Robert Wood Johnson University Hospital - Somerset

“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 Based on medical record review, staff interview and review of facility documents, it was determined the facility failed to provide care in a safe setting by ensuring items identified on the Environmental Safety Risk Assessment, as a possible ligature opportunity, are not available to at risk patients Findings include: On 7/10/24 review of the Environmental Safety Risk Identification and Prioritization Worksheet for 5 West, dated 5/22/24, states, “ ...Category Furniture ...Description of Environmental Risk Hospital Bed presents looping ligature opportunity ...Risk Location ...Unsupervised Patient Areas ...Supervised Patient Areas ...Proposed Remediation Replaced bed with platform bed unless hospital bed is absolutely necessary ...”. On 7/9/24 at 10:47 AM a tour was conducted on the 5 West Behavioral Health unit, a 28-bed inpatient unit with involuntary and voluntary adult patients. S6 (Nursing Director of 5 West) indicated the patients on 5 West have a psychiatric primary diagnosis but can have medical comorbidities that can be managed as well. S6 stated that Patient (P) 1, in room 583, has a bed which is a “medical psychiatric bed [Sizewise Behavioral Health Bed].” S6 indicated P1 was transferred from a medical floor to 5 West with a Foley catheter. S6 stated the patient came with a regular medical bed to hang the Foley catheter bag to, and 1:1 observation was ordered. S6 indicated once the Foley catheter was discontinued, the “medical psychiatric bed [Sizewise Behavioral Health Bed]” was put back in the room and the 1:1 observation was discontinued. Upon observation of the Sizewise Behavioral Health Bed in room 583, it was identified that the side rails could pose as a possible ligature risk. At 11:15 AM, an interview was conducted with S8 (Registered Nurse [RN]), S8 indicated patients are put into room 583 based on a judgment call. On 7/9/24 at 12:47 PM, medical record review was conducted. P1 presented to the facility on 7/1/24 for a same day procedure for a Cystoscopy with a Transurethral Resection of the Prostate (TURP). P1 had a medical history of Benign Prostatic Hyperplasia, Schizoaffective Disorder, Schizophrenia, and Transsexualism. P1 was admitted on 7/1/24 to the oncology floor. The History and Physical from 7/4/24 at 7:00 AM states, “ ...Medical Clearance [P1] is [age] adult who is admitted to five west for schizoaffective disorder. Pt [patient] was evaluated by psych pre-TURP as [he/she] had made suicidal statements to staff. ...3. S/P (status post) TURP ...foley in place with collection bag ...”. P1 was transferred to room 583 on 5 West on 7/4/24 at 1:04 AM with an order for 1:1 observation and denied suicidal ideation. The Nurse Practitioner (NP) Progress Note from 7/5/24 at 12:44 PM, stated, “ ...patient reported [he/she] is feeling better after [he/she] was started back on [his/her] medication. [He/she] reported depression and anxiety 3/10. [He/she] denied SI/HI thought or plan. ... Safety Continue q15 min [every 15 minutes] patient monitoring. Discontinue 1:1 patient no longer with foley, switch medical bed to regular inpatient bed. ...Medical patient is medically stable ...” P1 was discharged on 7/9/24 at 12:29 PM. On 7/9/24 at 2:00 PM, S6 confirmed P1 was not moved to a room with a platform psychiatric bed because P1 was transgender, and room 583 is the only room with a single bed. S6 stated, “there is no order needed for the [Sizewise Behavioral Health Bed] or patient criteria for that bed.” On 7/10/24 at 12:48 PM, a tour was conducted on unit 5 West. At 12:57 PM, S20 (RN) confirmed room 583 has been used for patients without medical necessity. S20 stated, “patients with just a psychiatric diagnosis have been in that room, it all depends on the bed availability and census.” S20 indicated if a patient is medically cleared while in that room, they will most likely stay there because it does not make sense to move them. On 7/10/24 at 2:24 PM, the above findings were confirmed with S1 (Director of Quality and Regulatory) and S3 (Vice President and Chief Nursing Officer).”

