Saint Clare’s Hospital/ Denville Campus

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 50124 Based on three of four medical records reviewed for patients (P)14, P15, and P17, staff interview, and review of facility documents, it was determined the facility failed to ensure that 1.) Controlled Dangerous Substances (CDS) discrepancies are monitored and forwarded for further investigation in accordance with facility policy; and 2.) the pharmacy staff follow up on identified Controlled Dangerous Substances (CDS) discrepancies sent to a nurse manager or physician for investigation, to confirm resolution as required by facility policy. Findings include: 1) The facility’s policy titled “Controlled and Dangerous Substances Distribution and Accountability,” revised 4/17/25, stated, “... Procedure: ... 3. Inventory accountability for CDS Drugs in Patient Care Areas a. Controlled substances in automated dispensing cabinets (ADC) must be inventoried at a minimum of every 24 hours ... ii. Daily discrepancy reports will be monitored by Pharmacy and forwarded to the nursing unit leadership if there are any outstanding discrepancies ...” On 11/7/25 at 11:10 AM, Staff (S) 7 stated that the Automated Dispensing Cabinet’s (ADC) reports, for overrides, wastes, and returns, are monitored daily by a pharmacist. S7 stated that the facility also utilizes a drug diversion system that is linked to the ADC and is reviewed daily by a pharmacy specialist or the director of pharmacy. On 11/7/25 at 11:50 AM, S6 stated that all Controlled Dangerous Substances (CDS) discrepancies are followed by pharmacy. S6 stated that it takes approximately three days, from the date of occurrence of the potential CDS discrepancy, for a report to be generated by the facility’s drug diversion system. On 11/7/25 at 11:58 AM, S8 stated it takes three business days, from the date of occurrence, for the facility to receive a CDS discrepancy report generated by the facility’s drug diversion system. S8 also stated that once the potential CDS discrepancy report is generated, it is reviewed by a pharmacist and closed out within one week. A request was made for the policies and procedures regarding the use of the drug diversion software. On 11/7/25 at 2:09 PM, S8 stated that the facility did not develop policies and procedures specific to the drug diversion system utilized by the facility, and that the facility utilized the policy referenced above which indicates that discrepancy reports should be monitored daily. The CDS discrepancy report for “pending” incidents was requested for the date range 5/14/25 to 11/4/25. This report was reviewed with S8. The report included 36 CDS discrepancies documented as “pending” which S8 explained as unresolved incidents of CDS discrepancies. On 11/10/25 at 12:15 PM, S8 explained that the “incident action date” column on the report was the date the CDS incident occurred and the “incident status time stamp,” was the date and time the pharmacist initiated the investigation of the CDS discrepancy. Comparison of the “incident action date” and the “incident status time stamp” found on the CDS discrepancy report for the 36 “pending” incidents, dated 5/14/25 to 11/4/25, identified that the pending CDS discrepancy investigations were initiated by pharmacy staff 3 to 30 days after the occurrence of the incident. The following was identified: Three incidents were initiated three days after the occurrence, four were initiated four days after the occurrence, one was initiated five days after the occurrence, seven were initiated six days after the occurrence, one was initiated seven days after the occurrence, one was initiated 11 days after the occurrence, two were initiated 12 day after the occurrence, three were initiated 13 days after the occurrence, one was initiated 14 days after the occurrence, two were initiated 15 days after the occurrence, two were initiated 16 days after the occurrence, one was initiated 18 days after the occurrence, one was initiated 19 days after the occurrence, one was initiated 20 days after the occurrence, one was initiated 21 days after the occurrence, one was initiated 22 days after the occurrence, one was initiated 23 days after the occurrence, one was initiated 26 days after the occurrence, one was initiated 29 days after the occurrence, and one was initiated 30 days after the occurrence. On 11/10/25 at 12:34 PM, these findings were confirmed by S8. S8 stated that CDS discrepancies considered “higher issues” are made a priority and resolved first. 2) The facility’s policy titled, “Controlled and Dangerous Substances Distribution and Accountability,” revised 4/17/25, stated “... Procedure: ... 