Jersey City Medical Center

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 41646 Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure: 1.) the flow of contaminates to clean areas are minimized by a physical barrier by adhering to recommended airflow pattern in accordance with CDC guidelines; 2.) the floors in the sterile processing department are kept clean, with terminal cleaning records kept, in accordance with facility policy; and 3.) the external surfaces of the automated washers in the sterile processing department (SPD) are cleaned and disinfected daily in accordance with manufacturer instructions for use. Findings include: 1. Reference: Centers for Disease Prevention and Control (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019 states, “... Physical Facilities - The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items. In the decontamination area, reusable contaminated supplies (and possibly disposable items that are reused) are received, sorted, and decontaminated. The recommended airflow pattern should contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas. The American Institute of Architects recommends negative pressure and no fewer than six air exchanges per hour in the decontamination area (AAMI [Association for the Advancement of Medical Instrumentation] recommends 10 air changes per hour) and 10 air changes per hour with positive pressure in the sterilizer equipment room. ...” On 07/08/25 at 10:35 AM, during a tour of the Sterile Processing Room, an open pass-through window leading from the decontamination room was observed. On the window was a sign stating, “Keep Window Closed at All Times.” This finding was confirmed with Staff (1), S4, and S5. 2. On 07/09/25 at 10:30 AM, a tour of the Sterile Processing Room was conducted in the presence of S1, S4, and S5. In front of the washers, the white floors were observed with multiple black scratches, scuff marks, and brownish colored residue, inside and around a long seam extending to the washer. Along the base of the washers, thick brown colored residue was observed. S5 stated that the floors are cleaned by Environmental Services [EVS]. At 10:53 AM, an interview was conducted with S7. S7 stated that the floors are swept and mopped each day during the afternoon shift. He/she further stated that “once a week we do terminal cleaning, which includes high dusting and wall washing” and that a scrubber machine is used to clean inside the black scratches. A request was made to view the terminal cleaning logs of the sterile processing room, or any documentation that the floors are being cleaned. S7 stated that they did not keep logs at this time. At 1:15 PM, during an interview with S14, he/she stated the brownish residue observed in and around the floor seam is a filler used to repair the gap in the flooring. At 3:16 PM, S1 confirmed that there was no terminal cleaning log. Upon request, S1 provided the facility’s EVS policy for cleaning the Sterile Processing Department (SPD) area, titled, “[name of company] 9.05 - Sterile Processing; Managing Department(s): Environmental Services,” Date Issued 10/01/24, which stated, “Policy Statement: Sterile Processing is one of the most critical areas of the hospital. Extreme care must be taken to ensure the following schedule is carried out rigorously and in accordance with departmental procedures. ... Daily Routine Cleaning ... Note: Terminal Cleaning Logs should be kept for record keeping. ...” 3. On 07/09/25 at 10:30 AM, during a tour of the Sterile Processing Room in the presence of S1, and S5, the Getinge automated washers were observed with visible streak marks, white splatter marks, and discolored areas. S5 stated that the SPD staff are responsible for cleaning the washers, and that the outside of the washer is wiped down weekly. Upon request, S5 was unable to provide documentation of the weekly washer cleaning. A request was made to review the instructions for use (IFU) for the washer. Review of the “Getinge 86-Series User Manual” provided by S1 stated, “... 4. Maintenance ... 4.1 Daily Inspection: the following points are performed as part of a daily inspection of the machine: Clean the outer parts of the machine (see section 4.2.5 Cleaning the exterior) ... 4.2.5 Cleaning the exterior ... The front and side panels can be cleaned and disinfected with an alcohol-based cleaning agent or medical spirit. The operator panel is cleaned in the same way. Remove stains from metal parts with an ordinary cleaner for stainless steel. ...” These findings were confirmed on 07/10/25 during exit conference with S1, S2, S3, and S14.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 48913 Based on observation, facility document review, medical record (MR) review, and staff interviews, it was determined the facility failed to ensure pharmacy services are provided in a safe manner. This failure resulted in an Immediate Jeopardy, posing a serious risk of harm to patients. Findings include: The facility failed to ensure that policies and procedures that address the accountability for, and control of, Controlled Dangerous Substances (CDS), are developed and implemented. 