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671 HOES LANE WEST

PISCATAWAY, NJ 08854

PATIENT RIGHTS

Tag No.: A0115

Based on observations, medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure: 1). Every 15 minutes (Q15) patient observation checks are conducted in all inpatient units (A0144); 2). Safety interventions are implemented for all patients identified at high risk for suicide (A0144); 3). All patient units are free from ligature risks (A0144); 4). One-to-one (1:1) observations are implemented for patients identified as high risk for suicide (A0144); and 5). Provider orders are obtained for all patients placed in restraint and/or seclusion (A0168). These failures resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patients.

On January 9, 2025 at 12:13 PM, an IJ was identified due to the facility's failure to identify and mitigate ligature risks present on inpatient units. On January 9, 2025 at 1:27 PM, the IJ template was presented to the administration and a removal plan was requested. On January 10, 2025 at 2:57 PM, a second IJ was identified due to the facility's failure to implement facility policy and procedure for conducting Q15 checks for patients on inpatient units (A0144); and at 3:13 PM a third IJ was identified for the facility's failure to implement a 1:1 observation for a suicidal patient per facility policy and procedure. A revised IJ template, consisting of all three IJs identified (A-0114), was provided to the facility administration on January 10, 2025 at 4:50 PM. A removal plan was requested. On January 13, 2025 at 3:46 PM, an acceptable removal plan was received for all three IJs. The facility implemented the following to address the IJ: Revisions to the environment of care rounds; staff re-education of the following: environment of care rounds, monitoring for ligature risks, escalation process when requiring a 1:1 and extra staffing, policy and protocol for the care of a suicidal patient; and removal of items on the units that pose a ligature risk. The IJ was removed on January 13, 2025 at 4:40 PM, after the State Survey Agency verified the full implementation of the removal plan, and Condition Level non-compliance remains.

Cross Reference:
482.13(c)(2) Patient Rights: Care in a Safe Setting
482.13(e)(5) Patient Rights: The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure: 1). Every 15 minutes (Q15)patient observation checks are conducted in accordance with facility policy in five of 17 medical records reviewed (MR 3, 4, 5, 16, and 17); 2). Safety interventions are implemented for a patient identified at high risk for suicide in one of 17 medical records reviewed (MR13); 3). All patient units are free from ligature risks; and 4). One-to-one (1:1) observation is implemented for a patient identified as high risk for suicide, in one of 17 medical records reviewed (MR1).

Findings Include:

1. Facility policy titled, "Observation Status and Levels" stated, "... 3. Any individual served who is considered to be an imminent risk at time of physician assessment for injury to self or others will be placed on 1:1 by a medical provider in writing (order) and reevaluated as clinically indicated. ... Q15 minute safety observation 1. The individual served is observed randomly no more than 15 minutes apart and 4 times within the hour. 2. Monitoring activities: a. The staff member assigned to monitor the individual served will make sure he/she observes the individual served randomly, no more than 15 minutes apart and a minimum of 4 times per hour".

On 1/8/24 at 11:42 AM, during a tour of the Child & Adolescent Inpatient Services (CAIS), Staff (S)14 (RN), was observed documenting Q15 observation checks for patients. S14 was observed seated at a computer and documented on three patients, P3, P4, and P5 for 11:15 AM, and 11:30 AM. Upon interview, S14 stated he/she was going through to make sure all the Q15s were done. In addition, S14 was observed documenting the 11:45 AM observations without moving from his/her position on the unit and therefore had no direct visual observation of the patients. When asked how he/she knew where a patient was, S14 stated, "I am here all the time, so I know what group rooms the patients go to."

On 1/9/25 at 12:50 PM, the medical record review for P3, P4, and P5 revealed the following:

P3 was transferred from the Emergency Department (ED) to the facility on 1/3/25, with a chief complaint of suicidal ideations. P3 had an order placed on 1/3/25 at 12:48 AM for "Patient monitoring safety checks ...Frequency: Routine q15 min [every 15 minutes] ..."

The "Random/15 Minute Check" for P3 were documented as follows:

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:12 AM, that P3 was in the group room, with staff, calm and cooperative. This EMR (Electronic Medical Record) entry was time stamped as entered on 1/8/25 at 12:31 PM.

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:27 AM, that P3 was in the group room, with staff, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 12:31 PM.

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:42 AM, that P3 was in the group room, with staff, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 11:48 AM.

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:57 AM, that P3 was in the group room, with staff, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 12:31 PM.

P4 was transferred from the ED to the facility on 1/6/25, with a chief complaint of suicidal ideation and self-injurious behaviors. P4 had an order placed on 1/6/25 at 6:13 PM for "Patient monitoring safety checks ...Frequency: Routine q15 min [every 15 minutes] ..."

The "Random/15 Minute Check" for P4 were documented as follows:

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:13 AM, that P4 was in the group room, engaging in group activity, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 11:51 AM.

