Carewell Health Medical Center

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 50613 Based on observations, staff interviews, review of facility documents and review of nationally recognized guidelines, it was determined that the facility failed to ensure: 1) that humidity levels are monitored and maintained in accordance with facility policy and nationally recognized guidelines; 2) sterile storage carts had a solid bottom shelf, in accordance with the Association for the Advancement of Medical Instrumentation (AAMI) guidelines and facility policy; 3) sterile supplies were removed from external corrugated cardboard boxes before being stored in the sterile storage area, in accordance with facility policy and AAMI guidelines; 4) packages containing surgical instruments are labeled appropriately prior to sterilization, in accordance with AAMI guidelines; 5) sterile peel-pouched packages are not bent or crushed, compromising the sterility of the contents in accordance with facility policy and AAMI guidelines; 6) all surfaces are maintained in a cleanable manner in accordance with centers for Disease Control and Prevention (CDC) guidelines; 7) environmental cleaners and disinfectants are used in accordance with the manufacturer’s IFUs and CDC guidelines; 8) routine cleaning of operating room surfaces are performed after procedures in accordance with facility policy and The Association of PeriOperative Registered Nurses (AORN) Guidelines for PeriOperative Practice; and 9) expired items are not available for patient use, in accordance with facility policy. Findings include: On 8/28/25 at 09:54 AM, Staff (S)3 confirmed that the facility follows Centers for Disease Control and Prevention (CDC) Guidelines, The Association of PeriOperative Registered Nurses (AORN) Guidelines for PeriOperative Practice, and Association for the Advancement of Medical Instrumentation (AAMI) guidelines. 1. Reference: The Association of PeriOperative Registered Nurses (AORN) Guidelines for PeriOperative Practice, 2024 Edition, stated, “... Table 5. Design Parameters for Heating, Ventilating, and Air Conditioning ... Area ... Operating Room ... Temperature. 68 -75 [degrees] F [Fahrenheit] ... Relative Humidity 2-60% [percent] ... “ On 08/28/25 at 10:03 AM, during a tour of the Operating Room (OR) Suite accompanied by S2 and S3, it was observed that OR 4 was unoccupied. Upon entrance to OR 4, the thermometer reading was 63 degrees Fahrenheit, 54 % humidity. Facility policy titled, “Temperature and Humidity (Revised August 2022)” stated, “ ... Temperature /Humidity Ranges ... OR: 68-75 degrees Fahrenheit, max 60% humidity ... If any of the areas fall outside the recommended parameters departmental management, Infection control and Facilities are notified ... Facilities will make changes to the Building Automation system until temperature and humidity are in acceptable range. If acceptable ranges are unable to be restored within 4 hours the affected area will be taken out of service ...” Upon request, S1 provided the temperature and humidity log for the OR suite for the month of August (all readings were documented as obtained at 07:00 AM), which revealed the following: OR 1: On 08/18/25, the humidity level documented was 73%. OR 2: the humidity level was out of range on all days in August, with the highest reading of 82.1% humidity recorded on 8/24/25 and the lowest reading of 63.8% humidity recorded on 08/27/25. OR 3: the humidity level was out of range on all days in August except for 08/11/25 and 08/27/25. The highest humidity level recorded was 77.5% on 08/18/2025 and the lowest reading recorded was 61% on 08/05/2025. OR 4: Humidity levels were out of range on 08/16/2025 (62%), 08/17/25 (63%), 08/18/25 (74%), 08/20/25 (62.2%), and 08/24/25 (68.8%), with the highest reading of 74% on 08/18/2025. OR 4 was in use on 08/20/2025, when the humidity reading was 62.2%. Upon interview, S3 stated that he/she was provided with different readings, and all readings provided to him/her were within normal range. At 3:15 PM an interview was conducted with S12. S12 stated that the HVAC sensor that measures the temperature and humidity in the OR is not working correctly, so the readings are being taken with a Klein tool (infrared thermometer), and stated that the readings initially provided to the surveyor were not correct. No documentation was provided to demonstrate that the readings obtained from the in-room monitoring system should be disregarded, and the temperature and humidity would be obtained using the infrared thermometer. In addition, no documentation of calibration for the infrared thermometer was provided. At 3:28 PM, S3 provided a different temperature and humidity log that included dates through 08/22/2025. S3 stated that this was the log that was being sent to him/her daily from S15. The document provided by S3 was reviewed and revealed the humidity level in the operating room suite was out of the required range on 8/18/25, with a reading of 61%. The reading was documented as being obtained at 07:00 AM. This was confirmed with S1, S2, S3, and S12 at 4:00 PM. 2. Reference: AAMI ST79:2017 and 2020 amendments A1, A2, A3, A4 (Consolidated Text): Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities., section 11.1.1 stated, “Storage facilities ... Shelving, carts, and bins used for sterile storage should be maintained organized, clean and dry. The bottom shelf of storage carts or shelving should be solid ...” On 8/28/2025 at 10:29 AM, a tour of the Sterile Storage area was conducted accompanied by S2 and S3. It was observed that the bottom shelf of a wire cart used for storage was not solid. Facility policy titled Storage of Sterile and Clean Supplies SPD (reviewed 03/2021) was reviewed and stated, “ ... iv. When open wire shelving is used, the bottom shelf and top shelf should be solid ...” These findings were confirmed with S2 and S3 at the time of discovery. 3. Reference: AAMI ST79:2017 and 2020 amendments A1, A2, A3, A4 (Consolidated Text): Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities, section 11.1.1 stated, “Storage facilities ... Sterile items should not be stored on floors, on windowsills, or in areas other than designated shelving, ... Supplies should be removed from external and web-edged shipping containers before transport to any restricted area ... Rationale: External shipping containers and web-edged corrugated cardboard boxes can collect dust, debris, or insects during shipment and bring contaminants into the facility.” On 8/28/2025 at 9:57 AM, during a tour of the Sterile Storage area, in the presence of S2 and S3, a cardboard box that contained protective gowns was observed stored on the floor. At 10:29 AM, during a tour of a second Sterile Storage area corrugated cardboard box that contained arthroscopy pumps was observed stored on the floor. Facility policy titled, “Storage of Sterile and Clean Supplies SPD” (reviewed 03/2021) was reviewed and stated, “ ... J. Outside shipping cartons are prohibited in clean/sterile storage locations ...” These findings were confirmed with S2 and S3 at the time of discovery. 