1) The facility did not have a process in place to limit staff access to CDS stored in the Pyxis; 2) the facility did not ensure that CDS were wasted in accordance with facility policy; 3) the facility failed to identify CDS diversion by failing to utilize their CDS monitoring tools. A nurse accessed multiple Pyxis consoles and removed approximately 304 vials of Fentanyl (a CDS), during nine working shifts, between 1/22/2024 and 2/14/2024. On 2/28/2024 at 2:17 PM an Immediate Jeopardy (IJ) was identified. The facility was made aware of the IJ, a copy of the IJ template was provided to the facility at 3:15 PM, and an immediate removal plan was requested. On 2/29/2024 at 10:48 AM, an acceptable removal plan was received. The facility implemented the following: development of a new policy and procedure that addressed Controlled Dangerous Substance Monitoring and Audit process and Tracking Tool, and staff re-education. On 2/29/2024, during an onsite visit, the surveyors verified the implementation of the removal plan through staff interviews and review of facility documents, which included staff education. On 2/29/2024 at 12:43 AM, it was determined the facility implemented the IJ removal plan. Cross Reference: 482.25(b) Pharmaceutical Services: Delivery of Services The facility failed to ensure the implementation of policies and procedures that address the monitoring of, and accountability for, CDS. (Cross refer to Tag A-500) The facility failed to ensure the development and implementation of policies and procedures that address the limitation of staff access to the Pyxis, an automated dispensing cabinet, and the CDS stored inside. (Cross refer to Tag A-500) The facility failed to ensure the implementation of policies and procedures that address the wasting of CDS. (Cross refer to Tag A-500) The facility failed to ensure the development and implementation of policies and procedures that address the maintenance of the patient list in the Pyxis, and the accessibility of medications, including CDS, stored inside. (Cross refer to Tag A-500) The facility failed to ensure implementation of policies and procedures that address the reporting of CDS loss or diversion to the required agencies. (Cross refer to Tag A-509)”

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 48913 Based on medical record review, facility document review, and staff interviews, it was determined the facility failed to ensure 1) the implementation of policies and procedures that address the monitoring of, and accountability for, Controlled Dangerous Substances (CDS); 2) the development and implementation of policies and procedures that address the limitation of staff access to the Pyxis, an automated dispensing cabinet, and the CDS stored inside; 3) the implementation of policies and procedures that address the wasting of CDS; and 4) the development and implementation of policies and procedures that address the maintenance of the patient list in the Pyxis, and the accessibility of medications, including CDS, stored inside. Findings include: 1. On 2/27/2024 at 12:35 PM, an interview with Staff #5 (S5), the Director of Pharmacy, was conducted. When interviewed regarding the processes the facility follows to ensure the accountability of CDS, S5 stated the pharmacy staff did not have access to the corporate drug diversion software, Med Assist, however pharmacy staff performed randomized audits to ensure the accountability of CDS inventory and usage in patient care areas. During an interview on 2/28/2024 at 9:45 AM, S5 stated that S25, a pharmacy staff member no longer working in the facility, was in charge of monitoring CDS reports daily. S5 stated that since S25 left, they reviewed CDS accountability reports for the processes completed within the pharmacy department, such as monitoring the narcotic safe transactions. When questioned regarding the monitoring of CDS usage in patient care areas, S5 stated he/she monitored CDS overridable drug reports from patient care areas “randomly.” S5 identified S16, the Information Technology (IT) Pharmacist, as the other staff member responsible for monitoring CDS reports. Policies and procedures that address the monitoring of CDS usage, including but not limited to, distribution, administration, and disposal (waste) in all areas of the hospital, were requested at this time. On 02/28/2024 at 9:50 AM, the CDS monitoring, and audit documentation were requested. On 02/28/2024 at 10:45 AM, S5 stated that while the pharmacy staff completed CDS usage monitoring, the facility did not maintain documentation of the CDS monitoring. The facility failed to provide evidence that the pharmacy staff were monitoring the CDS distribution, administration, and waste, in the facility. On 02/28/2024 at 1:28 PM, S16, the Information Technology (IT) Pharmacist, was introduced by S5 as a staff member who was responsible for monitoring some of the CDS accountability reports. During an interview on 2/28/24 at 1:55 PM, S16 stated that while CDS reports should be monitored on a routine basis, he/she had not completed report monitoring in January or February of 2024. S16 also confirmed that the pharmacy staff did not have documentation to ensure that monitoring of CDS usage in the facility was completed on a routine basis. On 02/28/2024 at 10:55 AM, S5 stated the facility did not have a current updated policy that outlined the process used to monitor the CDS usage in patient care areas, to ensure accountability. S5 provided a policy titled “Pyxis (Automated Dispensing Machine/ ADM) Controlled Substance Minimum Monitoring Standards,” dated 6/15. S5 confirmed the facility followed the CDS monitoring found in this archived policy, however S5 could not provide documentation that the monitoring required in this policy was completed. Further review of facility documents revealed the facility policy provided on 02/27/2024 at 10:15 AM, titled, “Controlled Dangerous Substance Management Procedure,” dated 02/08/2024 states, “... Monitoring ... When possible, diversion detection software will be used to monitor user’s CDS practice trends. If unable to utilize diversion detection software, the Department of Pharmacy will renew the controlled substance use on patients. The audit will be performed on a minimum of 10 patient charts/anesthesia records. The audit will compare the medication order with the record of administration (MAR, Anesthesia Record, and the controlled substance accountability report...” S5 was not aware of the content of this policy, when interviewed on 02/28/2024 at 10:55 AM. During an interview on 02/27/2024 at 12:35 PM, Staff (S) S5, the Director of Pharmacy, stated she/he received an email from Staff #3, the Chief Nursing Office on 02/15/2024 that requested corporate security personnel generate a Pyxis CDS usage report for S24, a Registered Nurse (RN), using the corporate drug diversion software, as RNs working in the Interventional Radiology (IR) Unit brought up concerns to S9, the Director of Nursing for the IR unit, regarding S24’s behavior. On 02/28/2024, review of the facility’s investigation, including the DEA (Drug Enforcement Administration) Form-106 and the Pyxis Reconciliation Report for S24, identified that S24, removed approximately 304 vials of Fentanyl 100 micrograms (mcg)/ 2 milliliters (ml) from the Pyxis consoles over the course of 9 working shifts, between 01/22/2024 to 02/14/2024. This discovery was identified by nurses who reported suspicious behavior, and was not identified by the routine audit of CDS usage. The facility failed to ensure the accountability of CDS. On 02/28/2024 at 9:50 AM, S5 provided overridable drug list that applied to all Pyxis consoles in the facility which indicated Fentanyl was an overridable drug in all procedural areas including the Emergency Department (ED), Cardiac Catheterization Lab, Labor and Delivery Unit, Operating Room, and Interventional Radiology (IR). S5 stated that Pyxis consoles located in procedural areas, are not profiled by the pharmacy department, and all medications stored inside the Pyxis, could be removed with an override. Review of Pyxis reports, dated 01/22/2024 to 02/14/2024, indicated the 304 vials of Fentanyl removed from the Pyxis by S24, were removed from consoles located in procedural or non-profiled areas, including the Interventional Radiology Unit and the Trauma Unit. During an interview on 02/28/2024 at 1:25PM, when interviewed regarding how CDS administration and waste was monitored in the procedural areas, S5 stated there was no routine audit of CDS usage completed in the procedural areas. This is not in accordance with facility policy. The facility policy titled, “Controlled Dangerous Substance Management Procedure,” dated 02/08/2024 states, “... CDS overrides are audited routinely by a Registered Pharmacist providing coverage to the area. Upon identification of an override without a corresponding order, in the EMR [Electronic Medical Record], the Nurse Manager of the unit and Pharmacy Administration, will be notified, and the occurrence(s) will be investigated...” On 02/28/2024 at 12:10 PM, six of eleven medical records (MR) reviewed, MR1, MR3, MR4, MR8, MR9 and MR10, in the presence of S18, the Clinical Informatics Site Manager, and S4, Assistant Vice President, lacked documentation of a physician’s order for Fentanyl. Review of the corresponding Pyxis User Reports, dated 1/22/24 to 2/14/24, indicated Fentanyl was removed from the Pyxis console for P1, P3, P4, P8, P9, and P10, by S24. The following was identified: Review of Pyxis medication removal reports for P1, dated 02/14/2024, indicate 4 vials of Fentanyl (a Controlled Dangerous Substance) 400 mcg (micrograms) was dispensed from the Pyxis located in the Trauma unit, at 17:06 [5:06 PM], by S24. MR1 lacked a physician order for Fentanyl on 02/14/2024. Review of Pyxis medication removal reports for P3, dated 02/12/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Trauma unit at 8:38 AM, by S24. MR3 lacked a physician order for Fentanyl on 02/12/2024. Review of Pyxis medication removal reports for P4, dated 02/09/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Trauma unit at 7:11 AM, by S24. MR4 lacked a physician order for Fentanyl on 02/09/2024. Review of Pyxis medication removal reports for P8, dated 02/01/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Trauma unit at 9:37 AM, by S24. MR8 lacked a physician order for Fentanyl on 02/01/2024. Review of Pyxis medication removal reports for P9, dated 01/30/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Trauma unit at 10:04 AM, by S24. MR9 lacked a physician order for Fentanyl on 01/30/2024. Review of Pyxis medication removal reports for P10, dated 01/29/2024, indicate 2 vials of Fentanyl (a CDS) 200 mcg, was dispensed from the Pyxis located in the Interventional Radiology unit at 10:13 AM, by S24. MR10 lacked a physician order for Fentanyl on 01/29/2024. These findings were confirmed by S4 and S18 on 2/28/24 at 1:20PM. The CDS audit required by facility policy, was not completed. This discrepancy was not identified by the facility. The facility policy titled, “Pyxis (Automated Dispensing Machine/ADM) Controlled Substance Minimum Monitoring Standards” dated 06/2015 states, “...Pyxis Console Overrides Review entire house for one 24-hour period twice per month...” 