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ERIE COUNTY MEDICAL CENTER 462 GRIDER STREET BUFFALO, NY 14215 Oct. 7, 2013
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on policy and procedure review, medical record review, staff interview and document review, the hospital failed to provide the criteria for monitoring behavioral health patients while on observational status.

An Immediate Jeopardy situation related to safety of behavioral health patients under observation was declared during this investigation on 10/08/13 at 1:49 PM.

The Immediate Jeopardy was abated on 10/09/13 at 11:00 AM after the hospital had taken corrective actions sufficient to ensure patient safety. An attestation signed by Chief Safety Officer Staff #1 was received, with implementation of facility policies, directives and staff inservicing, including:

- Revision of PSY-36 policy "Level of Patient Observation in Psychiatry" for Level 1 observations to include the monitoring of sleeping patients by visually checking for breathing via chest movement, and the verification that a patient is in no apparent distress. Patient Safety Assistants (PSAs) on behavioral health units will manage all unit entry points during a medical emergency.
- Education was provided on 10/08/13 and 10/09/13 to all behavioral health staff including: nursing, occupational and recreational therapy staff, social workers and PSAs.

See findings under Tags A-0144 and A-0395.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on policy and procedure review, medical record review and staff interview, the hospital failed to ensure each behavioral health patient receives care in a safe environment, as evidenced for Patient #1. There was lack of criteria for monitoring patients on Level 1 observational status while sleeping, and lack of adherence to established policies regarding the need for patient room doors to remain open.

Findings include:

Review of policy PSY-36 "Level of Patient Observation in Psychiatry" (revised 11/2012) revealed four levels of patient observation: Level I (observations every 15 minutes), Level IIIA (one to one, arm's length observation), Level IIIB (continual line of sight observation) and Level IIIC (forensic patients only). All observation levels are ordered by a physician. For Level I patient observations: The patient's location and activity will be observed and documented on the Behavioral Health Patient Activity Flow Sheet in real time every 15 minutes by the assigned staff member. Checks are to be staggered to prevent predictable observations, but are not to go beyond 15 time intervals. The policy requires that if a patient is sleeping, staff are to visualize there is chest movement and confirm there is no apparent distress for Level IIIA and Level IIIB observations, but this is not a requirement for Level I patient observations.

Review of policies PSY-081 "Environment of Care-Safety Audits" (last reviewed 09/2011) and NUR-182 "Safety of the Psychiatric Patient" (last revision 07/2013) revealed doors to patient rooms must be open at all times.

Review of the Behavioral Observation sheet (staff rounding observations) dated 10/03/13 for Patient #1 revealed she was on Level 1 observation status. Checks were performed approximately every 15 minutes on 10/03/13 from 12:03 AM through 6:00 AM. It was documented for each check that Patient #1 was in her room and in bed.

Medical record review for Patient #1 revealed:
- A nursing progress note dated 10/03/13 at 6:54 AM revealed when Registered Nurse (RN) Staff #15 was doing checks/second set of environmental rounds at 6:25 AM, she found Patient #1 sitting in front of the sink with a sheet tied around her neck and the other end of the sheet tied to the sink faucet. Patient #1 was cold, her lips were blue, and she was unresponsive and pulseless.
- The Code Note dated 10/03/13 at 6:50 AM documented that Code Blue was called at 6:28 AM and CPR initiated immediately upon arrival. Patient #1 was noted to be pulseless, apneic (without breathing) and cyanotic (skin blueness) with rigor mortis (temporary stiffening of muscles occurring after two to four hours after death). Heart rhythm was asystole (absence of heartbeat). IV access was attempted. CPR was performed for 13 minutes with advanced rigor mortis and cyanosis noted. Despite attempts at resuscitation, Patient #1 was unable to be revived and was pronounced dead at 6:41 AM.

