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PATERSON, NJ 07503

PATIENT RIGHTS

Tag No.: A0115

Based on observation, staff interviews, review of facility documents and review of one of 14 Medical Records (Patient (P) 1), it was determined that the facility failed to ensure the rights of each patient is protected.

Findings include:

1. The facility failed to ensure patients with aggressive and/or threatening behavior towards staff or other patients were placed on "Constant Observation" per facility policy. (Cross-refer to Tag 0144).

3. The facility failed to ensure patients on the Regan 2 (R2) Behavioral Health (BH) Unit were observed every 15-minutes as per facility policy. (Cross-refer to Tag 0144).

4. The facility failed to ensure a policy addressing Adult Medical Emergencies (Cardiac or Respiratory Arrest) was developed and implemented. (Cross-refer to Tag 0144).

5. The facility failed to ensure the use of seclusion was in accordance with the order of a physician or other Licensed Independent Practitioner (LIP) who was responsible for the care of the patient. (Cross-refer to Tag 0168).

6. The facility failed to ensure seclusion orders were time limited to 4 hours, based on patient age. (Cross-refer to Tag 0171).

7. The facility failed to submit notification of the patient death in seclusion to the CMS (Centers for Medicare Services) Regional Office (RO) by close of the next business day following the day in which the hospital was aware of the patient's death. (Cross-refer to Tag 0213).

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on staff interview, review of one of one Medical Record (Patient (P) 1) and review of facility documents, it was determined that the facility failed to ensure: 1. patients with aggressive and/or threatening behavior towards staff or other patients, were placed on "Constant Observation" per facility policy; 2. patients on the Regan 2 (R2) Behavioral Health (BH) Unit were observed every 15-minutes, as per facility policy, and 3. a policy addressing Adult Medical Emergencies (Cardiac or Respiratory Arrest) was developed and implemented.

Findings include:

1. P1 was admitted to the R2 Behavioral Health (BH) unit on 8/22/22 at 23:02 [11:02 PM], with an admitting diagnosis of schizophrenia [a disorder that affects a person's ability to think, feel, and behave clearly] unspecified.

Review of Nursing Progress Notes revealed multiple incidences where P1 was agitated, aggressive and/or threatening towards staff or other patients:

The Nursing Progress Note on 8/26/22 at 5:10 AM stated, " ...At start of shift pt [Patient] was calm and cooperative however became loud, disruptive, and disorganized after large group room was closed ...Pt became increasingly loud, disruptive, and walking around with clenched fists. Physician called for orders, Haldol 5 mg [milligram][Antipsychotic medication] and Benadryl 50 mg [Antihistamine medication] administered IM [Intramuscular] at 1246 am [12:46 AM] with help of security ... Pt did not resist IM. Medication had calming effect however pt only slept for about an hour and remains hyper vigilant but more in control. At around 3:30 AM pt became oppositional, agitated and threatening. Making aggressive gestures towards other patients and pacing the hallway ...All attempts to redirect and deescalate failed. Pt started slamming hands on nurse's station door, shaking door, and attempting to step over to enter nurse's station. When security arrived pt attempted multiple times to grab security. Pt physically brought back to room. Thorazine 50 mg [Antipsychotic medication] and Midazolam 2 mg [Sedative medication] IM administered as ordered by physician with security. Pt then walked to quiet room by security, pt able to regain control in quiet room and is noted resting comfortably. ..."

The Nursing Progress Note on 8/26/22 at 18:22 [6:22 PM] stated, " ... Patient was intrusive, touching, and hugging patients, pointing fingers and in one event tried to attack another patient in the small room. ...Patient needed constant redirections and strict implementation of boundaries. ..."

The Nursing Progress Note on 8/27/22 at 5:53 AM stated, "Patient woke up at approximately 1215am [12:15 AM], disorganized, getting loud on the unit while peers were asleep, gesturing, and threatening staff. Attempts of verbal redirection were made with least restrictive measures such as distractions, all yielded no effect. Patient was offered nightly meds [medications] but refused also offered PRN [as needed] medications multiple times with multiple attempts of encouragement but refused ...order for Haldol 5mg/ Benadryl 50 mg IM obtained and were administered ...with little effect ...Pt went to bed shortly after did not sleep ...remained restless through the night."

