/11 at 11: 00 A.M. at Hospital B. SA 32 stated that he had not received any formal training regarding the management of a suicidal patient. SA 32 stated that on 2/25/11, Security Manager (SM) 1 informed them about the orange wrist bands that were used on suicidal patients.

An interview with SA 33 was conducted on 3/1/11 at 11:30 A.M. at Hospital B. SA 33 stated that he did not receive any formal training regarding the management of a suicidal patient. SA 33 also stated that he had been called in the emergency room to assist with a suicidal patient.

An interview with SA 34 was conducted on 3/1/11 at 3:35 P.M. at Hospital A. SA 34 stated that he had been called to assist with suicidal patients in the emergency room . SA 34 was asked what he would do if he was assigned to watch a suicidal patient in the emergency department waiting room and the patient wanted to use the bathroom. SA 34 stated that he would take the patient to the bathroom and would wait for the patient outside while the patient was inside by him or herself.

An observation of Hospital A's emergency department waiting room bathroom was conducted on 3/2/11 at 9:00 A.M. The bathroom had the following: a glass mirror, two grab bars, and a metal container that stored the toilet seat protectors that could pose a potential safety risk for any patient with an intent to harm him/herself or others.

An interview with security manager (SM) 1 was conducted on 3/3/11 at 9:40 A.M. SM 1 was asked what he expected the security agents, who were assigned to watch suicidal patients in the emergency department waiting room to do, if the patient wanted to use the bathroom. SM 1 stated that the security agent would take the suicidal patient inside the bathroom while the security agent waited outside.

An interview with the Director of Emergency Services (DES) was conducted on 3/3/11 at 9:55 A.M. The DES stated that she informed the security managers that security agents, who were assigned to watch suicidal patient in the emergency department waiting room, should stay with the patient at all times. DES stated, "Eyes on at all times." DES stated that she did not give specific instructions to the security department on how to deal with suicidal patients who needed to use the bathroom. DES acknowledged that more training was needed.
VIOLATION: PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS Tag No: A0147
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and document review, Hospital A failed to safeguard the protected healthcare information of three patients (21, 22, 23). A clinical nutritionist left a Clinical Nutrition Screening form for each patient, which contained medical information such as medical history, diagnoses, lab results, weights, medications, diet orders and treatment plans, unattended on the counter in a restroom that was accessible to other staff and visitors.

Findings:

On 2/23/11 at 10:50 A.M., Staff 21, a clinical nutritionist, was observed leaving a stack of papers unattended on the counter in a restroom prior to entering a restroom stall. The restroom was located off a hallway that was accessible to staff and visitors.

The unattended papers were Clinical Nutrition Screening forms for Patients 21, 22, 23 and contained protected health information for each patient such as: name, history, diagnoses that included [DIAGNOSES REDACTED]

An interview was conducted with Staff 21 on 2/23/11 at 11:00 A.M. Staff 21 stated that she thought it was okay to leave the forms on the counter because that particular restroom was intended for staff only. Staff 21 acknowledged that, even if the restroom was accessible to staff only, it was still a breach of confidentiality for each patient, as other staff in the facility did not necessarily have the right to access the protected health information on each of those patients.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0166
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, Hospital A failed to develop a written plan of care regarding the use of restraints on 2 occasions, for 1 of 15 sampled restraint patients (42).

Findings:

A review of Patient 42's electronic medical record (EMR) was conducted on 3/2/11 at 11:15 A.M. Patient 42 was admitted on [DATE] per the facesheet. A Physician's Order, dated 2/17/11 at 1:15 A.M., indicated that wrist restraints were applied on Patient 42 because he was pulling and removing lines, tubes, equipment and dressing. According to the treatments flowsheet, dated 2/17/11 at 6:00 A.M., 8:00 A.M., and 10:00 A.M., Patient 42 had wrist restraints applied. Per the same flowsheet, at 12:00 P.M., a trial restraint release was performed and the wrist restraints were removed. On 2/17/11 at 2:00 P.M., Patient 42's wrist restraints were discontinued. According to the flowsheet dated 2/20/11 at 8:00 A.M., 10:00 A.M., 12:00 P.M., 2:00 P.M., 4:00 P.M., and 6:00 P.M., Patient 42's wrist restraints were reinstituted. There was no documented evidence that a plan of care was initiated or developed when the need for wrist restraints was identified on 2/17/11 and reinstituted on 2/20/11.

An interview and joint EMR review with the clinical nurse specialist (CNS) was conducted on 3/2/11 at 11:45 A.M. The CNS stated that there was no documented evidence to show that a plan of care related to restraint use was initiated or developed when Patient 42's need for restraints was identified on 2/17/11 or 2/20/11.

An interview with the Director of Nursing Quality was conducted on 3/2/11 at 2:30 P.M. The DNQ acknowledged that the plan of care related to Patient 42's restraint use had not been developed.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0167
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, Hospital A failed to ensure that their policy and procedure related to restraints was implemented, for 3 of 15 sampled restraint patients (41, 43, 44). There was no documented evidence that face-to-face assessments were performed by the physician for Patients 41, 43 and 44 who were in restraints.

Findings:

1. A review of Patient 41's electronic medical record (EMR) was conducted on 3/1/11 at 2:00 P.M. Patient 41 was admitted on [DATE] per the facesheet. A Physician's Order, dated 2/28/11 at 7:44 P.M., indicated to continue mitten (medical restraint) application on Patient 41 for 24 hours due to attempts of pulling and removing lines, tubes, equipment and dressings. According to the flowsheets dated 2/28/11 at 10:00 P.M., and 3/1/11 at 12:00 A.M., 2:00 A.M., 4:00 A.M., 6:00 A.M., 7:00 A.M. and 9:00 A.M., Patient 41 had a mitten on the right hand. There was no documented evidence that a face-to-face assessment was performed by the physician to determine the continued use of Patient 41's medical restraint.

An interview and joint EMR review with Registered Nurse (RN 42) was conducted on 3/1/11 at 2:35 P.M. RN 42 stated that there was no documented evidence to show that a face-to-face assessment was performed by the physician for Patient 41's medical restraint in accordance with the hospital's policy.

An interview with the Director of Nursing Quality (DNQ) was conducted on 3/1/11 at 3:15 P.M. The DNQ acknowledged that the face-to-face assessment performed by the physician should have been in the renewal order set found in Patient 41's EMR.

On 3/1/11 at 3:31 P.M., an observation of Patient 41 was conducted with the Director of Regulatory for Outpatient Services and confirmed that Patient 41 had a mitten on the right hand.

A review of the hospital's policy and procedure entitled "Restraints and Seclusion," effective date of 1/20/11, indicated that under "continuation of medical restraints for all ages: ... (2). The documentation of the face-to-face assessment will be part of the electronic reorder of the restraint by the physician, nurse practitioner, or physician assistant."

2. On 3/1/11 at 3:38 P.M., an observation of Patient 43 was conducted with the Director of Regulatory for Outpatient Services. Patient 43 was laying in bed with wrist restraints on both wrists.

A review of Patient 43's electronic medical record (EMR) was conducted beginning on 3/1/11 at 3:40 P.M. Patient 43 was admitted on [DATE] per the facesheet. A Physician's Order, dated 3/1/11 at 10:29 A.M., indicated to continue the application of Patient 43's wrist restraints for 24 hours. There was no documented evidence that a face-to-face assessment was performed by the physician for Patient 43's medical restraint.

A review of the hospital's policy and procedure entitled "Restraints and Seclusion," effective date of 1/20/11, indicated that under "continuation of medical restraints for all ages: ... (2). The documentation of the face-to-face assessment will be part of the electronic reorder of the restraint by the physician, nurse practitioner, or physician assistant."

An interview and joint EMR review with the Director of Nursing Quality (DNQ) was conducted on 3/1/11 at 3:48 P.M. The DNQ acknowledged that the face-to-face assessment performed by the physician should have been in Patient 43's EMR in accordance with the hospital's policy.

3. A review of Patient 44's electronic medical record (EMR) was conducted on 3/2/11 at 9:30 A.M. Patient 44 was admitted on [DATE] per the facesheet. A Physician's Order, dated 3/1/11 at 10:28 A.M., indicated to continue the application of wrist restraints on Patient 44 for 24 hours. There was no documented evidence that a face-to-face assessment was performed by the physician for Patient 44's medical restraint.

A review of the hospital's policy and procedure entitled "Restraints and Seclusion," effective date of 1/20/11, indicated that under "continuation of medical restraints for all ages: ... (2). The documentation of the face-to-face assessment will be part of the electronic reorder of the restraint by the physician, nurse practitioner, or physician assistant."

An interview and joint EMR review with the Director of Nursing Quality (DNQ) was conducted on 3/2/11 at 9:43 A.M. The DNQ stated that a face-to-face assessment performed by the physician was not documented in Patient 44's EMR. She acknowledged that the documentation of the face-to-face assessment should have been in the EMR in accordance with the hospital's policy.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, Hospital A failed to obtain a physician's order prior to the use of wrist restraints, for 2 of 15 sampled restraint patients (41, 42).

Findings:

1. A review of Patient 41's electronic medical record (EMR) was conducted on 3/1/11 at 2:00 P.M. Patient 41 was admitted to Hospital A on 2/26/11 per the facesheet. According to the flowsheets dated 2/28/11 at 1:00 A.M., 4:00 A.M., 6:00 A.M. and 2/28/11 at 8:00 P.M., Patient 41 had a wrist restraint applied to the right wrist. There was no documented evidence to show that a physician's order was obtained for the use of wrist restraints on 2/28/11.

A review of the hospital's policy and procedure entitled "Restraints and Seclusion," effective date of 1/20/11, was conducted. The policy indicated that for medical restraints, "An order must be written and signed by the physician, nurse practitioner or physician assistant within 12 hours after the initiation of restraints." Per the same policy, it indicated that "medical restraints that continue beyond 24 hours will have a renewal order written each calendar day."

An interview and joint EMR review with the Director of Nursing Quality (DNQ) was conducted on 3/1/11 at 3:15 P.M. The DNQ acknowledged that a physician's order was not obtained when wrist restraints were used on Patient 41 on 2/28/11 at 1:00 A.M., 4:00 A.M., 6:00 A.M. and 8:00 P.M. She stated that the hospital's policy was to obtain a physician's order that specified the appropriate restraint used within 12 hours after the initiation of the restraints.

2. A review of Patient 42's electronic medical record (EMR) was conducted on 3/2/11 at 11:15 A.M. Patient 42 was admitted on [DATE] per the facesheet. According to the treatments flowsheet dated 2/20/11 at 8:00 A.M., 10:00 A.M., 12:00 P.M., 2:00 P.M., 4:00 P.M., and 6:00 P.M., Patient 42 had wrist restraints applied. There was no documented evidence that a physician's order was obtained for the use of the wrist restraints on 2/20/11.