2. During a tour of the Trauma unit on 02/27/2024 at 10:30 AM, Staff #7 (S7), the Nurse Educator, stated staff nurses have access to all Pyxis consoles in each unit. On 02/27/2024 at 11:10 AM, during an interview with S10, the Patient Care Coordinator, he/she stated that registered nurses (RNs) have access to all Pyxis consoles in the facility. During an interview on 02/27/2024 at 12:35 PM, with Staff #5 (S5), the Director of Pharmacy, the facility’s policies and procedures addressing the limitation of staff access to the Pyxis and Pyxis Console Access Reports for three RNs, were requested. A review of Pyxis Console Access Reports for S25, S26, and S27 indicated the three RNs could access the Pyxis, and the CDS stored inside, in 29 areas. S5 confirmed that all RNs could access any Pyxis console located in the facility. S5 stated the facility did not have policies and procedures that addressed the limitation of staff access to the Pyxis consoles, and the CDS stored inside, as required by State regulations. On 02/28/2024 at 1:50 PM, S5 and S16, the IT Pharmacist, confirmed this finding. Reference: N.J.A.C. 13:39-10.3 (c) (2) New Jersey State Board of Pharmacy Regulations state, “... The pharmacist-in-charge shall be responsible for the following: ... 2) Ensuring that there are written policies and procedures, which are reviewed and approved by the pharmacist-in-charge for system operation, safety, security, accuracy, and access, patient confidentiality and prevention of unauthorized access and malfunction, and ensuring compliance with such policies and procedures; ...5) Assigning, discontinuing or changing personnel access to the automated medication system; ...” 3. During an interview on 02/27/2024 at 10:40 AM S7, a RN Nurse Educator, stated that when a CDS needs to be wasted, a second RN is required to witness the waste of the partial dose or full unused doses of CDS, and the waste documentation should be completed immediately after the medication is removed from the Pyxis. On 02/28/2024, the Pyxis “Dispense to Reconciliation Report,” dated 01/22/2024 to 02/14/2024 for S24, a RN, was reviewed. The report indicated that 72 of 135 incidences of Fentanyl, a Schedule II CDS, wasting were completed more than one hour after the medication was removed from the Pyxis console. The late wasting of the Fentanyl occurred from 1.04 hours up to 9.41 hours after removal of the medication from the Pyxis console. This is not in accordance with facility policy. The facility policy titled,” Pyxis ES Medication Storage and Distribution System” dated 05/01/2022, states, “... Wasting medications 1. The waste function shall be utilized for both partial and full unused doses of CDS...2. Immediately upon determination that a CDS will not be administered, the item shall be wasted...” This finding was confirmed by S1 and S5 on 02/28/2024 at 3:15 PM. 4. On 02/27/2024 at 10:40 AM, a tour of the Trauma Unit was conducted with S1, the Vice President of Quality, Safety, and Regulatory, S3, the Chief Nursing Officer, S4, the Assistant Vice President, S6, the Director of Nursing-Emergency Department, and S7, a RN Nurse Educator. S7 stated that the Trauma Unit has 2 Pyxis consoles on each side and staff nurses have access to all Pyxis in each unit. S7 stated that the patient list available in each Pyxis console was the complete patient list for the hospital, and to remove medication from the Pyxis, a nurse would select the patient’s name from the list, then select the medication for removal. On 02/28/24 at 11:00 AM, S5 stated the patient lists available in the Pyxis consoles included the entire patient census. S5 stated that a patient’s profile could be accessed from any Pyxis console. During an interview on 02/28/2024 at 1:30 PM, when interviewed regarding the management of the patient list available in the Pyxis console, S5 stated he/she thought that patient names were removed from the console after discharge, however he/she was not aware of the length of time the names, and their corresponding profiles, were available after discharge. The facility policy and procedure for the maintenance of the Pyxis patient list was requested from S5 on 02/28/2024. On 02/28/2024 at 1:40 PM, S5 confirmed the facility did not have a policy that addressed the maintenance of the Pyxis patient list, as required by the State regulation below. Reference: N.J.A.C. 13:39-10.3 (c) (2) New Jersey State Board of Pharmacy Regulations state, “ ... The pharmacist-in charge shall be responsible for the following: ... Ensuring that there are written policies and procedures, which are reviewed and approved by the pharmacist-in-charge for system operation, safety, security, accuracy, and access, patient confidentiality and prevention of unauthorized access and malfunction, and ensuring compliance with such policies and procedures ...””