The Nursing Progress Note Addendum on 8/27/22 at 7:19 AM stated, "At approximately 0645am [6:45 AM], patient got agitated again, running/rushing towards staff, threatening, banging and very difficult to verbally redirect as patient would not comply. Patient would not take PO [oral] medications upon offering. Patient posed an imminent danger to self and others. ... Versed 2 mg [Midazolam] IM and Benadryl 50 mg IM which was administered ..."

The Nursing Progress Note on 8/27/22 at 5:34 PM stated, " ...impulsive, and inappropriate trying to wrap the arm of other patients' arm and staff and touch them ...difficult to redirect and place in quiet room for few minutes. ... complied with medication ...At visiting time, the patient went to the dining room talking loud and trying to touch some of the visitors ...redirected and left from the room ... later came back to dining room to try to do the same thing again and got agitate and aggressive ... At dinner time the patient was running in the hallway and restless, the nurse tried unsuccessful to redirected [sic] him, which he was place [sic] in the quiet room for 20 minutes and where he ate his dinner."

The facility policy titled, "BH - Assessment; Suicidal/Homicidal Risk (Levels of Observation) REGAN2" last reviewed 2/28/22 stated, "...Policy: It is the policy of (Name of facility) and Medical Center's Inpatient Behavioral Health Unit to maintain safety and security of patients at risk or potentially a danger to themselves or others, using level of observation system. Procedure: ...3. Definitions for the level of observation/criteria are as follows: Constant Observation (CO) ...A patient who has strong desire to hurt others and is verbally threatening towards others also falls in this category. ... The observer must be within arm's length of the patient at all times (this includes the bathroom and shower). ..."

Review of P1's medical record lacked evidence and orders for "Constant Observation" as per the facility policy referenced above, when P1's behavior was documented as agitated, aggressive and/or threatening towards staff or other patients.

On 8/15/23 at 12:15 PM, during an interview, Staff (S)1 (Director of Patient Safety and Regulatory) stated that "Constant Observation" is only used for Suicidal/Homicidal patients, on a case-by-case basis.

On 8/15/23 at 2:43 PM, on the R2 unit, an interview was conducted with S8 (R2 Registered Nurse [RN]). S8 stated that aggressive patients on the unit are identified on the daily assignment sheet as a "Code Purple." This alerts staff of the patients that have a history of violent behavior. S8 stated that these patients are not placed on "Constant Observation" unless there is actual intent. The daily assignment sheet for 8/28/22 was reviewed and indicated that P1 was listed as a "Code Purple." The policy regarding "Code Purple" was requested. S1 stated that the facility does not have a "Code Purple" policy and that this is something only the R2 Unit utilizes.

On 8/15/23 at 11:20 AM, S4 (RN Patient Safety and Quality) indicated that staff receive de-escalation, restraint and seclusion training upon orientation and annually. S11 (Director of Security) provided the "De-escalation Presentation 2023" training that is provided to staff. Staff training for 2022 and 2023 were verified via facility document review and staff interview.

The facility failed to ensure that patients with aggressive and/or threatening behavior towards staff or other patients, were placed on "Constant Observation" per facility policy.

2. The facility policy titled, "BH- Assessment; Suicidal/Homicidal Risk (Levels of Observation) REGAN2" last reviewed 2/28/22 stated, "...Policy: It is the policy of (Name of Facility) and Medical Center's Inpatient Behavioral Health Unit to maintain safety and security of patients at risk or potentially a danger to themselves or others, using level of observation system. Procedure: ...3. Definitions for the level of observation/criteria are as follows: ...15 minute observation safety check- for all patients not on constant observation. ...10. Once a patient is on 15 minutes observation, no new order is required unless a change in the level of observation is indicated."

On 8/15/23 at 1:38 PM, during an interview, S4 stated, "every patient on the R2 unit is on 15-minute observation, it's unit rules, no order is required." S4 stated that all patients on the BH unit are on every 15 minute checks from admission to discharge unless otherwise ordered to be on "Constant Observation."

During an interview at 2:07 PM, S7 (R2 Unit Manager) stated that "every patient on the unit is on Q15 minute observations." S7 explained the 15-minute observation documentation. The Electronic Medical Records (EMR) of P1, P10 and P11 were reviewed with S7. P1's medical record, lacked 15-minute observation documentation on the following dates and times:

8/23/22 at 6:00 AM, 6:45 AM, 10:00 AM, 10:45 AM, 14:15 [2:15 PM], 15:00 [3:00 PM].

8/24/22 at 3:30 AM, 4:45 AM, 7:30 AM, 12:45 PM, 23:45 [11:45 PM].