“ANESTHESIA SERVICES CFR(s): 482.52 If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital. This Condition is not met as evidenced by: 43209 Based on staff interviews, review of (1 of 11) medical records, and review of facility policy and procedures, it was determined that the facility failed to ensure that: 1.) life functions are supported, pertinent events are documented, and consultations are obtained by anesthesia during surgical procedures (A-1004); and 2.) the anesthesia record is documented completely and accurately (A-1004). Cross Reference: 482.52(b)(2) - An intraoperative anethesia record”

“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: 49077 Based on staff interviews, review of medical record, and review of facility policy, it was determined that the facility failed to ensure: 1.) all patients with one-to-one observation orders remain within arm’s length as per facility policy; 2.) a patient was observed in accordance with a physician order, preventing ingestion of non-edible items. Findings include: 1) Director of 1 East (Staff [S]25) interviewed at 11:09 AM. When asked to describe any event he/she was aware of where Patient (P)12 was able to lock themselves in the bathroom, S25 indicated “back in January there was an incident where P12 was able to get into the bathroom and lock themself in the bathroom. The one-to-one (S38) attempted to open the door and did not call for help. Avasys [video monitoring system] had to notify security and the nursing supervisors about the event. All the bathrooms can be opened with a coin from the nurse’s station, the nursing staff opened the door and found the patient with their hospital gown around their neck. P12’s Columbia-Suicide Severity Rating Scale from 01/16/2024 at 8:00 AM states “ ... Suicidal ideation ... actual suicide attempt ... Clinical Status ... Highly impulsive behavior ...” Review of P12’s medical record reveals order for one-to-one observation. “Other orders” states “1:1 patient ... Frequency: Routine Continuous x 24 hours 01/15/2024 1430 [2:30 PM] - 24 hours .... Indication: danger to self of others ...” Policy titled “Patient Safety Watch in Non-Behavioral Health Setting” (effective date: 10-1-2021) states “ ...One to One Observation: Patients placed on this precaution are under constant observation and shall remain at a distance not exceed an arm’s length away from the staff member assigned to monitor this precaution, including when the patient is in the bathroom ...” On 01/16/2024 at 8:54 PM, Registered Nurse (S42) documented in a Nursing Note: “At 1745 [5:45 PM] ... patient was in bathroom unattended,trying to open door patient did not open [he/she] got locked inside, security called for help. 1:1 monitoring PCT [patient care technician] outside bathroom...opened bathroom door patient found tangled hospital dress around neck connected to the sidebar, skin assessed patient noted redness under neck and back neck [Physician (S40)] and father made Aware events ... [S40] communicated with patient, stayed in room for more than 1 hour [sic] ...” At 3:20 PM, - during an interview, Regulatory Coordinator (S2) stated “the patient was in the bathroom for two to five minutes and that the patient did not sustain any injuries from the incident.” Director of Nursing (S37) interviewed at 1:49 PM. When asked how Clinical Care Technician (CCT) (S38) has been re-educated after the incident, S37 provided S38’s transcript of education which consists of “Patient Safety Watch Education,” “2023 Patient Safety Watch Policy,” and “Somerset Panic Alarm Education”. Transcript reveals a completion date of 02/29/2024. S37 continued “S38 has not been assigned to work as a one-to-one since this event. When they do resume being a one-to-one, they will be monitored by S25.” Inspection of P12’s room conducted on 03/15/2024 at 3:04 PM in presence of Assistant Vice President of Nursing (S3) and S25. Room number 167 on the 1 East Unit. 1 East is described as a cardiac/telemetry unit by S25. P12 observed to be sitting in