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:28 AM, that P4 was in the group room, engaging in group activity, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 11:51 AM.

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:43 AM, that P4 was in the group room, engaging in group activity, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 11:52 AM.

P5 was transferred from the ED to the facility on 1/5/25, with a chief complaint of suicidal ideation. P5 had an order placed on 1/7/25 at 4:43 PM for "Patient monitoring safety checks ...Frequency: Routine q15 min [every 15 minutes] ..."

The "Random/15 Minute Check" for P5 were documented as follows:

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:14 AM, that P5 was in the group room, engaging in group activity, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 11:45 AM.

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:29 AM, that P5 was in the group room, engaging in group activity, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 11:45 AM.

On 1/8/25, S14 documented on the "Random/15 Minute Check" flowsheet for 11:44 AM, that P5 was in the group room, engaging in group activity, calm and cooperative. This EMR entry was time stamped as entered on 1/8/25 at 11:46 AM.

On 1/13/25 at 2:08 PM, the above findings were confirmed with S22 (Nurse Manager). S22 stated, staff who are performing the Q15 checks are expected to document in real time as they physically observe each patient.


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On 1/9/2025 at 1:00 PM, a review of P16's medical record revealed the following:

P16 presented to the facility on 12/8/2024 with a chief complaint of SI (suicidal ideation). P16 was placed on observation for patient safety monitoring. On 12/13/24 at 1:57 PM, an order was placed for "Patient monitoring safety checks ... Frequency: Routine q15min [every 15 minutes] ... until specified ..."

A review of the Random/15 Minute Check flowsheet revealed that the medical record lacked documented evidence of every 15 minute checks on 12/13/24 from 1:05 PM until 1:59 PM.

The above findings were confirmed with S9 (Child/Adolescent Nurse Manager), on 1/10/2025 at 12:28 PM.

On 1/9/2025 at 2:00 PM, a review of P17's medical record revealed the following:

P17 presented to the facility on 12/4/2024 with chief complaint of SIB (self-injurious behavior), cutting forearm with a knife, unable to contract for safety. The Columbia Suicide Severity Rating Scale (C-SSRS) for P17 was documented as Moderate Risk. P17 was placed on observation for patient safety monitoring. On 12/16/24 at 2:16 PM, an order was placed for "Patient monitoring safety checks ... Frequency : Routine q15min [every 15 minutes] until specified ..."

A review of the Random/15 Minute check flowsheet revealed that the medical record lacked documented evidence of every 15-minute checks on 12/16/2024 from 11:33 AM until 2:21 PM.

The above findings were confirmed with S9 on 1/10/2025 at 12:39 PM.

On 1/10/2025 at 12:16 PM, during an interview concerning the gaps in documentation, S9 stated, "there is a gap in the times due to an EPIC (electronic medical record system) issue, staff will document in the patient's chart, and it will disappear. I have put a ticket in with IT (Information Technology) for this." Upon request, S9 was unable to provide paper or electronic documentation pertaining to the gaps of documentation of the every 15 minute checks.


51986


2. Facility policy titled, "Suicide Precautions" (issued 2017 with no revision) stated, " ... Implementation of Suicide Precautions ... Levels of observation: 1. One to One (1:1) for individuals who are high risk ... "

Facility policy titled, "Observation Status and Levels: Acute Inpatient (One to One Observation)" revised 9/23 stated, " ...3. Any individual served who is considered to be an imminent risk at time of physician assessment for injury to self or others will be placed on 1:1 by a medical provider in writing (order) and reevaluated as clinically indicated ...4. Monitoring activities: a. The individual served is visible and within arm's reach of the assigned nursing staff at all times. b. The individual served is monitored at all times including when using the bathroom or asleep, unless otherwise specified in writing (order) by a medical provider. c. If the individual served is asleep, staff must assess for respirations ...6. The Registered Nurse (RN) is responsible for assigning a nursing staff member to any individual(s) for the entire shift. Assignments must be documented on the assignment sheet ..."

On 1/10/25 at 10:25 AM, a review of P13's medical record revealed the following:

On 11/19/24, P13 was admitted with chief complaint of suicidal ideation. He/she was found by Emergency Medical Services (EMS) lying in the street with traffic, nude. On 11/22/24, a discharge summary written by S42 (Psychiatrist) stated, "[P13] presents due to Suicidal Ideation (SI) with plan and intent, commanding Auditory Hallucinations (AH) precipitated by non-compliance with medication... Had SI with plan and intent to go and lie in the middle of the street with incoming traffic to die... Reports hearing commanding AH of a 'demon voice that tells' him/her that he/she will die in 5, 4, 3, 2, 1." Columbia Suicide Severity Rating Scale (C-SSRS) screener completed by S43 (RN) indicated a high risk for suicide. Admission note by S43 states, "[P13] refused nursing 1:1 stating 'I'm tired'." The medical record lacked evidence of documentation to the provider from nursing that P13 was a high risk for suicide and would require a 1:1.

