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Based on document review, interview, and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.13 Patient's Rights

Based on observation, medical record review, review of facility policy, and staff interview, it was determined that the facility failed to ensure all patient rights are protected.

Findings include:

1. The facility failed to incorporate education regarding advance directives in their annual education for its employees, in accordance with New Jersey Administrative Code (N.J.A.C.). Refer to Tag A-132.

2. The facility failed to ensure that care was provided in a safe setting. Refer to Tag A-144.

3. The facility failed to ensure the use of restraints is in accordance with the order of a physician. Refer to Tag A-168.

An Immediate Jeopardy was identified on 9/22/14 related to patient safety. The Immediate Jeopardy was removed on 9/22/14, upon receipt of an acceptable Plan of Correction (PoC).

Based on review of the facility's 2013 Annual Staff Education Plan, review of employee files, and staff interview, it was determined that the facility failed to incorporate education regarding advance directives in their annual education for its employees, in accordance with New Jersey Administrative Code (N.J.A.C.).

Findings include:

Reference: N.J.A.C. Title 8, Chapter 43 G Hospital Licensing Standards states at 5.9 (b) 8. that a facility's staff education plan shall include education programs that address at least the following: Rights and responsibilities of staff under the New Jersey Advance Directives for Health Care Act (P.L. 1991, c.201) and the Federal Patient Self Determination Act (P.L. 101-508), and internal hospital policies and procedures to implement these laws.

1. On 9/23/14 the facility's 2013 Annual Mandatory Education was reviewed and lacked evidence of education regarding advance directives.

2. On 9/24/14, the education files for three registered nurses (Staff #10, Staff #13, and Staff #14) were reviewed in the presence of Staff #21, and lacked evidence of annual education for advance directives.

3. Staff #21 confirmed during interview on 9/24/14 that the facility's 2013 Annual Mandatory Education did not include education on advance directives.

A. Based on observation, medical record review, and staff interview, it was determined that the facility failed to ensure that care is provided in a safe setting.

Findings include:

Reference #1: Facility Policy Number: S-27, titled "Therapeutic Sitter" states, "Therapeutic Observation of the hospitalized patient outside of the Behavioral Health Setting ... The Therapeutic Sitter assigned to the patient must remain with the patient at all times so that he/she can physically intervene/respond to sudden or impulsive actions by the patient. The patient must remain within the staff member's line of vision at all times including while in the bathroom/shower." On page 4, number 5 states, "The sitter may be assigned to monitor two patients in the same room..."

1. A tour of the 4th floor was conducted on 9/22/14 at 11:00 AM in the presence of Staff #15. The following was observed:

a. Two patients (#5 and #6 ) were in Room #461.

b. Staff #16 was sitting in Room #461 with Patient #5 and Patient #6, monitoring and documenting their behavior.

c. Staff #16 was asked by the surveyor if the two patients were on one-to-one observation or fifteen minute checks. Staff #16 indicated that both patients were on one-to-one observation.

(i) Staff #15 confirmed that both patients were on one-to-one observation.

d. Staff #15 was asked how one person can watch two patients on one-to-one observation at the same time. Staff #15 indicated the facility policy titled "Therapeutic Sitter" states this is allowed.

2. Documentation in Medical Record #5 revealed the following:

a. Physician order dated 9/17/14 at 4:11 PM, "Therapeutic Sitter."

b. Nursing notes dated 9/19/14 at 10:32 AM stated, "Pt [patient] attempted to get OOB [out of bed], 1:1 sitter was unable to follow patient, so PCT [Patient Care Technician] followed patient. Patient was not speaking to staff and would not move from hallway. (name) RN Manager was on the floor to assist with pt, security guards were also assisting with pt. Pt was agreeable to get in wheelchair to be escorted back to room. 1:1 sitter used walkie talkie and requested assistance with pt secondary to pt taking pen from bedside table that sitter was using for documentation and attempted to stab himself with the pen..."

c. The "Patient Observation Checklist" dated 9/19/14 from 7:00 AM-2:45 PM indicated that Staff #31 was documenting the patient's behavior.

d. The "Patient Observation Checklist" dated 9/19/14 between 9:15 AM and 9:30 AM revealed that the patient became agitated.

e. The "Patient Observation Checklist" dated 9/19/14 between 8:00 AM and 2:15 PM was initialed by Staff #31, indicating that he/she was the Therapeutic Sitter observing the patient.

3. Documentation in Medical Record #6 revealed the following:

a. On 9/19/14 from 6:15 AM to 9:00 AM, Staff #31 documented the patient's behavior on the "Patient Observation Checklist."

b. On 9/19/14 from 7:30 AM to 9:00 AM, Staff #31 initialed the "Patient Observation Checklist" indicating that he/she was the Therapeutic Sitter observing the patient.

c. There was no documentation on the "Patient Observation Checklist," dated 9/19/14 between 9:15 AM and 2:00 PM.