12. Discrepancies ...b. At the end of each shift, the off-going charge nurse and the on-coming charge nurse are responsible to review and resolve any open discrepancies ... found in the ADC ...d. If the inventory discrepancy or unreconciled waste event discrepancy cannot be reconciled, Pharmacy and Administration will be contacted to investigate the discrepancy. Unresolved discrepancy will be documented in the Incident Report (Verge) system. e. Staff who create discrepancies, do not reconcile wasted CDS or do not follow CDS handling policies will be re-educated on the correct process ...g. The manager of the patient care area, or his/her designee, is responsible for monitoring discrepancies in the area and for seeing that their open issues are investigated and resolved. h. The Pharmacy screens information on discrepancy resolutions to assess whether or not they appear to be valid. Unresolved discrepancies or resolutions that do not provide adequate information are questioned and may require additional follow up. 13. Unresolved Discrepancies a. Unresolved discrepancies (losses) of controlled substances are to be handled and reported in accordance with applicable State and Federal regulations ...” On 11/7/25 at 1:35 PM, upon interview, S6, S7, and S8, stated that Controlled Dangerous Substances (CDS) discrepancies are reviewed by a pharmacist and if they cannot be resolved, they are sent to the Nurse Manager, or designee, for resolution. If the discrepancy still cannot be resolved, an incident report should be filed by the Nurse Manager or designee. S6 and S8 stated that a pharmacist does not always follow up to confirm that the CDS discrepancy was resolved. This is not in accordance with facility policy referenced above. The “pending” CDS discrepancy incident report and the correlating notes, dated 5/14/25 to 11/4/25, for three of four patients (P) 14, P15, and P17, were reviewed. The following was identified: P14 was listed, on the “pending” CDS discrepancy incident report for a CDS discrepancy that occurred on 5/14/25. The action taken by a pharmacist was documented on the report as occurring on 5/21/25. This was 7 days after the occurrence of the incident. Review of an email sent to the nurse manager by a pharmacist, dated 5/21/25, stated “ ... Please see attached “Unreconciled Controlled Substance Form” for details of an unreconciled controlled substance.” The attached Omnicell report, noted that two (2) tablets of Oxycodone Immediate-Release (IR) 5 mg were removed from the Omnicell on 5/14/25 at 8:21 PM. The Omnicell report noted on 5/14/25 at 8:33 PM, under comment “patient refused saying she is allergic.” The waste was documented on the Omnicell report as “0 mg.” The email sent by a pharmacist, on 5/21/25, further stated, “REPLY ALL to this email with the following information: 1. Within 3 calendar days: Determination of what occurred and if any CDS remain unaccounted for. Failure to do so will result in reporting the dose as missing to Prime corporate and legal entities ...2. Within 5 business days*: Return completed Unreconciled Controlled Substances Form (attached) containing reconciliation and re-education documentation ...*If not scheduled to work in the next 5 business days, REPLY ALL with the next expected date of work and date of reconciliation/education is planned to take place.” The response noted on the “pending” CDS discrepancy incident report, for P14, by a pharmacist stated, “No response, Response from [nurse manager] on 6/24 that he/she is waiting on a per diem.” The attached “Unreconciled Controlled Substance Form,” that was sent to the Nurse Manager on 5/21/25 and was to be filled out within 5 business days, was not completed and returned to the pharmacist. There was no additional follow up or resolution documented, by a pharmacist, for this “pending” CDS discrepancy incident. On 11/10/25 at 12:36 PM, S8 was not sure if an incident report was filed as required by facility policy. An incident report was requested but not provided for the unresolved “pending” CDS discrepancy incident. S8 stated he/she would look into it and sent notifications from his/her phone. On 11/10/25 at 12:37 PM, S6 informed S8, the Nurse Manager of the unit, that the incident that occurred was no longer with the facility as of 8/1/25. On 11/10/25 at 12:38 PM, the above finding was confirmed by S8. P15 was listed on the “pending” CDS discrepancy incident report for a CDS discrepancy that occurred on 10/9/25. The action taken by a pharmacist was documented on the report as 10/13/25. This was 4 days after the occurrence of the incident. On 11/10/25 at 12:51 PM, S8 stated that pharmacy reviewed this discrepancy and identified that one (1) tablet of Oxycodone Immediate-Release (IR) [CDS used for pain management] 5 milligrams (mg) tablet was removed under the wrong patient’s name, however was administered to the right patient. S6 stated that an email was sent by a pharmacist to the nurse manager to reeducate the nurse that made the error. The response noted on the “pending” CDS discrepancy incident report, for P15, by a pharmacist stated, “updated response received on 10/16 from ...” S8 stated that this meant that the nurse manager of the unit would reeducate the staff involved in the CDS discrepancy incident. An “Unreconciled Controlled Substance Form” that notes “Date Re-education completed” and “Corrected action taken; documentation in employee file,” was not sent by a pharmacist to the nurse manager for this