On 1/10/25 at approximately 2:40 PM, staff interviews were conducted with S9 and S22, the Nurse Manager of the Adult Inpatient Unit (AIPU). S9 stated, "in the event a nurse felt that a patient required a 1:1, that nurse may initiate a nurse driven 1:1, alert the provider, and anticipate the provider to see the patient face-to-face at the bedside to order a 1:1." During the interview, S9 confirmed the above findings and stated that a patient "cannot refuse a 1:1, not even a nursing 1:1. In the event a patient attempted to refuse a 1:1 when clinically indicated, a nurse or staff member would be designated to be close by, near the patient." S22 was in agreement.
3. On 1/9/25, a review of the facility's document titled, "Environment of Care Patient Safety Risk Assessment Checklist" for the UBHC-P Child & Adolescent Inpatient Services, dated 7/2/24 revealed, "... Risk Reduction Feature: ...11. Light fixtures are not easily accessible to client, tamper resistant, lenses secured with tamperproof screws, shatterproof lens...'Met'... 43. Sheets are routinely removed from unoccupied beds to prevent patients from hiding or hoarding sheets...'Met'... 45. No fitted bed sheets or other sheets with elastic are used...'Met'... 47. Bedroom wardrobes/closets are without closet poles, hooks, wires hangers or loop-able fixtures or hardware, check if doors are removed if they provide an anchor point/ligature risk...'Met'... 63. No fixtures in the bathroom create a ligature risk: ...paper towel dispenser...'Met'..."

On 1/9/25 at 10:00 AM, a tour was conducted of the Child & Adolescent Inpatient Services (CAIS), a unit with patients at high-risk for suicide, with S3 (Director of Accreditation & Standards), S4 (Assistant Director of Nursing), and S22. During the tour, the following ligature risks were identified:
Mattresses covered with fitted sheets, were observed in the following rooms: Room 231, 234, 239, 243, 245, 249, 251, 253, 255, 257, 259, 261, 268, and 270.

Wall-mounted wooden dressers, with drawers that could be pulled completely out creating a loop-able fixture, were observed in the following occupied rooms: Room 234, 239, 243, 245, 249, 251, 253, 255, 257, 259, 261, 268, and 270.

Paper towel holders/dispensers with an open slot that presented a ligature risk were present in all bathrooms on the unit.

In Room A268, a ceiling light fixture with exposed mounting brackets was identified.
On 1/9/25 at 10:41 AM, a tour of the Adult East Wing was conducted with S20 (Accreditation Coordinator), S21 (Director of Environment of Care), and S22. The following ligature risks were identified:
Mattresses covered with fitted sheets, were observed on the following rooms: Room B236-B238, B245, B249, B251, B253, B255, and B263.

Wall-mounted wooden dressers, with drawers that could be pulled completely out creating a loop-able fixture, were observed in the following rooms: Room B239, B243, B249, B251, B255, B257, B259, and B263.

Paper towel holders/dispensers with an open slot that presented a ligature risk were present in the bathrooms in the following rooms: A261A, A239A, and A239B.
On 1/9/25 at 10:24 AM, during an interview with S21 (Director of Environment Care), regarding Environment of Care (EOC) rounding, S21 stated that EOC rounds should be completed every day and every shift by nursing or a Mental Health Specialist (MHS). S21 confirmed there are three shifts that the daily EOC should be conducted. During the interview, S21 stated that the daily EOC rounding does not include observing for ligature risk, it is for "general safety and maintenance." S21 further stated that he/she performs random EOC rounds, at least once a month. S21 confirmed identification of ligature risks was not part of the random EOC rounding. The random EOC rounds included, "environmental awareness, required maintenance, and cleanliness of facility." S21 stated that ligature risks are identified on the EOC risk assessments, completed once per year.

4). Facility policy titled, "Suicide Precautions" (Issued 2017, no revisions) stated, "Policy: ... In an emergency situation, any clinical staff member can initiate suicide precautions until the treating physician is contacted. This policy is applicable to individuals upon admission and throughout the hospital stay. ... Procedure: ... 4. Implementation of Suicide Precautions: a. An order for intense observation is required by the medical provider (physician/APN [Advanced Practice Nurse]), and the written order will indicate the rationale for the required observation status is identified by the acronym "SP" for "Suicide Precautions" ... i. Levels of Observation: 1. One to One (1:1) for individuals who are high risk. ... 5. Documentation: a. When suicide precautions are initiated, the RN (Registered Nurse) progress note must indicate the reason for instituting suicide precautions or changing the observation status ... b. The RN will write one note per shift for those individuals on suicide precautions indicating the status of suicidal ideation including the presence of a plan, ability to contract for safety, and any other factors that may influence suicide risk including current mental status."