bed wearing paper scrubs with observer at bedside. Restroom door no longer has lock, however, there were multiple ligature risks present including: door hanger, doorknob, door hinge, handrails, light fixture, toilet, sink, and soap dispenser. S3 interviewed at 3:16 PM. S3 made aware of ligature risks that still exist in restroom. S3 responded “these risks would be mitigated by the presence of the one-to-one observer. When asked what has been done to prevent this from happening again, S3 indicated all staff has been provided verbal education on use of panic button and safety watch. Content of education titled “Patient Safety Watch - Suicidal Patient” provided. Education states “ ... Patient Attire ... must be in a hospital gown or paper scrubs ... 1:1 Observers ... must remain within arm’s length’s distance of the patient at all times including when the patient is toileting. The 1:1 observer must also maintain constant visualization of the patient at all times ...” S3 provided copy of work order submitted on 02/05/2024 to change all bathroom locks on 1 East Unit. Email from 03/15/2024 at 5:18 PM from Administrative Director of Operations (S41) to S3 states “The 1 East bathroom door lock project has been completed. We will be doing 4 East next. We are working with locksmith to complete this project ... time is to be determined based on contractor availability ...” Facility provided CCT Committee Meeting Minutes from 02/07/2024. Discussion included “ ...Mentioned the importance of always being within arm’s reach of 1:1 patient, even with toileting. When the patient tries to go in bathroom alone - call for help and press panic alarm if unable to open door ...” 2) S25 interviewed at 11:09 AM. When asked to describe any event she was aware of where P12 was able to swallow a potentially harmful item S25 stated “[P12] was able to swallow the plastic cap of a lancet.” S25 indicated that she was unaware why the lancet cap was on the floor of the room. At 12:00 PM, policies and P12’s medical record reviewed in presence of S3 and Clinical Informatics Liaison (S7) the following was revealed: Policy titled “Patient Safety Watch in Non-Behavioral Health Setting” (effective date: 10-1-2021) states “ ... Line of Sight: is defined as a staff member observing a maximum of 2 patients, all of whom are within the same physical space and/or room as the “observer” and within the same visual field of the “observer” at all times. ... Line of Sight For the patient who has an altered mental status ... whose behavior places the patient at risk for self-injury ... The Patient Watch Observation Form will be completed noting the behavior of the patient ... and report any changes in patient status or behavior to the RN immediately ...” “Other Orders” in P12’s medical record states, “Patient monitoring line of sight ... Frequency: 11/25/2023 1053 [10:53 AM] - 2 days ... order comments: Patient is Danger to Self or Others ...” Patient Watch Observation Form from 11/26/2023 signed by nurses and observers as having ensured a safe environment for all shifts. Nursing note entered on 11/26/2023 at 8:18 PM states “ ... (AM [morning] CCT) also reported that she saw the patient swallowed the cover of lancet earlier today. [Physician (S40)] notified... Nursing Supervisors ... came to the unit and were informed of the situation. Housekeeping was called to come and thoroughly clean pt’s [patient’s] room.” Nursing note entered on 11/28/2023 at 4:30 PM by S25 states “ ... patient obtained small plastic cap from floor and swallowed ...” On 11/26/2023 at 8:18 PM, Registered Nurse (S42) documented in a Nursing Note “ ... (AM [morning] CCT) also reported that she saw the patient swallowed the cover of lancet earlier today. S40 notified... Nursing Supervisors ... came to the unit and were informed of the situation. Housekeeping was called to come and thoroughly clean pt’s [patient’s] room.” Nursing note entered on 11/28/2023 at 4:30 PM by S25 states “ ... patient obtained small plastic cap from floor and swallowed ...””