incident. There was no other evidence of staff education documentation provided for this incident. On 11/10/25 at 12:53 PM, S8 stated that the “Unreconciled Controlled Substance Form” is not utilized for all CDS discrepancies. On 11/10/25 at 12:56 PM, this finding was confirmed by S6 and S8. S6 stated that there was no evidence of staff re-education. S8 stated that there was no follow up by a pharmacist to confirm that the staff involved in the CDS discrepancy incident was educated regarding the error. P17 was listed, on the “pending” CDS discrepancy incident report for a CDS discrepancy that occurred on 9/13/25. The action taken by a pharmacist was documented on the report as 10/9/25. This was 26 days after the occurrence. On 11/10/25 at 1:06 PM, S8 stated that the CDS discrepancy was for lorazepam [a CDS used for anxiety] 0.25 mg that was removed from the Omnicell and was documented as “0 mg” being wasted. An email sent by a pharmacist to the nurse manager, dated 10/9/25, stated “... Please see the attached Unreconciled Controlled Substances Form for details of an unreconciled controlled substance. The waste amount for this dose was documented as “0” mg so no witness was required by Omnicell ... “REPLY ALL to this email with the following information: 1. Within 3 calendar days: Determination of what occurred and if any CDS remain unaccounted for. Failure to do so will result in reporting the dose as missing to Prime corporate and legal entities ...2. Within 5 business days*: Return completed Unreconciled Controlled Substances Form (attached) containing reconciliation and re-education documentation ...*If not scheduled to work in the next 5 business days, REPLY ALL with the next expected date of work and date of reconciliation/education is planned to take place.” The response noted on the “pending” CDS discrepancy incident report for P17 by a pharmacist was, “Still pending.” The attached “Unreconciled Controlled Substance Form,” that was sent to the Nurse Manager on 5/21/25, to be filled out within 5 business days, was not completed and returned to the pharmacist. There was no additional follow up or resolution documented, by a pharmacist, for this “pending” CDS discrepancy incident. On 11/10/25 at 1:15 PM, S8 the finding was confirmed by S8. S8 stated that there is “Not enough manpower to invest” in CDS discrepancies that are considered “non-issues.””

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 47131 Based on the review of one of one medical record (MR1), staff interviews, and review of facility documents, it was determined the facility failed to ensure that a Risk Incident Report was generated after an adverse patient event in the Emergency Department. Findings include: Facility document titled, “Patient Safety Plan” (Reviewed/Revised 1/2025) stated, “ ...IV. Definition: ... Patient Safety Event: Any identified defect, error, medical accident, near miss, sentinel event, medication error, significant procedural variance, or other threat to safety that could result in patient injury ...VI. Reporting Medical/Healthcare Errors: A. Reporting Policy: ... To promote openness, the organization shall ensure that all reported mistakes be handled without threat of punitive action. ... All incidents, especially clinical errors, must be reported immediately. B. Unusual Occurrence / Risk Incident Reporting: ... When a medical / healthcare error is identified, the patient care provider will immediately: ... Complete a Risk Incident Report in addition to reporting the error to the immediate Director of Manager as appropriate.” A review of the medical record for Patient (P)1, revealed that Patient (P)1 arrived at the ED on 04/04/25 at 7:40 AM. The patient’s arrival complaint was documented as “sob (short of breath) asthma attack.” A review of the ED Timeline revealed the following: On 04/04/25 at 14:10 (2:10 PM) Orders Placed: Respiratory Care-Intubation In the ED Course Note dated 04/04/25 at 1708 (5:08 PM) written by S17 (ED Physician) it stated, “I was called to the room by staff due to a difficult intubation. Entering the room the patient had blood from the left side of [his/her] mouth and [he/she] was not paralyzed. [He/She] was being ventilated with BVM (Bag Valve Mask). [BVM is a manual resuscitator used to provide rescue ventilation to patients who are not breathing or are having difficulty breathing.] ... oral pharynx was visualized with glide scope. Focal [sic] cords were not visible due to blood in oropharynx and apparent trauma from previous intubation attempts ...There were no additional attempts to pass endotracheal tube through non-visualized vocal cords. [He/She] was continued to be ventilated with the BVM with supplemental oxygen. ... non-rebreather mask was applied maintaining oxygen saturation. Anesthesia was called to re-evaluate nonemergent intubation. Shortly after the incident pulmonologist [S31] was available for consultation. [He/She] agreed that intubation was not emergent, and [he/she] attempted to optimize with medication. [The patient] was transferred to the ICU (intensive