4. Reference: ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Section 13.3.2 Package labeling and expiration dating, stated, “Each item or package intended for use as a sterile product should be labeled with a lot control identifier prior to sterilization. The lot control identifier should identify ... c) the person who assembled the package; ...” On 8/28/25 at 10:38 AM, during a tour of the sterile storage area with S2 and S3, the following items were observed to be available for patient use, and the initials identifying the person that sterilized the items was not documented: Hip retractor sterilized on 10/1/24 Gelpi retractor sterilized on 8/7/25 Hip retractor sterilized on 12/20/24 This was confirmed with S3 at 10:40 AM. 5. Reference: ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities, section 11.1.1 stated, “... Sterile items should be ... 4) Stored so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is not otherwise compromised.” On 08/28/25 at 10:39 AM, in the Sterile Storage area, in the presence of S2 and S3 more than five sterilized peel-pouched packages containing surgical instruments were crushed and bent in a plastic storage bin. Facility policy titled Storage of Sterile and Clean Supplies SPD (reviewed 03/2021) was reviewed and stated, “ ...G. Sterile packs should not be subjected to sharp objects, moisture, dropping, compression, or any other activity that could affect the sterility of the device ...” This finding was confirmed with S3 at the time of discovery. 6. CDC (Centers for Disease Control and Prevention) Guideline for Prevention of Surgical Site Infection, 1999 page 261 stated, “(2) Environmental Surfaces ... (e.g., tables, floors, walls, ceilings, lights) ... it is important to perform routine cleaning of these surfaces to reestablish a clean environment after each operation.” On 8/28/25 at 10:16 AM, while in operating room (OR)4 with S2 and S3, white tape, as well as tape residue, was observed on the the C-arm (an x-ray system that provides real-time x-ray images during surgical procedures). The tape and tape residue makes the surface an uncleanable surface. The metal base of the operative table was observed with paint chipping and visible cracks. When touched, paint chips easily detached from the base, resulting in loose fragments on the floor beneath the table. The cracked and chipped areas create a porous and uncleanable surface, which does not allow for effective cleaning and disinfection. A black, upholstered chair with multiple cracks and tears was observed in OR 4. At 10:34 AM, while in OR 1, a black upholstered chair with multiple cracks and tears was observed. The surface cracks make the chairs uncleanable. These findings were confirmed with S2 and S3 at the time of discovery. 7. Reference: Centers for disease Control and Prevention, “Guideline for Disinfection and Sterilization in Healthcare Facilities (2008, Last update June 2024). https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html” stated, “5. Cleaning and Disinfecting Environmental Surfaces in Healthcare Facilities ...5c. Follow manufacturer’s instructions for proper use of disinfection (or detergent) products ...” On 08/28/25 at 10:16 AM, upon entrance to Operating Room (OR) 4, which was not in use, a canister of Sani-Cloth AF3 disposable wipes was observed with the lid open. The Sani-Cloth Germicidal Disposable Wipe AF3, Instructions for Use (IFU) was reviewed and, stated, “ ...When not in use, keep lid closed to prevent moisture loss.” The findings were discussed with S3 at 10:18 AM, who confirmed the lid on the canister of Sani-Cloth AF3 disposable wipes should be closed when not in use. 8. Reference: AORN Guidelines for PeriOperative Practice, 2024 Edition, stated, “ ... Environmental Cleaning ... 4. OR and Procedure Rooms ... 4.2 Operating and procedure rooms must be cleaned and disinfected after each patient procedure 4.2.1 ... 4.2.2 Remove trash and used linen from the room ... 4.2.3 Clean and disinfect all items used during patient care, including anesthesia carts, including the top and drawer handles; anesthesia machines, including dials, knobs, and valves ... The anesthesia work area, consisting of the anesthesia machine, anesthesia cart ... contains irregular, complex surfaces that encounter frequent hand contact. Failing to clean these surfaces properly can lead to cross transmission of potential pathogens ...” Facility policy titled, “Environmental Sanitation and Terminal Cleaning OR” (last reviewed March 2025) stated, “ ... Rooms will be properly cleaned between cases ... After Surgery-Environmental Services. 15. Anesthesia ventilator machine and work surface and locked cart are to be wiped down ... 45. All waste and soiled linen bags are closed and removed from the OR area ...” On 08/28/25 at 10:13 AM, during a tour of OR4 with S2 and S3, the trash receptacle without a lid was observed to contain discarded items including, but not limited to, a contaminated swab stick, and soiled gloves. A stainless steel two-level cart was observed in the room with seven packages of sterile gloves, a package of gauze sponges, and a package of povidine-iodine solution scattered on the top shelf. The lower shelf had two bags of intravenous solution and a wrapped sterile pack. A blue bin that was designated for the collection of reusable medical devices for third-party reprocessing was observed to be overflowing. The container contained excess items piled above the rim, including cords and tubing, which were not contained within the bin. When asked if the room was ready for the next case, S3 confirmed the room turnover was complete and ready for the next scheduled procedure. During an observation of a post-procedure room turnover on 08/28/25 at 10:34 AM, in OR 1, S7 was cleaning the work surface of the anesthesia machine; however, a paper towel and supplies that were on the surface were not moved, and the cleaning was performed around the items. At 10:40 AM, the finding was confirmed with S3. 