A review of the hospital's policy and procedure entitled "Restraints and Seclusion," effective date of 1/20/11, was conducted. The policy indicated that for medical restraints, "An order must be written and signed by the physician, nurse practitioner or physician assistant within 12 hours after the initiation of restraints." Per the same policy, it indicated that "medical restraints that continue beyond 24 hours will have a renewal order written each calendar day."

An interview and joint EMR review with the DNQ was conducted on 3/2/11 at 11:50 A.M. The DNQ acknowledged that a physician's order was not obtained for the wrist restraint used on Patient 42 in accordance with the hospital's policy.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, Hospital A failed to implement their policy and procedure related to the use of restraints, for 3 of 15 sampled restraint patients (31, 41, 42). There was no documented evidence that assessments were performed every 2 hours for Patients 31, 41 and 42, who were in restraints.

Findings:

1. On 3/1/11, a review of Patient 31's medical record was conducted. Patient 31 was admitted to Hospital A on 2/1/11 per the facesheet. A review of the physician orders indicated that wrist restraints were ordered on [DATE] at 5:03 P.M. and expired on [DATE] at 5:03 P.M. Per the same document, the reason for the use of restraints was due to Patient 31 attempted to pull or remove lines and tubings.

A review of Patient 31's "Inpatient Restraint Documentation Medical Restraint," dated 2/21/11, indicated several categories for which the licensed nurse was supposed to assess a patient in restraints. The categories were the following: Skin/circulation assessment, patient turned, hydration/nutrition, hygiene/ elimination, safety/comfort, ROM (range of motion) of extremities, mental status code, restraints properly applied, patient continues to meet clinical indications for restraints, and restraints discontinued. Patient 31's "Inpatient Restraint Documentation Medical Restraint," showed no documented evidence that the patient was assessed on all the categories at 8:00 A.M., 10:00 A.M., 12:00 P.M., 2:00 P.M., and 4:00 P.M. There was no documentation that indicated that the restraints were removed during those times.

A review of the facility's policy and procedure titled "Restraint and Seclusion" indicated that for medical restraints monitoring, "Patients will be assessed at least every 2 hours and observed as often as possible." The policy and procedure also indicated that, "Appropriately qualified staff will monitor/evaluate and document the following: 1. The physical and emotional well being of the patient. (a) Vital Signs (b) Circulation (c) Any hydration, hygiene, elimination, range of motion, or comfort needs the patient may have (d) Skin integrity (e) level of distress and agitation (f) Mental status (g) Cognitive functioning 2. That the patient's rights, dignity, and safety are maintained. 3. Whether less restrictive measures are possible 4. Changes in the patient's behavior or clinical condition required to initiate the removal of restraints. 5. Whether the restraint has been appropriately applied, removed, or reapplied."

A joint record review and interview with the unit manager was conducted on 3/1/11 at 3:15 P.M. The unit manager acknowledged that, there was no documented evidence that the required every 2 hour assessments for a restrained patient was done, for Patient 31 on 2/21/11 from 8:00 A.M. until 4:00 P.M.





2. A review of Patient 41's electronic medical record (EMR) was conducted on 3/1/11 at 2:00 P.M. Patient 41 was admitted to Hospital A on 2/26/11 per the facesheet. A Physician's Order, dated 2/28/11 at 1:11 A.M., indicated to apply mittens (a medical restraint) to Patient 41 due to attempts of pulling and removing lines, tubes, equipment and dressings. According to the treatments flowsheet dated on 2/28/11 from 7:00 A.M. to 7:00 P.M., there was no documented evidence to show that assessments were performed every 2 hours for the use of mittens on Patient 41.

An interview and joint EMR review with RN 41 was conducted on 3/1/11 at 2:01 P.M. RN 41 stated that Patient 41 had a mitten on the right hand because she pulled out her feeding tube on 2/28/11. He stated that the hospital's policy was to assess patients with restraints every 2 hours. He stated it was the nurse's responsibility to document skin, turning, circulation, hydration, nutrition, hygiene, elimination, comfort, range of motion of extremities, proper application of restraints, mental status, restraint status, restraint type, clinical justification, alternatives attempted, education, patient's response to the restraint used, and restraint order.

On 3/1/11 at 3:31 P.M., an observation of Patient 41 was conducted with the Director of Regulatory for Outpatient Services. Patient 41 had a mitten on the right hand.

A review of the hospital's policy and procedure entitled "Restraints and Seclusion, "effective date of 1/20/11, was conducted. The policy indicated that for medical restraints monitoring, "Patients will be assessed at least every 2 hours and observed as often as possible." The policy and procedure also indicated that, "Appropriately qualified staff will monitor/evaluate and document the following: 1. The physical and emotional well being of the patient. (a) Vital Signs (b) Circulation (c) Any hydration, hygiene, elimination, range of motion, or comfort needs the patient may have (d) Skin integrity (e) level of distress and agitation (f) Mental status (g) Cognitive functioning 2. That the patient's rights, dignity, and safety are maintained. 3. Whether less restrictive measures are possible 4. Changes in the patient's behavior or clinical condition required to initiate the removal of restraints. 5. Whether the restraint has been appropriately applied, removed, or reapplied."

An interview and joint EMR review with the Director of Nursing Quality (DNQ) was conducted on 3/1/11 at 3:15 P.M. The DNQ acknowledged that restraint assessments every 2 hours should have been performed in accordance with the hospital's policy.

3. A review of Patient 42's electronic medical record (EMR) was conducted on 3/2/11 at 11:15 A.M. Patient 42 was admitted on [DATE] per the facesheet.

According to the Treatments Flowsheet dated 2/20/11 at 8:00 A.M., 10:00 A.M., 12:00 P.M., 2:00 P.M., 4:00 P.M., and 6:00 P.M., Patient 42 had wrist restraints applied. There was no documented evidence to show that restraint assessments were performed every 2 hours on 2/20/11 from 7:00 P.M. to 7:00 A.M.

An interview and joint EMR review with the clinical nurse specialist (CNS) was conducted on 3/2/11 at 11:40 A.M. The CNS stated that Patient 42 had wrist restraints on 2/20/11 and 2/21/11 from 8:00 A.M. to 6:00 P.M. She acknowledged that there was no documented evidence to show that restraint assessments every 2 hours were performed on 2/20/11 from 7:00 P.M. to 7:00 A.M.

A review of the hospital's policy and procedure entitled "Restraints and Seclusion" effective date of 1/20/11 was conducted. The policy indicated that for medical restraints monitoring, "Patients will be assessed at least every 2 hours and observed as often as possible." The policy and procedure also indicated that, "Appropriately qualified staff will monitor/evaluate and document the following: 1. The physical and emotional well being of the patient. (a) Vital Signs (b) Circulation (c) Any hydration, hygiene, elimination, range of motion, or comfort needs the patient may have (d) Skin integrity (e) level of distress and agitation (f) Mental status (g) Cognitive functioning 2. That the patient's rights, dignity, and safety are maintained. 3. Whether less restrictive measures are possible 4. Changes in the patient's behavior or clinical condition required to initiate the removal of restraints. 5. Whether the restraint has been appropriately applied, removed, or reapplied."

An interview with the DNQ was conducted on 3/2/11 at 11:50 A.M. The DNQ acknowledged that restraint assessments every 2 hours should have been performed in accordance with the hospital's policy.
VIOLATION: QAPI Tag No: A0263
Based on interview, record and document review the hospital failed to ensure that an effective quality assessment and performance improvement program (QAPI) was implemented when a thorough and credible root cause analysis and investigation was not conducted on a Sentinel Event (a significant process variation, medical or hospital error that caused an unanticipated death or major permanent loss of function unrelated to the natural course of the patient's illness or condition and includes serious physical or psychological harm to the patient, or the risk thereof); and, another serious adverse event. By not conducting a thorough and credible investigation and analysis of these serious events the hospital failed to identify critical systemic issues and processes in an effort to prevent recurrence. The hospital failed to provide adequate nursing resources to meet the needs of the patients and reduce risk in the Emergency Department (ED) of Hospital B. In addition, the hospital failed to implement a previously submitted corrective action plan pertaining to hourly rounding in the Emergency Department (ED) waiting rooms. The hospital failed to ensure that the electronic Quality Variance Report (eQVR) submitted following the unanticipated cardio-pulmonary arrest of a patient outside the ED of Hospital A was an accurate description of the facts.

1. The hospital failed to conduct a thorough and credible root cause analysis after Patient 2 committed suicide by strangulation in an ED room of Hospital B.
(A-tag 287 #1)

2. The hospital failed to conduct a thorough nursing investigation following an unanticipated patient outcome after Patient 1 sustained a cardio-pulmonary arrest while being escorted out of the ED of Hospital A.
(A-tag 287 # 2)

3. The hospital failed to ensure that the Root Cause Analysis (RCA) action plan following the suicide of Patient 1 identified or established a means by which to measure the success of each action item's implementation in order to demonstrate that the plan achieved the desired goals and outcomes.
(A-tag 290)

4. Hospital B failed to provide adequate nursing staff to reduce risk and meet the needs of the patients in the Emergency Department.
(A tag 316)

5. The hospital failed to ensure that a previous plan of correction that pertained to nurse assessments and management of patients in Hospitals A and B's ED waiting rooms was fully implemented.
(A-tag 288)

6. The hospital failed to ensure that an eQVR (electronic quality variance report) submitted following an unanticipated patient outcome, after Patient 1 sustained a cardio-pulmonary outside of the ED of Hospital A, was based on honest and reasonable observations of the facts, per their policy and procedure.
(A tag 286)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Quality Assessment and Performance Improvement.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, the facility failed to ensure that a plan of correction, which pertained to nurse reassessments and management of patients in Hospital A and B's Emergency Department (ED) waiting rooms, was consistently implemented at both hospitals. A new process which established hourly rounding in the ED waiting areas was not consistently performed to ensure that timely reassessments of patients were conducted.

Findings:

1. On 1/6/11 a statement of deficient practices was issued to the facility for Hospital A's non-compliance with it's own ED Standards of Patient Care pertaining to pain management, and facility policies and regulatory requirements pertaining to patient reassessments in the ED.

A plan of correction was received from the facility which documented that "a new process was implemented that included hourly rounding of the patients in the ED waiting room by either the triage nurse or the greeter (Emergency Department Technician EDT). Any change in a patient's condition that is identified by the Greeter, (i.e. the patient complains of worsening pain) will be reported to the Triage RN (registered nurse) for further assessment." Per the plan of correction, the new hourly rounding process was implemented on [DATE].