Facility policy titled, "Suicide Assessment" (Revised 7/20/23) stated, " ... 3. The decision to reassess for suicide risk is considered as a result of: a. An expression of suicidal ideation on the part of the individual served ... 4. All individuals determined to be at a high or moderate risk for suicide will develop a Safety Plan with his/her service provider as soon as the risk is identified to effectively recognize, manage, plan for and prevent a mental health crisis. If there is a change in the risk level, then the Safety Plan will be reviewed and updated as necessary."

Review of P1's medical record on 1/10/25 revealed the patient was admitted to the Child/Adolescent In-Patient Unit (CAIS) on 1/1/25. The Initial Psychiatric Evaluation completed on 1/1/25 stated, " ... Chief Complaint: The school saw I was looking up ways to kill myself, and alerted the counselor, who sent me to be evaluated. ... HPI (History of Present Illness): ...Patient endorsed low mood, low self-esteem, suicidal ideations, and occasional self-injurious behavior by cutting (on thighs and arms, though patient denies any current self-injurious behavior.) Patient also endorsing poor sleep and chronic anxious mood related to social situations. ... Safety: Level 1 observation, Reviewed safety plan with patient and team reviewed with patient/family, patient able to commit to plan, continue to monitor for risk of suicide and self-harm."

On 1/1/25, the C-SSRS (Columbia Suicide Severity Rating Scale) assessment for P1 indicated "High Risk" for suicide. On 1/1/25, an order was placed for Suicide Precautions. Upon review, the medical record lacked evidence that P1 was placed on 1:1 observation.

A review of a "Behavioral Health Nursing Note" dated 1/4/25 at 5:55 PM by S44 (RN), stated, "[P1] is maintained on level 1 for sp (Suicide Precautions). Reported to staff [he/she] had SI (suicidal ideation) urges and did not feel [he/she] could CFS (contract for safety). ..." The medical record lacked evidence that P1's provider was notified that the patient did not contract for safety or that the patient was placed on 1:1 observation.

The "Random/15 Minute Check" flowsheet dated, 1/4/25 at 1807 [6:07 PM] until 1/5/25 at 0836 [8:36 AM], indicated that P1 slept in the "group room" on the night [he/she] reported having "SI urges" to S44. There was no order in P1's medical record that P1 was placed on 1:1 or line-of-sight observation.

A "Progress Note" completed on 1/5/25 at 3:09 PM by S45 (a Physician) stated, "Patient seen for weekend coverage. Patient was interviewed, chart was reviewed, and no overnight events were reported. ... Patient reported having passive suicidal ideation in the a.m., [he/she] denied having any intent or plan at this time ... Patient stated that during bedtime, [he/she] experiences racing thoughts, and has concern for [his/her] own safety as [he/she] always imagines someone coming in and killing [him/her] on the unit. ... Plan: ... 2. Continue current safety level ... Education: Encouraged patient to use safe and health coping skills while in the hospital and to seek support from staff when in distress. ..." The provider note lacked evidence that S45 was notified that P1 reported suicidal ideation 1/4/25 at 5:55 PM.

During an interview with S5 (Alternate Medical Director of Adult Services), and S6 (Medical Director of Child Services) on 1/10/25 at 3:00 PM, S5 stated, "if a patient refuses to contract for safety, the nurse is to contact the medical provider. If it is after hours, the nurse is to contact the 'On call' provider. The patient will be placed on 1:1 observation until he/she is evaluated by the Psychiatrist, and a safety plan will be updated. This process must be followed."

Upon interview on 1/10/25 at 12:50 PM with S22, he/she stated, "If a patient refuses to contract for safety, the patient must be placed on 1:1 observation and the medical provider must be called." S22 confirmed that a provider's order is required to initiate and discontinue one to one (1:1) observation status.

Upon interview on 1/10/25 at 1:55 PM with S9, when questioned concerning the process if a patient refuses to contract for safety, S9 stated, "If the patient will not contract for safety, we must inform the medical provider and place the patient on a 1:1."

On 1/10/25 at 2:04 PM, S9 confirmed that the medical record of P1 lacked documentation that the medical provider was notified that P1 reported "SI urges" and did not contract for safety. S9 confirmed the patient was not placed on 1:1 monitoring when [he/she] reported SI urges and did not contract for safety, as per facility policy.


N.J.A.C. 8:43G-26.2(a)(2)

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on medical record review, staff interviews, and review of facility policies, it was determined the facility failed to ensure that physician orders for restraint and/or seclusion are obtained in three of three medical records reviewed (MR 15, 16, and 17).

Findings include:

Facility policy titled, "Mechanical Restraint and Seclusion in Inpatient Services and Emergency Services" last reviewed on 8/25/2022, stated, "Policy ... 11. The use of restraint or seclusion must be in accordance with the order of a medical provider/physician or other licensed independent practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law ... c. Qualified staff must obtain an order from the licensed independent practitioner as soon as possible but no longer than one hour following the application of restraint or seclusion."