9. On 08/28/25 at 10:41 AM, in the Sterile Storage area, in the presence of S2 and S3, three manufacturer-prepared trocars with an expiration date of 06/27/25 were identified on the shelves and available for patient use. Facility policy titled, Storage of Sterile and Clean Supplies SPD (reviewed 03/2021) was reviewed and stated, “ ... F. All manufacturer-prepared sterile packages are considered sterile unless an expiration date has been reached ...” This finding was confirmed with S3 at the time of discovery.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 41646 Based on observation, staff interview, review of facility video surveillance from 04/01/25, medical record review (Patient (P)1), and review of facility documents, it was determined that the facility failed to ensure that: 1.) the patients outcome behaviors and medications administered as an alternative to restraints, are documented in accordance with facility policy (A0186); 2.) Behavioral Health and security staff received recertification training and utilized de-escalation techniques in accordance with the facility’s “Handle with Care “ de-escalation training, and restraint policy (A0200); and 3.) visitors who have been restricted from the facility, are denied access as per facility policy and procedure (A0215). This failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patients. On 04/09/25 at 2:21 PM, an IJ was identified for the facility’s failure to ensure Behavioral Health and security staff received recertification training and utilized de-escalation techniques in accordance with the facility’s “Handle with Care “ de-escalation training, and restraint policy (A0200). At 4:08 PM, the IJ template was provided to Staff (S)1 (Senior Director of Clinical Transformation) and a removal plan was requested. An acceptable removal plan was received on 4/10/25 at 10:08 AM. The facility provided education to all nursing and security staff on verbal de-escalation prior to their next shift, a handout document summarizing de-escalation techniques, and an attestation signed by the staff members stating that he/she will maintain current with the complete de-escalation course requirement. The IJ was removed on 04/11/25 at 11:00 AM, after the State Survey Agency verified the full implementation of the removal plan, and Condition Level non-compliance remains (A0115). Cross Reference: 482.13(e)(16)(iii) Patient Rights: Restraint or Seclusion 482.13(f)(2)(ii) Patient Rights: Restraint or Seclusion: Staff Training Requirements 482.13(f)(h) Patient Rights: Patient Visitation Rights”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(16)(iii) [there must be documentation in the patient’s medical record of] Alternatives or other less restrictive interventions attempted (as applicable); This Standard is not met as evidenced by: 41646 Based on medical record review, staff interview, review of facility documents, and review of facility video surveillance from 04/01/25, it was determined that the facility failed to ensure the patients outcome behaviors and medications administered as an alternative to restraints, are documented in accordance with facility policy. Findings include: Facility policy titled, “Restraint Policy,” last revised date February 2023, stated, “... Documentation: ... Documentation must clearly reflect patient risk, associated behaviors and all alternatives attempted. ...” On 04/08/25, review of Patient (P)1’s EMR (electronic medical record) was conducted with Staff (S)2 (Registered Nurse [RN] Clinical Coordinator, Behavioral Health Unit). A progress note from 04/01/25 at 20:00 [8:00 PM], from S41 [Advanced Practice Nurse] revealed that P1 had been placed in 4-point restraints for safety. Upon request to view the restraint documentation, S2 stated that the orders for restraint and restraint charting are on paper, which is currently on the Behavioral Health Unit with P1. A request was made for copies of the paper restraint documentation. At 2:03 PM, a review of security video surveillance from 04/01/25 at 19:32 [7:32 PM] on the Behavioral Health Unit, was conducted with S4 (Safety Manager) and S5 (Director of Risk). A person, identified by S4, as S6 (Clinical Coordinator) was observed standing and speaking to P1, who was sitting in a wheelchair in the visiting room beside a visitor, identified by S4 as the patient’s mother. Another camera view showed four people watching and listening while S6 and P1 were speaking to each other. S6 was observed leaving the waiting area through one door, then returning through the farther door from the patient. When S6 returned through the farther door, he/she was observed pointing his/her finger at P1, and P1 was observed pointing back. At 19:34 [7:34 PM], P1 threw a full fountain soda cup in the direction of S6, and it struck the wall beside him/her. Staff members then entered the room and surrounded the patient, wheeling P1 out of the waiting area and towards his/her room. At 19:43 [7:43 PM], P1 required restraints and seclusion. On 04/09/25 at 11:35 AM, a review was conducted of P1’s medical record with S3 (RN Quality Control). The paper restraint documentation included a “Restraint or Seclusion Debriefing” checklist, that stated the following: “Manager or Supervisor will conduct and document the debriefing as soon as patient and staff are safe and stabilized.” The form includes a series of “Debriefing Topic” questions requiring a “yes” or “no” response and an area for comment is provided. Question: “All appropriate alternatives to restraint were attempted and documented, including patient outcomes behaviors.” Comment: “Appropriate alternatives were offered, meds and negotiation.” Question: “Any other alternatives available that should have been attempted before restraint” Comment: “All other appropriate alternatives were exhausted such as meds and limit setting that wasn’t effective.” A review of P1’s electronic medical record with S3 revealed that at 20:00 [8:00 PM], 17 minutes after restraint, P1 received Benadryl 50 mg (milligrams) IM (intramuscular) and Thorazine (schizophrenia and bipolar symptom medication) 50 mg IM. S3 confirmed that no PRN (as needed) meds were documented as administered, prior to P1 being placed in restraints. S3 confirmed that the last psychiatric medications that P1 received, prior to the Benadryl and Thorazine given after restraint, were scheduled medications at 5:14 PM, 5:16 PM, and 5:26 PM. The medical record lacked documentation of which medications were given as an alternative to restraint, and the patient’s outcome behaviors from the medication. These findings were reviewed with S3 and S1. On 04/09/25 at 3:03 PM, a telephone interview was conducted with S40 (RN). S40 confirmed that he/she was P1’s nurse on 04/01/25. S40 stated that before taking his/her meal break, P1 was “responding, talking to [himself/herself], usual baseline.” S40 stated that while on break, he/she heard a noise, and when he/she returned “[Named S6, Clinical Coordinator], was medicating [P1] when I took over in the seclusion room.” S40 was unable to confirm that any medications were administered to P1 as an alternative to restraints, as documented in the “Restraint or Seclusion Debriefing” document.