On 2/23/11 at 8:45 A.M. the ED waiting area hourly rounding logs from 1/21/11 through 2/17/11 for Hospital A were reviewed. There was no evidence that hourly rounding had been performed on the following dates: 1/24/11, 1/25/11, 1/26/11,1/27/11, 1/29/11, 2/6/11, 2/7/11, 2/9/11, 2/10/11, 2/15/11, 2/19/11, 2/20/11. No hourly rounding logs for the dates 2/19/11- 2/20/11 were available for review per the Licensing and Accreditation Specialist (LAS) because hourly rounding was not performed.

Of the 20 hourly rounding logs that were available for review, 8 demonstrated inconsistent and sporadic implementation of the hourly rounding process.

On 1/23/11 at 7:00 P.M., a tech documented on the log that a patient was "lying on the ground (floor of ED), helped pt. (patient) to chair." There was no evidence that the Triage or Charge RN was informed, or that an assessment/reassessment of the patient was done to determine why the patient was lying on the ground (floor).

On 3/1/11 at 2:30 P.M., an interview was conducted with the ED Educator and ED Nurse Manager (EDNM). Both acknowledged that the facility's plan of correction pertaining to the ED waiting area hourly rounding process was not implemented consistently in an effort to ensure that patients received thimely reassessments and appropriate interventions per the facility's own policies and procedures and plan of correction.





2. On 1/6/11 a statement of deficient practices was issued to the facility for Hospital A's non-compliance with it's own ED Standards of Patient Care pertaining to pain management, and facility policies and regulatory requirements pertaining to patient reassessments in the ED.

A plan of correction was received from the facility which documented that "a new process was implemented that included hourly rounding of the patients in the ED waiting room by either the triage nurse or the greeter (Emergency Department Technician EDT). Any change in a patient's condition that is identified by the Greeter, (i.e. the patient complains of worsening pain) will be reported to the Triage RN (registered nurse) for further assessment." Per the plan of correction, the new hourly rounding process was implemented on [DATE].

On 2/22/11 at 3:46 P.M., an interview with Patient 32 was conducted in Hospital B's Emergency Department waiting room. Patient 32 stated that she arrived at the Emergency Department at 12:50 P.M. and was triaged at 1:00 P.M. Patient 32 stated that she came to the Emergency Department for abdominal pain. Patient 32 also stated that from 1:00 P.M. to 4:00 P.M., no staff member had reassessed or came out to the waiting room to check on her status.

On 2/22/11 at 3:50 P.M., an interview with Patient 33's family member was conducted in Hospital B's Emergency Department waiting room. Patient 33's family member stated that she brought the patient to Hospital B's Emergency Department because the patient had recently been confused and was having visual hallucinations. Patient 33's family member stated that the patient was last seen by the triage nurse (a nurse assigned to assess and determine priority of patient's needs) at 1:30 P.M. and that nobody had checked on the patient since then, 2 hours and 20 minutes later.

An interview with registered nurse (RN) 32 was conducted on 3/1/11 at 8:45 A.M. RN 32 stated that hourly rounds in the Emergency Department waiting room were conducted to evaluate the patients for any changes and to assess any patient needs to be addressed.

The assistant manager of Hospital B's Emergency Department was asked for the Waiting Room Log for Hourly Rounding sheets from 1/20/11 thru 2/27/11. Based on the records provided, the waiting room log was not completed everyday from 1/20/11 thru 2/22/11 at Hospital B's Emergency Department. The records provided by the hospital were from the following dates: 1/20/11, 1/24/11, 1/25/11, 1/26/11, 1/27/11, 1/28/11, 1/31/11, 2/2/11, 2/3/11, 2/5/11, 2/7/11, 2/8/11, 2/9/11, 2/10/11, 2/11/11, 2/13/11, 2/14/11, 2/15/11, 2/16/11, 2/17/11, 2/18/11, 2/19/11, 2/21/11, and 2/22/11.

Out of 34 days, 10 waiting room logs were not available for review. In addition, out of the 24 waiting room logs that were provided for review, only 3 were completed for the entire 24 hour shift. The other 21 waiting room logs were not consistently completed on an hourly basis. The waiting room log, dated 2/19/11, was left blank from 2:00 A.M. thru 11:00 P.M., a total of 22 hours of no documented hourly rounding. The waiting room log, dated 2/21/11, had one documented hourly rounding at 7:00 P.M. while the rest were left blank, a total of 23 hours of no documented hourly rounding.

An interview with Hospital B's Emergency Department Assistant Manager was conducted on 3/1/11 at 9:15 A.M. The Emergency Department Assistant Manager stated that if the Waiting Room Log for Hourly Rounding was left blank then it was not done.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review the facility failed to ensure that, following a Sentinel Event (a significant process variation, medical or hospital error that caused an unanticipated death or major permanent loss of function unrelated to the natural course of the patient's illness or condition and includes serious physical or psychological harm to the patient, or the risk thereof ), the suicide of Patient 1, the Root Cause Analysis (RCA-an analysis that focuses on systems and processes to identify basic and causal factors that underlie variation in performance), action plan identified or established a means by which to measure the success of each action item's implementation, in order to demonstrate that the plan achieved the desired goals and outcomes, and prevented a recurrence of the event.

Findings:

An interview was conducted with the Director of Regulatory Affairs (DRA) on 2/4/11 at 4:20 P.M. Per the DRA, on 2/2/11, Patient 2 was admitted to the ED at Hospital B following a suicide attempt at another healthcare facility. While in the ED at Hospital B, the patient took oxygen tubing and a temperature probe cord and wrapped it around her neck multiple times. The patient was found on the floor. Emergency resuscitation efforts were implemented and the patient was intubated (breathing tube placed in throat) and sent to the Intensive Care Unit (ICU). According to the Discharge Summary dated 2/3/11, Patient 1 expired on [DATE] at 7:49 P.M. The discharge diagnosis was "suicide by hanging."

According to the DRA, a root cause analysis pertaining to Patient 2's suicide was completed on 2/3/11, and an action plan was implemented on 2/4/11.

On 2/23/11 the facility's Performance Improvement and Patient Safety (PIPS) Plan for 2010/11, and the Sentinel Event and Significant Adverse Event (10/21/10) policy and procedure were reviewed.

Per the PIPS plan Sentinel Events were analyzed and managed to prevent such incidents from recurring. Per the Sentinel Event policy, RCA's were conducted for all Sentinel Events which included patient suicide. An action plan was the product of an RCA. To be acceptable, the action plan must 1) identify changes that can be implemented to reduce risk, or formulate a rationale for not undertaking such changes; and 2) identify who was responsible for implementation,when the action would be implemented, define the measure of success, and identify when the outcomes would be measured and evaluated.

On 2/23/11 at 9:15 A.M., the facility's RCA action plan was reviewed with the following members of the RCA team: Director of Risk Management (DRM), Director of Emergency Services (DES), ED Nurse Manager (EDNM), Risk Manager (RM), Accreditation and Licensing Principal Consultant (ALPC), and Medical Doctor (MD) 22.

The action plan contained 9 immediate actions that included education of the ED staff on the new SI (suicide ideation/intent) criteria checklist. A start date to begin education was 2/4/11; however, there was no target completion date determined. Another action item was to define the work flow for the physician order to remove the patient armband. The start date for that item was 2/4/11, but there was no defined target date for completion. A third action item documented that the plan focused on Hospital B's ED only.

The action plan documented that 2 future actions would be implemented "ASAP" (as soon as possible), but no target date for completion was established.

The DRM acknowledged that target dates for completion were not established for the action items. Per the DES, the Hospital B ED staff were provided education on the new process "as they came to work."

Without the establishment of targeted completion dates, the facility would not be able to identify when outcomes would be measured and evaluated as required per it's own policy and procedure.

In addition the RCA action plan did not identify or establish a means by which to measure the success of each action item's implementation to ensure that the plan achieved the desired goals or outcomes.

The facility failed to ensure that an acceptable plan of action was developed, following a Sentinel Event, Patient 2's suicide. The RCA action plan did not include targeted dates of completion and actions items that were measurable, in order to ensure that the plan was effective and sustainable in an effort to improve patient safety and prevent a recurrence of the event.
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on interview and document review, the hospital failed to ensure that an eQVR (electronic quality variance report) submitted following a cardio-pulmonary arrest of a patient (Patient 1) outside of the Emergency Department (ED) of Hospital A, was "based on honest and reasonable observations of the facts," in accordance with hospital policy and procedure.

Findings:

A review of Patient 1's medical record was conducted on 1/6/11 at 4:00 P.M. Patient 1 was admitted to Hospital A's ED on 3/24/10 for the treatment of a hard palate superficial ulceration after sustaining a burn to the roof of her mouth according to the ED MD notes. According to a nursing note, dated 3/24/10 and timed at 2:20 P.M., Patient 1 "refused to leave initially and to sign paperwork...was escorted from ED w (with) security, walking w out assistance."

An interview was conducted with the ED Charge RN (ECRN 1) on 2/23/11 at 1:47 P.M. The ECRN 1 thought that the Security Agents, EDT 1, and he escorted Patient 1 out of the ED. Patient 1 walked 30 to 50 yards to the bench at the loop (an area outside the ED for taxi cabs to pull up). When the taxi cab arrived Patient 1 resisted being placed in the cab. ECRN 1 stated that he made the decision to take Patient 1 out of the taxi cab. ECRN 1, EDT 1, and Security Agent 1 carried Patient 1 prone (face down) halfway to the bench and placed the patient on the cement on her stomach. ECRN 1 then got on the phone and called the ED Nurse Manager (EDNM). When the EDNM arrived she assessed the patient. Patient 1 was not breathing and had no detectable pulse. CPR was initiated.

According to the hospital's policy and procedure, entitled "Electronic Quality Variance Report (eQVR) (Event Reporting)", "eQVRs will be submitted in good faith, based on the reporters honest and reasonable observations of the facts."

An interview was conducted with ECRN 1 on 2/23/11 at 1:47 P.M. ECRN 1 stated that he completed an eQVR on 3/24/10 because of the unusual occurrence involving Patient 1. ECRN 1 reported that he documented in the eQVR that Patient 1 was removed from the cab unresponsive and cyanotic. During the interview, ECRN 1 acknowledged that the eQVR was an "inadequate description of the events that occurred."

