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Based on review of hospital policies/procedures, medical record review, patient family and staff interviews, the hospital's administrative staff failed to ensure Neonatal Intensive Care (NICU) Overflow Unit patients were not vulnerable to abduction, and/or undetected medical emergencies.

1. This determination was evidenced by:

a. Two unsecured, unmonitored access and egress doors from the Critical Care Unit (CCU) to the NICU overflow unit. One of the doors was two feet from an unlocked and unmonitored door to the outside. (See A-0144)

b. The hospital failed to have a system in place to verify the identity of people prior to their entering the NICU Overflow Unit. (See A-0144)

c. The hospital failed to include the NICU Overflow Unit in the infant abduction drills conducted, as part of the hospital's infant security plan, in the newborn nursery and the Neonatal Intensive Care Unit. (See A-0144)

d. The hospital failed to have a system in place to ensure nursing staff could hear the NICU Overflow Unit patient cardiac alarms at all times. (See A-0144)

e. NICU Overflow Unit staff failed to respond to a patient's cardiac alarm until a family member called out the door for assistance. (See A-0144)

2. The cumulative effect of these systemic failures and deficient practices resulted in the hospital's significant inability to ensure the health, safety, and welfare of its NICU Overflow Unit patients.

Based on observation, tour of the Neonatal Intensive Care Unit (NICU) and the NICU Overflow Unit, patient family interviews, hospital policy/ procedure review, document review, and staff interviews the hospital administrative staff failed to ensure that critically ill newborns received care in a safe and secure environment. Hospital administrative staff failed to ensure that the security systems in place to assure the security of newborns was effective. On August 31, 2010, the hospital had a census of 9 newborns on the NICU Overflow Unit.
Failure to have security systems in place, and to periodically test those security systems, to ensure the safety and security of critically ill newborns put 9 of 9 newborns at risk for unidentified medical emergencies, abduction, and/or harm from unauthorized persons having unmonitored access to the NICU Overflow Unit.
Findings include:
1. Observations made while on tour of the NICU (located in Blank Children's Hospital), accompanied by the Chief Nursing Officer (CNO) of Blank Children's Hospital and the Nurse Manager of the NICU/NICU Overflow Unit, on 8/30/10 at 11:30 AM, showed the NICU is located on the top floor of Blank Children's Hospital and accessible by one set of elevators and one locked/alarmed stairwell. The Nurse Manager reported that visitors and family can only reach the NICU receptionist lobby by using the elevator. Observations showed that all entrances into the NICU were monitored by cameras. All visitors must stop and identify themselves to a receptionist who sits at a desk in the lobby. The receptionist ensures that the visitors are on the parent(s) approved visitor list before allowing the them into the NICU. The Nurse Manager reported that the reception desk is manned from 7:00 AM to 7:30 PM. After 7:30 PM the doors to the NICU are locked and may only be opened by staff or with an access badge. We entered the NICU and observed a large nurses station at the end of the hallway. The Nurse Manager reported that this nurses' station is used by the Unit Clerk. On either side of the nurses station, "U" shaped hallways led to patient rooms. Each "U" shaped hallway contained 15 private patient rooms and was referred to as a "pod" (total of 30 patient rooms). Nursing staff were observed sitting or standing in the hallways outside the patient rooms in both pods. Desks were available in the hallways to allow nursing staff to complete paperwork and stay close to their assigned patients.

When asked if infant security bracelets (an infant security system that utilizes a bracelet secured to an infants ankle and used to electronically monitors infant movements through out a preset monitored area) are utilized on infants at the hospital, the Nurse Manager reported that the bracelets were not used . The Nurse Manager stated that "because all infants are connected to cardiac monitors we rely on them as a security device. (A cardiac monitor is a piece of medical equipment that monitors a patient's heart and respiratory rate using wires and patches attached to a patients' body). The Nurse Manager reported that staff rely on the cardiac monitor to alert them with an audible alarm. When the infant's heart rate or respirations go below or above set parameters or the patches are removed, the monitor will audibly alarm. On the NICU, six to seven individual infant cardiac monitor were connected to a centralized monitor located in each hallway (two to three to a pod). The monitors detected if an infant was in distress, an infant's monitor patches were removed, or if someone tried to remove an infant from the NICU. It is the nursing staff 's responsibility to monitor and respond to cardiac monitor alarm. The alarms are a signal that something is wrong with the infant or the monitor. Inspection of the cardiac monitors, located at the patients' bedside and centralized monitors, revealed no volume control mechanism. The Nurse Manager confirmed that the nursing staff could not adjust the volume of the cardiac monitors.