On 1/9/2025 at 12:00 PM, a review of P15's medical record revealed the following:

The Behavioral Health Nursing Progress Notes, signed by S31, Registered Nurse (RN), on 11/12/2024 at 12:20 AM, stated, "... Behavioral code called at around 7:30 PM [on 11/11/2024] ... Patient placed on hold with another staff then assisted back to seclusion room with the rest of staff who attended the behavioral code at 7:37 PM ...Released [from seclusion] at 2135hrs [9:35 PM]."

The Behavioral Code Note dated 11/11/2024 at 7:48 PM stated, "Behavioral code called at about 7:30 PM ... Patient was subsequently restrained and moved to seclusion room ... Per staff, patient did not require restraints, so patient was left in seclusion."

A Nursing Note signed by S31, RN, on 11/12/2024 at 4:57 PM, stated, "received in quiet room [seclusion room]."

The flowsheet documentation titled, "Seclusion" dated 11/11/2024 at 7:39 PM, stated, "Licensed Practitioner notified Yes, Order Obtained Yes."

The flowsheet titled, "Random/15 Minute Check" documentation was written as follows: 11/11/2024 at 4:05 PM, 4:20 PM, and 4:25 PM, S31 documented, Patient location: Quiet room (seclusion room) ... 11/11/2024 at 7:05 PM and 7:20 PM, S31 documented, Patient location: Quiet Room ... 11/16/2024 at 6:57 AM, S47 documented, "Patient Location: Quiet Room."

Upon review, P15 's medical record lacked documented evidence of a physician's order for seclusion. This finding was confirmed with S9, Child/Adolescent Nurse Manager, on 1/10/2025 at 12:22 PM.

On 1/9/2025 at 1:00 PM, a review of P16's medical record revealed the following:

The Child/Adolescent Initial Psychiatric Evaluation dated 12/8/2024 at 12:42 PM, stated, "HPI ... [P16] was seen today in the seclusion room ....He/she ended up being disruptive and being restrained. He/she was in 4-point restraints ... at 10:10 AM."

A Nursing Note signed by S33, RN, on 12/8/2024 at 5:10 PM, stated, "Patient received asleep in the quite room [seclusion room]."

A Nursing Note signed by S49, RN, on 12/9/2024 at 12:59 AM, stated, "Patient is received in the QR [Quiet Room, Seclusion Room]."

A Nursing Note signed by S25, RN, on 12/9/2024 at 12:38 PM, stated, "[P16] was met on the unit in the QR."

A Nursing Note signed by S25 (RN) on 12/9/2024 at 2:10 PM, stated, "Behavioral code called at 1:42pm after [P16] made verbal threats to staff and was sent to QR ... A second behavioral code was called around 1:50pm while [name, S16] continued to escalate attempting to come out of QR."

A Nursing Note signed by S31, RN, on 12/9/2024 at 3:52 PM, stated, "Received awake in quite room."

A Progress Note signed by S50, Advanced Practice Nurse (APN), on 12/10/2024 at 2:30 PM, stated, "Patient received in quiet room."

A review of the flowsheet titled, "1:1 checks," the documentation indicated that from 12/8/2024 at 8:25 AM to 12/10/2024 at 12:24 PM, P16 's location was documented as "Quiet Room."

P16 's medical record lacked evidence of a seclusion order or a seclusion face-to-face. This finding was confirmed with S9 on 1/10/2025 at 12:28 PM.

On 1/9/2025 at 2:00 PM, a review of P17's medical record revealed the following:

A Nursing Note signed by S44, RN, on 12/10/2024 at 8:48 PM, stated, "Behavioral code called at 5:40PM ....[Name, P17] was escorted to QR by staff and restraints were started at 5:45pm until 7:40pm."

The "1:1 Checks" flowsheet documentation indicated that from 12/10/2024 at 5:52 PM until 12/11/2024 at 7:55 AM, P17's location was documented as in the "Quiet Room." On 12/11/2024 from 11:08 AM to 11:37 AM, P17's location was documented as in the "Quiet Room," then again at 4:36 PM until 5:43 PM.

P17's medical record lacked evidence of a seclusion and a restraint order. This finding was confirmed with S9 on 1/10/2025 at 12:39 PM.

On 1/9/2025 at 12:56 PM, an interview was conducted with S9 concerning the quiet room. S9 stated that the quiet room is the seclusion room for agitated patients. S9 further stated that if a patient is in the seclusion room, there should be documentation every 15 minutes on the patient until seclusion is discontinued.

On 1/9/2025 at 1:35 PM, an interview was conducted with S13 (Advanced Practice Nurse), concerning the Quiet Room. S13 stated that the quiet room is the seclusion room. S13 further stated that staff needs an order to use the quiet room, if a patient needs a moment to "take a breath" there is no need for an order to use the quiet room.