On 2/23/11 an interview was conducted with the EDNM at 2:47 p.m. The EDNM acknowledged that the events described on the eQVR by the ECRN "were not accurate."
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview, record and document review, the facility failed to implement it's policy and procedure pertaining to Sentinel (a significant process variation, medical or hospital error that caused an unanticipated death or major permanent loss of function unrelated to the natural course of the patient's illness or condition and includes serious physical or psychological harm to the patient, or the risk thereof) and Significant Adverse Events, as well as it's 2010-2011 Performance Improvement and Patient Safety Plan, when it failed to perform a thorough and credible Root Cause Analysis, (RCA-an analysis that focuses on systems and processes to identify basic and causal factors that underlie variation in performance) following Patient 2's successful suicide attempt while a patient in the Emergency Department (ED) at Hospital B. The facility's RCA action plan was implemented at Hospital B only, though the facility was comprised of 2 campuses. The RCA failed to identify inconsistencies with policies and procedures; identify and address nurse staffing and related policy issues; contain measurable goals or strategies; identify the need for an education plan for security personnel; and establish time lines for the implementation and completion of all action items.

In addition, the facility failed to thoroughly investigate an unanticipated outcome, after Patient 1 went into cardiac/respiratory arrest outside of the ED at Hospital A.

Findings:

1. An interview was conducted with the Director of Regulatory Affairs (DRA) on 2/4/11 at 4:20 P.M. Per the DRA, on 2/2/11, Patient 2 was admitted to the ED at Hospital B following a suicide attempt at another healthcare facility. While in the ED at Hospital B, the patient took oxygen tubing and a temperature probe cord and wrapped it around her neck multiple times. The patient was found on the floor. Emergency resuscitation efforts were implemented and the patient was intubated (breathing tube placed in throat) and sent to the Intensive Care Unit (ICU). According to the Discharge Summary dated 2/3/11, Patient 1 expired on [DATE] at 7:49 P.M. The discharge diagnosis was "suicide by hanging."

According to the DRA, a root cause analysis pertaining to Patient 2's suicide was completed on 2/3/11, and an action plan was implemented on 2/4/11. Per the DRA, a new safety precautions checklist was implemented for patients who present with suicidal ideation. In addition, a special colored armband would be applied to all patients with a suicidal ideation diagnosis.

On 2/22/11 a review of the following facility documents, and policies and procedures, was conducted: "Care of Psychiatric Patients in the ED," "Suicide Risk Management" dated 12/16/10, "Constant Observation" dated 8/08, and the Checklist for Patients Presenting to the ED with Suicide Ideation (SI, no date).

The policies and procedures, along with the checklist, provided unclear and conflicting information and guidelines to staff with regards to monitoring requirements and required documentation for patients with suicide ideation or other psychiatric diagnoses. Various monitoring terms were used by facility staff to include "sitter", "constant observation attendant," "patient care attendant," and "direct observation;" however, facility policies and procedures did not clearly define the difference between direct observation and constant observation. The facility's Suicide Risk Management Policy dated 12/10 referred to the use of a "constant observation attendant" for 1:1 monitoring, or a "patient care attendant" for 2:1 or 3:1 monitoring. A policy entitled "Care of Psychiatric Patients in the ED" (no date), instructed staff to use a sitter in a specific situation and "adhere to the patient care attendant policy (MCP 300.3)." However, policy # MCP 300.3 was the "Constant Observation" policy and procedure which pertained to 1:1 monitoring, not 2:1 or 3:1. In addition, per the "Care of Psychiatric Patients in the ED" policy, psychiatric patients who were determined to be a danger to self or others were managed differently at each hospital when no beds were immediately available in the ED.

On 2/23/11 the facility's Performance Improvement and Patient Safety (PIPS) Plan for 2010/11, and the Sentinel Event and Significant Adverse Event (10/21/10) policy and procedure were reviewed.

Per the PIPS plan Sentinel Events were analyzed and managed to prevent such incidents from reoccurring. Per the Sentinel Event policy, RCA's were conducted for all Sentinel Events which included patient suicide. An action plan was the product of an RCA. To be acceptable, the action plan must 1) identify changes that can be implemented to reduce risk, or formulate a rationale for not undertaking such changes; and 2) identify who was responsible for implementation,when the action would be implemented, define the measure of success, and identify when the outcomes would be measured and evaluated.

On 2/23/11 at 9:15 A.M., the facility's RCA action plan was reviewed with the following members of the RCA team: Director of Risk Management (DRM), Director of Emergency Services (DES), ED Nurse Manager (EDNM), Risk Manager (RM), Accreditation and Licensing Principal Consultant (ALPC), and Medical Doctor (MD) 22.

The action plan contained 9 immediate actions that included education of the ED staff on the new SI criteria checklist. A start date to begin education was 2/4/11; however, there was no target completion date determined. Another action item was to define the work flow for the physician order to remove the patient armband. The start date for that item was 2/4/11, but there was no defined target date for completion. A third action item documented that the plan focused on Hospital B's ED only.

The action plan documented that 2 future actions would be implemented "ASAP" (as soon as possible), but no target date for completion was established.

The DRM acknowledged that target dates for completion were not established for the action items. Per the DES, the Hospital B ED staff were provided education on the new process "as they came to work."

Without the establishment of targeted completion dates, the facility would not be able to identify when outcomes would be measured and evaluated as required per it's own policy and procedure.

In addition the RCA action plan did not identify or establish a means by which to measure the success of each action item's implementation to ensure that the plan achieved the desired goals or outcomes.

Per the Sentinel Event policy and procedure, RCA's were conducted utilizing the Root Cause Analysis Matrix. According to the matrix, a "detailed inquiry into all areas designated on the matrix for each specific sentinel event would be conducted." For a suicide, a detailed inquiry into 14 areas was required which included: patient observation procedures, availability of information, security systems and processes, and staffing levels.

Although the RCA summary sheet provided by the team documented that facility policies and procedures were evaluated, the RCA action plan failed to identify the inconsistencies in it's own policies and procedures pertaining to patient observation and monitoring requirements.

The DRM acknowledged that per the matrix, policies and procedures fell under the matrix category of "availability of information."

The RCA action plan failed to include an educational plan for security personnel, who at times were assigned to watch patients with diagnoses of SI when no beds were immediately available in the ED, per the "Care of Psychiatric Patients in the ED" policy and procedure. Per the RCA matrix, a detailed inquiry of security systems and processes was required.

Per an interview with a Security Agent (SA) 34 on 3/1/11 at 3:35 P.M. at Hospital A, under his watch, he would allow a patient at risk for suicide to use the restroom alone. An observation of Hospital A's ED waiting area restroom , on 3/2/11 at 9:00 A.M., revealed a glass mirror, two grab bars, and a metal container for toilet seat protectors that patients with Suicide Ideation could use to harm themselves.

The RCA action plan failed to identify any concerns related to nurse staffing. Interviews conducted with RN 2 on 2/11/11 at 2:10 P.M., and RN 4 on 2/11/11 at 4:15 P.M., revealed that an RN was not assigned to Patient 1 until approximately 1 1/2 hours after her admission to the ED. Therefore, there was not an assigned RN to ensure plan of care implementation and monitoring of the patient. An interview on 3/2/11 at 11:20 A.M. with ECRN 2, who was the charge nurse when Patient 2 arrived in the ED, revealed that she assumed the assignment of Patient 2 at 7:00 P.M. on 2/2/11 while she was still in charge of the unit.

Per the Department of Emergency Medicine Staffing Requirements (DEMSR) guidelines (no date), "Staffing patterns are based on patient needs,....and Title 22 regulations." The guidelines directed the charge nurse to take a patient assignment, if necessary, to ensure staffing standards. When ECRN 2 assumed the assignment of Patient 2, she became included in the nurse to patient ratio.

The DES was interviewed on 3/2/11 at 3:30 P.M. The DES stated that staffing issues were discussed during the RCA, but acknowledged there were no action items developed. The DES was unaware of the conflicting information in the DEMSR guidelines concerning regulatory requirements and Charge Nurse staffing responsibilities. The RCA failed to identify and address the staffing guidelines discrepancies.

The facility failed to ensure that a Sentinel Event, Patient 2's suicide, was thoroughly and credibly analyzed per it's own policies and procedures; and an acceptable plan of action developed, in order to improve patient safety and prevent a reccurrence of the event.





2. A review of Patient 1's medical record was conducted on 1/6/11 at 4:00 P.M. Patient 1 was admitted to Hospital A's ED on 3/24/10 for the treatment of a hard palate superficial ulceration after sustaining a burn to the roof of her mouth according to the ED MD notes.

According to a nursing note, dated 3/24/10 and timed at 2:20 P.M., Patient 1 "refused to leave initially and to sign paperwork...was escorted from ED w (with) security, walking w out assistance."

An interview was conducted with the ED Charge RN (ECRN 1) on 2/23/11 at 1:47 P.M. The ECRN 1 thought that the Security Agents, EDT 1, and he escorted Patient 1 out of the ED. Patient 1 walked 30 to 50 yards to the bench at the loop (an area outside the ED for taxi cabs to pull up). When the taxi cab arrived Patient 1 resisted being placed in the cab. ECRN 1 stated that he made the decision to take Patient 1 out of the taxi cab. ECRN 1, EDT 1, and Security Agent 1 carried Patient 1 prone halfway to the bench and placed the patient on the cement on her stomach. ECRN 1 then got on the phone and called the ED Nurse Manager (EDNM). When the EDNM arrived she assessed the patient. Patient 1 was not breathing and had no detectable pulse. CPR was initiated.

According to Patient 1's medical record, Patient 1 was placed on a backboard and lifted on to a gurney and taken into the emergency room . Patient 1 was resuscitated, intubated (passage of a tube through the mouth in to the trachea for the maintenance of an airway) and admitted to the Intensive Care Unit (ICU).

An interview was conducted with the Director of Emergency Services (DES) on 2/17/11 at 1:45 P.M. The DES stated that is her expectation that when an incident like this occurs a thorough investigation should occur to see if there were any preventable issues that could be identified. And, if so, education should take place to prevent a recurrence. The DES remembered being informed after this incident occurred. However, she did not remember being involved in any sort of Quality Assurance process or Performance Improvement action plan.

On 2/23/11 an interview was conducted with the Accrediting and Licensing Principal Consultant (ALPC) at 10:05 A.M. The ALPC stated that an eQVR (electronic quality variance report) was submitted on 3/24/10. The incident was discussed at the Significant Events Committee meeting held on 3/30/10. The committee recommended physician peer review which was conducted by the ED MD in charge of Quality. The ALPC acknowledged that the event did not go thorough a formal performance improvement process from a nursing standpoint.

A review of the Significant Events Meeting Minutes, dated March 30, 2010, was reviewed. There was a notation that the Director of Risk Management and/or a certain Risk Manager were to call the Emergency Department Nurse Manager (ERNM) regarding this event.