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(2)(ii) [The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:] (ii) The use of nonphysical intervention skills. This Standard is not met as evidenced by: 41646 Based on observation, staff interview, review of facility video surveillance from 04/01/25, medical record review (Patient (P)1), and review of facility documents, it was determined that the facility failed to ensure Behavioral Health and security staff received recertification training and utilized de-escalation techniques in accordance with the facility’s “Handle with Care “ de-escalation training, and restraint policy. Findings include: Facility policy titled, “Restraint Policy,” last revised February 2023, stated, “... IV. Procedure: ... 2. Attempt to de-escalate the situation: Use non-physical de-escalation techniques to help patient regain control of behavior. Be supportive, firm, and empathetic. ... Be aware of personal space, body position, and language. Keep all non-verbal cues non-threatening. ...” Facility document titled, “Handle With Care Behavior Management System Verbal Intervention Manual for Participants” stated, “Support: ...1. Listen: Allow the client to ventilate verbally without your becoming defensive or reactive. This is difficult when you or other staff are subjects of the complaint ... Be aware that your body language - nonverbal communication (facial expressions, hand gestures, pointing etc) reveals your true affect. ...” On 04/08/25 at 11:13 AM, during a tour of the Behavioral Health involuntary unit, Patient (P)1 stated that he/she “was assaulted, me and my Mom.” Staff (S)7 (Nurse Manager) stated to the patient from behind survey staff, “You were assaulted? You did the assaulting.” The staff member failed to allow the client to ventilate verbally in accordance with facility “Handle with Care” de-escalation training. At 2:03 PM, a review of security video surveillance from 04/01/25 at 19:32 [7:32 PM] on the Behavioral Health Unit, was conducted with S4 (Safety Manager) and S5 (Director of Risk). A person, identified by S4, as S6 (Clinical Coordinator) was observed standing and speaking to P1, who was sitting in a wheelchair in the visiting room beside a visitor, identified by S4 as the patient’s mother. Another camera view showed four people watching and listening while S6 and P1 were speaking to each other. S6 was observed leaving the waiting area through one door, then returning through the farther door from the patient. When S6 returned through the farther door, he/she was observed pointing his/her finger at P1, and P1 was observed pointing back. At 19:34 [7:34 PM], P1 threw a full fountain soda cup in the direction of S6, and it struck the wall beside him/her. Staff members then entered the room and surrounded the patient, wheeling P1 out of the waiting area and towards his/her room. At 19:43 [7:43 PM], P1 required restraints and seclusion. At 3:25 PM, an interview was conducted with S6 regarding P1. During the interview, S6 stated that during the time observed on video, P1 was yelling and threatening staff. S6 stated that he/she completes de-escalation training at the facility every year, and that during interactions with P1 “I set limits, boundaries, before it gets physical.” On 04/10/25 at 3:08 PM, during a second interview with S6, he/she confirmed pointing at the patient in order to direct the patient to move. On 04/09/25 at 10:46 AM, a video review was conducted with S6. The video surveillance was from 04/01/25 at 19:43 [7:43 PM] on the Behavioral Health involuntary unit, of Seclusion Room 2. P1 was observed being placed in 4-point restraints with 11 staff members present. As staff were exiting the room, a person, identified by S4, as S12 (Registered Nurse [RN]) was observed approaching the patient, who was in restraints, pointing his/her finger and speaking to the patient while posturing forward towards the patient prior to exiting the room. On 04/10/25 at 1:31 PM, a telephone interview was conducted with S12. S12 stated that when a patient is restrained, “someone has to stay back and make sure [he/she] is ok. I rechecked the wrists and ankles. [He/she] was cursing me out. I think [he/she] spat at me or something like that. I was just making sure [he/she] was comfortable.” P12 further stated, “I really cannot recall specifically pointing fingers.” For non-verbal communication skills taught in Handle with Care, S12 confirmed, learning about non-verbal cues, non-verbal stances, and not to assume a stance that looks ready to be aggressive, or offensive towards [him/her].” S12 stated that when P1 was restrained, “I made sure [he/she] as a patient was very safe. No one was putting hands on [him/her]. I made sure [he/she] didn’t spit on everybody. It was a safe de-escalation.” At 11:46 AM, an interview was conducted with S20, the manager responsible for the Handle With Care de-escalation training. S20 stated that education is provided for staff on handling a patient escalating in behavior and making threats. S20 stated that staff are taught “limit setting” which includes “keeping your voice low, almost whispering,” “not yelling back,” and “not pointing. You’re giving attitude. It’s not going to calm the patient down.” S20 confirmed that all staff are required to receive Handle With Care Training upon hire and are recertified annually. On 04/09/25 at 12:03 PM, S1 (Senior Director of Clinical Transformation) provided a list of the last time all security officers and staff members from the in-patient behavioral health unit completed the Handle With Care training. Twenty-two out of 64 staff members from the behavioral health unit and 21 out of 37 security officers had not received the Handle with Care recertification within the past year. At 2:21 PM, S1 confirmed that the security officers and behavioral health staff were not up to date with their annual re-certification of Handle with Care. S6 (Clinical Coordinator), S22 (Mental Health Aide), S17 (Security Officer), S18 (Security Officer), S16 (Security Officer), and S25 (Security Officer) were identified on the provided lists as staff members who have not received Handle With Care within the past year. These staff members were identified on video as assisting when P1 was restrained on 04/01/25.”