“REPORTING ABUSES/LOSSES OF DRUGS CFR(s): 482.25(b)(7) Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate. This Standard is not met as evidenced by: 48913 Based on review of facility documents and staff interviews, it was determined the facility failed to ensure implementation of policies and procedures that address the reporting of Controlled Dangerous Substances (CDS) loss or diversion to the required agencies. Findings include: On 02/27/2024 at 9:45 AM, during an interview, S1, the Vice President of Quality, Safety, and Regulatory, confirmed the facility identified and reported an incidence of potential drug diversion. The facility’s policies and procedures that address drug diversion reporting and the facility’s investigation documentation were requested at that time. Review of facility documents on 02/27/2024 identified that the facility failed to report the incidence of CDS theft or loss, discovered on 02/15/2024, to the New Jersey (NJ) Board of Pharmacy and NJ Drug Control Unit as required by facility policy referenced below. The facility reported the event to these agencies on the day of survey, 02/27/2024, after documentation was requested. This finding was confirmed by S5 and S1 on 02/29/2024 at 1:15 PM. The facility policy titled,” Controlled Dangerous Substance Management Procedure” dated 02/08/2024, states, “ ... When a significant CDS diversion concern is identified, the Director of Pharmacy along with Nursing or Physician leadership must ensure that appropriate reports are made to the following agencies...External notification as the investigation dictates. Notified agencies may include: ... New Jersey Board of Pharmacy... New Jersey CDS ... “”

“PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING CFR(s): 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care. This Standard is not met as evidenced by: 49510 # NJ00170380 Based on medical record review, staff interviews, and review of facility documents, it was determined the facility failed to ensure a non-verbal developmentally disabled patient’s caregiver was provided with discharge instructions, in one of one medical record reviewed (Patient (P) 2). Findings include: Facility Policy titled, “Discharge Planning” dated 8/13/21, stated, “...Procedure: ...Planning: ...Discharge planning occurs in consultation with the patient and their family caregivers, or representative. ...Implementation: ...A written discharge summary is completed by the licensed healthcare provider involved in the patient’s care. Discharge instructions are completed by the nurse involved in the patient’s care. A copy of the discharge instructions including a phone number of a contact person in case there are questions post discharge is provided.” On January 17 and 18, 2024, P2’s medical record was reviewed and revealed the following: P2 was admitted to the facility on 12/17/23 at 9:04 AM with a diagnosis of pneumonia. The physician History and Physical (H&P) indicated the patient had a history of Reye’s syndrome, cerebral palsy, seizures, scoliosis, and asthma, and was non-verbal at baseline. On 12/18/23 at 8:00 PM, a Registered Nurse (RN) documented a skin assessment, which included a wound (blister) on the anterior, proximal right arm. The Wound Care RN consult on 12/21/23 at 4:00 PM documented two additional wounds: a closed blister on the interior dorsal left foot and a blister on the posterior distal left leg. The Wound Care RN documented “multiple closed blisters with serous fluid inside on the left lower extremity and foot.” The Wound Care RN recommended TruVue boots, low air loss (LAL) bed, and cover with foam every 72 hours. P2 was discharged on 12/27/23 at 5:55 PM. Upon review of P2’s discharge instructions, the section titled “Signatures,” stated, “(Patient Name), on 12/27/23, received patient instructions and the after visit summary was reviewed with me. I have read or had the instructions reviewed with me and understand the instructions given to me by my caregivers.” The “Patient/Caregiver:” signature section stated, “patient unable to sign.” On 1/18/24 at 12:38 PM, an interview was conducted with Staff (S) 34, a Registered Nurse (RN). S34 indicated that if a patient was unable to understand or sign the discharge instructions, the RN would reach out to the physician to let them know. The discharge instructions would then be given to the primary caregiver. S34 stated that a nursing note would then be written indicating the caregiver received discharge instructions. The medical record lacked evidence that the discharge instructions were reviewed with P2’s caregiver prior to discharge on 12/27/23, in accordance with facility policy. The After Visit Summary [discharge instructions] provided to the caregiver, lacked evidence of instructions for wound care post discharge. P2 presented back to the Emergency Department (ED) on 12/27/23. On 12/27/23 at 7:37 PM the ED Provider Notes HPI (History of Present Illness) stated, “...The patient was admitted here for pneumonia and COVID, and was discharged earlier this morning. Mom states since being home, she noticed the left ankle wound, along with redness, blistering, and swelling to the area, with discoloration of the left 2nd toe. She states she is not sure of what caused his/her symptoms, and she was not told of any injuries while he/she was admitted.” P2 was re-admitted on 12/28/23 at 3:50 PM for intravenous antibiotic therapy for cellulitis of the left foot, and was discharged on 1/13/24. A review of the Verge complaint and grievance, entry date 12/29/23, stated, “...Responder Comments: 1/14/24 2:24 PM. Patient had blister on right arm documented on 12/18. On the 21st patient had multiple closed blister [sic] on the left LE [lower extremity] and foot discoloration of toe. Wound care consult was ordered and provider was notified. It does not appear that there was communication to the family about the new wounds prior to the patient being discharged on the 27th ...””