On 2/23/11 at 2:35 P.M., an interview was conducted with the Emergency Department Nurse Manager (EDNM). The EDNM stated that any time any eQVRs are submitted by an ED staff member the eQVR is automatically electronically mailed to the EDNM and several other people. It was the EDNM's responsibility to investigate the incident and evaluate the need for follow-up. The EDNM stated that because she was there when the event happened she did not do anything further and was expecting risk management to contact her for any further follow-up. The EDNM acknowledged that she was wrong to assume that since risk management also were notified of the eQVR they would contact her for further action. The EDNM stated that no one from risk management ever contacted her. In addition, the EDNM stated that an eQVR should initiate an investigation. She acknowledged that a full investigation did not occur. And, the EDNM acknowledged that, by hind sight, this was a performance issue.

A review of the hospital's policy and procedure entitled "Electronic Quality Variance report (eQVR) (Event Reporting) Section C. Event reporting and follow-up indicated that "The manager (or supervisor/designee) of the area will conduct the investigation, achieve resolution and implement corrective action as needed...The manager (or Supervisor/designee) of the department involved in an event...Reviews eQVRs and initiates event investigation within 7 days of occurrence. This includes identification of contributing factors, determination of patient outcome, and development and timely implementation of corrective actions."

An interview was conducted with the Director of Nursing Quality (DNQ) on 3/1/11 at 2:10 P.M. The DNQ stated that her expectation was that the EDNM should automatically inform Risk Management when the incident occurred and then delegate duties to herself, the DNQ, and ED Educator to conduct an investigation.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review the facility failed to ensure that, following a Sentinel Event (a significant process variation, medical or hospital error that caused an unanticipated death or major permanent loss of function unrelated to the natural course of the patient's illness or condition and includes serious physical or psychological harm to the patient, or the risk thereof ), the suicide of Patient 1, the Root Cause Analysis (RCA-an analysis that focuses on systems and processes to identify basic and causal factors that underlie variation in performance), action plan identified or established a means by which to measure the success of each action item's implementation, in order to demonstrate that the plan achieved the desired goals and outcomes, and prevented a recurrence of the event.

Findings:

An interview was conducted with the Director of Regulatory Affairs (DRA) on 2/4/11 at 4:20 P.M. Per the DRA, on 2/2/11, Patient 2 was admitted to the ED at Hospital B following a suicide attempt at another healthcare facility. While in the ED at Hospital B, the patient took oxygen tubing and a temperature probe cord and wrapped it around her neck multiple times. The patient was found on the floor. Emergency resuscitation efforts were implemented and the patient was intubated (breathing tube placed in throat) and sent to the Intensive Care Unit (ICU). According to the Discharge Summary dated 2/3/11, Patient 1 expired on [DATE] at 7:49 P.M. The discharge diagnosis was "suicide by hanging."

According to the DRA, a root cause analysis pertaining to Patient 2's suicide was completed on 2/3/11, and an action plan was implemented on 2/4/11.

On 2/23/11 the facility's Performance Improvement and Patient Safety (PIPS) Plan for 2010/11, and the Sentinel Event and Significant Adverse Event (10/21/10) policy and procedure were reviewed.

Per the PIPS plan Sentinel Events were analyzed and managed to prevent such incidents from recurring. Per the Sentinel Event policy, RCA's were conducted for all Sentinel Events which included patient suicide. An action plan was the product of an RCA. To be acceptable, the action plan must 1) identify changes that can be implemented to reduce risk, or formulate a rationale for not undertaking such changes; and 2) identify who was responsible for implementation,when the action would be implemented, define the measure of success, and identify when the outcomes would be measured and evaluated.

On 2/23/11 at 9:15 A.M., the facility's RCA action plan was reviewed with the following members of the RCA team: Director of Risk Management (DRM), Director of Emergency Services (DES), ED Nurse Manager (EDNM), Risk Manager (RM), Accreditation and Licensing Principal Consultant (ALPC), and Medical Doctor (MD) 22.

The action plan contained 9 immediate actions that included education of the ED staff on the new SI (suicide ideation/intent) criteria checklist. A start date to begin education was 2/4/11; however, there was no target completion date determined. Another action item was to define the work flow for the physician order to remove the patient armband. The start date for that item was 2/4/11, but there was no defined target date for completion. A third action item documented that the plan focused on Hospital B's ED only.

The action plan documented that 2 future actions would be implemented "ASAP" (as soon as possible), but no target date for completion was established.

The DRM acknowledged that target dates for completion were not established for the action items. Per the DES, the Hospital B ED staff were provided education on the new process "as they came to work."

Without the establishment of targeted completion dates, the facility would not be able to identify when outcomes would be measured and evaluated as required per it's own policy and procedure.

In addition the RCA action plan did not identify or establish a means by which to measure the success of each action item's implementation to ensure that the plan achieved the desired goals or outcomes.

The facility failed to ensure that an acceptable plan of action was developed, following a Sentinel Event, Patient 2's suicide. The RCA action plan did not include targeted dates of completion and actions items that were measurable, in order to ensure that the plan was effective and sustainable in an effort to improve patient safety and prevent a recurrence of the event.
VIOLATION: PROVIDING ADEQUATE RESOURCES Tag No: A0315
Based on interview and record review, the facility failed to ensure that Hospital B's Emergency Department had adequate licensed staff to meet the needs of the patients, to reduce risks, and maintain patient safety. When Patient 2 was admitted to the Emergency Department of Hospital B following a suicide attempt, a registered nurse was not assigned to the patient for approximately 1 1/2 hours in an effort to oversee and implement the plan of care; after 1 1/2 hours, the charge nurse assumed Patient 2's assignment while still performing her charge nurse duties. In addition, the charge nurse did not give a hand-off report concerning the status of Patient 2 to the receiving nurse.

The facility also failed to ensure that the facility had a designated triage nurse at all times, when at times one registered nurse assumed both the triage nurse and the charge nurse roles at the same time.

Findings:

1. On 2/22/11 at 5:05 P.M., an interview was conducted with Emergency Department Charge Nurse (ECRN) 31. According to ECRN 31, charge nurse duties included staff assignments, patient safety, patient flow, and break relief. ECRN 31 also stated that when the department was short or busy, the charge nurse would take patient assignments.

On 3/1/11 at 8:45 A.M., an interview was conducted with ECRN 32. According to ECRN 32, charge nurse duties included staff assignments, trouble shooting, and patient flow. ECRN 32 also stated that when the department was busy, the charge nurse would take up to 1 to 4 patient assignments depending on the needs at that time.

A review of the facility's policy and procedure titled "Department of Emergency Medicine Staffing Requirements" indicated that, "Staffing patterns are based on patient needs, analysis of acuity trends and Title 22 (State) regulations. At all times there is a minimum 1:4 nurse/patient ratio for the emergency patients."
The policy and procedure further indicated that, "If the standard is compromised due to patient acuity, patient volume, lack of nursing or ancillary personnel, and/or lack of in-house resources, the charge nurse will implement the following actions in the recommended sequence. A. Take a patient assignment."

The facility's practice of ED charge nurses taking patient assignments wen needed, while still conducting charge nurse duties, did not ensure that an RN was immediately available to meet the needs of the patients.

On 2/2/11, Patient 2 was admitted to the Emergency Department (ED) at Hospital B after having attempted suicide by cutting her wrists at another healthcare facility, according to the ED Triage Record. A review of Patient 2's medical record was conducted on 2/4/11 at 4:30 P.M. Patient 2 arrived at the ED of Hospital B via ambulance at 5:28 P.M. Patient 2 was placed on gurney T-16 upon arrival. T-16 was a gurney located in the hallway. Patient 2's initial nursing assessment was conducted by Registered Nurse (RN 2) at 6:12 P.M. RN 2 documented in the initial nursing assessment that Patient 2 had expressed suicidal ideation/intent. RN 2 also documented in the nursing notes that "pt states to me 'I just want to die'...placed in front of nursing station for continuous monitoring. assure pt. (patient) that she is in a safe place. will continue to observe." On 2/2/11 at 7:25 P.M., a Psychologist arrived in the ED to interview and assess Patient 2. According to his psychology note "At interview, Patient was mentally competent and expressed her desire not to live and her desire not to be a burden to her daughter. She stated that she wanted to die and that she would do everything possible to die. She then stated that she 'just wanted a room in which she could sleep' and I requested of one of the nurses that she be moved into a room when possible, from the noisy and busy hallway where I interviewed her."

On 2/4/11 at 4:35 P.M., a review of the hospital policy entitled "Suicide Risk Management" was reviewed. According to the policy, if a patient is identified as a possible risk for suicide "The RN will inform the charge RN of the possible risk. The charge RN will assist with initiating appropriate precautions to ensure the patient's safety while in the emergency department according to the "ED Psychiatric Standards of Care." These Standards of Care indicated to "CONSIDER a sitter (continuous one-to-one monitoring) for the following situations only...If unable to place patient in room where patient is easily observable...rooms 8, 9, and 10" at Hospital B.

An interview with RN 2 was conducted on 2/11/11 at 2:10 P.M. RN 2 stated that she did the initial assessment on Patient 2. However, RN 2 stated that she was not the nurse assigned to the Patient 2. RN 2 stated that she thought ED Charge RN (ECRN 2) was the assigned nurse for Patient 2.

An interview with ECRN 2 was conducted on 3/2/11 at 11:20 A.M. The ECRN 2 stated that when Patient 2 arrived in the ED, via ambulance, she instructed the Emergency Medical Technicians to put Patient 2 on gurney 16 so the patient could be constantly observed. ECRN 2 triaged Patient 2 and RN 2 conducted the initial nursing assessment. ECRN 2 stated that she put her name next to Patient 2's name on the patient assignment board because all of the other RNs had full assignments. ECRN 2 stated that at about 7:00 P.M. she officially became Patient 2's nurse. In addition, ECRN 2 continued to carry out all her other duties as the ED Charge RN. ECRN 2 thought that the Psychologist came to see Patient 2 at about 7:25 P.M. RN 2 and a unit secretary told ECRN 2 that the Psychologist wanted Patient 2 moved to a private room. ECRN 2 stated that she just assumed that the Psychologist had cleared Patient 2 from a psychiatric standpoint. ECRN 2 moved Patient 2 to room 7 at 8:25 P.M. ECRN 2 thought that Patient 2 no longer required constant observation. She acknowledged that the Psychologist never verified nor did she clarify that Patient 2 had been cleared psychiatrically. ECRN 2 chose room 7 because it was the first available room. ECRN 2 was never told that Patient 2 was being placed on a 5150. ECRN 2 stated that she did not remember if she gave report to the receiving nurse assigned to room 7. At 8:42 P.M., Patient 2 was found on the floor of room 7, 17 minutes after the patient was transferred to room 7 from the hallway gurney. According to the nursing note written by RN 3 on 2/2/11 at 8:42 P.M., "...pt. (patient) found lying on floor on lt. (left) side. Pt. found to have thermometer probe cord around her neck along with her oxygen tubing. Pt. unresponsive, no spont. (spontaneous) resp. (respirations) or pulse. Code blue called. cpr (cardio-pulmonary resuscitation) started."

