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NYU WINTHROP HOSPITAL 259 FIRST STREET MINEOLA, NY 11501 Oct. 1, 2015
VIOLATION: PATIENT RIGHTS Tag No: A0115
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Based on observation, record review, and staff interview in four (4) of four (4) observations, the facility failed to have in place a functioning child abduction alarm system.

This places all newborn patients at potential risk for abduction.

Findings:

See Tag A 144
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VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
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Based on observation, staff interview and review of procedures, it was determined that the facility failed to ensure a safe environment for infants. Specifically, the facility failed to have a system in place for the protection of infants in order to minimize the potential risk for harm or abduction. This was based on four (4) of four (4) observations.

The facility's failure placed all infants at risk for abduction.

Findings:

Observations in the facility's Mother Baby Unit during a tour between 11:00AM and 12:00Noon on 09/28/15 identified the following:

During an interview with Staff #5 (Vice President of Nursing) and Staff #4 (Security) they explained that the "Safe Place" Electronic Transmitter System is used to augment safety and tracking of newborn infants. The transmitter is placed around the infant's ankle. Anyone that comes to the Unit must be buzzed in by staff. A monitor behind the Nursing Station displays a picture of the person at the door.

The Unit is accessed via employee swipe cards only but the Exit Doors are unlocked for anyone who tries to depart the Unit. There is a Staff Elevator on the Unit that is only accessible with an employee swipe card.

If the infant wearing the device gets within approximately two (2) feet of the Exit Doors to the Unit, the door automatically locks. This was demonstrated by the staff.

The device is linked electronically to a computer tracking system which activates a visual and audible electronic alarm.

There are four (4) Exits on the Unit besides the Employee Elevator:

1) The North Pavilion has an elevator and is the Visitor's Entrance.

2) The North Side Stairwell Exits to Labor and Delivery, the Basement and the 4th and 5th Floors.

3) The Potter Pavilion West Side Exits to the Non-Invasive Cardiology Unit.

4) The South Entrance Potter Pavilion Exits to the Cardiac Catheterization Lab and other Cardiac Areas.

During an interview with Staff #4 (Security) the staff member explained that there are cameras at each stairwell and door. Officers at the Front Desk in the Main Lobby monitor the cameras twenty-four (24) hours seven (7) days a week.

Inspection of the facility's electronic infant security was conducted with Staff #5(Vice President of Nursing) and Staff #4 (Security). They explained if there is no contact between the transmitter and the baby's skin for brief period of time it will alarm as a Yellow Code "Check Band". The monitor behind the Nurses' Station will display a yellow box with the infant's name, date, time and location and a "chirping sound" would come from the "slaves" (monitors in the corridors). The four (4) "slaves" in the hallway also display the information that is posted at the monitor at the Nurse's Station. The doors and the elevators do not lock. Security calls the Unit and gives the infant's name and room number. The expectation is that the Nurse will check the transmitter on the infant and disarm the monitor. If the alarm is not responded to in one (1) minute, it escalates to a "Code Red". The volume of the alarm increases and the doors and elevators lock. If the band is cut off the infant, a "Code Red" alarm is immediately activated. A louder steady alarm is activated, the doors and elevators lock, Security comes to the Unit and another Security Officer calls the Unit.

The first simulation test inspection was conducted at 11:15AM. Staff #4 (Security) placed the transmitter on his finger. When the transmitter was removed from his finger, it failed to alarm for one (1) minute. The alarm incorrectly alarmed as a Yellow Code "Check Band". A low-level chirping sound could be heard. The doors and elevators did not lock. It failed to alarm Code Red "Band Off".

A second simulation test was then performed at 11:28AM. When the transmitter was removed from Staff #4's (Security) finger, it failed to immediately alarm as a "Code Red". After one (1) minute and five (5) seconds it once again incorrectly alarmed as a Code Yellow "Check Band" instead of a Code Red "Band Off". The alarm rang for five (5) minutes without escalating to a "Code Red". Staff #4 (Security) stated that "the alarms need to be adjusted".

Staff #4 immediately called the Alarm Company and was notified by Technical Support that the system was programmed to alarm nine (9) minutes after the transmitter is removed from the baby. The facility was not aware of the alarm timeframe. He then stated that Technical Support adjusted the system so when the transmitter is cut off, it will alarm immediately. If the "Check Band" is not acknowledged in one (1) minute, it will escalate to a "Red Alarm". The doors and elevators will lock and the alarm will sound louder. Staff #4 also stated "If the transmitter is removed from the infant, it should alarm instantly".

After the system was adjusted a third simulation test was then performed at 11:42AM. When the transmitter was removed from Staff #4's (Security) finger it failed to immediately alarm as a "Code Red". It failed to alarm for two (2) minutes after it was removed and then incorrectly alarmed as a Code Yellow "Check Band". After an additional fifty (50) seconds it alarmed as a "Code Red". However, the alarm was difficult to hear in the corridors. The doors and elevators did not lock.

A fourth simulation test was then performed at 11:48AM. The transmitter was cut. However, the alarm was not immediately activated. After two (2) minutes and twenty-five (25) seconds a "Code Red" was activated. Two (2) of the four (4) Exit Doors did not lock (North Side Stairwell and South Entrance Potter Pavilion).

During an interview with Staff #7 (Senior Vice President), Staff #6 (Director of Regulatory Affairs), Staff #5 (Vice President of Nursing) and Staff #4 (Security) on 09/29/15 at 1:30PM, the following information was revealed:

The Safe Place / Code Alert System was installed by RF Technologies on 02/13/13 and 02/14/13. The system was installed with preset default alarm settings. The staff were not aware of the default timeframes. The Safe Place Manual does not define the timeframes of all of the alarms and instructed the facility to establish alarm settings for their system.

There is no facility Policy and Procedure to define the alarms and the timeframes at which the alarms will be activated.

There was no evidence provided of preventative maintenance, testing, and annual comprehensive inspection and recertification of the Safe Place / Code Alert System.

The Safe Place / Code Alert System Preventative Maintenance and Testing, dated December 29, 2011, documented "Systems and components must be tested on a regular basis according to the procedures in schedule and related product demonstration. Each facility should review and set maintenance and test intervals according to its needs. Customers should assign a champion to perform and document all system maintenance and testing. It is the responsibility of the facility to establish and facilitate a regular maintenance schedule for your system, as outlined in the applicable system guides. This includes regular inspection, testing and cleaning. RF Technologies, Inc. recommends monthly maintenance and testing of your system. It is also recommended that your facility keep records of maintenance and test completions. Failure to provide regular maintenance and testing of these products may result in equipment and / or system failure. Each quarter vacuum out the dust on and in the computer and devices. RFT recommends annual comprehensive inspection and recertification by RF Technologies Service."

Infant / Pediatric Abduction Drills are performed quarterly. In 2013 there were no Abduction Drills.

In 2014 Abduction Drills were performed on 06/25/14 and 11/13/14.

In 2015 only one (1) Abduction Drill was performed on 04/02/15. The documentation of the 04/02/15 drill did not include the Drill Summary, Code Amber Perimeter Door Assignment and Code Amber Drill Observer Sheets.

The Safe Place / Code Alert System Quick Start Reference Guide dated August 3, 2011, further documented the facility's responsibility to "Enable the escalate Check Band to Band Off Alarm feature and select the number of minutes the system should wait before it escalate a Check Band alarm to a Band Off Alarm. Red Alarms are high priority alarms and include "Cut Band", and "Band Off". Yellow Alarms include "Check Band". If the "Check Band" Alarm is not addressed, it may escalate to a Red "Band Off" Alarm (per your facility's configuration preferences)."