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 48414 # NJ00169942 Based on medical record review, video surveillance observation, facility documents and staff interviews, it was determined the facility failed to ensure 1) patients are free from excessive use of force and abuse; 2) One-to-One observation monitoring is documented in Emergency Department in accordance with the facility policy and procedure. Findings include: 1) Reference: Facility policy titled, “Use of Force,” states, “Policy: Use of force should only be used when all other alternatives have been exhausted. ... Guidelines for the Use Of Force ...Use of physical force shall only be employed as a last resort after all other methods have been exhausted.” On 1/17/24 at 11:20 AM, medical record review of Patient (P)1 was conducted. P1 arrived at the Emergency Department (ED) VIA EMS (Emergency Medical Services) on 12/26/23 at 1:29 AM, with a chief complaint of Alcohol Intoxication. The ED Nursing Note on 12/26/23 at 1:29 AM stated, “Pt bib [brought in by] BLS [medical transportation] and JCPD [Jersey City Police Department]. As per ems, pt [patient] is drunk and was chasing a woman in the streets and punching cars. Pt is screaming during triage and not providing any useful information for triage. ... .” On 12/26/23 at 1:29 AM the ED Physician Note stated, “ ...The patient was initially cooperative on arrival, however the patient got out of his stretcher and began urinating on the floor in the ED hallway and became aggressive. The patient presents a threat to the safety of staff and patients, was unable to be verbally de-escalated, prompting restraints/sedation. ...Non-physical interventions were attempted. Due to the imminent risk of the individual physically harming themselves or others, the patient was restrained. ... .” On 12/26/23 at 3:08 AM orders were placed for “CT [Computed Tomography Scan] Facial Bones Without IV [intravenous] Contrast. On 12/26/23 at 7:14 AM the Final Results for the “CT Facial Bones Without IV Contrast” were “1. Acute bilateral nasal bone fractures with fracture line extending through the midline nasal bone. ...” An Oral and Maxillofacial Surgery Consult from 12/26/23 at 12:17 PM stated; “ ...Reason for Consult: facial trauma with facial fractures ...Physical Exam: ...Head: mild facial swelling overlying nose, consistent with the injury. ... Nose: Minimal dorsum deviation. No septal hematoma. ...Assessment/Plan: 21 y.o. [male/female] presents to ED with CT confirmed nasal bone fx [fracture] ... .” On 1/17/24 at 2:36 PM, a review of the video surveillance was conducted in the presence of S1 (Vice President of Safety and Regulatory), S21 (Security Director) and S22 (Security Manager). The video surveillance reviewed did not have any audio recording. Review of the video surveillance dated 12/26/23 revealed the following: First Camera View - “Rear Hallway Pod D” in the ED 1:30 AM - P1 was observed being transported on a stretcher in the ED hallway in the supine position while handcuffed to the stretcher. P1 appeared to be calm. S21 confirmed the video surveillance location was the “Rear Hallway” and identified the individuals in the camera surveillance as members of the local police department, EMS members, 2 (two) facility security officers - S19 and S40, and S17 (RN). S21 also confirmed that P1 was handcuffed to the stretcher by the local police department. 1:32 AM - P1 was observed to be transported to a room by EMS members and facility staff. P1 appeared calm and remained handcuffed to the stretcher. 1:34 AM - Police removed P1 from the handcuffs and exited the room. P1 appeared to be calm. S15 (Patient Care Technician [PCT]) and S17 were observed in the room. Security staff were observed standing outside P1’s room. 1:36 PM - S17 exited the room and turned off the lights. P1 appeared calm. 1:37 PM - An EMS member walked into the room and P1 sat up and appeared to communicate in an aggressive manner. The EMS member exited the room. 1:39 PM - S15 and S17 were observed in the room. P1 appeared agitated and was observed to stand up and removed his/her pants and walked out of the room into the ED hallway. Second Camera View - “ED-Stairwell Exit/Pod D” 1:39 AM - P1 was observed walking in the ED hallway and pushed a recliner chair into the hallway. S15 and S17 were observed walking behind P1. 1:40 AM - P1 was observed to walk out of view of the camera surveillance. S21 indicated that P1 began to urinate on medical equipment and a panic alarm was activated at this time. S15 and S17 were observed talking to P1. S15 walked into another room and returned with absorbent pads. S21 indicated the absorbent pads were to clean up the urine from P1. Four (4) Security Officers - S19, S20, S40 and S41, were observed standing in the hallway. 1:41 AM - P1 appeared agitated and verbally communicated in what appeared to be an aggressive manner. A stretcher was brought into the hallway. Security officers and S15 were observed to physically restrain P1 onto the stretcher in the supine position. S17 and the ED Provider were observed standing in the hallway communicating with each other. 