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Based on a review of medical records, hospital policies and procedures, staff interviews, tours of the facility, and review of relevant documentation, it was determined that the governing body failed to demonstrate that it is effective in carrying out its' responsibility for the operation and management of the hospital. It did not provide the necessary oversight and leadership as evidenced by the facility's lack of compliance with the Medicare Conditions of Participation for hospitals, specifically:

42 CFR 482.13: Patient Rights

42 CFR 482.21: QAPI (Quality Assurance Performance Improvement).

Based on observation, medical record review, staff interview and review of facility documentation, it was determined that the facility failed to protect and promote the rights of each patient.

Findings include:

1. The facility failed to ensure that patient's are provided care in a safe setting. Refer to Tag A-0144.

Based on staff interview and document review on 4/11/13, it was determined that the facility governing body failed to be responsible for the effective operation of the grievance process.

Findings include:

Reference #1: The facility policy titled "Complaint and Grievance Policy - Issue #831-200-005" states "...It is the responsibility of the Patient Advocate to coordinate the investigation and resolution of all grievances...A representative of the Patient Advocacy department will meet monthly with the Grievance committee. Grievances received during the month will be reviewed including status and resolution issues related to the grievance process...The Grievance Committee will prepare a biannual report of grievances/resolutions for submission to the Board of Directors Quality of Care Committee for review and appropriate action..."

1. On 4/11/13, Staff #9 provided documentation of a grievance filed in December 2012 by the family of pediatric Patient #1, regarding the lack of placement of a "HALO Infant Abduction System" security device, from the time of admission on 12/1/12 to 12/5/12.

2. Staff #11 and Staff #15 stated on 4/11/13, that the grievance involving Patient #1 was reported to the Patient Advocacy Department of the hospital in December 2012, however upon request on 4/11/13, neither Staff #1, Staff #9, Staff #11 nor Staff #15 could provide evidence that the grievance was reported to the facility Grievance Committee.

A. Based on staff interview, document review, and observation of 1 of 3 pediatric patients (#2) on the pediatric unit, "F Blue," it was determined that the facility failed to ensure that patients receive care in a safe setting.

Findings include:

Reference #1: The facility policy titled "Code Amber Infant/Children Safety From Abduction-Issue #831-200-168" states "...The HALO Infant Abduction System is maintained by ADT...Prior to any tag being utilized on a patient, it must be tested on the HALO system..."

Reference #2: The facility policy titled "Policy for Child Protection Alarm System" states "...Patient Alarm System...Purpose: Prevent the unauthorized removal of an infant neonate or child...Patients of the pediatric unit will be tagged and entered into the system immediately upon admission..."

1. Staff #9 confirmed on 4/11/13, that the HALO system is used for infants and children (18 years of age and under) on the pediatric units of the hospital and that this system will set off an alarm if the patient is removed from the unit.

a. Medical Record #1 contains documentation that Patient #1 (date of birth 4/4/12) was admitted to the facility on 12/1/12 and discharged on 12/6/12. Medical Record #1 fails to contain documentation that a HALO abduction security system was applied to this pediatric patient during the hospital stay from 12/1/12 to 12/5/12.

b. Staff #9 confirmed via interview and via written documentation, of a facility grievance report on 4/11/13, that Patient #1 failed to have the HALO abduction security system in place from the date of admission on 12/1/12 through 12/5/12.

2. On 4/11/13 at 11:00 AM, this surveyor toured the pediatric unit with Staff #1 and Staff #9. Upon entering room # F219, at 11:06 AM Staff #9 examined Patient #2 and could not locate the HALO abduction security system device on this 3 year old patient, who was alone in the room and lying in a crib.

Reference #3: The Plan of Correction for the deficiency in #2 above received from the facility on 4/11/13 states "...All staff will inspect for ID bands and Abduction Tags on their hourly rounds and document on an hourly rounding sheet and report this information daily to the Nurse Manager..."

3. Upon request on 4/17/13, Staff #1 could not provide the hourly rounding sheet for Patient #1 for the evening of 4/11/13 through 4/15/13.


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B. Based on a tour of the pediatric intensive care unit (PICU), review of facility documentation and staff interview, it was determined that the facility failed to ensure the safety of all patients.