“PATIENT VISITATION RIGHTS CFR(s): 482.13(h) A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation .... This Standard is not met as evidenced by: 41646 Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that visitors who have been restricted due to staff safety are denied entrance to the facility. Findings include: Facility policy titled, “Visitation Policy,” reviewed April 2025, stated, “... IV. Procedure: ... 4. Visitor Limitations... B. Visitors who display behavior that is aggressive, offensive, belligerent, or disrespectful to other people within the hospital will not be tolerated and may be requested to leave. ... C. ... ii. Visitor’s visitation privileges will be reinstated pending review by administration. ...” On 04/08/25 at 3:44 PM, during an interview with Staff (S)6 (Clinical Coordinator, behavioral health unit) and S12 (Registered Nurse, behavioral health unit), S12 stated that a patient’s visitor (V) had punched him/her during visiting hours on 04/01/25. S12 stated that the visitor (V2), who had arrived with another visitor (V1), had been removed from the unit by staff and security. After the visitor was removed, S6 stated that the behavioral health unit began receiving threatening phone calls from another family member (V3) of the patient. S12 stated that he/she called the police. S12 further stated that V1, V2, and V3 had been placed on the facility’s visitor restriction list; however, S12 stated that over the weekend, he/she saw V1 and another visitor in the elevator on the way to the unit. On 04/09/25 at 2:27 PM, S1 (Senior Director of Clinical Transformation) and S4 (Safety Manager) provided copies of the lists of patients who were restricted from visitation at the facility from 04/01/25 until present. Two lists were provided, dated 04/01/25 and 04/07/25. S4 confirmed that the list from 04/01/25 remained in effect until 04/07/25, when there was a change. On the list dated 04/01/25, there were three names listed under “visitors not allowed: V1, V2, and V3.” A review of the listing of all visitors who had logged in at the front desk from 04/01/25 until 04/07/25 revealed that on 04/06/25, V1 and V3 had logged in as visitors. S4 stated that on 04/06/25, “there was a miss because the hostess went on break. She was relieved, and the visitors got up to the floor but did not get on the unit.” S4 stated that the hostess was relieved by a security guard, who allowed the visitors to enter the facility despite being on the restricted list. When asked if any action had taken place as a result of this miss, S4 stated that he/she “spoke to the hostess.” S4 was unable to confirm that the security officer had been educated on the miss. S4 stated that when P1’s family arrived on the unit, they were informed of the visitor restriction and not allowed to enter.”

“LIFE SAFETY FROM FIRE CFR(s): 482.41(b)(1)(2)(3) (b) Standard: Life safety from fire. (1) Except as otherwise provided in this section— (i) The hospital must meet the applicable provisions and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4.) Outpatient surgical departments must meet the provisions applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served. (ii) Notwithstanding paragraph (b)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors. (2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a hospital, but only if the waiver will not adversely affect the health and safety of the patients. (3) The provisions of the Life Safety Code do not apply in a State where CMS finds that a fire and safety code imposed by State law adequately protects patients in hospitals. This Standard is not met as evidenced by: 33557 Based on observation, staff interview, and facility document review, it was determined that the facility failed to ensure: 1.) portable space heating devices are not used in patient care areas; and 2.) Items located in the corridor are limited to the following: equipment carts in use, medical emergency carts, and/or patient lifting and transport equipment. Findings include: 1. Reference: National Fire Protection Association (NFPA) 101 Life Safety Code 2012 Edition, stated, “...19.7.8 Portable Space-Heating Devices. Portable space-heating devices shall be prohibited in all health care occupancies, unless both of the following criteria are met: (1) Such devices are used only in non-sleeping staff and employee areas. (2) The heating elements of such devices do not exceed 212 degrees Fahrenheit (F).” On 04/08/25 at 11:33 AM, in the presence of Staff (S)1 (Director of Quality) an electrical powered portable space heating device was in use on the fourth floor inpatient Voluntary Behavioral Health Unit. The heating device was a Dayton Salamander Heater, Model 1RKT9C. This portable heating unit was located in the corridor outside the Nurses’ Station and was plugged into an electrical outlet on the wall. A staff member was noted to be sitting beside the heater. On 4/9/2025 at 10:51 AM, during a tour of the Voluntary Behavioral Health Unit, S7 (Nurse Manager) stated that temperatures fluctuate on the North side (voluntary unit), and the heater is used to keep patients warm. S7 confirmed that the heater is monitored by a nurse or technician, and they are assigned to sit there every shift. On 04/08/25 at 11:33 AM, in the presence of S1, patients were observed walking up and down the corridor near the heater. A label affixed to the top of the heater read, “Caution: Hot Surface. The front surface temperature could reach above 150 degrees Fahrenheit.” During an interview on 04/10/25 at 10:15 AM, S24 (Director of Plant Operations), confirmed the portable heating units were used on the unit during brief periods of extreme cold weather. 2. Reference: NFPA 101 Life Safety Code 2012 Edition, “...19.2.3.4(4) Projections into the required width shall be permitted for the wheeled equipment, provided that all of the following conditions are met . . . (c) The wheeled equipment is limited to the following: i. Equipment in use, ii. Medical emergency equipment not in use, iii. Patient lift and transport equipment.” On 04/08/25 and 04/09/25, the portable heating unit, which measured approximately 28 inches wide, was located in the patient care corridor reducing the overall width of the corridor to approximately 68 inches.