The Nurse Manager stated that unannounced Code Purple (infant abduction) drills are done on the NICU at random times through out the year. The purpose of the Code Purple drills are to test all hospital staff's knowledge of Code Purple duties and to identify any concerns or "holes" in their infant security systems. Code Purple drills involve staff from the Mother/Baby Unit, the NICU, but not the NICU Overflow unit.

While talking with the Nurse Manager, on 8/30/10 at 11:55 AM, a cardiac monitor alarmed in a patient room. The patient's door was shut but the alarm was audible 10 feet away from the patient's room. Observation showed nursing staff immediately stood up, entered the patient's room, and checked on the infant.

Further observation revealed one locked, alarmed, and monitored door at the back of both pods (Pod A and Pod B). The Nurse Manager explained that Pod B's door led to the Mother/Baby Unit. This door could only be opened with a valid access badge (Mother/Baby staff, NICU staff, and a patient's parent). The Nurse Manager reported that this door is used to gain access to the NICU when transporting infants from a delivery room to a NICU bed.
The Nurse Manager reported the door located at the back of pod A is an emergency exit and not used for general traffic. This door is locked and has a 15 second alarmed delay. The Nurse Manager explained that if someone tried to open this door the door would alarm and stay locked for 15 seconds before opening to allow the person to exit. The 15 second delay is to give staff time to respond to the alarm.
The Nurse Manager explained that when a patient is admitted to the NICU Overflow Unit the parents receive infant security education. The nurses explain all the security measures on the unit including the how to use access badge, to not share the access badge with anyone, that the parent(s) must give permission before visitors are allowed on the unit, how the cardiac monitors work and what the alarms mean, and that the parent(s) are to report any suspicious activity or persons to nursing staff.

2. Observations made while on tour of the NICU Overflow Unit, accompanied by the CNO for Blank Children's Hospital and the Critical Care Unit (CCU) Nurse Manager, on 8/31/10 at 9:00 AM, showed the NICU Overflow Unit had four doors available for entrance/exit. Two doors, located at the west end of the unit, were locked and required an access badge or a key to enter/exit. The CCU Nurse Manager stated that these doors were equipped with exit alarms that sound loudly when someone exits without authorization.

Two doors at the east end of the unit provided access from CCU to the back of the NICU Overflow Unit. The CNO for Blank Children's Hospital reported that these doors were always left unlocked, unmonitored, and unalarmed. These doors provided unmonitored access from the CCU to the NICU Overflow infant rooms. One of the east doors was located approximately two feet from an unlocked, unmonitored outside exit door available for general public use. This outside exit door allowed unmonitored access by the general public to the CCU and NICU Overflow Unit.

The CNO for Blank Children's Hospital reported that at the time nursing staff admitted an infant to the NICU Overflow Unit each set of parents were given one access badge that allowed them access to the unit through the west doors. The CNO reported that nursing staff tell parents they could use the east doors when visiting their children. When the newborn is discharged the parent's access badge is inactivated.

During the tour the surveyor observed the CCU Nurse Manager open one of the unlocked east NICU Overflow Unit doors (two feet from an unlocked, unmonitored outside exit door). The door did not alarm and there was not a camera monitoring the doorway. We entered the NICU Overflow Unit through this door and observed five patient rooms. The hallway was empty and there were no cameras or monitoring devices of any kind. Staff at the nurses' station were not able to visualize the entrance/exit door or two of the patient rooms closest to this door. Further observation showed staff at the nurses' station would have had to stand in the hallway to see the patient rooms closest to the unmonitored hallway door.

The CCU Nurse Manger stated that "anyone can walk through the unmonitored, unlocked doors and I don't know if staff would see them."