An interview with RN 5 was conducted on 2/11/11 at 1:55 P.M. RN 5 stated that she was the registered nurse assigned to Patient 2 in room 7. However, RN 5 stated that she did not receive a hand-off report from the charge nurse, ECRN 2, regarding Patient 2.

According to interviews of RN 2 on 2/11/11 and the interview of ECRN 2 on 3/2/11, nursing staffing pattern concerning the care and management of Patient 2, on 2/2/11, failed to establish clear nurse/patient assignment to ensure adequate oversight, continuity of care, and implementation of the patient's care plan. Patient 2 was not assigned a nurse for about 1 1/2 hour to assume full oversight, management, and implementation of the patient's care plan. There were different nurses involved with receiving pertinent information regarding Patient 2's care plan which was not conveyed to the nurse assigned to the patient. Furthermore, the nurse assigned to Patient 2 continued her charge nurse role while assigned to the patient.

An interview with the Director of Emergency Services (DES) was conducted on 3/2/11, at 3:00 P.M. The DES stated that she did not know that charge nurses were not supposed to take patient assignments. The DES acknowledged that the facility's own policy and procedure related to staffing requirements had conflicting information, and that the charge nurse should have not taken patient assignments while assigned the charge nurse role.

2. A tour of Hospital B's Emergency Department (ED) was conducted with the Assistant ED Manager on 2/22/11 at 3:14 P.M. The ED had 11 beds and 4 hallway gurney beds. On 2/22/11 at 5:05 P.M., an interview was conducted with Emergency Department Charge Nurse (ECRN) 31. According to ECRN 31, charge nurse duties included staff assignments, patient safety, patient flow, and break relief. ECRN 31 was also the triage nurse from 7:00 A.M. until 11:00 A.M., until another registered nurse (RN) arrived to be the triage nurse (an RN assigned to assess and determine the priority of patient's needs as they entered the ED.)

On 3/1/11 at 8:45 A.M., an interview was conducted with ECRN 32. According to ECRN 32, charge nurse duties included staff assignments, trouble shooting, and patient flow. EDCN 32 was also the triage nurse from 7:00 A.M. until 11:00 A.M., until another RN arrived to be the triage nurse.

A review of the facility's policy and procedure titled "Department of Emergency Medicine Staffing Requirements" indicated that, "A dedicated triage nurse is assigned 24 hours/day."

Hospital B's Emergency Department was not in compliance with their own policy and procedure, when the facility assigned one RN to dual roles, charge nurse and triage nurse. Therefore, the facility was not able to establish a dedicated triage nurse who shall be immediately available to triage patients at all times.

An interview with the Director of Emergency Services (DES) was conducted on 3/2/11 at 3:00 P.M. The DES acknowledged that there should be a dedicated triage nurse 24 hours per day at Hospital B's Emergency Department.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, interview, record and document review, Nursing Leadership failed to provide adequate oversight to ensure, that nursing practices pertaining to timely focused nursing assessment of a patient (24) presenting to the Emergency Department (ED) with suicidal ideation; reassessment of the needs of a patient (1) during the discharge process; timely assignment of a registered nurse to a patient (2) who presented to the ED after a suicide attempt; adequate licensed nurse staffing requirements were being met; effective nursing communication by means of a handoff report when a patient (2) at risk for suicide was assigned to another nurse; and written documentation of verbal counseling that was conducted with a registered nurse after an adverse event had occurred, in order to establish and maintain safe and effective care of patients.

Findings:

1. Hospital A failed to perform and document a focused nursing assessment within the two hour time frame established by the ED Standards of Care for a patient (24) who was admitted to the ED with suicidal ideation.
(A tag 395 #1)

2. Hospital A failed to ensure that RN's reassessed the needs of a patient (1) during the discharge process.
(A tag 395 #2)

3. Hospital B failed to ensure that effective continuum of care occurred for a patient (2) who was not assigned a RN until 1 hour and 45 minutes after her arrival at the ED for attempted suicide.
(A tag 397 #1)

4. Hospital B's Emergency Department failed to ensure that licensed nurse staffing requirements were sufficient in order to meet the needs of a patient (2) admitted after an attempted suicide.
(A tag 392)

5. Hospital B failed to ensure that effective communication occurred between nurses when a handoff report did not take place regarding the management of a patient (2) who had attempted suicide.
(A tag 397 #2)

6. Hospital A failed to ensure that verbal counseling of an RN that occurred following an adverse event, was documented in the RN's personnel file as required by the hospital's policy and procedure.
(A tag 395 #3)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Nursing Services.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital failed to ensure that the licensed nurse staffing requirements were sufficient in order to meet the needs of Patient 2 who was admitted to the Emergency Department (ED) of Hospital B after an attempted suicide.

Findings:

A review of Patient 2's medical record was conducted on 2/4/11 at 4:30 P.M. Patient 2 was admitted on [DATE] after having attempted suicide by cutting her wrists according to the ED Triage Record.

Patient 2 arrived at the ED of Hospital B via ambulance at 5:28 P.M. Patient 2 was placed on gurney T-16 upon arrival. T-16 is a gurney located in the hallway. Patient 2's initial nursing assessment was conducted by Registered Nurse (RN) 2 at 6:12 P.M. It was documented in the initial nursing assessment that Patient 2 had expressed suicidal ideation/intent. RN 2 also documented in the nursing notes that "pt states to me 'I just want to die'...placed in front of nursing station for continuous monitoring. assure pt. (patient) that she is in a safe place. will continue to observe."

A tour of Hospital B's Emergency Department (ED) was conducted with the Assistant ED Manager on 2/11/11 at 1:10 P.M. The ED had 11 beds and 4 hallway gurney beds.

An interview was conducted with the ED Charge RN (ECRN 2) on 3/2/11 at 11:20 A.M. ECRN 2 stated that there is a patient status/assignment board in the ED of Hospital B. ECRN 2 put her name next to Patient 2's name on the patient assignment board because all of the other RNs had full assignments. ECRN 2 stated that at about 7:00 P.M. she officially became Patient 2's nurse. In addition, ECRN 2 continued to carry out all her other duties as the ED Charge RN.

A review of the hospital's policy and procedure entitled "Department of Emergency Medicine Staffing Requirements indicated that "Staffing patterns are based on patient needs, analysis of acuity trends and Title 22 regulations..."

The Emergency Department Charge Nurse Competencies and Responsibilities was reviewed. One of the fifteen responsibilities of an ED Charge RN listed was "Provides clinical care back up for ED staff - may need to occasionally take patient care assignment and/or assist with meal breaks."

By establishing this practice of the ED Charge RN occasionally assigned to patient care along with his/her other charge RN duties, the ED did not ensure that an RN was always immediately available to meet patient needs.

An interview was conducted with the Director of Emergency Services (DES) on 3/2/11 at 3:00 P.M. The DES acknowledged that charge RNs at Hospital B are given patient assignments when the ED gets very busy. The DES stated that she did not know that the charge RNs were not supposed to take patient assignments in addition to their charge nurse duties. The DES acknowledged that the hospital's own policy and procedure related to ED staffing requirements had conflicting information.
VIOLATION: EMERGENCY SERVICES Tag No: A1100
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and record review, the hospital failed to ensure that the needs of 2 sampled patients (1,2) were met in accordance with acceptable standards of emergency medical care. Patient 1 sustained a cardio-pulmonary arrest while being escorted from the ED of Hospital A. The hospital failed to ensure that the ED Nurse Manager contacted Risk Management regarding the events leading up to Patient 1's cardio-pulmonary arrest outside the ED of Hospital A.

Patient 2 committed suicide while a patient in the Emergency Department (ED) of Hospital B.
The hospital failed to ensure that consistent, clear, and thorough procedures and guidelines were implemented pertaining to the management of suicide risk patients in the ED. The hospital failed to ensure that staffing of the Registered Nurses in the ED of Hospital B were in compliance with their staffing policies. The hospital failed to provide adequate education for security agents who might be involved in the management of patients at risk for suicide.

Findings:

1. A review of Patient 1's medical record was conducted on 1/6/11 at 4:00 P.M. Patient 1 was admitted to Hospital A's ED on 3/24/10 for the treatment of a hard palate superficial ulceration after sustaining a burn to the roof of her mouth according to the ED physician notes.

According to a nursing note written by Registered Nurse 1 (RN 1), dated 3/24/10 and timed at 2:20 P.M., Patient 1 "refused to leave initially and to sign paperwork...was escorted from ED w (with) security, walking w out assistance."

A telephone interview was conducted with Patient 1's home health caregiver on 1/7/11 at 10:55 A.M. The caregiver stated that Patient 1 told her that she did not want to leave the ED because she could not breathe. Patient 1 further stated that she did not want to go home because she did not feel well.

On 1/14/11 an interview was conducted with ED Technician (EDT) 1 at 4:45 P.M. EDT 1 stated that after returning from lunch, he went outside of the ED to make a phone call. That's when he saw two security agents escorting Patient 1 out of the ED. Patient 1 was walking. The ED Charge Registered Nurse (ECRN 1) was present, as well. ECRN 1 told EDT 1 that the plan was to put Patient 1 in a cab to go home. When the two security agents, the ECRN 1, and EDT 1 tried to put Patient 1 in the cab she went limp and put up a fight. The ECRN 1 decided to take Patient 1 out of the cab. Patient 1 was then carried toward a bench and placed prone (lying with the front or face downward) on the sidewalk in front of the bench. EDT 1 stated that this was not the best position for Patient 1 to be in given her anatomy. EDT 1 further explained that by "anatomy" he meant that she was morbidly obese (a medical condition in which excess body fat has accumulated to the extent that it may have an adverse effect on health). EDT 1 stated that Patient 1 was prone for a couple of minutes until they turned Patient 1 over and it was established that she was not breathing.