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47131 Based on review of medical records (MR), staff interviews, review of video surveillance, and review of facility documents, it was determined that the facility failed to ensure: 1). Q15 (Every 15 minutes) patient monitoring on the involuntary psychiatric unit was conducted to ensure patient safety (A0144); and 2). an incident report and investigation were completed concerning an allegation of assault (A0144). This failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patients. On January 14, 2025, at 4:11 PM, an Immediate Jeopardy (IJ) was identified for the facility’s failure to ensure that staff conduct Q15 patient monitoring on the behavioral health involuntary unit (A-0144). On January 14, 2025, at 4:33 PM, the IJ template was presented to the administration and a removal plan was requested. On January 15, 2025, at 10:41 AM, a second IJ was identified for the facility’s failure to ensure that staff complete an incident report upon a patient’s allegation of assault and the the facility completes an investigation of the alleged event (A-0144). On January 15, 2025, at 12:11 PM, the IJ template was presented to the administration and a removal plan was requested. On January 15, 2025, at 2:24 PM, an acceptable removal plan was received. The facility implemented the following to address the IJs: education was provided to Behavioral Health Unit nurses, mental health aides, and mental health counselors about compliance to the safety rounding policy and impact on patient safety by the Chief Nursing Officer, Director of Quality, and Clinical Manager. The education included: Review of the policy titled, “Safety Rounds,” which indicated that rounds are to be completed every 15 minutes; Importance of accurate documentation, integrity, and data validity; Licensing requirements and impact of noncompliance to safety rounds; and Reinforced teamwork for coverage to complete safety rounds. Policies for Incident Reporting, Patient Abuse Reporting, and Reportable Police Cases were updated. All Behavioral Health Unit staff including nursing, mental health aides, mental health counselors, therapists, discharge planners, psychiatric providers (MD [Medical Doctor], APN [Advanced Practice Nurse], PA [Physician Assistant]), and security officers were provided this education. The IJ was removed on January 15, 2025, at 3:07 PM, after the State Survey Agency verified the full implementation of the removal plan, and 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: 47131 Based on the review of medical records (MR), staff interviews, review of video surveillance, and review of facility documents, it was determined the facility failed to ensure: 1). Q15 (Every 15 minutes) patient monitoring was conducted on the behavioral health involuntary unit to maintain patient safety; and 2). staff complete an incident report upon a patient’s allegation of assault and that the facility conducts an investigation of the alleged event. Findings include: 1. Facility policy titled, “Safety Rounds” (Reviewed January 2022) stated, “ ... I. Policy: ...A. The Charge Nurse is responsible for assigning nursing staff to make unit rounds in order to account for all patients’ whereabouts and ensure a safe environment. B. Rounds are made a minimum of every fifteen (15) minutes. ... D. Rounds are completed by assigned staff. ... III. Procedures: ... C The assigned staff member(s) personally locates each patient listed (unless on pass or out on hospital outing), and documents the patient’s location on the Rounds Sheet under the appropriate time column. The staff member places his/her initials at the top of the column above the time. ... G. The staff member must enter the room to observe the condition of the patient.” On 01/14/25 at 1:45 PM, a video surveillance footage review of “Unit 4-Main, Hall-East” was conducted with Staff (S)9 (Safety Manager) and S2 (Director of Risk, Compliance and Privacy). The following was revealed: On 12/27/24 from 03:00 AM until 04:00 AM, there were no staff members observed in the hallway conducting Q15 patient monitoring rounds. At 4:11 AM, S18 (Registered Nurse [RN]) was observed opening the doors to patient rooms and entering the patient rooms. A review of Patient (P)1’s medical record revealed that on 12/27/24, S19 (Mental Health Aide [MHA]) documented the following Q15 safety rounds: 12/27/24 at 03:03 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there were no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/27/24 at 03:29 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there were no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/27/24 at 03:44 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there were no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/27/24 at 03:59 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there were no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/27/24 at 04:04 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there was no staff observed conducting Q15 safety rounds on the unit at the time this was documented. On 01/14/25 at 2:05 PM, S9 confirmed that Q15 Safety Rounds were not conducted on 12/27/24 from 03:00 AM until 04:11 AM. S2 confirmed that S19 documented Q15 Safety Rounds in the patient’s medical record as indicated above, but did not conduct the Q15 Safety Rounds as per facility policy. Upon request, S9 failed to provide the “11-7” Nursing Assignment sheet for 12/26/24 (11:00 PM on 12/26/24 until 07:00 AM on 12/27/24). A review of the “12/28/24, 11-7” Nursing Assignment sheet (11:00 PM on 12/28/24 until 07:00 AM on 12/29/24) documented the nursing shift assignments as follows: S17 (Registered Nurse [RN]) was assigned “Q Hourly Rounds” (every hour); S18 (RN) was assigned “Q Hourly Rounds” and “Q15 mins (minutes)” 2am-3am (02:00 AM until 03:00 AM) and 5am-6am (05:00 AM until 06:00 AM); S16 (MHA) was assigned “all patients.” The Nursing Assignment sheet lacked documentation of the staff member responsible for conducting the Q15 safety rounds from 11:00 PM until 02:00 AM, 03:00 AM until 05:00 AM, and 06:00 AM until 07:00 AM. A review of the video surveillance footage from 12/29/24 (02:00 AM until 04:00 AM) revealed that there was no staff observed conducting Q15 patient monitoring rounds from 02:00 AM until 02:40 AM, when S17 (RN) appeared on video and was observed opening the doors and entering the patient rooms at 02:40 AM. There was no staff observed conducting Q15 patient monitoring rounds, again, until S16 appeared to conduct Q15 patient monitoring rounds at 04:29 AM. Review of Patient (P)1’s medical record revealed that on 12/29/24, S17 documented the following Q15 safety rounds for P1: 12/29/24 at 02:02 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there was no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/29/24 at 02:29 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there was no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/29/24 at 02:31 AM, “BH (Behavioral Health) Patient Location: Hallway.” P1 was observed to be in the hallway at the nursing station at that time. 12/29/24 at 02:53 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Awake.” Video surveillance review showed S17 opening the doors and entering the patient rooms at 02:40 AM. On 12/29/24, S16 (MHA) documented the following Q15 safety rounds for P1: 12/29/24 at 03:14 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there was no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/29/24 at 03:35 AM, “BH (Behavioral Health) Patient Location: Patient Room; BH Patient Activity: Appears sleeping.” A review of the video surveillance revealed that there was no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/29/24 at 03:59 AM, “BH (Behavioral Health) Patient Location: Seclusion-1; BH Patient Activity: [Blank].” During the review of the video surveillance, P1 was observed speaking with S16 and S20 (Security Officer) in the hallway outside of the Seclusion Room. There were no staff observed conducting Q15 safety rounds on the unit at the time this was documented. 