4. Documentation on the "Patient Observation Checklist" for Patient #5 and Patient #6 revealed that Staff #31 was observing both patients at the same time.

5. The lack of documentation on the "Patient Observation Checklist," dated 9/19/14 between 9:15 AM and 2:00 PM, for Patient #6 indicated that when Patient #5 began to get agitated, there was no one observing Patient #6.

6. An interview with Staff #17 was conducted on 9/22/14 at 11:45 AM. Staff #17 was asked if Patient #5 and Patient #6 were both on one-to-one observation. Staff #17 stated, "Yes." Staff #17 was asked why the physician's order for one-to-one was not written as one-to-one but as "Therapeutic Sitter." Staff #17 stated that there is no option in the computer under Patient Care Orders for one-to-one; only Therapeutic Sitter.

7. The above was confirmed by Staff #3.


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Reference #2: Facility Policy Number: S-8, titled "Suicide Risk Assessment and Intervention for Adolescent and Adult Emergency Department and Hospitalized Patient (Excludes Behavioral Health Setting)'' states, "PROCEDURE: STEPS 1. Screening for suicide risk: Adolescent and adult emergency department (ED) patients and hospitalized patients are screened for risk of suicide. ... 3. Intervention - Suicide Precautions: Environmental Safety Measures for patients with active suicide thoughts - total risk assessment screen score 2 or greater: ... 4. Place patient in eye-sight observation."

Reference #3: Facility Policy NO: Emergency Department 204, titled "Behavioral Health Patients in the Emergency Departments" states, "PROCEDURE: ... 3) Patients at risk for suicide will be placed on suicide precautions. ... 4) The following suicide precautions will be implemented to prevent injury and ensure effective delivery of care: a) Create safe environment b) Patient may be placed in eyesight observation c) Eyesight observation to include patient observation every 30 minutes (See attachment A for patient Observation checklist). ..."

1. On 9/22/14, the Emergency Department was toured in the presence of Staff #1 and Staff #30. The Shower Room nurse call cord, hanging from the upper half of the wall, was 2-3 inches in length and not accessible should a patient fall to the floor.

2. On 9/23/14, a review of Medical Record #12 was conducted. Per the Triage Notes dated and timed 9/21/14 at 02:49, the patient was irritated and crying, stated that he/she was smoking crack related to stress, his/her mother passed away a week ago, had thoughts of killing himself/herself, and would like to overdose on pills that he/she has access to.

a. Per the 'Safety Assessment' in the Triage notes on 9/21/14 at 02:51, the "Patient agrees with the statement: I would like to kill myself. Risk Level: 2, ... Suicide precautions initiated."

b. Upon review of the the Emergency Department notes, the 'Emergency Department Patient Observation Checklist' form indicated suicide precautions and eyesight observation were implemented as per Reference #2.

(i) The 'Emergency Department Patient Observation Checklist' form lacked evidence of documentation of 30 minute observations at 0830, 0900, and 0930, as per Reference #3.

(ii) Staff #23 confirmed during an interview on 9/23/14 at 11:30 AM, that the 30 minute observations for Patient #12 were missing on the 'Emergency Department Patient Observation Checklist' form for 0830, 0900, and 0930 on 9/21/14.

c. Without documentation of the 30 minute observations, a safe environment could not be ensured for Patient #12.



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B. Based on staff interview and review of documentation, it was determined that the facility failed to ensure that all verbal and written complaints regarding the patient's safety is managed in accordance with facility policy for such occurrences.


Findings include:


Reference: Facility policy titled "Incident Investigation Reports," states on page 2, "Definition, ... c) Hazard Condition: Any set of circumstances (exclusive of the disease or condition in which the patient is being treated), that significantly increases the likelihood of a serious physical or psychological adverse patient outcome." Under section titled Procedure, ... "2. The person discovering the incident completes a Healthcare Incident Report, no later than by the end of their shift, ... "


1. On 12/10/13, the facility received written correspondence from the family member of Patient #17 alleging abusive treatment during his/her hospital stay.

a. A narrative of the complaint was written on 12/11/13 at 12:32 PM by Staff #29.


2. On 9/23/14 at noon, Staff #24 stated, "The event was handled as a complaint on 12/12/13 after I received a phone call from either Staff #1 or Staff #29, I don't remember which one notified me. I submitted the report to Hippocrates (reportable events reporting system through the Department of Health) on December 12, 2013 at 5:34 PM and then followed up with a description of the event to the Department of Health with an email."


a. Staff #24 confirmed that the complaint should have been written up as an incident report.