Interviews with hospital staff revealed:
- On 10/07/13 at 9:30 AM, Unit Manager of Behavioral Health Staff #2 revealed the standard for patient observation is 15 minute checks. A patient's location and actions are observed and documented. During the night shift, staff go into patient rooms with flashlights, go to the bedside and observe for chest rising.
- On 10/07/13 at 1:40 PM, Mental Health Worker Staff #5 revealed she was knowledgeable on how to perform Level 1 observation rounding. She stated that doors to patient rooms are supposed to be open, but patients do close doors for privacy.
- On 10/08/13 at 6:05 AM, Hospital Aide Staff #7 revealed when she does her rounds, she listens to the patient's breathing because the rooms can be dark and it is difficult to visualize the patient. Flashlights are not available. Staff #7 stated on 10/03/13 during rounding, Patient #1's door was closed and the room was totally dark. At approximately 6:00 AM, Staff #7 went into Patient #1's room and thought she was lying in her bed on her back with the covers pulled up to her chest and asleep. Staff #7 stated that around 6:20 AM, she heard RN Staff #15 screaming. Due to the patient doors on the unit being closed, Staff #15 could not be found immediately. Upon entering Patient #1's room, Staff #7 saw Staff #15 with Patient #1, who was sitting on the floor next to the sink.
- On 10/8/13 at 6:50 AM, RN Staff #8 revealed patients will close the doors for privacy. Flashlights are not available for rounding.
- On 10/08/13 at 7:15 AM, Physician Assistant Staff #9 revealed he was the first Rapid Response Team member on the scene for Patient #1's code on 10/03/13. He stated Patient #1 did not have a pulse, was cold and mottled (blotched in coloring) with "rigor," was hard to lie flat, was cyanotic and her fingertips were purple. He believed the anesthesia service "called the code" (ended the code) after unsuccessful resuscitation attempts because Patient #1 was too contracted (drawn together).
- On 10/08/13 at 10:15 AM, during telephone interview Nurse Practitioner Staff #12 revealed she responded to the code for Patient #1 on 10/03/13 as a member of the Rapid Response Team. She stated Patient #1 was blue and unresponsive with mottled hands and no evidence of life. Staff #12 attempted to place a femoral central line, but it was difficult to straighten the patient's leg due to "rigor," and she did not expect that level of "rigor" in Patient #1. She believed anesthesia "called the code," and at first medicine was uncomfortable with the decision, but concurred because Patient #1 had "rigor."
- On 10/8/13 at 11:35 AM, Staff #11, Medicine Resident PGY-3 (post graduate year 3) for the Code Blue Team, revealed that when she arrived on 10/03/13 at the code for Patient #1, Patient #1 was cyanotic and was pulseless. When the cardiac monitor arrived, Patient #1 was hooked up, but the first rhythm was asystole. A central line was attempted femorally; however, due to Patient #1 being in "rigor," the team was unable to move Patient #1 to get the access in. The code was "called" due to Patient #1 was with rigor.
- On 10/08/13 at 3:15 PM, RN Staff #15 revealed when she found Patient #1 on rounds on the morning of the code on 10/03/13, Patient #1 was cold with no pulse.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on policy and procedure review, medical record review, document review and staff interview, nursing staff did not supervise and evaluate the care provided to Patient #1, as evidenced that behavioral health staff did not follow facility policy related to calling a Code Blue.

Findings include:

Review of policy ADM-019 "Rapid Response Team" (last revision 06/2012) revealed the Rapid Response Team is not intended for patients in cardiac/respiratory arrest. Responsibility of the primary nurse includes: initiate the Rapid Response Team, obtain patient vital signs, give the Rapid Response Team a report on the patient including problem and pertinent history, remain at bedside as primary caregiver, assist with further assessment, and document events leading up to Rapid Response and patient responses to interventions.

Review of policy CLIN-028 "Cardiopulmonary Resuscitation" (last revision 03/2013) revealed that basic life support measures shall be initiated immediately for any person who experiences cardiopulmonary arrest. It is the responsibility of the staff/personnel in the immediate area of the arrest to identify the need for medical assistance and have a "Code Blue" announced. Roles and Responsibilities of Unit Personnel include: ensuring initiation of Basic Life Support and initiation of Code Blue services; after arrival of the code team, the unit nurse will assist as necessary until relieved; the patient's assigned unit/clinic nurse will be present during the code and will remain with the patient to provide support, supply critical information about the patient to the code team and document events leading up to the code.
Protocol/ Procedure:
- The patient should never be left alone.
- Verify unresponsiveness; call for help.
- Check for pulse for at least 5 seconds, but no longer than 10 seconds. If no pulse, begin cardiopulmonary resuscitation. Perform chest compressions and ventilations.
- Obtain suction equipment, oxygen gauge and set up immediately. Obtain code cart and defibrillator/AED (automated external defibrillator).
- Continue CPR according to American Heart Association CPR standards.