12/29/24 at 04:12 AM, “BH (Behavioral Health) Patient Location: Seclusion-1; BH Patient Activity: [Blank].” During the video surveillance review, P1 was observed entering the Seclusion Room at 04:01 AM without any staff member and the door to the seclusion room remained open. There were no staff observed conducting Q15 safety rounds on the unit at the time this was documented. On 01/14/25 at 2:33 PM, S9 confirmed that no staff were observed in the patient hallway conducting safety rounds, and that Q15 Safety Rounds were completed only once from 02:00 AM until 04:29 AM (at 02:40 AM). S2 confirmed that S16 and S17 documented the Q15 Safety Rounds in the patient’s medical record, but did not conduct the Q15 Safety Rounds as per facility policy. 2.) Facility policy titled, “Patient Abuse Reporting” (Reviewed February 2022) stated, “ ... All personnel who provide direct or indirect care to patients either on an occasional or regular basis will attend an educational program on an annual basis regarding the identification and reporting of diagnosed and/or suspected cases of elderly or disabled adult abuse and/ or neglect.” Facility policy titled, “Incident Reporting” (Reviewed February 2023) stated, “ I. POLICY: ...All (Name of facility) employees are required to complete an incident report, documenting events that either result in, or have the potential to result in, injury or property damage or loss to patients ... III. SCOPE: All (Name of facility) employees are required to enter an incident in the electronic incident reporting system report at the time it occurred or as soon as possible. ... IV. QUALIFICATIONS/RESPONSIBLE PARTIES: ... The (Name of facility) Director, Risk Management reviews all electronic incident reporting system reports and will determine need for further investigation and when appropriate, report to external regulatory agencies ...VI. PROCEDURE: ... Employees must enter the incident in the electronic incident reporting system at the time it occurred or as soon as possible. Next steps: i. If the incident is having a direct patient impact, the incident must be documented in the patient record.; ii. Notify the immediate supervisor, Administration of the incident; iii. When appropriate, an investigation will be conducted. ...VII. DOCUMENTATION: Patient related incidences are documented within the patient’s medical record. All incidences are captured and documented in the electronic incident reporting system reporting platform.” A review of P1’s medical record revealed the following: P1 was admitted to the Behavioral Health Unit (BHU) involuntary unit on 12/17/24 with a diagnosis of schizoaffective disorder. In a Behavioral Health Note by S5 (Psychiatrist, BHU Medical Director) on 12/29/24 at 11:53 AM, it stated, “... History of Present Illness: Patient was seen this morning and continues to be delusional and paranoid. Patient states that [he/she] was possibly assaulted last night, despite not seeing anyone in [his/her] room. Patient states [he/she] had ‘lines on my back’, suggestive of an assault, that [he/she] refused to show writer and states ‘it is not there anymore.’ ... MSE (Mental Status Exam): ... Description of abnormal or psychotic thoughts including: AH (Auditory Hallucinations), VH (Visual Hallucinations), delusions: Delusional and paranoid ... Mood/affect: Upset affect: blunted ...Plan: 1. Mood/psychosis: Continue with current treatment regimen ...” There was no evidence in the medical record that the patient was examined for injury. In a Behavioral Health Form - Interdisciplinary Team Meeting BH (Behavioral Health) entry on 12/30/24 it stated, “... Patient stated [he/she] thinks someone probably rape (sic) him last night. However [he/she] is not to (sic) sure if anything happened. Psychiatrist told patient if anyone should touch [him/her], [he/she] should reported (sic) so the proper procedures will take place.” A review of the BH IP (Inpatient) Provider Progress Note, written on 12/30/24 at 13:46 EST (1:46 PM), revealed, “ ...History of Present Illness: ...Patient reports during treatment team [he/she] woke up during Saturday night around 4AM and felt like someone was putting pressure on [his/her] back but [he/she] did not see anyone. Reports [he/she] woke up in cold sweats and told the staff members. Patient reports a similar experience on the outside and reported [he/she] was raped at at (sic) that time, but no reports were made to the police.” Upon interview with S5 on 1/14/25 at 11:50 AM, when asked to describe the procedure if a patient reports a sexual assault, S5 stated, “First, the patient would be placed on 1:1 for safety, the medical team will conduct a physical exam, then submit an incident report if it is a confirmed event.” When questioned if an incident report is submitted only if it was confirmed that an assault occurred, S5 stated, “No, an incident report should be generated if it is a confirmed or reported event.” S5 confirmed that an alleged sexual assault would be discussed during the interdisciplinary treatment team meetings, which occur three times per week. When questioned if S5 recalls P1 reporting sexual assault to [him/her] on 12/29/24, S5 stated, “I asked the patient if [he/she] wanted to be examined, and the patient refused.” When asked if S5 filed an incident report for the patient’s allegation, S5 said “No.” A review of the facility’s incident report log (November 2024-January 2025) lacked documentation that an incident report was filed on 12/29/24 when P1 reported the alleged sexual assault to BHU staff and the medical provider. Upon interview with S2 (Director of Risk, Compliance, and Privacy) on 1/13/25 at 10:00 AM, he/she explained that according to the facility’s policy, all staff are expected to file an incident report if a patient reports an alleged sexual assault, and an investigation would be conducted. On 1/15/25 at 10:15 AM, S2 confirmed that staff did not complete an incident report on 12/29/24 when P1 reported a possible sexual assault. S2 confirmed the facility did not conduct an investigation concerning the patient’s allegation.”