An interview was conducted with Security Agent 1 on 2/17/11 at 2:15 P.M. Security Agent 1 stated that he was called to ED Room 12 B shortly after 2:00 P.M. When he arrived at Room 12 B in the ED, Patient 1 was refusing to get off of the gurney. Patient 1 said that she was not going to leave. Security Agent 1 never heard Patient 1 say why she did not want to leave. Eventually, Patient 1 got off the gurney and she was escorted by himself and Security Agent 2 to the "loop" which is an area outside the ED where taxi-cabs pull up. Security Agent 1 further stated that an unidentified male staff member told the patient that if she did not leave the premises they were going to call the police for trespassing. That statement was repeated to the patient by both of the security Agents. Security Agent 1 then explained that Patient 1 sat on the bench at the loop waiting for the taxi cab to arrive. When the taxi cab arrived, they opened the back passenger door. Patient 1 went limp on purpose. They were joined by EDT 1. They were not successful in getting Patient 1 into the taxi cab. The taxi cab driver did not want to take the patient home if she could not help herself. Security Agent 1 recalled Patient 1 saying that she was not leaving but the words were broken because she was short of breath. Patient 1 was hanging half way out of the taxi. It took three people to carry the patient, ECRN 1, EDT 1, and Security Agent 1. Patient 1 was carried face down and placed face down on the cement in front of the bench. About 5 minutes later, the ED Case Manager arrived and suggested that they turn Patient 1 over. When they did, Patient 1's lips were observed to be purple. Cardio-Pulmonary Resuscitation (CPR) was initiated. Patient 1 was then placed on a back board, raised to a gurney and taken back in to the ED.

On 2/17/11 an interview was conducted with RN 1 who was the ED discharge RN for Patient 1 on 3/24/10. RN 1 did not remember if Patient 1 told her why she did not want to leave the ED. There was no documentation in the nurses notes regarding why Patient 1 was refusing to leave the ED. However, RN 1 did state that she thought that Patient 1 had significant lung problems. RN 1 believed that Patient 1 had COPD (Chronic Obstructive Lung Disease). A review of Patient 1's medical records from four previous hospitalization s at Hospital A verified that Patient 1 had been diagnosed with COPD and obesity hypoventilation (inadequate ventilation).

A security surveillance video tape scanning the loop area at the time of the incident was observed on 2/23/11 at 10:30 A.M. The video tape supported the details of the incident as described by both EDT 1 and Security Agent 1.

An interview was conducted with the ECRN 1 on 2/23/11 at 1:47 P.M. The ECRN 1 thought that the Security Agents, EDT 1, and he escorted Patient 1 out of the ED. Patient 1 walked 30 to 50 yards to the bench at the loop. When the taxi cab arrived Patient 1 resisted being placed in the cab. ECRN 1 stated that he made the decision to take Patient 1 out of the taxi cab. ECRN 1, EDT 1, and Security Agent 1 carried Patient 1 prone halfway to the bench and placed the patient on the cement on her stomach. ECRN 1 then got on the phone and called the ED Nurse Manager (EDNM). When the EDNM arrived she assessed the patient. Patient 1 was not breathing and had no detectable pulse. CPR was initiated.

On 1/14/11 at 2:45 P.M., an interview was conducted with the EDNM. The EDNM stated that she had no involvement with Patient 1 prior to being called by ECRN 1. When she arrived at the loop area she saw two security agents, EDT 1, and the ECRN 1. Patient 1 was lying face down. The EDNM stated that she was a little surprised and upset to see Patient 1 lying prone on the sidewalk outside the ED. After the incident the EDNM spoke to ECRN 1. ECRN 1 was counseled by being told that the prone position was not a safe position for an obese person to be placed in due to the potential for respiratory compromise.

According to Patient 1's medical record, Patient 1 was resuscitated, intubated (passage of a tube through the mouth into the trachea for the maintenance of the airway) and admitted to the intensive care unit (ICU). During Patient 1's 28 day hospital stay she required the insertion of a tracheostomy (surgical operation that creates an opening into the trachea with a tube inserted to provide a passage for air). Patient 1 was discharged on [DATE] with a tracheostomy stent (a device used to support the trachea) in place.

2. A review of Patient 2's medical record was conducted on 2/4/11 at 4:30 P.M. Patient 2 was admitted on [DATE] after having attempted suicide by cutting her wrists according to the ED Triage Record.

Patient 2 arrived at the ED of Hospital B via ambulance at 5:28 P.M. Patient 2 was placed on gurney T-16 upon arrival. T-16 is a gurney located in the hallway. Patient 2's initial nursing assessment was conducted by Registered Nurse (RN 2) at 6:12 P.M. It was documented in the initial nursing assessment that Patient 2 had expressed suicidal ideation/intent. RN 2 also documented in the nursing notes that "pt states to me 'I just want to die'...placed in front of nursing station for continuous monitoring. assure pt. (patient) that she is in a safe place. will continue to observe." At 7:25 P.M. a Psychologist arrived in the ED to interview and assess Patient 2. According to his psychology note "At interview, Patient was mentally competent and expressed her desire not to live and her desire not to be a burden her daughter. She stated that she wanted to die and that she would do everything possible to die. She then stated that she 'just wanted a room in which she could sleep' and I requested of one of the nurses that she be moved into a room when possible, from the noisy and busy hallway where I interviewed her."

On 2/4/11 at 4:35 P.M., a review of the hospital policy entitled "Suicide Risk Management" was reviewed. According to the policy, if a patient is identified as a possible risk for suicide "The RN will inform the charge RN of the possible risk. The charge RN will assist with initiating appropriate precautions to ensure the patient's safety while in the emergency department according to the "ED Psychiatric Standards of Care." These Standards of Care indicate to "CONSIDER a sitter (continuous one-to-one monitoring) for the following situations only...If unable to place patient in room where patient is easily observable...rooms 8, 9, and 10" at Hospital B.

An interview was conducted with the Assistant (Asst.) ED Nurse Manager on 2/11/11 at 1:20 P.M. The Asst. Manager acknowledged that the best beds for constant observation from the nursing station in the ED at Hospital B were rooms 8, 9, 10.

On 2/25/11 an interview was conducted with Patient 2's Psychologist. He stated that he saw Patient 2 in the ED at about 8:00 P.M. on 2/2/11. The Psychologist stated that Patient 2 was an elderly female who was determined to die. He interviewed Patient 2 but he did not complete his assessment. The patient asked to be moved to a quiet place to sleep. The Psychologist spoke to an ED RN and asked that Patient 2 be placed in a room. The Psychologist was going to continue his assessment in a private area. Patient 2's Psychologist stated that it was absolutely his intention for Patient 2 to remain on constant observation. According to the hospital policy entitled "Constant Observation" the definition is an increased level of observation and supervision in which continuous one-to-one monitoring techniques are used to assure the safety and well being of an individual patient. His intention was to place Patient 2 on a 5150 (involuntary 72 hour psychiatric hold for patients who are either a danger to themselves or others).

An interview was conducted with the ED Charge RN (ECRN 2) on 3/2/11 at 11:20 A.M. The ECRN 2 stated that when Patient 2 arrived in the ED, via ambulance, she instructed the Emergency Medical Technicians to put Patient 2 on gurney 16 so she could be constantly observed. The ECRN 2 conducted the triage for Patient 2 and RN 2 conducted the initial nursing assessment. ECRN 2 thought that the psychologist came to see Patient 2 at about 7:25 P.M. RN 2 and a unit secretary told the ECRN 2 that the Psychologist wanted Patient 2 moved to a private room. ECRN 2 stated that she just assumed that the psychiatrist had cleared Patient 2 from a psychiatric standpoint. ECRN 2 moved Patient 2 to room 7 at 8:25 P.M. The ECRN 2 thought that Patient 2 no longer required constant observation. She acknowledged that the Psychologist never verified that Patient 2 had been cleared psychiatrically. The ECRN 2 chose room 7 because it was the first available room. The ECRN 2 was never told that Patient 2 was being placed on a 5150.

According to the ED Psychiatric Standards of Care when a patient is placed on a 5150 hold "A SITTER must be assigned to the patient."

A nursing note entry written by RN 5 documented that at 8:42 P.M. "...pt. (patient) found lying on floor on lt. (left) side. Pt. found to have thermometer probe cord around her neck along with her oxygen tubing. Pt. unresponsive, no spont. (spontaneous) resp. (respirations) or pulse. Code blue called. cpr (cardio-pulmonary resuscitation) started.

Patient 2 was successfully resuscitated, intubated (breathing tube placed in the throat) and transferred to the Intensive Care Unit (ICU) where she eventually expired on [DATE]. According to the Discharge Summary, dated 2/3/11, Patient 2 expired on [DATE] at 7:49 P.M. The discharge diagnosis was "suicide by hanging."

During the interview conducted with the Assistant ED Nurse Manager, the Assistant Manager stated that it was his expectation that, if a patient was on constant observation on gurney 16 in the hallway, constant observation of the patient would continue in room 7 by assigning a trauma technician to be one-on-one which means the patient is never left alone. The Assistant Manager acknowledged that constant observation of Patient 2 did not occur in this case.

3. The hospital failed to ensure that consistent, clear, and thorough procedures and guidelines were implemented pertaining to the management of suicide risk patients in the Emergency Department of both hospital campuses.
(A tag 1104)

4. The hospital failed to ensure that the staffing of Registered Nurses in the Emergency Department of Hospital B was in accordance with their own ED Staffing Requirements policy and procedure.
(A tag 1112)

5. The hospital failed to ensure that the Emergency Department Nurse Manager contacted Risk Management regarding the events surrounding a cardio-pulmonary arrest of Patient 1 that occurred while Patient 1 was being escorted from the ED of Hospital A.
(A tag 1103)

6. The hospital failed to ensure that adequate education was provided for security guards, at both hospital campuses, for the management of patients at risk for suicide.
(A tag 1103 #1)

The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Emergency Services.
VIOLATION: INTEGRATION OF EMERGENCY SERVICES Tag No: A1103
Based on interview and document review, the hospital failed to ensure that adequate education was provided for security agents, at both hospital campuses, for the management of patients at risk for suicide. In addition, the Emergency Department Nurse Manager (EDNM) never contacted Risk Management regarding the events surrounding a cardio-pulmonary arrest that occurred while Patient 1 was being escorted from the ED during discharge from Hospital A.

Findings:

1. An interview with security agent (SA) 31 was conducted on 3/1/11 at 10:45 A.M. at Hospital B. SA 31 stated he did not recall having any formal training regarding the management of a suicidal patient. SA 31 stated that their department had monthly briefings which may include training.

An interview with SA 32 was conducted on 3/1/11 at 11:00 A.M., at Hospital B. SA 32 stated that he had not received any formal training regarding the management of a suicidal patient. SA 32 stated that on 2/25/11, Security Manager (SM) 1 informed them about the orange wrist bands that were used on suicidal patients.

An interview with SA 33 was conducted on 3/1/11 at 11:30 A.M. at Hospital B. SA 33 stated that he did not receive any formal training regarding the management of a suicidal patient. SA 33 also stated that he had been called to the emergency room to assist with a suicidal patient.

An interview with SA 34 was conducted on 3/1/11 at 3:35 P.M. at Hospital A. SA 34 stated that he had been called to assist with suicidal patients in the emergency room . SA 34 was asked what he would do if he was assigned to watch a suicidal patient in the Emergency Department waiting room and the patient wanted to use the bathroom. SA 34 stated that he would wait for the patient outside while the patient was inside by him or herself.