“INTRAOPERATIVE ANESTHESIA RECORD CFR(s): 482.52(b)(2) [The policies must ensure that the following are provided for each patient:] An intraoperative anesthesia record. This Standard is not met as evidenced by: 43209 Based on staff interviews, review of (1 of 11) medical records, and review of facility policy and procedures, it was determined that the facility failed to ensure that: 1.) life functions are supported, pertinent events are documented, and consultations are obtained by anesthesia during surgical procedures; and 2.) the anesthesia record is documented completely and accurately. Findings include: 1. On 3/14/24 at 2:30 PM, a medical record review of Patient (P) 1 was conducted. This review revealed that on 3/5/24, P1 arrived in the facility at 6:37 AM for a scheduled cesarean section [the surgical delivery of a baby through a cut (incision) made in the mother’s abdomen and uterus]. P1 was documented in the Operating Room (OR) at 8:41 AM. The anesthesia record indicated at 8:41 AM, P1 was administered 0.2mg (milligrams) of morphine (an opioid pain medication) and 1.4 mL (milliliters) of bupivacaine (an anesthetic medication used to decrease sensation) intrathecally (injection into the spinal canal or the subarachnoid space, spinal anesthesia). At 8:51 AM, P1 was administered intravenous (IV) ephedrine (a central nervous system stimulant used to prevent low blood pressure during anesthesia by increasing heart rate and blood pressure). The surgical start time was 8:47 AM, delivery time was 9:03 AM, surgery end time was 9:35 AM, out of room time was 9:41 AM and anesthesia end time was 9:51 AM. During the cesarean section, P1’s intraoperative vital signs, Blood Pressure (BP), Heart Rate (HR), Pulse (P), Respiratory Rate (RR), and Oxygen Saturation (SP02) were documented as the following: 8:50 AM - HR 79 P 79 RR 28 SPO2 100% BP 126/78 8:54 AM - HR 166 P 81 RR 39 SP02 100.% 8:55 AM - HR 170 P 158 RR 39 SP02 100% 8:56 AM - HR 175 P 165 RR 48 SP02 100% 8:57 AM - HR 177 P 165 RR 38 SP02 95% 8:58 AM - HR 169 P 168 RR 36 SP02 93% BP 159/85 8:59 AM - HR 110 P 149 RR 41 SP02 92% 9:00 AM - HR 182 P 165 RR 38 SP02 90% BP 217/160 9:01 AM - HR 155 P 135 RR 45 SP02 90% 9:02 AM - HR 147 P 139 RR 36 SP02 89% 9:03 AM - HR 134 P 134 RR 40 SP02 87% 9:04 AM - HR 122 P 97 RR 33 SP02 87% BP 176/98 P1’s medical record revealed that in the PACU, the Rapid Response Team (RRT) was called at 10:00 AM, Computerized Tomography (CT) scans of the head and chest were ordered at 11:21 AM, RRT ended at 11:26 AM, and the head CT was performed at 12:36 PM. P1 was transferred to the Intensive Medical Care Unit (IMCU) at 1:00 PM, and the head CT results were received at 1:32 PM, which indicated a left parenchymal hemorrhage (bleeding in the brain). P1 was then transferred to another hospital at 2:26 PM for a higher level of care. On 3/14/24 at 1:48 PM, a telephone interview with S20, Chief Anesthesiologist, P1’s anesthesiologist, was conducted. S20 stated that P1 had a spinal block for the cesarean and that the only “weird” thing he/she noticed during the procedure was an arrhythmia, premature ventricular contractions (PVC’s) and supraventricular tachycardia (SVTs). S20 stated that the cardiac monitor being used was not working properly, so the vital signs documented are not correct. S20 stated that during the procedure, him/herself and S21 (OBGYN Surgeon) talked about having P1 consulted by cardiology. Upon interview, S21 confirmed the conversation between him/herself and S20, regarding the need for a cardiac consult. S21 indicated that anesthesia is responsible for maintaing the patients vital signs, and that he/she was not aware of any critical events during the procedure, nor was he/she made aware of any concerns. On 3/15/24 at 11:23 AM, P1’s medical record was reviewed with Staff (S) S4, the Performance Improvement (PI) Coordinator and S1, the Interim Director Quality/Safety/Regulatory. S1 and S4 both confirmed that P1 had three elevated blood pressures; elevated heart rates and pulses from 8:54 AM until 9:03 AM; and that P1’s Oxygen saturation levels remained between 70-89% after 9:02 AM until