On 1/10/2025 at 12:13 PM, an interview with S9 confirmed that the quite room is the seclusion room. S9 stated that staff need an order for seclusion, and a face-to-face by the doctor needs to be completed. S9 stated, "the seclusion order is separate from the restraint order, seclusion and restraint face to face should be separate also." When asked who audits restraints and seclusion documentation, S9 stated the Assistant Nurse Managers (ANM) are responsible for auditing documentation weekly and it "should be done weekly."

N.J.A.C. 8:43G-26.2(b)

QAPI

Tag No.: A0263

Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to maintain an effective, ongoing, and data-driven quality assessment and performance improvement program that reflects the complexity of the facility's services and failed to focus on indicators of ligature risk in high-risk inpatient units that would improve health outcomes (A0283).

Cross Reference:
482.21(c)(3) Program Activities: The hospital must take actions aimed at performance improvement

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on observation, staff interviews, and review of facility documents, it was determined that the facility failed to ensure oversight of the detection and monitoring of ligature risks on inpatient units.

Findings include:

On 1/8/25 at 12:25 PM, a review of the Environment of Care (EOC) Meeting Minutes for 2024 revealed that Staff (S)21, Director of Environment of Care, reports at each EOC meeting regarding the weekly and monthly EOC rounding that is conducted at the facility as follows:

From 11/15/2023 to 9/18/2024, EOC meeting minutes indicated that there was not 100% compliance within programs for weekly rounding. The need for further action indicated, "Continue to check for compliance Responsibility EOC ..."

From 11/15/2023 to 9/18/2024, EOC meeting minutes indicated that there was not 100% compliance within programs for monthly rounding. The need for further action indicated, "Continue to check for compliance Responsibility EOC ..."

On 1/9/25 at 10:00 AM, during an interview, S21 confirmed that he/she has the oversight of all the EOC rounding. S21 stated the reports are sent to him/her for review and he/she reports the data at the EOC committee meetings. Upon request, S21 was unable to provide documentation of plans in place to increase compliance of rounding within programs and was unable to provide information on areas of noncompliance within the programs.

On 1/8/25 at 3:45 PM, upon request, S21 provided copies of the weekly and monthly EOC rounds that were conducted on the inpatient units at the facility for the last three months. Review of the monthly EOC rounds noted, " Cleanliness/Maintenance ... No ligature risks on inpatient or Residential units; No patient safety risks ..." Review of the EOC weekly round checklist noted that the checklist did not include monitoring for ligature risks on the patient units.

On 1/9/25 at 10:00 AM, upon interview, S21 confirmed the above findings regarding the EOC reports. S21 stated that each unit has someone designated to conducted monthly EOC rounds. S21 also stated that there should be a designated staff member to perform daily EOC rounds once per shift and that there are three total shifts per day on each unit. S21 confirmed that the daily EOC rounds are not always being completed. When asked if S21 did random audits to check on the units for EOC rounds, S21 replied that he/she would do spot checks if called to the unit, but that these audits are not documented and there is no set number of times per month that he/she may conduct the spot checks. S21 also stated that during these spot checks, he/she is not looking for ligature risks on the unit.

N.J.A.C. 8.43G-26.14(a)

PHARMACY DRUG RECORDS

Tag No.: A0494

Based on observation, medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that policies and procedures concerning the control and accountability of Controlled Dangerous Substances (CDS) are implemented.

Findings include:

Facility policy titled, "Controlled Substances" (undated) stated, " ...When a controlled substance is administered to a patient, the date, time, patient name, and dose are recorded on the 24-Hour Controlled Substance Log ..."

On 1/8/25 at 11:30 AM, during a tour of the West Unit medication room with Staff(S)16 (Pharmacy Manager), and S17 (Registered Nurse), the inventory of the CDS stored in the locked cabinet was counted and compared with the count documented on the 24-Hour Controlled Substance Log, dated 1/8/25. The 24-Hour Controlled Substance Log indicated that one container of Methadone oral solution (a Schedule II CDS used for opioid detoxification) should have been in the locked cabinet. However, there was no Methadone found in the locked cabinet. This was confirmed by S16 and S17 at the time of the discovery.

Upon interview, S17 stated that S34 (a Registered Nurse), probably administered the Methadone to Patient(P) 6 earlier that day. P6's medical record was reviewed, and the medication administration record dated 1/8/25, indicated that the Methadone was administered to P6 at 8:15 AM by S34.

On 1/8/25 at 11:35 AM, during an interview, S34 described the steps required to administer CDS to a patient. S34 stated that the 24-Hour Controlled Substance Log should be completed at the time the medication is administered to the patient. S34 stated, "I missed that today" in reference to documenting the administration of the Methadone to P6 on 1/8/25.