8/25/22 at 00:45 [12:45 AM], 2:00 AM, 3:30 AM, 4:15 AM, 5:45 AM, 6:15 AM, 7:15 AM, 9:45 AM, 11:15 AM, 12:45 PM, 19:30 [7:30 PM].

8/26/22 at 1:15 AM, 3:45 AM, 7:30 AM, 11:00 AM, 13:45 [1:45 PM], 15:15 [3:15 PM], 20:45 [8:45 PM], 21:00 [9:00 PM], 23:00 [11:00 PM].

8/27/22 at 4:30 AM, 5:00 AM, 8:30 AM, 14:30 [2:30 PM], 15:45 [3:45 PM], 16:15 [4:15 PM], 17:15 [5:15 PM], 18:00 [6:00 PM], 22:00 [10:00 PM], 23:00 [11:00 PM].

8/28/22 at 00:30 [12:30 PM], 01:30 AM.

The facility failed to ensure P1 was observed every 15-minutes, as per the "BH- Assessment; Suicidal/Homicidal Risk (Levels of Observation) REGAN2" policy referenced above.

On 8/15/23 at 2:43 PM, during an interview, S8 (R2 RN) indicated that the person assigned to do the 15 minute observations, are responsible for documenting.

3. On 8/15/23 at 10:20 AM, S1 confirmed that the facility had a death of a patient [P1], while in seclusion. P1's medical record was requested and reviewed.

The Nursing Narrative Note dated 8/28/22 at 16:25 [4:25 PM] located in P1's medical record stated, "Upon patient falling down, additional assistance was immediately called, and patient was immediately attended to. Patient was observed with food in [his/her] mouth, appearing distressed, appeared to have difficulty breathing. Based on assessment, Heimlich maneuver [a first aid procedure used to dislodge an obstruction, when a person is choking] was performed on patient by staff. Staff then activated rapid response team [RRT] immediately. Rapid response team arrived shortly afterwards, CPR [Cardiopulmonary Resuscitation] initiated, patient wasn't responding well. Adult medical emergency activated and all other interventions initiated."

The "Progress Notes Rapid Response Team Record" and "Adult CPR Documentation Form" were reviewed.

The Progress Notes Rapid Response Team Record dated 8/28/22 (untimed) stated, "...Assessment: ...Upon RRT arrival; CPR initiated; + Adult medical emergency. ..."

P1's "Expiration Record" stated, "...Date/Time of Death: 8/28/22 at 10:16 [10:16 AM]."

The facility's policy regarding medical emergencies, such as respiratory/cardiac emergency/arrest was requested on 8/15/23. S1 indicated that the facility refers to respiratory/cardiac emergency/arrest as "Adult Medical Emergencies." On 8/15/23 at 5:04 PM, S10 stated "We do not have a policy, we follow AHA [American Heart Association] guidelines." On 8/17/23, the policy addressing Adult Medical Emergencies was requested a second time and not received. On 8/17/23 at 1:48 PM, S1 confirmed the facility did not have a policy regarding Adult Medical Emergencies.

On 8/17/23 at 12:45 PM, during an interview, S8 stated that he/she was working on the R2 unit on 8/28/22 and recalls P1's incident. He/she stated that S19 was assigned to P1 and was sitting outside the seclusion room at the time of the incident. S8 indicated that S19 shouted for help and that he/she was one of the staff who assisted S19 with P1. S8 indicated that he/she was the one who called the RRT for P1 and brought the emergency equipment to the patient room.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on staff interview, review of one of one Medical Record (Patient (P) 1) and facility document review, it was determined that the facility failed to ensure the use of seclusion was in accordance with the order of a physician or other Licensed Independent Practitioner (LIP) who was responsible for the care of the patient.

Findings include:

Review of the "BH [Behavioral Health] Patient Location" section of P1's medical record, indicated that P1's location was documented as being in the Seclusion/Quiet Room on the following dates and times:

Seclusion/Seclusion Room on 8/26/22 at 6:00 AM, 6:15 AM, 6:30 AM.

Open Seclusion on 8/26/22 at 9:00 AM, 9:15 AM, 9:30 AM.

Open Quiet Room on 8/26/22 at 19:15 [7:15 PM], 19:30 [7:30 PM], 19:45 [7:45 PM].

Quiet Room on 8/27/22 at 00:30 [12:30 PM], 00:45 [12:45 PM], 00:59 [12:59 PM], 1:15 AM, 1:30 AM, 1:45 AM, 2:00 AM.