1:42 AM- P1 appeared to lift his/her head and spit towards S20. S19 was observed to put his/her open hand on P1’s throat and forcefully push P1 back down on the stretcher. S15, S19, S20, S40, S41 and S42 were observed to apply 4-point restraints to P1’s wrists and ankles. S21 confirmed these observations and indicated that staff is not trained to put hands on a patient’s neck through the facility Handle with Care Training. S21 indicated this was considered excessive use of force and the only time staff can use excessive force is when they are in immediate danger and need to defend themselves. S21 confirmed that S19 was not in immediate danger during this event. Camera View - “Rear Hallway Pod D” in the ED 1:43 AM - P1 was transported back to the room. S19 appeared to hold the bed sheet up near P1’s face during transportation in the hallway due to a limited view from video surveillance. P1’s face was unable to be seen. S15, S19 and S42 were observed in the room standing around P1’s stretcher. S19 appeared to strike P1’s face with a closed fist. S21 confirmed these observations. S21 indicated he/she believes the bed sheet was held near P1’s face to prevent P1 from spitting on staff and did not believe it was covering P1’s face. S21 indicated S19 was immediately suspended pending an investigation which led to his/her termination. 1:44 AM - S19 and S42 exited the room. S15 was observed to stay in the room standing next to the stretcher. S1 confirmed S15 was the staff member responsible for the 1:1 observation of P1. The video surveillance concluded at this time. On 1/17/24 at 2:45 PM, an interview was conducted with S21 and S22. Both S21 and S22 confirmed they were alerted that S19 and S20 were accused of hitting P1 on 12/26/23. S21 confirmed both S19 and S20 were both immediately suspended pending an investigation. S21 confirmed that S19 was terminated and S20 had resigned. S21 indicated through video surveillance review that S19 was identified as hitting P1 with a closed fist. S21 indicated that S20 was not identified during video surveillance to use excessive force. The video surveillance review revealed that S19 used excessive force on P1 twice. There were multiple staff members present when S19 was observed to put his/her open hand on P1’s throat and forcefully push P1 back down on the stretcher. No intervention was done at this time to remove S19 from P1’s care and therefore S19 was able to use excessive force for a second time when he/she hit P1 with a closed fist leading to P1 having a nasal fracture. 2) Reference: Facility policy titled, “Patient Safety Watch for Non-Behavioral Locations” (effective 6/4/22), states, “ ...One-to-One Observation: For patients exhibiting behaviors that present a danger to self or others as evidenced by ....uncontrollable, agitated, and/or threatening behavior, is actively violent and/or destructive ...RN or designated Staff Member- The Patient Watch Observation Form will be completed noting the behavior of the patient, by the designated staff member every 15/30 minutes as per order and report any changes in patient status or behavior to the RN immediately. Patient Watch Observation forms are a permanent part of the patient’s medical record. ...” Facility policy titled, “Restraints-Violent and Non-Violent Non Self Destructive” (effective 5/2022), states, “Definitions: Restraint: Any manual method or physical/mechanical device, material or equipment that immobilizes or reduces the ability of a patient to freely move his/her arms/legs/body or head ...Restraint types include those for Violent Self Destructive behaviors ...Violent Self Destructive- VSD (i.e Behavioral) Restraint: Used to protect the individual against the immediate risk of harm to self or others due to violent or self-destructive behavior. Restraints in this category may include locked restraints or 4 point restraints. ... Monitoring ...For Violent Self Destructive restraints: ...1:1 staff observation is required for all patients in VSD. ...” On 1/17/24, a review of P1’s medical record revealed, that on 12/26/23 at 1:45 AM, physician’s orders were placed for “Restraints violent or self-destructive adult (age 18 and older)” and “1:1 patient” observation. On 1/17/24 at 12:17 PM, the 1:1 Patient Watch Observation Form for P1 was requested and could not be located. The medical record lacked evidence that the 1:1 Patient Watch Observation Form was completed. On 1/17/24, a review of medical record for P15 revealed that P15 had physician’s orders for “Restraints violent or self-destructive adult (age 18 and older)” and “1:1 patient” observation placed on 12/10/23 at 10:25 PM. On 1/17/24 at 1:06 PM, the 1:1 Patient Watch Observation Form for P15 was requested and could not be located. The medical record lacked evidence that the 1:1 Patient Watch Observation Form was completed. On 1/18/24 at 1:36 PM, S1 (Vice President of Safety and Regulatory) confirmed the Patient Watch Observation forms were not scanned into P1 or P15’s medical record. S1 indicated that the ED uses 1:1 Watch Observation forms, that are filled out on paper, and when the patient is discharged, the paper is supposed to be scanned into the electronic medical record.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) [the patient must be seen face-to-face within 1 hour after the initiation of the intervention -- ] §482.13(e)(12)(ii)To evaluate - 1. The patient’s immediate situation; 2. The patient’s reaction to the intervention; 3. The patient’s medical and behavioral condition; and 4. The need to continue or terminate the restraint or seclusion. This Standard is not met as evidenced by: 48414 # NJ00169942 Based on medical record review, staff interview, and review of facility documents, it was determined the facility failed to ensure all restrained patients receive a face-to-face evaluation within one (1) hour after the application of restraints Findings include: Reference: Facility policy titled, “Restraints-Violent and Non-Violent Non Self Destructive” (effective 5/2022), states, “Definitions: Restraint: Any manual method or physical/mechanical device, material or equipment that immobilizes or reduces the ability of a patient to freely move his/her arms/legs/body or head ...Restraint types include those for Violent Self