care unit). Incident discussed with ICU attendings.” In a Procedure Note written on 04/04/25 at 5:30 PM by S21 (Physician Assistant, Critical Care) it stated, “Intubation: Date/Time: 04/04/25 2:03 PM; Performed by: [S21]; ... The procedure was performed in an emergent situation. Verbal consent obtained. ... Attempted intubation was performed due to worsening respiratory failure secondary to asthma exacerbation. Patient was unable to be intubated after 1 (one) attempt. Following the attempt, patient was stabilized and subsequently intubated by anesthesiology in the ICU.” On 04/17/25 at 10:00 AM, interviews were conducted in the presence of S2, S6 (Chief Medical Officer), S19 (MD [Medical Doctor], ICU [Intensive Care Unit] Director), S20 (Assistant Program Director), and S22 (Manager of Quality/Performance Improvement). During the interview, S19 stated, “On 4/4/25, the midlevel provider (Physician Assistant) attempted to intubate [P1] twice and ‘failed’ both times. Following the incident, the patient had an X-Ray completed. The patient was stabilized in the emergency department (ED), and successfully intubated by S23 (Anesthesiologist) in the ICU.” S19 further stated that the incident was verbally reported to him/her and is currently under peer review. During the interview, S2 confirmed that the failed intubation on 04/04/25 was classified as a “Patient Safety Event,” and an incident report should have been completed on 04/04/25, in accordance with the facility’s “Patient Safety Plan.” On 04/17/25 at 10:14 AM, S2 confirmed that there was no incident report generated for this event.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 38289 Based on staff interview and review of facility documents, it was determined the facility failed to ensure the central log, of patients presenting in the emergency department (ED), was maintained. Findings include: On 10/23/24 at 10:27 AM, the ED central logs for the dates of 9/21/24, 9/22/24, 9/23/24, 9/24/24, and 9/25/24, were requested for review. Upon review, seven patients did not have an ED disposition. Facility policy, titled, “EMTALA - Compliance with the Emergency Medical Treatment and Active Labor Act,” revised 9/18/24, stated, “... Guidelines: ... 2. Central Log: Each department of the hospital that provides medical screening examination shall maintain a central log recording the following: ...m. Disposition of patient including refusal of treatments, transfers, admitted, stabilized and transferred or discharged ...” On 10/24/24 at 10:27 AM, Staff (S) 1 confirmed the dispositions were missing and a review of the facility policy was shared with S1 regarding the items required per policy, on the ED central log. S1 stated that the ED Director would be the person to monitor the central log for completeness. S1 further stated the facility was in a transition period with regards to an ED director. The prior ED director left his/her position in July of 2024 and the new ED director, S7, started at the facility in September of 2024.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 38289 Based on review of medical records (MR), review of facility documents, and interview with staff, it was determined the facility failed to implement it’s policy and procedure for the care of a suicidal patient, resulting in patient elopement in one of one medical record reviewed of a suicidal patient. This failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to patients. On October 24, 2024, at 2:55 PM, an IJ was identified for the facility’s failure to follow it’s policy and procedure on the care of a patient identified at high risk for suicide (A-0144). On October 24, 2024, at 3:23 PM, the IJ template was presented to administration and a removal plan was requested. On October 24, 2024, at 1:59 PM, an acceptable removal plan was received. The facility implemented the following to address the IJ: Re-education to all emergency department (ED) staff on the policy, “Suicide- Risk Screen/Assessment Self Harm/Suicide,” for the care of a patient in the ED that is identified as at risk for suicide. The IJ was removed on October 25, 2024, at 2:25 PM, after the State Survey Agency verified full implementation of the removal plan. Condition Level non-compliance remains (A0144). Cross Reference: 482.13(c)(2) Patient Rights: Care in Safe Setting”