At the time of the tour the CNO for Blank Children's Hospital said that anyone may walk through the two east doors and have access to infant rooms without being monitored or seen. The CNO also stated that the unmonitored area put the infants in danger for abduction.

3. During an interview on 8/31/10 at 9:20 AM, Staff E, NICU staff nurse, reported that the hospital lacked infant security policies and procedures specific to the NICU Overflow Unit. Staff E reported that newborn security education, in the NICU Overflow Unit, consisted of staff educating parents in regards to how the two alarmed doors operate, that the parents should never leave the infant alone without informing staff, and how to use the access badge provided to the parents.

Staff E further reported that the Environmental Safety Officer/Risk Manager provided infant security/abduction education (Code Purple) to all hospital staff during their orientation. Additionally, all hospital staff are required to complete an online infant security education module annually. Staff E reported having completed the Code Purple orientation and online education module. According to Staff E, Code Purple requires staff from every area of the hospital to respond.

When questioned about infant security on the NICU Overflow Unit, Staff E reported that infant patients are allowed to be alone in their room unattended and staff rely on the cardiac monitor to alert them with an audible alarm. The monitors detected if an infant was in distress, an infant's monitor patches were removed, or if someone tried to remove an infant from the NICU Overflow Unit. (A cardiac monitor is a piece of medical equipment that monitors a patient's heart and respiratory rate using wires and patches attached to a patients' body). When the heart rate or respirations go below or above set parameters or the patches are removed, the monitor will audibly alarm. Each cardiac monitor is connected to a centralized monitor located in the nurses' station. Staff E stated that when the centralized monitor alarms it is audible to nursing staff at the nurses' station. Staff E reported that even though nursing staff are not always at the nurses' station the centralized monitor alarm can be heard in all the patient rooms. It is the nursing staff 's responsibility to monitor and respond to cardiac monitor alarms. The alarms are a signal that something is wrong with the infant or the monitor. Staff E stated that "If someone were to try to abduct an infant the monitor would alarm at the nurses' station and the nurse's would go to investigate."

4. During an interview on 8/30/10 at 6:30 PM, Patient #22's parent reported that Patient #22 was admitted to the NICU Overflow Unit from the NICU on 8/16/2010. Patient #22, a premature infant, was transferred to the NICU Overflow Unit to physically mature and gain weight. The patient was connected to a cardiac monitor for monitoring of heart rate and respirations. Patient #22"s parent reported that when the patient was transferred to the NICU Overflow Unit the nursing staff educated them on the use of the access badge and how to enter/exit the unit. Patient #22's parent said "there were four doors to enter/exit the NICU Overflow Unit, only two of the doors were locked. The other two doors (east entrance door less than two feet from the unlocked outside door) were connected to the CCU and then to an outside door." Patient #22's parent said that nursing staff suggested they use the west doors to enter but that the unmonitored, unlocked east doors were also available for use. "There were no cameras, monitors, and the babies did not have security bracelets." Patient #22's parent reported that nursing staff never asked visitors for identification or questioned why they were on the unit.

Patient #22's parent stated that "right from the first day my child was on the NICU Overflow Unit I was worried about security. In the NICU, visitors had to stop at a manned desk and sign in before they could enter the unit. The visitors had to have permission from the parent (s) before they were allowed on the NICU. In the NICU Overflow Unit, anyone could walk in through the unlocked, unmonitored doors (east entrance door less than two feet from the unlocked outside door) and walk right into a patient room." Patient #22's parent reported "I witnessed people walk through the unlocked doors from CCU numerous times and walk around the unit while the nurses' were in a patient room. They would walk around for about 5 minutes before the nurses would see them and ask if they needed help." Patient #22's parent reported that a family member always stayed with the patient. "I was very worried for the babies on the NICU Overflow Unit that were left alone."

Patient #22's parent reported that Patient #22 had a cardiac monitor, attached with wires and patches, the entire time the patient was in the NICU Overflow Unit. "The monitor would alarm all the time and it would take 5 to 10 minutes before the nurses came to investigate. One night the monitor started to alarm, I waited 10 minutes, then I left the room to go find a nurse. The nurses were all in patient rooms and told me that they did not hear the alarm. I thought that the night shift nurses were less responsive than the day shift nurses."