3. Review of documentation titled "Incident Reports of 12/2013" revealed that no incident report regarding the complaint of Patient #17's treatment during the hospital stay on 12/3/13 to 12/6/13 was completed.

Based on medical record review, review of facility policy, and staff interview, it was determined that the facility failed to ensure that the use of restraints is in accordance with the order of a physician.

Findings include:

1. Documentation in Medical Record #9 on the "Restraint Order and Flow Sheet" indicated the patient was in restraints on 8/4/14 from 7:00 AM until 7:00 PM.

2. The physician order section of the "Restraint Order and Flow Sheet" was not completely filled out.

3. Documentation on the physician order section included the physician's signature, beeper number, and date and time. The type of restraint(s) to be used, reason for the restraint(s), order duration, mental status, and monitoring timeframe for the restraints was not completed on the form.

4. The above was confirmed by Staff #3.

Based on a review of nurse staffing for the week of 9/14/14 to 9/20/14 and staff interview, it was determined that the facility failed to ensure that the assignment and availability of a charge nurse to each patient care unit, was in accordance with the New Jersey Administrative Code (N.J.A.C.).

Findings include:

Reference: N.J.A.C. Title 8, Chapter 43 G Hospital Licensing Standards states at 17.1(c), "There shall be at least one registered professional nurse in charge and assigned exclusively to each patient care unit on each shift. Additional staff shall be assigned by the hospital as required by the acuity levels."

1. On 9/22/14 at 11:45 AM, Staff #7 stated during an interview that the facility's three medical surgical units (4 West, 4 East, 3 Southwest) had one pool of staff and one charge nurse was assigned for all three units. Staff #7 further stated that the charge nurse is included in the staffing numbers for Unit 4 West.

2. A review of nurse staffing for the week of 9/14/14 to 9/20/14 was completed in the presence of Staff #7. Staff #7 indicated that the charge nurse on the night shift always has an assignment; the day shift may or may not have an assignment. There was no indication that the charge nurse did or did not have an assignment on the day shift.

3. The facility did not ensure that one individual charge nurse was assigned to each patient care unit.

Based on medical record review, review of policies and procedures, and staff interviews, it was determined that the facility failed to ensure that medications are administered in accordance with the practitioner responsible for the patient's care.

Finding include:

Reference: Facility policy titled "Use of Propofol for Sedation in the Intubated Patient" states, "...Daily Sedation level assessment a. The critical care RN will provide a daily "sedation vacation" (sedation turned off) as ordered by the physician....Documentation: the critical care registered nurse will document the rate of the Propofol infusion on the critical care flowsheet hourly and/or more frequently as dictated by titration and hemodynamic status."

1. Medical Record #10 lacked a physician's order for a "sedation vacation."

a. Medical Record #10 contained documentation in the electronic "Critical Care Flow Sheet", under respiratory notes, that the nurse performed a "sedation vacation" on the following dates and times:

(i) 8/2/14 at 0800

(ii) 8/3/14 at 0745

(iii) 8/4/14 at 0800

(iv) 8/5/14 at 0800

(v) 8/6/14 at 0800

(vi) 08/07/14 at 0816

b. On 9/24/14 at 1:30 PM, Staff #2 and Staff #26 confirmed that a "sedation vacation" was documented by the nurse on the above dates and that Medical Record #10 lacked a physician order for the sedation vacation.

2. It could not be determined if Propofol was administered in accordance with the physician's orders in the following instances because the rate of infusion was not recorded on the "Critical Care Flow Sheet" for the following dates and times:

a. From 8/1/14 at 2000 until 8/3/14 at 0600.

b. From 08/3/14 at 1900 until 8/4/14 at 0600.

c. From 8/5/14 at 1200 until 8/5/14 at 1400.

d. From 8/6/14 at 0900 until 8/7/14 at 0900.

3. Medical Record #11 contained a physician order dated 8/2/14 at 1908 for, "Daily Sedation Vacation per policy, Once per day" with the following instructions noted "Discontinue Sedation and Evaluate Patient at 6AM Every Morning. Contraindications Include Homodynamic Instability, Hypoxemia or 92% or Less, Pre-Op Surgery, Patient Receiving NMBA, or Physician Order."

a. According to the "Critical Care Flow Sheet", a "sedation vacation" was performed on 8/3/14 at 8:00 AM and 8/4/14 at 8:00 AM.

b. The "sedation vacation" was not done in accordance with physician's orders.

Based on medical record review, review of policies and procedures, and staff interview, it was determined that the facility failed to ensure that medical records are accurately written.

Findings include:

Reference: Facility policy titled "Charting/Documentation" states, "...Documenting for Ventilators: 1. Initial Ventilator Assessment will be completed upon intubation and re-intubation. The paper Ventilator Flow sheet is to be completed every four hours...."