An observation of Hospital A's Emergency Department waiting room bathroom was conducted on 3/2/11 at 9:00 A.M. The bathroom had the following: a glass mirror, two grab bars, and a metal container that stored the toilet seat protectors that could pose a potential safety risk for any patient with an intent to harm him/herself or others.

An interview with security manager (SM) 1 was conducted on 3/3/11 at 9:40 A.M. SM 1 was asked what he expected the security agents, who were assigned to watch suicidal patients in the Emergency Department waiting room to do, if the patient wanted to use the bathroom. SM 1 stated that the security agent would take the suicidal patient inside the bathroom while the security agent waited outside.

An interview with the Director of Emergency Services (DES) was conducted on 3/3/11 at 9:55 A.M. The DES stated that she informed the security managers that security agents, who were assigned to watch a suicidal patient in the Emergency Department waiting room, should stay with the patient at all times. DES stated, "Eyes on at all times." DES stated that she did not give specific instructions to the security department on how to deal with suicidal patients who needed to use the bathroom. DES acknowledged that more training was needed.

2. A review of Patient 1's medical record was conducted on 1/6/11 at 4:00 P.M. Patient 1 was admitted to Hospital A's ED on 3/24/10, for the treatment of a hard palate superficial ulceration after sustaining a burn to the roof of her mouth according to the ED physician notes. According to a nursing note, dated 3/24/10 and timed at 2:20 P.M., Patient 1 "refused to leave initially and to sign paperwork...was escorted from ED w (with) security, walking w out assistance."

An interview was conducted with the ED Charge RN (ECRN) 1 on 2/23/11 at 1:47 P.M. The ECRN 1 thought that the Security Agents, EDT 1, and he escorted Patient 1 out of the ED. Patient 1 walked 30 to 50 yards to the bench at the loop (an area outside the ED for taxi cabs to pull up). When the taxi cab arrived Patient 1 resisted being placed in the cab. ECRN 1 stated that he made the decision to take Patient 1 out of the taxi cab. ECRN 1, EDT 1, and Security Agent 1 carried Patient 1 prone halfway to the bench and placed the patient on the cement on her stomach. ECRN 1 then got on the phone and called the ED Nurse Manager (EDNM). When the EDNM arrived she assessed the patient. Patient 1 was not breathing and had no detectable pulse. CPR was initiated.

According to Patient 1's medical record , Patient 1 was placed on a backboard and lifted on to a gurney and taken into the emergency room . Patient 1 was resuscitated, intubated (passage of a tube through the mouth in to the trachea for the maintenance of an airway) and admitted to the Intensive Care Unit (ICU).

An interview was conducted with the Director of Emergency Services (DES) on 2/17/11 at 1:45 P.M. The DES stated that is her expectation that when an incident like this occurs a thorough investigation should occur to see if there were any preventable issues that could be identified. And, if so, education should take place to prevent a recurrence. The DES remembered being informed after this incident occurred. However, she did not remember being involved in any sort of Quality Assurance process or Performance Improvement action plan.

On 2/23/11 an interview was conducted with the Accrediting and Licensing Principal Consultant (ALPC) at 10:05 A.M. The ALPC stated that an eQVR (electronic quality variance report) was submitted on 3/24/10. The incident was discussed at the Significant Events Committee meeting held on 3/30/10. The committee recommended physician peer review which was conducted by the ED M.D. in charge of Quality. The ALPC acknowledged that the event did not go thorough a formal performance improvement process from a nursing standpoint.

A review of the Significant Events Meeting Minutes, dated 3/30/10, was reviewed. There was a notation that the Director of Risk Management and/or a certain Risk Manager were to call the Emergency Department Nurse Manager (ERNM) regarding the this event.

On 2/23/11 at 2:35 P.M., an interview was conducted with the Emergency Department Nurse Manager (EDNM). The EDNM stated that any time any eQVRs are submitted by an ED staff member the eQVR is automatically electronically mailed to the EDNM and several other people. It was the EDNM's responsibility to investigate the incident and evaluate the need for follow-up. The EDNM stated that because she was there when the event happened she did not do anything further and was expecting risk management to contact her for any further follow-up. The EDNM acknowledged that she was wrong to assume that since risk management also were notified of the eQVR they would contact her for further action. The EDNM stated that no one from risk management ever contacted her. In addition, the EDNM stated that an eQVR should initiate an investigation. She acknowledged that a full investigation did not occur. And, the EDNM acknowledged that, by hind sight, this was a performance issue.

A review of the hospital's policy and procedure entitled "Electronic Quality Variance report (eQVR) (Event Reporting) Section C. Event reporting and follow-up indicated that "The manager (or supervisor/designee) of the area will conduct the investigation, achieve resolution and implement corrective action as needed...The manager (or Supervisor/designee) of the department involved in an event...Reviews eQVRs and initiates event investigation within 7 days of occurrence. This includes identification of contributing factors, determination of patient outcome, and development and timely implementation of corrective actions.

An interview was conducted with the Director of Nursing Quality (DNQ) on 3/1/11 at 2:10 P.M. The DNQ stated that her expectation was that the EDNM should automatically inform Risk Management when the incident occurred and then delegate duties to herself, the DNQ, and ED Educator to conduct an investigation.
VIOLATION: EMERGENCY SERVICES POLICIES Tag No: A1104
Based on observation, interview and policy review, the hospital failed to develop consistent, clear, and thorough procedures and guidelines pertaining to the management of 2 suicide risk patients (3,24) in the Emergency Department (ED).

Findings:

A general observation tour of the Emergency Department (ED) of Hospital A was conducted on 2/22/11, at 2:40 P.M. At that time there were two patients in the ED with suicidal ideation, Patient 3 and Patient 24. Patient 3 was in room 12 bed A and Patient 24 was on hallway gurney. Certified Nursing Assistant (CNA 3) was assigned as a "constant observer" for both Patient 3 and Patient 24.

An interview was conducted with CNA 3 on 2/22/11 at 3:05 P.M. CNA 3 verified that she was a "constant observer" for both Patient 3 and Patient 24. She explained that she monitored the suicidal patients behaviors.

An interview was conducted with Patient 3's ED Registered Nurse (RN 3) on 2/22/11 at 3:20 P.M. RN 3 stated that patients that present to the ED who are suicidal are assigned a 1:1 "sitter" or "constant observer."

On 2/22/11 a review of the following facility documents, and policies and procedures, was conducted: "Care of Psychiatric Patients in the ED," "Suicide Risk Management" dated 12/16/10, "Constant Observation" dated 8/08, and the Checklist for Patients Presenting to the ED with Suicide Ideation (SI, no date).

The policies and procedures, along with the checklist, provided unclear and conflicting information and guidelines to staff with regards to monitoring requirements and required documentation for patients with suicide ideation or other psychiatric diagnoses. Various monitoring terms were used by facility staff to include "sitter," "constant observation attendant," "patient care attendant," and "direct observation;" however, facility policies and procedures did not clearly define the difference between direct observation and constant observation. The facility's Suicide Risk Management Policy dated 12/10 referred to the use of a "constant observation attendant" for 1:1 monitoring, or a "patient care attendant" for 2:1 or 3:1 monitoring. A policy entitled "Care of Psychiatric Patients in the ED" (no date), instructed staff to use a sitter in a specific situation and "adhere to the patient care attendant policy (MCP 300.3). " However, policy # MCP 300.3 was the "Constant Observation" policy and procedure which pertained to 1:1 monitoring, not 2:1 or 3:1. In addition, per the "Care of Psychiatric Patients in the ED" policy, psychiatric patients who were determined to be a danger to self or others were managed differently at each hospital when no beds were immediately available in the ED.

A meeting was held with members of the hospital's senior management on 2/22/11, at 6:00 P.M. In attendance was the Chief of Risk Management, Director of Regulatory Affairs, Accreditation and Licensing Principal Consultant, Director of Emergency Services, Director of Medical Surgical Specialties, Director of Nursing Quality, and the Director of Nurses at Hospital B. These members of the senior management team acknowledged that the policies and procedures referred to above were conflicting and confusing and lacked definitive guidelines for the clinical staff while caring for patients at risk for suicide.
VIOLATION: QUALIFIED EMERGENCY SERVICES PERSONNEL Tag No: A1112
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, the hospital failed to ensure that the staffing of Registered Nurses (RN) in the Emergency Department (ED) was in accordance with the hospital's own policies and procedures.

Findings:

A review of Patient 2's medical record was conducted on 2/4/11 at 4:30 P.M. Patient 2 was admitted on [DATE] after having attempted suicide by cutting her wrists according to the ED Triage Record.

Patient 2 arrived at the ED of Hospital B via ambulance at 5:28 P.M. Patient 2 was placed on gurney T-16 upon arrival. T-16 is a gurney located in the hallway. Patient 2's initial nursing assessment was conducted by Registered Nurse (RN 2) at 6:12 P.M. RN 2 documented in the initial nursing assessment that Patient 2 had expressed suicidal ideation/intent. RN 2 also documented in the nursing notes that "pt states to me 'I just want to die'...placed in front of nursing station for continuous monitoring. assure pt. (patient) that she is in a safe place. will continue to observe."

An interview was conducted with the ED Charge RN (ECRN 2) on 3/2/11 at 11:20 A.M. ECRN 2 stated that there is a patient status/assignment board in the ED of Hospital B. ECRN 2 put her name next to Patient 2's name on the patient assignment board because all of the other RN's had full assignments. ECRN 2 stated that at about 7:00 P.M., she officially became Patient 2's nurse. In addition, ECRN 2 continued to carry out all her other duties as the ED Charge RN.

A review of the hospital's policy and procedure entitled "Department of Emergency Medicine Staffing Requirements indicated that "Staffing patterns are based on patient needs, analysis of acuity trends and Title 22 regulations..."

The Emergency Department Charge Nurse Competencies and Responsibilities was reviewed. One of the fifteen responsibilities of an ED Charge RN listed was "Provides clinical care back up for ED staff - may need to occasionally take patient care assignment and/or assist with meal breaks."

By establishing this practice of the ED Charge RN occasionally assigned to patient care along with his/her other Charge RN duties, the ED did not ensure that an RN was always immediately available to meet the patient needs.

An interview was conducted with the Director of Emergency Services (DES) on 3/1/11 at 10:50 A.M. The DES acknowledged that Charge RN's at Hospital B are given patient assignments when the ED gets very busy. The DES stated that she did not know that charge nurses were not supposed to take patient assignments in addition to their charge nurse duties. The DES acknowledged that the hospital's own policy and procedure related to ED staffing requirements had conflicting information.