5. Observation during an interview with Patient #14's parent on 8/31/10 at 9:35 AM, revealed Patient #14 a premature infant connected to a cardiac monitor and receiving oxygen through the nose. Patient #14 was admitted the NICU Overflow Unit to physically mature, gain weight, and facilitate lung development. Patient # 14's parent reported that the NICU Overflow Unit was not equipped with infant security. "In fact, one day I did not have an access badge so I came in the back way (came in from the outside door through the east entrance door ), walked to my [child's] room, and was in there for over 30 minutes before the nurses knew I was there. I had concerns about security because I saw visitors from CCU wander around the NICU Overflow Unit unmonitored by staff."

6. Observation during an interview with Patient #21's Grandparent on 8/31/10 at 9:50 AM, revealed Patient #21 a premature infant connected to a cardiac monitor and receiving oxygen through the nose. Patient #21 was admitted the NICU Overflow Unit to physically mature and gain weight. In Patient #21's room, with the door shut, Patient #21's Grandparent reported "I have entered the NICU from the back doors (came in from the outside door through the east entrance door) and was in my grandchild's room for a while before the nurses knew I was here." Patient #21's Grandparent also reported having seen non-hospital employees (visitors) come in through the east doors from CCU and walk around the NICU Overflow Unit. "I thought they must be lost." As the Grandparent spoke, Patient #21's cardiac monitor began to audibly alarm. After 30 seconds, the Grandparent stood up, went to the patients' room door, and called out loudly to the nurses, "The alarm is going off." Observation showed that three NICU Overflow nursing staff, the nursing supervisor, and the Chief Nursing Officer were sitting at the nurses' station and the centralized monitor was not audibly alarming.

7. During interview on 8/31/10 at 9:55 AM, the CNO for Blank Children's Hospital acknowledged nursing staff failed to respond to the cardiac monitor alarm. The CNO reported the centralized monitor used in the NICU Overflow Unit was a different model than the monitors used in NICU. The centralized monitor in the NICU Overflow Unit can be turned down with a volume knob although nursing staff are instructed not to turn the alarms off. "A nurse must have turned down the volume of the centralized monitor at some point last night". The CNO also acknowledged that there was no procedure for checking to make sure the volume of the centralized monitor was loud enough for nurses to monitor alarms in all patient rooms. The CNO stated that rendering the alarm inaudible put the newborns in danger from unknown physical harm or abduction.

8. During interview, on 8/31/10 at 10:10 AM, Staff E, NICU staff nurse, stated h/she had never seen or heard of a nurse turning down the volume on the centralized cardiac monitor. Staff E also reported that although Staff E knew how to turn the volume down Staff E was told never to turn the monitor volume down because "it is dangerous to the patients." Staff E stated that there was no way to block someone from turning the volume down. Staff E acknowledged that when the nurses' were busy in patient rooms anyone could access the volume control on the monitor.

9. During interview, on 8/31/10 at 1:30 PM, the Nurse Manager for the NICU and NICU Overflow Unit stated that infant security is extremely important and that "we have taken many steps to ensure the security of our patients." When asked about the differences in security between the NICU and the NICU Overflow Unit, the Nurse Manager responded that the NICU Overflow Unit is only utilized for patient care when the NICU is full. The NICU Overflow Unit was never intended to be a permanent patient care area although it had been used for the past 6 or 7 consecutive months. The Nurse Manager reported that nursing staff from the NICU also staff the NICU Overflow Unit and "we assumed that they were utilizing all the same security measures. We did not consider the unlocked, unalarmed, unmonitored doors at the east end of the NICU Overflow unit as a security risk. I believe we just overlooked it."