Destructive behaviors ...Violent Self Destructive- VSD (i.e Behavioral) Restraint: Used to protect the individual against the immediate risk of harm to self or others due to violent or self-destructive behavior. Restraints in this category may include locked restraints or 4 point restraints. ... Monitoring ...For Violent Self Destructive restraints: ...Face to Face: An LIP [Licensed Independent Practitioner] must see the patient in person within 1 hour after the initiation of the intervention (regardless of whether the intervention has already been discontinued). The evaluation includes: the patients immediate situation, the patients reaction to the situation, the patient’s medical and behavioral condition and the need to continue or terminate the intervention. ...” On 1/17/24, review of P5’s medical record revealed P5 had a physician’s order for “Restraints violent or self-destructive adult (age 18 and older),” placed on 12/20/23 at 6:08 PM. The medical record lacked documentation of a Face-to-Face evaluation from a LIP within one hour of the application of restraints on 12/20/23. On 1/17/24, review of P7’s medical record revealed P7 had a physician’s order for “Restraints violent or self-destructive adult (age 18 and older),” placed on 12/23/23 at 9:47 AM. The medical record lacked documentation of a Face-to-Face evaluation from a LIP within one hour of the application of restraints on 12/23/23. On 1/17/24 at 12:17 PM, during interview with S5 (AVP of Nursing), he/she confirmed the medical record for P5 and P7 lacked documentation of a Face-to-Face evaluation from a LIP within one hour of the application of restraints.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 49510 # NJ00170380 Based on medical record review, staff interviews, and review of facility documents, it was determined the facility failed to ensure an initial nursing skin assessment was completed for a patient presenting to the Emergency Department (ED), in one of three medical record reviewed (Patient (P) 2), in accordance with facility policy. Findings include: Facility policy titled, “Initial and Subsequent Nursing Assessments in Patient Care Settings” Effective date: 2/18/22, stated, “...1. Purpose Statement: ...Activities that comprise an assessment are determined by each discipline’s scope of practice. (Refer to department specific Policies/Procedures or Bylaws). ...3. Procedure: Performed By (title/area): Nursing/Emergency Department...Required Action Steps: Initial Assessment... .” On January 17 and 18, 2024, P2’s medical record was reviewed and revealed the following: P2 was admitted to the facility on 12/17/23 at 9:04 AM, with a diagnosis of pneumonia. On 12/18/23 at 8:00 PM, a Registered Nurse (RN) documented a skin assessment which included a wound (blister) on the anterior, proximal right arm. The Wound Care RN consult on 12/21/23 at 4:00 PM, documented two additional wounds: a closed blister on the interior dorsal left foot and a blister on the posterior distal left leg. The Wound Care RN documented “multiple closed blisters with serous fluid inside on the left lower extremity and foot.” P2 was discharged on 12/27/23 at 5:55 PM. P2 presented back to the Emergency Department (ED) on 12/27/23. On 12/27/23 at 7:37 PM, the ED Provider Notes HPI (History of Present Illness) stated, “...The patient was admitted here for pneumonia and COVID, and was discharged earlier this morning. Mom states since being home, she noticed the left ankle wound, along with redness, blistering, and swelling to the area, with discoloration of the left 2nd toe. She states she is not sure of what caused his/her symptoms, and she was not told of any injuries while he/she was admitted.” P2 was re-admitted on 12/28/23 at 3:50 PM for intravenous antibiotic therapy for cellulitis of the left foot, and was discharged on 1/13/24. P2’s medical record lacked an ED nursing skin assessment. The first documented skin assessment was completed on admission to the Telemetry unit. The following wounds were documented on the nursing flow sheet “Wound Assessment/Care” section: 12/28/23 at 4:21 PM - Foot Anterior; Left 12/28/23 at 4:22 PM - Foot Anterior; Left (2nd Toe) 12/28/23 at 4:23 PM - Distal Tibial; Left and Achilles; Left 12/28/23 at 4:24 PM - Foot Anterior; Right 12/28/23 at 4:26 PM - Dorsal Hand; Left and Dorsal Medial Hand; Left 12/28/23 at 4:32 PM - Pretibial Distal; Left The wound care consult dated 12/29/23 indicated the following: 12/29/23 at 1:22 PM - Leg Left; Posterior; Lower - Partial Thickness 12/29/23 at 1:24 PM - Foot Anterior; Left - Full Thickness 12/29/23 at 1:32 PM - Dorsal Hand; Left and Dorsal Medial Hand; Left - Full Thickness 12/29/23 at 1:35 PM - Foot Anterior; Left (2nd Toe) - Full Thickness 12/29/23 at 2:00 PM - Foot Anterior; Right - Scabbed area 12/29/23 at 2:00 PM - Pretibial Distal; Left - Healed area On 1/18/24 at 12:35 PM, a tour of the ED was conducted with S5 (Assistant Vice President of Nursing) and S39 (ED Director). At 12:36 PM, an interview was conducted with S37 (ED RN) who indicated that every patient that presents to the ED will have a skin assessment performed and would be documented in EPIC (electronic health record software) using the body avatar to document wounds. S37 indicated the priority is to stabilize the patient when they present to the ED, but every patient’s skin is assessed. S37 indicated if a patient is going to be admitted, a skin assessment would “definitely” be done. At 12:40 PM, an interview was conducted with S38 (ED RN) who indicated every patient’s skin is assessed, even if the chief complaint is not skin related. S38 indicated each patient’s skin assessment is documented in EPIC under the tab “wound assessment.” 48414”