“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: 38289 Based on medical record review, staff interview, and review of facility documents, it was determined the facility failed to implement it’s policy and procedure for the care of a suicidal patient, resulting in patient elopement in one of one medical record reviewed of a suicidal patient. Findings include: On 10/24/24 at 11:00 AM, the medical record of Patient (P) 20 was reviewed. P20 presented to the facility emergency department (ED) on 7/4/24 at 8:13 PM with complaints of alcohol withdrawal and wanting detoxification. The patient’s chief complaint was updated at 8:35 PM by Staff (S) 14, Triage Nurse, to include “Suicidal.” P20 was assessed to be a high risk per the Columbia Scale [a tool used to determine a patient’s risk of suicide]. The medical record lacked evidence of the following: interventions, in place, to ensure a safe environment for the patient; a patient observer to monitor the patient; and documentation of patient monitoring at least every 15 minutes. At 11:56 PM, S22, ED Nurse, documented, “Pt [patient] eloped from ER [emergency room]. This RN [registered nurse] call patient phone, went to voicemail. Three phone calls made to pt’s [family member], emergency contact. No answer. Charge nurse and MD [medical doctor] aware.” At 12:02 AM, S23, ED nurse, documented, “[Town] PD [police department] made aware of patient’s elopement.” On 10/24/24 at 11:33 AM, the above findings were shared with S1, Admin Director of Nursing. S1 confirmed the medical record was lacking documentation of interventions, a monitoring flow sheet, and notes from a patient observer. At 1:47 PM, S1 and S5, Manager of Quality and Performance Improvement, stated that P20’s medical record should have contained all of this information. S1 and S5 were unable to provide evidence that a patient observer had been assigned to this patient on 7/4/24. Facility policy, titled, “Suicide- Rick Screen/Assessment Self Harm/Suicide,” revised 8/1/2024, stated, “... Results of the suicide risk screen and assessment will address immediate safety needs and incorporate interventions focused on the safety of the patient ... High Risk severity: Patient with suicidal ideation with intent or intent with a plan in the past month or suicidal behavior within the past 3 months ... The patient is maintained on an appropriate level of observation for the identified risk level ...1:1 Observation - High Risk ... Implement suicide prevention strategies: a. The Patient and Room Environmental Safety Checklist ... will be utilized on every patient identified as low, moderate, or high risk for suicide on admission and every shift ... For patients with moderate or high risk the following measures should be implemented: -Have ALL personal items removed and searched by designated staff -Have attire restricted to a hospital gown -Be assigned a room visible to the nurses’ station ...””

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 38289 Based on staff interview, medical record review, and review of facility documents, it was determined the facility failed to ensure patients seeking emergency treatment were triaged by a nurse, according to facility policy, in four of 20 medical records reviewed (Patients (P) 1, 4, 6, 13). Findings include: On 10/23/24, 10/24/24 and 10/25/24, medical record review was conducted in the presence of Staff (S)1, Administrative Director of Nursing. The following was noted: P1 presented to the facility’s Emergency (ED) via ambulance on 9/24/24 at 1:20 PM, with hand and ankle pain, after being in a motor vehicle accident. P1 was placed in the ED waiting room. At 2:10 PM a note in the medical record stated, “Advised by registration that the patient was outside yelling as well as [patient’s spouse]. Security to go to the waiting room. Patient shouted to security and ED tech that [patient] was having shortness of breath. Speaking in full sentences, vital signa [sic] obtained.” A nursing note at 2:53 PM stated, “Patient was not found in waiting room.” The medical record of P1 lacked evidence that the patient’s vital signs contained an assessment of pain, and lacked evidence of an ED nursing triage or assessment, prior to the patient leaving the facility one hour and 33 minutes after arrival. P6 presented to the facility ED on 9/22/24 at 3:40 PM with complaints of weakness and low blood pressure. A nurse’s note at 5:38 PM stated, “ED registration staff reports pt [patient] has voluntarily departed the ED. Pt. to be dismissed.” The medical record of P6 lacked evidence of an ED nursing triage or an assessment prior to the patient leaving the facility one hour and 58 minutes after arrival. A tour of the ED Waiting room was conducted on 10/23/24 at 12:00 PM, in the presence of S1, Admin Director of Nursing. At the time of the tour, there was no staff member in the triage room. Upon asking who the triage nurse was, S1 stated the charge nurse could take on the triage nurse’s responsibilities if there was no one staff member designated as a triage nurse. An interview with S6 at 12:20 PM, ED Charge Nurse, confirmed the charge nurse’s responsibilities when there is no triage nurse. S6 stated he/she would remain in the main ED and would monitor a board that tracks patients once they come to the facility and have seen registration. S6 stated he/she would then assess and triage the patient. S6 stated that registration (present in the ED waiting room), would call S6 if the patient seems to be a higher level of acuity or if a patient has been waiting in the waiting room and needs additional assistance and need to be seen quicker. 