On 1/8/25 at 11:40 AM, S16, S17, and S34 confirmed this finding.

The facility policy titled, "Controlled Substances" (undated) stated, " ...An outgoing and incoming licensed nursing staff will count controlled substances at the end of every shift. Two licensed signatures are recorded for every change of shift count on the 24-hour Controlled Substance Log ..."

On 1/9/25 at 11:00 AM, the 24-Hour Controlled Substance Logs for the West unit and the APS unit, dated 12/1/24 through 1/8/25 were reviewed in the Pharmacy. Several of the Logs lacked documentation of the CDS shift count or the second signature required for the CDS shift count. The following was identified:

The 24-Hour Controlled Substance Logs for the West unit lacked a second signature for the CDS shift counts, as required by facility policy, on the following dates: 12/14/24, 12/29/24, 12/30/24, 1/1/25, and 1/2/25.

The 24-Hour Controlled Substance Logs for the APS unit lacked the completion of a CDS inventory for each shift, as required by facility policy, on the following dates: 12/1-3/24, 12/5-6/24, 12/9-20/24, 12/23/24, 12/26-27/24, 12/29/24, 1/1-3/25, and 1/6-7/25.

These findings were confirmed with S16 on 1/9/25 at 11:25 AM.

N.J.A.C. 8:43 G-23.2(a) (5)

DELIVERY OF DRUGS

Tag No.: A0500

Based on observation, staff interviews, and facility document review, it was determined that the facility failed to ensure that policies and procedures concerning the storage of vaccines are developed and implemented in accordance with nationally recognized guidelines.

Findings include:

Reference: The Centers for Disease Control and Prevention (CDC) Vaccine Storage and Handling Toolkit (January 2023, updated March 29, 2024) page 13, https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, stated, " ...Check and record storage unit minimum and maximum temperatures at the start of each workday. If your TMD [temperature monitoring device] does not read minimum/maximum temperatures, then check and record the current temperature a minimum of two times per workday (at the start and end of the workday). Record: minimum/maximum temperature, date, time, name of person who checked and recorded the temperature, any actions taken if a temperature excursion occurred ..."

During a facility tour conducted on 1/8/25 between 10:40 AM and 12:30 PM, with Staff (S) 16 (Pharmacy Manager), Flucelvax (influenza vaccine) was found stored in the medication refrigerators located in each of the following units, East Unit, West Unit, and Child/Adolescent Unit (CAIS). The corresponding temperature logs for each medication refrigerator was reviewed in the presence of S16. S16 confirmed that the refrigerator temperatures were monitored and documented once daily.

On 1/8/25 at 12:15 PM, upon interview, S16 stated that the thermometers used to monitor the medication refrigerators had data logging capability and should send alarms to the nurse managers if the temperatures went out of range. On 1/8/25 at 2:05 PM, in the pharmacy department, the electronic data logging thermometer temperature logs were reviewed with S16. The report indicated that the system was "not responding." The electronic temperature logs could not be reviewed and S16 was not sure why the refrigerator temperature data was not available.

On 1/8/25 at 2:10 PM, S16 stated that the Flucelvax vaccine was not stored in the medication room refrigerators on the units as floor stock until recently, about a month or two ago. Previously, vaccines were only stored in the pharmacy refrigerator.

On 1/9/25 at 10:00 AM, upon review of the facility policy titled, "Medication and Specimen Refrigerator and Freezer Monitoring and Use of Temperature Logs," the policy failed to include monitoring of refrigerators used to store vaccines at least twice daily, to ensure the maintenance of the storage cold chain, in accordance with CDC guidelines.

These findings were confirmed with S16 on 1/9/25 at 10:15 AM.

N.J.A.C. 8:43G-23.2 (a)(5)

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on observations, staff interview, and review of facility document, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the beyond use dating of blood glucose test strips and glucose control solutions in accordance with the manufacturer instructions for use (IFU).

Findings include:

On 1/8/25 at 12:32 PM, during the tour of the treatment room, located in the B Wing, the Adult Unit, in the presence of Staff (S)16 (Pharmacy Manager), and S18 (LPN), a 50-count vial of StatStrip Glucose Test Strips, removed from the manufacturer box, was found stored in a glucose monitoring supply box, ready for patient use. The vial lacked a beyond use date (BUD). The date the vial was opened could not be determined.

On 1/8/25 at 12:35 PM, the above findings were confirmed with S16 and S18. In addition, S18 stated he/she was not sure of the manufacturer's expiration dates, for the blood glucose test strips and for the blood glucose control solutions, once the vials are opened. S16 stated that the facility recently, a couple of months ago, started using the StatStrip Xpress blood glucose monitor. A request was made for the manufacturer's instructions for use and the facility policy for the blood glucose monitor at this time.

A review of the manufacturer blood glucose test strips product information stated, " ... Test Strip Stability: ... 180-day open-vial stability ..."