Seclusion Room on 8/27/22 at 3:00 AM, 3:15 AM, 3:30 AM, 3:45 AM, 3:52 AM, 4:36 AM, 4:46 AM, 5:15 AM, 5:30 AM, 5:45 AM, 5:55 AM, 6:15 AM, 6:30 AM, 6:44 AM, 6:58 AM, 7:15 AM, 7:30 AM.

Seclusion Room on 8/28/22 at 3:30 AM, 3:45AM, 4:00 AM, 4:11 AM, 4:18AM, 4:34 AM, 4:46 AM, 5:02 AM, 5:30 AM, 5:45 AM, 6:00 AM, 6:11 AM, 6:29 AM.

Quiet Room on 8/28/22 at 7:15 AM, 7:28 AM.

Seclusion Room on 8/28/22 at 7:45 AM, 8:00 AM.

The facility policy titled, "Seclusion," last reviewed 8/24/21, stated, "...Procedure: ...Obtain order for seclusion from physician/licensed independent practitioner (LIP). ..."

The "Orders" section of the medical record lacked evidence of a physician/LIP order for seclusion, when it was documented that P1 was in seclusion on the following dates and times:

On 8/26/22 at 6:00 AM, 6:15 AM, 6:30 AM.

On 8/27/22 at 3:00 AM, 3:15 AM, 3:30 AM, 3:45 AM, 3:52 AM, 4:36 AM, 4:46 AM, 5:15 AM, 5:30 AM, 5:45 AM, 5:55 AM, 6:15 AM, 6:30 AM, 6:44 AM, 6:58 AM, 7:15 AM, 7:30 AM.

On 8/28/22 at 3:30 AM, 3:45AM, 4:00 AM, 4:11 AM, 4:18AM, 4:34 AM, 4:46 AM, 5:02 AM, 5:30 AM, 5:45 AM, 6:00 AM, 6:11 AM, 6:29 AM.

On 8/15/23 at 2:07 PM, during an interview with S7 (R2 BH Unit Manager), he/she indicated that restraints or seclusion are not used on the BH unit often. S7 indicated that staff will use verbal de-escalation, PO [Oral] medication, IM [Intramuscular] medication and snacks, prior to placing a patient in restraints or seclusion. S7 stated that the "seclusion room" is rarely used. He/she stated that the "seclusion room" is used as a "quiet room" frequently, where the door remains open, and no doctor order is required. If the room were to be used as "seclusion," the door would be closed, and an order from a doctor would be required.

S7 stated that there are times when it is documented that P1's location is marked as "seclusion room" but believes it is because there is no drop down in the computer for "quiet room" for staff to select. S7 stated that P1 was only in seclusion, with the door closed on the morning of 8/28/22 around 7:15 AM. The other documented times P1 was in the seclusion room, the door remained open, which is known as the "quiet room." The verbal order for seclusion entered by S19 on 8/28/22 at 7:20 AM and the physician order for seclusion entered on 8/28/22 7:46 AM was reviewed.

There was no evidence in the medical record that indicated whether the door to the "seclusion room" remained open (Quiet Room) or closed (Seclusion Room), when it was documented "Seclusion" on the following dates and times:

On 8/26/22 at 6:00 AM, 6:15 AM, 6:30 AM.

On 8/27/22 at 3:00 AM, 3:15 AM, 3:30 AM, 3:45 AM, 3:52 AM, 4:36 AM, 4:46 AM, 5:15 AM, 5:30 AM, 5:45 AM, 5:55 AM, 6:15 AM, 6:30 AM, 6:44 AM, 6:58 AM, 7:15 AM, 7:30 AM.

On 8/28/22 at 3:30 AM, 3:45AM, 4:00 AM, 4:11 AM, 4:18AM, 4:34 AM, 4:46 AM, 5:02 AM, 5:30 AM, 5:45 AM, 6:00 AM, 6:11 AM, 6:29 AM.

On 8/15/23 at 2:43 PM, during an interview, S8 (R2 RN) indicated that the "seclusion room" is utilized as a quiet room and a seclusion room, and he/she documents as such.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0171

Based on staff interview, review of facility documents, and review of one of one Medical Record (Patient (P) 1) of a patient with a physician order for seclusion, it was determined that the facility failed to ensure the seclusion order was time limited to 4 hours, based on the patient's age.