Findings include:

1. A tour of the PICU was conducted on 4/16/13 at approximately 9:45 AM which revealed the following:

a. The PICU had a census of 6 patients.

b. All 6 patients had a security band in place.

c. A review of the computer program which tracks the security bands was conducted and there were 5 patients being tracked. However, Patient #8 was not in the security tracking system.

d. Documentation on the daily report for the security tracking system revealed that Patient #8, a 7 month old, was taken out of the security tracking system on 4/15/13 at 8:03 PM and marked as "Discharged."

e. Patient #8 was placed back in the security tracking system on 4/16/13 at approximately 10:15 AM when it was discovered by this surveyor.

f. Patient #8 was in the PICU for approximately 14 hours without having a security band that was activated, placing him/her at risk for abduction.

g. The above was confirmed by Staff #2.

2. A second tour of the PICU was conducted on 4/17/13 at approximately 3:00 PM. It was noted that a door between the PICU and the NICU (Neurological Intensive Care Unit), which houses adult patients with neurological issues, did not have a locking mechanism.

a. When exiting the NICU, into a main hallway which leads to elevators, the doors open automatically as you walk toward them. This would allow a person to exit the PICU with a pediatric patient, walk through the unsecured door into the NICU; through the automatic opening doors, and out into a main hallway leading to the elevators without passing any hospital staff or setting off any alarms when exiting.

b. This unsecured area leaves pediatric patients vulnerable for abduction.

c. The security alarm bands that pediatric patients wear are of the type that can be cut off and left in the room.

d. The above was confirmed by Staff #15.

Based on observation, staff interviews, and review of facility documentation, it was determined that the facility failed to maintain an effective, ongoing, quality assessment and performance improvement program.

Findings include:

1. The facility failed to conduct performance improvement activities that continually track adverse patient events, analyzes their causes, and implements preventive actions and mechanisms, throughout the hospital, to ensure patient safety. Please refer to Tag 0286.

Based on the facility's Quality Improvement Plan, Patient Safety Plan, staff interviews, and review of other facility documentation, it was determined that the facility failed to conduct performance improvement activities that continually track adverse patient events, analyzes their causes, and implements preventive actions and mechanisms throughout the hospital.

Findings include:

Reference #1:Facility's Quality Improvement Plan, Issue No. 831-200-127 states "... A) Planning and setting Priorities for Quality Improvement [QI]: ... High volume, high risk and problem prone processes are defined as high priorities. ... Functions of the QA/PI and Quality Council include but may not necessarily be limited to the following: ... 12) Reviews and analyzes reports and variance (sic) submitted by clinical services, hospital departments and /or committees concerning quality of patient care. ... 18) Re-evaluates unsolved problems for further corrective action and resolution. 19) Monitors corrective action effectiveness."

Reference #2: Patient Safety Plan, Issue Number 831-200-302, states "... DEFINITIONS: ... Unsafe condition/Near Miss is an event or situation that could have resulted in an adverse event but did not, either by chance or through timely intervention. Near miss is also called a "close call". ... SCOPE: The Patient Safety Plan is a hospital-wide program and applies to all departments and services of the -[facility name]- Hospital. The analysis and prevention of adverse events, unsafe conditions/no harm events not resulting in patient harm, and serious preventable events is a main purpose of this plan. ... II. OBJECTIVES The objectives of the Patient Safety Plan are defined by a set of continuous quality improvement processes designed to reduce and eliminate preventable harm by achieving the following: ... Learning from near-miss events and recognize them as opportunities for improvement. ...V. COMMITTEES AND OTHER FORMAL STRUCTURES FOR PATIENT SAFETY The following Committees and other formal -[name of facility]- structures each play a role in the development, implementation and evaluation of -[name of facility]- patient safety activities. ... G. Patient Safety Committee (PSC) Functions of the Patient Safety Committee: ... C. Ensure the achievement of the goals and objectives of the Patient Safety Plan. ... E. Review risk management data, including patient event reports, to develop priorities for patient safety and risk reduction activities. ..."