The manufacturer blood glucose control solution product information stated, " ... Precautions ... Check the expiration date on the control solution vial. Do not use the control solution if the expiration date has passed. Use only for 3 months after first opening. When you open a new vial of control solution, count forward 3 months and write that date on the label of the control solution vial. Discard any remaining solution after the date you have written on the vial ... Expiration The expiration date is printed on the control vials. Once opened, solutions stored as indicated will be stable for up to 3 months or until the expiration date, whichever comes first ..."

On 1/8/25 at 1:03 PM, during the tour of the medication room, located in the nurse's station on the Extended Crisis Intervention Service Unit, with S19 (RN), an opened 50-count vial of StatStrip Blood Glucose Test Strips, an opened 4 milliliters (ml) vial of StatStrip Control Solution level one (1), and an opened 4 ml vial of StatStrip Control Solution level three (3) were found stored in a glucose monitoring supply box, ready for patient use. The vial lacked a beyond use date. The date the vial was opened could not be determined. Upon interview, S19 stated that the night shift usually takes care of the glucose supplies and he/she was not sure of the manufacturer's expiration dates, for the blood glucose test strips and the blood glucose control solutions, once the vials are opened. A policy was requested for the blood glucose monitor. On 1/8/25 at 1:12 PM, these findings were confirmed with S16 and S19.

On 1/9/25 at 9:30 AM, the Manufacturer's information for use (IFU) for the StatStrip Xpress 2 and the facility policy titled, "Operating the Accudata Inform II Glucometer," last revised 9/29/20, were provided by S16. The facility policy provided, was for the previous blood glucose monitor utilized by the facility.

On 1/9/25 at 2:46 PM, upon interview, S2 (Director of Operations), confirmed that the facility initiated the utilization of the current brand StatStrip Xpress blood glucose monitor on 9/28/24, and that the facility does not have a policy for the current blood glucose monitor.

N.J.A.C. 8:43G-23.6(i)

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observations, staff interview, and facility document review, it was determined that the facility failed to ensure the development and implementation of policies and procedures that address the cleaning and disinfecting of blood glucose monitors, in accordance with the manufacturer instructions for use (IFU).

Findings include:

On 1/8/25 at 10:38 AM, a tour of the facility was conducted with Staff (S)16 (Pharmacy Manager). During the tour, an inquiry was made on each unit about the process for cleaning and disinfecting the StatStrip Xpress 2, the blood glucose monitor utilized by the facility.

On 1/8/25 at 11:13 AM, while on a tour of the A-Wing, S11, (Licensed Practical Nurse - LPN), stated that Clorox Bleach Germicidal Wipes are utilized to clean the blood glucose monitor. S11 stated that the facility recently, a couple of months ago, started using the StatStrip Xpress blood glucose monitor. A request was made for the manufacturer's instructions for use and the facility policy for the blood glucose monitor at that time.

On 1/8/25 at 11:47 AM, while on a tour of the West Wing, S17, Registered Nurse, stated that Clorox Bleach Germicidal Wipes are utilized to clean the blood glucose monitor.

On 1/8/25 at 12:05 PM, while on a tour of B-Wing, S18 (LPN), stated that Clorox Bleach Germicidal Wipes are utilized to clean the blood glucose monitor.

On 1/8/25 at 1:10 PM, S19 (RN), in the Extended Crisis Intervention Stabilization Unit, stated individually packaged Alcohol Wipes are utilized to clean the blood glucose monitor. At 1:11 PM, S16 (Pharmacy Manager), corrected S19 and stated that the Blood Glucose Monitor should be cleaned using Clorox Bleach Germicidal Wipes.

On 1/9/25 at 9:30 AM, the Manufacturer's information for use (IFU) for the StatStrip Xpress 2 and the facility policy was requested. The facility policy titled, "Operating the Accudata Inform II Glucometer" last revised 9/29/20, provided by S2 was for the previous blood glucose monitor utilized by the facility. A review of the manufacturer's instruction for use manual stated, " ...Cleaning and Disinfecting the Meter. Acceptable Cleaning and Disinfecting Materials Nova Biomedical recommends the use of Clorox Healthcare® Bleach Germicidal Wipes, EPA Registration #67619- 12, or any disinfectant product with EPA Registration #67619- 12 may be used ..."

On 1/9/25 at 2:41 PM, S2 confirmed that the Clorox Bleach Germicidal Wipes, made available to the staff and approved by the manufacturer, should be utilized to clean and disinfect the StatStrip Xpress 2 blood glucose monitor.

On 1/9/25 at 2:46 PM, S2 confirmed that the facility initiated the utilization of the StatStrip Xpress 2 blood glucose monitor on 9/28/24 and that the facility did not develop a policy for the the blood glucose monitor currently utilized by the facility.

N.J.A.C 8:43G-14.1(d)(4)