48965 A review of P4’s medical record revealed P4 arrived to the ED on 9/22/24 at 4:08 PM, seeking treatment for vomiting and an esophagus issue. P4 was fully registered at 4:30 PM. There was no evidence in P4’s medical record of triage or a medical screening exam (MSE). P4 left without treatment. The medical record had a discharge time of 7:26 PM. P13 had three ED visits during the time period of 10/21/24 and 10/22/24. Two of the three visit records for P13 revealed P13 left the hospital without treatment. P13 presented to the ED on 10/21/24 at 10:14 PM for alcohol withdrawal. P13 was fully registered at 10:58 PM. The medical record, on the 10/21/24 visit, lacked evidence of a triage assessment or any other stabilizing interventions of treatment before the patient left without being seen on 10/22/24 at 12:54 AM. P13 returned to the ED on 10/22/24 at 10:39 AM for alcohol detox. P13 was fully registered at 10:45 AM. At 11:57 AM, P13’s medical record indicated the triage nurse called for the patient in the waiting room but could not find him/her. The medical record on this visit lacked evidence of a triage assessment or any other stabilizing interventions of treatment before the patient left without being seen on 10/22/24 at 11:57 AM. On 10/22/24 at 1:35 PM, P13 returned for alcohol detoxification and a Librium prescription. P13 was fully registered at 1:44 PM. P13 waited 1 hour and 40 minutes to be triaged at 3:14 PM. On 10/24/24 at 11:38 AM, an interview was conducted with S15, Clinical Coordinator. S15 explained that the time goal of triage is to get to patients as soon as possible. According to S15, if there is a delay, it is due to multiple triages in the main ED or multiple ambulance arrivals. S15 reported that patients in the waiting room are reassessed every two hours for any notable changes. S15 further explained that the reassessment was eyes only unless a notable change was found. If there is a notable change, the triage nurse repeats vital signs and finds the patient a bed. S15 explained that the triage nurse is designated to monitor the patients in the waiting room. According to S15, if the triage RN observed a patient attempting to leave without being seen, he/she should have a conversation with the patient to encourage them to stay and be treated. Facility policy titled, “Assessment: Nursing Protocol” last reviewed on 8/29/23 stated, “Policy Statement: It is the policy of [Facility Name] to assess all patient parameters rapidly but thoroughly to ensure priority needs and to prevent decompensation or death. The process emphasizes the patient’s chief complaint and their subjective symptoms. The initial assessment is to be documented by the RN [Registered Nurse] on the nursing assessment form in the electronic medical record [EMR] within 1 hour of patient arrival ...” Facility policy titled, “Triage in the Emergency Department (ED)” last reviewed on 10/19/22 stated, “Policy: 1. Triage involves a rapid patient evaluation to determine the acuity level for each patient arriving in the Emergency Department ...” 51038”

“USE OF RESTRAINT OR SECLUSION CFR(s): 482.13(e) Patient Rights: Restraint or Seclusion. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. This Standard is not met as evidenced by: 48060 Based on staff interviews, medical record review, and review of facility documents it was determined that the facility failed to ensure freedom of restraints by utilizing a medical device to restrict patient movement, without appropriate documentation or orders by a physician, in a way in which the medical device was not designed for use. Findings include: Facility policy, “Restraints: Non-Violent Behavior” last reviewed 02/20/2024, states, “Definitions[:] ... Restraint - Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; ...Policy[:] ... 2. All patients have the right to be free from restraint, of any form ...11. The use of restraint is: 11.1 In accordance with a written modification to the patient’s plan of care ... 12. The use of restraint is in accordance with the order of a physician or other LIP (Licensed Independent Practitioner) who is responsible for the care of the patient. ...Time Limits for Orders -Non-Violent Restraints or Non-Self Destructive[:] 1. If restraints are applied by a RN, the attending physician is consulted as soon as possible and no longer than 1 hour of initiation and an order is obtained at that time. 2. A written order based on an examination of the patient by the physician is entered into the patient’s medical record within 24 hours of initiation of restraint. ... Documentation[:] 1. Use Electronic Medical Record Restraint Flow Sheet, restraint order forms and narrative notes to document all pertinent information in the medical record including but not limited to: ... 