1. During a survey on 4/16/13 and 4/17/13, the following was evident, indicating the facility is not reviewing all variance reports for quality of patient care, development of priorities for patient safety, using near miss events for opportunities for improvement, monitoring corrective actions for effectiveness, or evaluating unsolved problems for further corrective actions and resolution:

a. A Root Cause Analysis (RCA) for a code amber that was called for Patient #10 on 4/17/12 was reviewed. Patient #10 was found to not be in his/her room in the Pediatric Intensive Care Unit (PICU) on 4/17/12 at 1500, and the HALO system identification tag was noted on the bed. The patient was returned to the unit with two Division of Youth and Family Services (DYFS ) workers at approximately 1730.

i. The RCA After Action Report, identified in the 'Recommendations' sections, that alternative HALO bracelet applications will be reviewed, that PICU is not a locked unit; it is shared with the G level Neuro ICU, and that the family was able to leave the pediatric unit undetected.

ii. In interview with facility staff, it was determined that the facility is upgrading the HALO system and that the Pediatric Units now all have a card access or buzzed entry.

iii. A second tour of the PICU was conducted on 4/17/13, at approximately 3:00 PM. It was noted that the door between the PICU and the adult NICU (Neurological Intensive Care Unit) still did not have a locking mechanism. When exiting the NICU, into a main hallway which leads to elevators, the doors open automatically as you walk toward them. This would allow a person to exit the PICU with a pediatric patient, walk through the unsecured door into the NICU; through the automatic opening doors, and out into a main hallway leading to the elevators without passing any hospital staff or setting off any alarms when exiting.

iv. In interview on 4/17/13 at 3:30 PM Staff #1 stated that a locked door was not installed for life safety issues. The facility could not provide any further evidence of a corrective action or monitoring of the unresolved issue of this unlocked door between PICU and the adult NICU.

b. An Event Report filed in December 2012 by the family of pediatric Patient #1 regarding the lack of placement of a "HALO Infant Abduction System" security device, from the time of his/her admission in the PICU on 12/1/12 to 12/5/12. The event was identified with a Harm Score of 2 Near Miss.

i. In interview on 4/16/13 at 1:58 PM, Staff #14 and Staff #15 stated that they review all event reports that are entered into the Patient Safety Event report system, that they track and trend the events, and do QA thru the Patient Safety Committee and the Adverse Events Team. Staff #14 and Staff #15 indicated they both participate in the Patient Safety Committee.

ii. There was no evidence provided that the near miss event for Patient #1 was reported to the Patient Safety Committee for review and that quality initiatives or risk reduction activities were initiated at the time of this near miss event in December 2012.

c. On 4/11/13 at 11:00 AM, the pediatric unit was toured in the presence of Staff #1 and Staff #9. Upon entering room # F219, at 11:06 AM Staff #9 examined Patient #2 and could not locate the HALO abduction security system device on this 3 year old patient, who was alone in the room and lying in a crib. A plan of Correction submitted to the surveyor on 4/11/13 stated "...All staff will inspect for ID bands and Abduction Tags on their hourly rounds and document on an hourly rounding sheet and report this information daily to the Nurse Manager..."

i. Upon request on 4/17/13, Staff #1 could not provide the hourly rounding sheet for Patient #1 for the evening of 4/11/13 through 4/15/13.

ii. The facility failed to monitor its corrective actions as identified in their plan of correction dated 4/11/13.

d. A tour of the PICU was conducted on 4/16/13 at approximately 9:45 AM. The PICU had a census of six patients, and all six patients had a security band in place. However, a review of the computer program which tracks the security bands was conducted and there were 5 patients being tracked. Patient #8 was not in the security tracking system. Documentation on the daily report for the security tracking system revealed that Patient #8, a 7 month old, was taken out of the security tracking system on 4/15/13 at 8:03 PM and marked as "Discharged." Patient #8 was placed back in the security tracking system on 4/16/13 at approximately 10:15 AM, when this was discovered by the surveyor. Patient #8 was in the PICU for approximately 14 hours without having a security band that was activated, placing him/her at risk for abduction.

i. There was no evidence that the facility performs quality improvement activities on the HALO contracted vendor.

ii. Staff #4 indicated on 4/17/13, that the vendor did a performance check in January or February.

iii. The Invoices for the HALO vendor were reviewed and indicated the vendor was called on site to solve reported problems with the HALO system on 3/5/12, 4/6/12, 5/22/12, 10/11/12, 12/4/12 and 2/1/13.

e. In the absence of a controlled and effective quality assurance program for the application and usage of the HALO bands, it could not be determined if the issues identified above are mainly due to staff non-compliance with the application of the HALO bands, or a problematic HALO computer system.