10. Review of hospital policies/procedures and meeting minutes relevant to providing care in a safe setting included:

a. Review of the security plan for infants titled "Security Management Plan #7", dated December 2009, showed that Safety Officers were responsible for conducting a "Code Purple " drill (infant abduction drill) annually. However, the document failed to identify any of the specific areas of the hospital that infants are hospitalized including the NICU Overflow Unit.
b. Hospital policy titled "Safety in Patient Care", dated 2/2009, revealed: Purpose: "To assure the physical and environmental safety of the hospitalized child". Policy: "Employees at Blank Children's Hospital are responsible for the safety, welfare, and maintenance of protective measures, throughout the child's hospital stay".
c. Hospital policy titled "Patient Rights and Responsibilities", dated 2/2009, revealed: Every patient has the right to "Receive care in a safe and secure setting".

d. Monthly Hospital Safety Committee Meeting Minutes, from January 2010 to August 2010, lacked evidence of evaluation of newborn security in the NICU Overflow Unit.

e. Monthly Hospital Patient Quality and Safety Committee Meeting Minutes, from January 2010 to August 2010, lacked evidence of evaluation of newborn security in the NICU Overflow Unit.

11. During an interview on 8/31/10 at 11:10 AM, the Environmental Safety Officer/Risk Manager reported recently completing a risk assessment of the whole hospital. During the risk assessment, the Safety Officers look for areas at high risk for theft, abduction, fire, etc. The Environmental Safety Officer/Risk Manager stated they had included the NICU Overflow Unit in the risk assessment but failed to identify the lack of security for the infants in the NICU Overflow Unit. This risk assessment failed to identify that nursing staff had the ability to turn the cardiac monitors (relied on as a security device) down and/or off at the nurses' station placing the infants at risk of undetected medical or non medical emergency. Furthermore, the Environmental Safety Officer/Risk Manager said that infant abduction drills (Code Purple), were part of the security plan for infants however, they had never conducted a Code Purple from the NICU Overflow Unit.

Based on policy/procedure review, document review, and staff interview the hospital failed to ensure that Acute Dialysis employees, who applied restraints to hospital patients during acute dialysis, were trained and able to demonstrate competency on a periodic basis consistent with hospital policy for 4 of 4 Acute Dialysis staff members (Staff A, B, C, and D). Review of education records found no documentation that since December 2008 Acute Dialysis employees received required restraint training.

Failure to provide staff retraining in the application of restraints, that includes demonstration of competency, on a specified periodic basis has the potential to put patients at risk for physical or mental harm from under trained staff. Under trained staff have the potential to use restraints unnecessarily and/or improperly.

On 8/30/10, at 1:30 PM, the Chief Nursing Officer reported 17 patients were currently in restraints in various nursing units of the hospital.
Findings Include:

1. On 8/31/10 at 1:00 PM, review of hospital policy TX #07, titled "Restraint or Seclusion Use", updated October 2009, revealed: "Section V. Staff Education - During the orientation process and prior to use of restraint or seclusion, staff is trained to be competent in the appropriate use and application of restraints and implementation of seclusion. ...
A. All staff members who initiate seclusion and/or apply, maintain, or remove restraints must receive education each calendar year related to tasks performed...."

2. Review of Acute Dialysis Registered Nurse Job Description. effective April 2008, revealed: "... The Acute Registered Nurse plans and provides patient care for the adult and geriatric patients of the Acute Facility in accordance with Physician orders, hospital policies and procedures, dialysis policies and procedures, ... federal, state, and local regulations. ...The Acute Registered Nurse is responsible for providing acute treatment modalities as ordered and approved by the Acute Facility, and independently performs crucial tasks in assessing, initiating, monitoring, and terminating treatment modalities in Acute Facility settings."

2. Review of Acute Dialysis employee education records revealed that 4 of 4 staff lacked documentation of consistent ongoing training, or demonstrated competency with the use of restraints (Staff A, B, C, and D). Review of dialyses employee education records revealed the last time staff members completed hospital required restraint training was December 2008.

3. During an interview on 9/1/10 at 11:00 AM, the Nurse Manager for the Contracted Dialysis providers stated that contracted dialysis nursing staff are required to follow hospital restraint policies and procedures when applying restraints to hospital patients. The Nurse Manager also stated that the hospital requires any staff member who applies restraints to complete annual restraint education. When shown the education records for Staff A, B, C, and D the Nurse Manager confirmed that the contract dialysis nurses had not completed required restraint training for 2009.

4. During an interview, on 9/2/10 at 11:15 AM, the Chief Nursing Officer, acknowledged that that the Acute Dialysis staff are not following hospital policies and procedures for restraints and that hospital administrative staff did not have knowledge of when the last time dialysis RN's received restraint training.