1.2 Alternatives attempted 1.3 Circumstances that led to use of restraint/seclusion 1.4 Physician/family notifications 1.5 Monitoring activities 1.6 Plan of Care/Treatment Plan - include criteria for discontinuation when applicable ...” On 3/21/2024 at 10:40 AM, Staff (S)2, (Director of Performance and Quality) stated that on the night of 2/10/24-2/11/24, the night-shift nurse [S12] “placed a belt on Patient (P)1 as a protective device as [P1] kept trying to get out of bed and was getting out of bed all night needing to be reoriented as [P1] was a high fall risk ...” When asked for the Instructions for Use (IFU) for this device, S2 stated, “we don’t have it, we threw everything away since this incident.” Instead, a print out from the manufacturer’s website was provided, which lists this device under “Restraint Alternatives” and reads, “Self-release Belt [:] ...Designed to be used in either wheelchair or Geri-chair to keep the patient from sliding forward. ...” Evidence that this device could be used on a bed was requested and was unable to be provided by the facility. Facility policy showing that this device could be used in the bed for patients at high risk of falls was requested and policies provided by the facility lacked evidence that this device was approved for use in a bed, for this purpose, and without a physician’s order. During an interview with S13, (RN PCU [Progressive Care Unit]) on 3/22/2024 at 1:33 PM, when asked if he/she ever saw another patient with this device applied to on a bed what type of documentation might you see in the chart, S13 stated, “if they were used [in that fashion] I would think it would be documented as a restraint and contain all elements of restraint documentation, I’m not really sure though because I really haven’t ever seen them used.” Review of Medical Record (MR)1 lacked documentation of this device being applied to the patient (P1). MR1 also lacked documentation of P1’s patient’s behavior prior to application; physician notification, assessment, and order within one (1) hour; written modification to the patient’s plan of care; and, that the patient was educated on device application and how to remove, if necessary, in the same manner in which it was applied by the staff member. These findings were confirmed with S2 (Director of Performance and Quality), S6 (Registered Nurse [RN] Clinical Coordinator), and S11 (Director of Critical Care and PCU) on 3/22/2024 at 10:36 AM and again during the exit conference with S2, S3 (Chief Nursing Officer [CNO]), S4 (Administrative Director of Nursing [ADON]), and S11 on 3/22/2024 at 3:10 PM.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(1)(i)(A) Definitions. (i) A restraint is- (A) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or This Standard is not met as evidenced by: 48060 Based on staff interviews, medical record review, and review of facility documents, it was determined that the facility failed to utilize a medical device according to the Instructions for Use (IFU) and in a way that restricted Patient #1 (P1)’s ability to move freely. Findings include: Facility policy, “Restraints: Non-Violent Behavior” last reviewed 02/20/2024, states, “Definitions[:] ... Restraint - Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; ...Policy[:] ... 2. All patients have the right to be free from restraint, of any form ...” On 3/21/2024 at 10:40 AM, Staff (S)2, (Director of Performance and Quality) stated that on the night of 2/10/24-2/11/24, the night-shift nurse [S12] “placed a belt on Patient (P)1 as a protective device as [P1] kept trying to get out of bed and was getting out of bed all night needing to be reoriented as [P1] was a high fall risk ...” Review of P1’s medical record (MR1) lacked documentation that this device was applied to the patient, the reason for this device being applied, and that the patient was educated on device application and how to remove, if necessary, in the same manner in which it was applied by the staff member. When asked for the Instructions for Use (IFU) for this device, S2 stated, “we don’t have it, we threw everything away since this incident.” Instead, a print-out from the manufacturer’s website was provided, which lists this device under “Restraint Alternatives” and reads, “Self-release Belt [:] ...Designed to be used in either wheelchair or Geri-chair to keep the patient from sliding forward. ...” Evidence that this device could be used on a bed was requested and was unable to be provided by the facility. Facility policy showing that this device could be used in the bed for patients at high risk of falls was requested and policies provided by the facility lacked evidence that this device was approved for use in a bed, for this purpose, and without a physician’s order. During an interview with S13, (RN PCU [Progressive Care Unit]) on 3/22/2024 at 1:33 PM, when asked if he/she ever saw another patient with this device applied to on a bed what type of documentation might you see in the chart, S13 stated, “if they were used [in that fashion] I would think it would be documented as a restraint and contain all elements of restraint documentation, I’m not really sure though because I really haven’t ever seen them used.” These findings were confirmed with S2 (Director of Performance and Quality), S6 (Registered Nurse [RN] Clinical Coordinator), and S11(Director of Critical Care and PCU) on 3/22/2024 at 10:36 AM and again during the exit conference with S2, S3(Chief Nursing Officer [CNO]), S4 (Administrative Director of Nursing [ADON]), and S11 on 3/22/2024 at 3:10 PM.”