Medical record review for Patient #1 revealed:
- The Behavioral Observation sheet (staff rounding observations) dated 10/03/13 revealed at 6:00 AM, Hospital Aide Staff #7 noted Patient #1 was in bed (on behavioral health unit 11 zone 3). At 6:19 AM, "staff" entered the room and Patient #1 was on the floor. The code team was called at 6:30 AM.
- The Code Note dated 10/03/13 at 6:50 AM revealed Code Blue was called at 6:28 AM and CPR was initiated immediately upon arrival. Patient #1 was unable to be revived and was pronounced dead at 6:41 AM.
- The CPR report dated 10/03/13 revealed Patient #1 was found at 6:27 AM. CPR was started at 6:28 AM by the physician assistant (PA) on the Rapid Response Team. The initial heart rhythm was asystole (absence of heartbeat). The code was concluded at 6:41 AM.
- The Nursing Progress Note dated 10/03/13 at 6:54 AM revealed when registered nurse (RN) Staff #15 was doing checks/environment rounds at 6:25 AM, she found Patient #1 sitting in front of the sink with a sheet tied around her neck and the other end of sheet tied to the sink faucet. Staff #15 removed the sheet from the faucet. Patient #1 was unresponsive and pulseless. Staff #15 yelled down the hall for additional staff to come. She immediately ran to the phone to call a code. Code team staff responded and attempted to revive Patient #1.
- The Nursing Progress Note dated 10/03/13 at 7:00 AM revealed that RN Staff #15 shouted for RN Staff #8 to come. Upon entering the room, Staff #8 saw that Patient #1 was sitting slumped at the sink, and that Staff #15 was trying to remove a sheet from Patient #1's neck and had already removed the sheet from the faucet. Staff #8 immediately ran to call for a rapid response. When the first responder came, he began cardiopulmonary resuscitation and asked for a Code Blue to be called. Code Blue staff members responded and Patient #1 was worked on by the team. The code was called off with time of death at 6:41 AM.

Interviews with hospital staff revealed:
- On 10/08/13 at 6:50 AM, Charge Nurse RN Staff #8 revealed that on 10/03/13, RN Staff #15 was conducting the last environmental checks for the shift and found Patient #1 unresponsive. Staff #8 went to the room, but immediately left the room (leaving Patient #1 alone, timeframe unknown) to initiated the "code" (Rapid Response Team). A male RN from unit 11 zone 4 arrived to the room and started to assess Patient #1 for a pulse. Staff #8 was unsure who brought the crash cart to Patient #1's room. Staff #8 stated that while the "code team" was working on Patient #1, she was trying to control the milieu, directing patients away from the area.
- On 10/08/13 at 7:15 AM, Rapid Response Team PA Staff #9 revealed he was the first responder to the code for Patient #1 on 10/03/13. He was unable to enter the unit due to the unit door being locked and had to pound on the door. He does not have access to any of the behavioral health units. When Staff #9 arrived in Patient #1's room, she was still in sitting position. There was one male behavioral health staff member who was trying to assess Patient #1's pulse. CPR was not in progress and the crash/code cart was not in the room. Patient #1 had no pulse. Staff #9 instructed the male behavioral health staff to call a Code Blue. Staff #9 started compressions. Rapid Response Team nurse practitioner (NP) Staff #12 arrived and assisted in CPR. Staff #9 felt it was about three minutes from his arrival on the unit until the crash/code cart was brought to Patient #1's room. Staff #9 stated he was not informed Patient #1 had committed suicide and did not know the circumstance that lead up to the code. Staff #9 stated no behavioral health staff members assisted or were present in Patient #1's room during the code.
- Telephone interview on 10/08/13 at 10:15 AM with Rapid Response Team NP Staff #12 revealed she does not have key access to any of the behavioral health units. On 10/03/13, Staff #12 responded to the code on 11 zone 3. When she arrived on the unit, there were no behavioral health staff members available to direct responders, so she headed toward the area where she saw staff standing and they directed her. Upon entering the Patient #1's room, Rapid Response Team PA Staff #9 was performing compressions. The crash cart was not available and they did not have access to an Ambu bag (self-inflating resuscitator). She stated it took up to 1? minutes for the crash cart to arrive. Staff #12 stated the code was "clumsy" because there was no unit staff around for support. She did not recall a single unit staff person anywhere and was not informed Patient #1 had committed suicide by hanging.
- On 10/08/13 at 11:35 AM, Medicine Resident Physician PGY-3 (post graduate year 3) Staff #11 on the Code Blue Team revealed when she arrived, chest compressions were being administered by the "Med E" team. Staff #11 stated there were 2-3 people present in Patient #1's room and the crash cart was not in the room. She stated it took minutes for the code cart to arrive.
- On 10/08/13 at 3:15 PM, RN Staff #15 revealed she was completing her environmental rounds before the end of her shift on 10/03/13. She found Patient #1 slumped on the floor with a sheet around her neck and around the sink. Staff #15 untied Patient #1, who had no pulse, and screamed for help. Charge Nurse RN Staff #8 arrived. Staff #15 ran out of the room to call a Code Blue, but Staff #8 ran behind her (leaving Patient #1 alone), and cancelled the Code Blue, instead calling the Rapid Response Team. The "code team" began to arrive on the scene. Staff #15 went to retrieve the crash cart with the male RN from a different zone. She grabbed the Ambu bag off the cart and ran it back to the Patient #1's room. Staff #15 then went to the nursing station and did not return to Patient #1's room. Staff #15 stated neither she nor the male RN initiated CPR for Patient #1.

Personnel file review on 10/07/13 for Staff #7, 8 and 15 revealed evidence they all had current American Heart Association certification for Basic Life Support for Healthcare Providers.