he/she was placed on a non -rebreather [an oxygen mask that provides high concentrations of oxygen] in the Post Anesthesia Care Unit (PACU) at 9:41 AM. S1 and S4 confirmed that the intraoperative anesthesia record lacked documented evidence of interventions rendered for the increased blood pressure, decreased oxygen saturation or increased heart rate values. S1 and S4, both confirmed that there was no documented evidence of the arrhythmia, PVC’s or SVTs, no documented cardiac consult and no anesthesia notes that indicated concerns or issues with the cardiac monitor used, or interventions to correct the issues. The medical record lacked evidence that a new cardiac monitor was requested or that P1’s vital signs were taken manually. On 3/15/24 at 1:06 PM, S20 confirmed that ephedrine was administered at 8:51 AM, and stated that it was administered due to P1’s low heart rate. S20 also stated that there is no documented evidence of the arrhythmia, PVC’s or SVTs, no documentation of vital sign errors due to the cardiac monitor, and that the cardiac consult was not ordered, he/she stated, “mea culpa” [latin meaning “through my fault” or “I am to blame”] and “looking back I should have documented it.” On 3/15/24 at 2:07 PM, an interview with Staff (15), a Labor and Delivery (L&D) Registered Nurse (RN), P1’s nurse on 3/5/24, was conducted. During this interview S15 stated that he/she first noticed P1 was in distress when transferring P1 to the PACU. When P1 was propped up on the stretcher, S15 stated that he/she asked S20, “What did you give [her/him],” because P1 was “out of it.” S15 confirmed that P1 was not on oxygen while in the OR and a non-rebreather was placed by the anesthesiologist once in the PACU. S15 stated, “I was concerned about respiratory arrest. The patient [P1] was vomiting and I was trying to wake her with stimulation but it was not working.” S15 stated that at that time S20 was off the unit, so at 10:00 AM, the Rapid Response Team (RRT) was called. On 3/15/24, the facility document titled, “Equipment Work Order for L&D OR2 Patient Monitor” completed on 3/7/24 at 9:23 AM, was reviewed and revealed that the cardiac monitor “passed” and “verified functionality.” Facility policy titled, “Department of Anesthesiology Policies and Procedures” (5/8/23) stated, “ ...PATIENT CARE RESPONSIBILITIES ...D. Medical management of patients and the anesthetic for the planned procedures including obtaining consultations as necessary. ...Guidelines for Anesthesia Care...B. Perianesthetic care mean being responsible for ...7. Support of life functions under the stress of anesthetic, surgical, obstetrical, and procedural manipulations. 8. Recording pertinent events of the procedure.” 2. On 3/14/24 a review of P1’s anesthesia record for 3/5/24 was conducted. This review revealed that S20 was the anesthesiologist during P1’s cesarean section. The anesthesia summary states that P1’s “Anesthesia Type” is “general anesthesia, spinal.” P1’s medical record lacked evidence indicating that P1 received general anesthesia. The Anesthesia Post Procedure Summary stated, “Anesthesia Post Evaluation ...patient participation: complete- patient participated Level of consciousness: sleepy but conscious ...Respiratory status: acceptable ...No nausea or vomiting.” On 3/14/24 at 1:48 PM, during an interview, S20 confirmed that P1 did not receive general anesthesia during this procedure and that P1 had nausea and vomiting in the OR. On 3/15/24 at 11:23 AM, P1’s medical record was reviewed with S4, PI Coordinator and S1, Interim Director or Quality/Safety/Regulatory. It was revealed that on 3/5/24 at 8:40 AM, a nasal cannula was documented, with no documented flow. S1 and S4 confirmed there was no documented oxygen flow for the nasal cannula. On 3/14/24 at 1:22 PM, S22, Chief Medical Officer was interviewed. During this interview S22 stated that after the event he/she interviewed S20, “coached” him/her, reviewed P1’s medical record, and also had a interdisciplinary meeting with leadership where the decision was made to send this case for a medical peer review, as per the facility medical staff bylaws.”