“SCOPE OF RADIOLOGIC SERVICES CFR(s): 482.26(a) [§482.26 Condition of Participation: Radiologic Services The hospital must maintain, or have available, diagnostic radiologic services...] §482.26(a) Standard: Radiologic Services The hospital must maintain, or have available, radiologic services according to the needs of the patients. This Standard is not met as evidenced by: 47131 Based on staff interviews and review of facility document review, it was determined the facility failed to ensure CT (computed tomography) services are available for patients with signs and symptoms of stroke, in accordance with facility policy. Findings include: Reference #1: Facility policy titled “Stroke/TIA (Transient Ischemic Attack) Management Protocol” (Revised 03/27/23) states, “ ... Policy: ... 2. Managing a patient presenting to the Emergency Room with signs and symptoms of Stroke must follow the established patient care protocol. ... Procedure: ... 5 ... e. CT of the Brain shall be performed within 25 minutes following patient arrival. ... ED Stroke Patient Arrival Flowchart: Patient arrives to ED (Emergency Department) with signs and symptoms of Stroke/TIA ... Patient is triaged within 3 minutes of arrival ... Patient is seen by ED Physician within 5 minutes of arrival ... ED Physician places Code Stroke Order set within 10 minutes of arrival ... Patient is transported to Radiology for CT and/or CTA (Computed Tomographic Angiography) with ED RN (Registered Nurse) and monitor ... CT and/or CTA results are communicated to ED Physician within 25 minutes of arrival ... .” Reference #2: NJ (New Jersey) Administrative Code 8:43G states, “ ... 7A.2 Definitions ... ‘Primary stroke center’ means a licensed general hospital designated to evaluate, stabilize, and provide emergency care to patients with acute stroke symptoms, and to admit such patients for inpatient services as appropriate to the needs of the patient, but which has limited capacity to provide inpatient care to patients with a complex stroke. ... 7A.3 ... (a) To be designated as a primary stroke center, a hospital shall, at a minimum provide ... 3. Neuro-imaging services capability that is available 24 hours a day, seven days a week, such that imaging shall be performed within 25 minutes following order entry. ... i. Neuro-imaging services shall, at a minimum, include computerized tomography (CT) scanning ... .” A CT scan is an imaging test that takes detailed images of the inside of the body, including bones, muscles, fat, organs, and blood vessels. During the entrance conference conducted on 12/27/23 at 10:15 AM, in the presence of Staff (S) 1, (Director of Quality), S2 (ED Director of Nursing), S3 (Director of Critical Care), S4 (Director of Emergency Preparedness), and S5 (Chief Operating Officer), S1 confirmed that CT services had been on divert to another campus “several times this month,” due to staffing issues. During an interview on 12/27/23 at 10:30 AM, S6 (Director of Radiology) stated, “The CT department is extremely short-staffed right now. We’ve offered premium pay, bonus pay for extra shifts, and have started using ‘travelers’ (agency staff), but still cannot get all the shifts covered on the schedule. We have a few CT techs (technicians) that can ‘float’ between campuses to try and cover the schedule, but we’ve still had to divert CT services numerous times due to lack of staffing. When the CT department is on divert, patients are transported to [name of another facility in hospital system] via EMS. We cannot operate the CT department without staff, and we do not have enough staff to cover the schedule, so we have to divert CT services.” Upon interview on 12/28/23 at 11:20 AM, S16 (Chief Nursing Officer) confirmed the facility is a primary stroke center. Review of the facility’s Divert Logs on 12/27/23, revealed that CT services at the facility were on divert one time in October 2023, 13 times in November 2023, and 18 times in December 2023, as follows: Review of the CT technician staff schedule for October, November, and December 2023, confirmed that no CT technicians were scheduled during the dates and times CT services were on divert. The CT staff roster indicated there are nine CT technicians in the department - eight CT technicians are facility employees and one is an agency CT technician. Upon interview with S15 (EMS Director) on 12/28/23 at 10:15 AM, S15 stated, “If CT is on divert, the hospital is also considered to be on ‘Stroke Divert.’ If dispatch receives a call (from the community) that the person is exhibiting symptoms of a stroke, the patient is taken directly to [name of facility in hospital system] or the nearest hospital. EMS would not bring the patient here when we’re on CT divert.” Upon interview with S16 on 12/28/23 at 11:20 AM, it was confirmed that CT services at the facility were diverted thirty-two (32) times from 10/29/23 until 12/27/23, and the facility failed to provide CT services despite being a primary stroke center.”