Findings include:

The Nursing Progress Note in P1's medical record [a 51-year-old with a history of Schizophrenia] dated 8/28/22 at 7:41 AM stated, "Patient suddenly came out of his room, running very fast in the hallway, very anxious and agitated. Saying names and appeared very angry, punching doors and walls, unable to respond to de-escalation and redirections. Security was called for help and patient was put into seclusion room at 0720hr [7:20 hour], also Haldol 5mg [Milligrams] [Antipsychotic medication] IM [Intramuscular] and Benadry [sic] 50mg [Antihistamine medication] IM given."

Review of the "BH [Behavioral Health] Patient Location" section of P1's medical record, indicated that P1's location was documented as being in the Seclusion/Quiet Room on the following date and time:

Seclusion Room on 8/28/22 at 7:45 AM, 8:00 AM.

The BH Psychiatrist IP Progress Note dated 8/28/22 at 7:42 AM stated, "...Subjective: ...Denies thoughts to hurt self/others. Easily agitated, difficult to redirect. This morning pt was agitated early, not responding to less restrictive interventions, including redirection. Had to be put in seclusion. I saw the pt face to face around 7:30am. He received Haldol, Benadryl IM before he was put in seclusion around 7:10am. He was still moving around the room, responding to internal stimuli. No other concerns noted. He will be released from seclusion once calmer. ..."

The "Orders" section of P1's medical record was reviewed and revealed that there were two physician orders for Seclusion:
On 08/28/22 at 7:56 AM, a verbal order entered by S19 (Registered Nurse [RN]), Requested Start Date/Time 08/28/2022 07:10 AM, Stop Date/Time 08/28/2022 07:10 AM.
On 08/28/22 at 8:17 AM, an order entered by a physician, Requested Start Date/Time 08/28/2022 08:16 AM, Stop Date/Time 08/28/2022 08:16 AM.

It was identified that the start and stop Date/Time for the seclusion orders were the same time. The order was not time limited to four hours based on the patient's age, nor was there any indication on the order for the length of time that the patient could be in seclusion.

Upon interview, on 8/17/23 at 2:16 PM, Staff (S)25 (Director of Nursing Informatics) indicated that the stop date/time was the same as the start date/time "because the goal for seclusion is to discontinue as soon as possible, so it would not default to any certain time." Once it was brought to S25's attention, he/she indicated that he/she has now corrected the stop date/time and now it will have to be entered and discontinued when appropriate.

The facility policy titled, "Seclusion," last reviewed: 8/24/21, stated, "...Procedure: ...Obtain order for seclusion from physician/licensed independent practitioner (LIP). ..." The policy failed to address the need for the physician/LIP orders to contain time limits based on the patient's age.

The facility policy titled, "Restraints," last reviewed 8/10/21 stated, " ...Definitions: ...Seclusion: The involuntary confinement of a person alone in a room or an area where the person is physically prevented from leaving and may only be used for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient, a staff member, or others. ...Procedure: ...Licensed Independent Practitioner (LIP) Orders: Restraints for Violent or Self-Destructive Behavior: An order for restraint or seclusion shall be obtained prior to the application of restraints, except in emergency situations when the need for intervention may occur quickly. In these emergency application situations, the order shall be obtained either during the emergency application of the restraint or seclusion, or immediately (within a few minutes) after the restraint or seclusion has been applied. ...Written or telephone orders for initial or continued use of restraints are time limited as follows: Ages 18 and over: Four hours..."

Review of medical records of patients in non-violent and violent restraints, revealed that the orders were time limited and renewed when appropriate.

PATIENT RIGHTS:RESTRAINT/SECLUSION DEATH RPT

Tag No.: A0213

Based on staff interview and review of one of one Medical Record (Patient (P)1), it was determined that the facility failed to submit notification of the patient death in seclusion to the CMS (Centers for Medicare Services) Regional Office (RO) by close of the next business day following the day in which the hospital was aware of the patient's death.

Findings include:

On 8/15/23 10:19 AM, Staff (S)1 confirmed that the facility had a death of a patient [P1], while in seclusion. S1 stated that the death in seclusion incident was reported to CMS on 8/31/22.

P1's medical record was reviewed. The "Expiration Record" stated, "...Date/Time of Death: 8/28/22 at 10:16 [10:16 AM]." The Nursing Narrative Note dated 8/31/2022 at 13:03 [1:03 PM] states, "8/31/22 1057 [10:57 AM] pt death in seclusion reported to CMS."

The facility failed to ensure the death in seclusion notification to the CMS RO occurred by close of the next business day following the day of P1's death.