1. Medical Record #10 contained documentation indicating that the patient was placed on a ventilator on 8/1/14 at 0700.

a. There was no evidence of a paper "Ventilator Flow Sheet" for 8/1/14.

b. This was confirmed on 9/23/14 at 11:45 AM by Staff #4 and Staff #27.

2. Medical Record #10 contained a "Ventilator Flow Sheet" with the following dates and times: 8/4/14 at 11:45; 8/4/14 at 1420; 8/4/14 at 1630.

a. On 9/23/14 at 1:00 PM, Staff #27 stated that the "Ventilator Flow Sheet" was not dated accurately. Staff #27 stated that the dates should read as follows: 8/5/14 at 1145; 8/5/14 at 1420; 8/5/14 at 1630.

3. The "Clinical Notes" and the "Critical Care Flow Sheet" contained in Medical Record #10, for the administration of Propofol and Fentanyl, were not documented accurately.

a. A clinical note dated 8/4/14 at 2200, documented that Fentanyl was increased to 23 mcgs [micrograms] and Propofol was increased to 35 mcgs. The "Critical Care Flow Sheet" dated 8/4/14 at 2200, documented that Fentanyl was set at 2 mcgs/kg/hr [micrograms per kilograms per hour] and Propofol was set at 33 mcgs/kg/hr.

b. A clinical note dated 8/5/14 at 0300 documented that Fentanyl was decreased to 2 mcgs and Propofol was decreased to 33 mcgs. The "Critical Care Flow Sheet" dated 8/5/14 at 0300 documented that Fentanyl was set at 3 mcgs/kg/hr and Propofol was set at 35 mcg/kg/hr.

c. This was confirmed by Staff #26.

Based on medical record review, review of policies and procedures, and staff interviews, it was determined that the facility failed to ensure that patients' response to medications is documented.

Findings include:

Reference #1: Facility policy titled "Utilization of the Richmond Agitation and Sedation Scale (RASS)" states "...The critical care registered nurse will use the Richmond Agitation-Sedation Scale (RASS) to assess the patient receiving continuous intravenous sedation every 4 hours and/or more frequently as sedation is titrated...The critical care registered nurse will document the RASS scale on the critical care flow sheet every 4 hours and/or more when titrating the dosage of sedation..."

Reference #2: Facility policy titled "Guidelines for Completing the Critical Care Flow Sheet" states "...FLACC [Face, Legs, Activity, Cry Consolobility] scale and RASS Scale are located on the flow sheet for quick reference. The actual scoring of pain and sedation levels are on the vital sign section page of the flow sheet..."

1. One of three Medical Records (Medical Record #10) of ventilated patients, lacked documentation of the RASS score on the "Critical Care Flow Sheet" on the following dates:

a. 8/1/14

b. 8/2/14

c. 8/3/14

d. 8/4/14

e. 8/6/14

f. 8/7/14

2. This was confirmed by Staff #4 and Staff #26.

Based on medical record review, review of facility policy, and staff interview, it was determined that the facility failed to ensure all medical record policies were implemented.

Findings include:

Reference: Facility Policy titled "Medical Record Entries, Contents and Completion" states under C. General Entries, 3. Errors, "When an error is made in a medical record entry, proper error correction procedures must be followed: Draw a single line through the incorrect entry. Initial and date the entry and state the reason for the error..."

1. Medical Record #5 contained a "Patient Progress Note" dated 9/19/14 with two Xs drawn through it.

2. Medical Record #8 contained a "Patient's Progress Note," not dated, with one line drawn through the note diagonally. The note was not initialed, dated, and did not have a reason for the error.

3. The above was confirmed by Staff #3.

Based on observation, it was determined that the facility failed to ensure that adequate facilities are maintained.

Findings include:

1. On 9/22/14, the Emergency Department (ED) was toured in the presence of Staff #1 and Staff #30. The following was observed:

a. The hot water for the sink in the public bathroom of the ED waiting room did not go on when the hot water control knob was turned.

b. The bathroom wall to the left upon entry had an estimated 18 inch by 18 inch area of spackling that was not painted. The spackled area is not a cleanable surface.

Based on observation, it was determined that the facility failed to ensure all supplies are maintained to ensure an acceptable level of safety and quality.

Findings include:

1. On 9/22/14, the Emergency Department was toured in the presence of Staff #1 and Staff #30. The following was observed:

a. The EKG leads on the Code Cart opposite the nurses' station were stored in a plastic container. It could not be determined what the manufacturer's expiration date for the leads were because the leads were removed from the original packaging.

b. There was a small unsecured sharps disposal container on the countertop in the triage room.

c. There was a large unsecured sharps disposal container on the countertop in the Central Intake Room.