“DISCHARGE PLANNING CFR(s): 482.43 The hospital must have in effect a discharge planning process that focuses on the patient goals and treatment preferences and includes the patient and his or her caregivers support person(s) in the discharge planning for post-discharge care. The discharge planning process and the discharge plan must be consistent with the patient’s goals for care and his or her treatment preferences, ensure an effective transition of the patient from hospital to post-discharge care, and reduce the factors leading to a preventable hospital readmissions This Condition is not met as evidenced by: 49828 Based on medical records review and review of facility documents, it was determined that the facility failed to ensure that patients are transferred to another facility within the expected time frame of the discharge plan when hemodialysis (HD) services are not able to be provided. Cross Reference: 482.43(a)(1) Discharge Planning: Timely Evaluation”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 49828 Based on one of one medical record reviewed for blood transfusions, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the patient received a blood transfusion immediately, as prescribed. Findings include: A review of the medical record for Patient (P) 3 indicated that he/she was admitted to the facility on 10/06/24. P3 has a history of End Stage Renal Disease (ESRD) requiring hemodialysis (HD), and receives dialysis on a schedule of Tuesday, Thursday, and Saturday. On 10/14/24 at 3:26 PM, a critically low hemoglobin laboratory result of 6.8 g/dL (grams per deciliter), was called to Staff (S)17, the Registered Nurse (RN) caring for P3 at that time. A low hemoglobin level indicates a decrease in red blood cells. A normal hemoglobin range is 12.0-16.0 g/dL. On 10/14/24 at 3:56 PM, S17 documented a “Nursing Narrative Note” that stated, “... spoke with Dr [doctor] about critical hemoglobin and he/she asked me to notify GI [Gastroenterology] as well as Nephrologist for possible transfusion with dialysis ...”. On 10/14/24 at 7:23 PM, S17 documented a “Nursing Narrative Note” that stated, “... hematologist saw the patient and is trying to get consent for blood transfusion ...”. A “Progress Note” dated for the following day, 10/15/24 at 7:04 AM, documented by the physician stated, “ ...Blood work showed hemoglobin to be extremely low patient to have blood transfusion today.” Twenty hours and 53 minutes after the RN was notified of the critically low hemoglobin result, at 12:19 PM on 10/15/24, a physician’s order was placed to, “TRANSFUSE Red Blood Cells ...Priority Stat [immediately]...” Approximately five hours after the order was placed, on 10/15/24 at 5:14 PM, a “Progress Note” documented by the Hematologist stated, “... 10/15 pt [patient] seen in follow up for PRBC [packed red blood cell] transfusion ... Pt for PRBC transfusion, discussed with son about consent Follow cbc [complete blood count] ...”. On 10/16/24 at 2:29 AM, a “Nursing Narrative Note” documented by S16, the RN caring for P3 at that time, stated, “.... Pt also has uncompleted blood transfusion orders from the day. I contacted blood bank to prepare the unit per order. Consent, copy of the order and requisition forms faxed to blood bank. Pending receipt of blood to initiate transfusion. Pt v/s [vital signs] within normal limits. Pt is in no acute distress at this time ...” On 10/16/24 at 4:49 AM, P3 received their ordered blood transfusion, 16 hours and 30 minutes after the transfusion was ordered. This was also one day, 13 hours, and 23 minutes after the RN was notified of the critically low hemoglobin results. The above findings were discussed in an interview at 11:04 AM, with S15, Chief Medical Officer (CMO). S15 stated that he/she agrees that there was a “delay of care in terms of communication.” Facility policy titled, “Administration of Blood and Blood Components,” revised 06/06/23, stated, “... Procedure ... Blood must be administered as soon as possible and within 30 minutes of release from Blood Bank. ...””

“DISCHARGE PLANNING TIMELY EVALUATION CFR(s): Any discharge planning evaluation must be made in a timely basis to ensure the appropriate arrangements for post-hospital care will be made before discharge and to avoid unnecessary delays in discharge. This Standard is not met as evidenced by: 49828 Based on one of four medical record reviewed, staff interview, and review of facility documents, it was determined the facility failed to ensure that patients are transferred to another facility within the expected timeframe of the discharge plan when hemodialysis (HD) services are not able to be provided. Findings include: On 10/23/24 at 10:37 AM, a review of Patient (P) 3’s medical record revealed the following: P3 was admitted on 10/06/24 at 3:54 AM. P3 had a past medical history of End Stage Renal Disease (ESRD) requiring HD treatments on a schedule of Tuesday, Thursday, and Saturdays. While admitted to the facility, P3 received dialysis treatments regularly until Tuesday 10/15/24, when the facility went on dialysis divert. On 10/15/24 at 3:10 PM, a “Nursing Narrative Note” documented by Staff (S) 17, a Registered Nurse (RN) stated, “... Dialysis held today for RO [Reverse Osmosis] out of service MD [Medical Doctor] made aware ...” At 4:11 PM, a “Nursing Narrative Note” documented by S17 stated, “... report called to RN at [receiving facility] at 04:11 PM ...” On 10/16/24 at 2:29 AM, a “Nursing Narrative Note” made by S16, the RN caring for P3 at that time stated, “... I was informed during handoff that pt [patient] had been discharge and was just waiting to be picked up by transportation to [receiving facility] due to dialysis diversion at [current facility] by AM [morning] RN, [S17]. Pt however had no discharge orders placed, this writer attempted to call attending [physician name] multiple times to secure an order for discharge but my calls were unanswered. Nursing supervisor aware ... Pt v/s [vital signs] within normal limits. Pt is in no acute distress at this time ...” On 10/16/24 at 11:20 AM, P3 was transferred to a different facility capable of providing HD services. The above findings were discussed during an interview on 10/23/24 at 11:04 AM, with S15, Chief Medical Officer (CMO). S15 stated that the Hospitalist who is on the facility’s campus at all times would have been able to discharge the patient. S15 stated that he/she agreed that there was a delay of care in terms of communication. Per S15, the process for escalation in the event staff is unable to reach the attending is to attempt to reach out to the medical staff in the following order: 1. Attending, 2. Hospitalist, 3. Tele Intensivist, 4. Physician Advisor, 5. CMO. S15 stated that his/her personal number is posted on each unit. S15 stated that at the time of the interview he/she was unable to get in contact with the nursing supervisor to ask if the event was escalated. S15 confirmed that the event was not escalated to him/her. S15 stated that he/she called the attending physician for P3 and found that the attending physician stated he/she did not receive any calls. The attending did not realize he/she needed to place discharge orders because he/she had told the staff on 10/15/24 that the patient was being transferred and contacted the receiving facility personally. Due to the dialysis divert and the delay in receiving discharge orders from a physician, P3 did not receive dialysis on their scheduled day of 10/15/24. The facility provided a document on 10/23/24 at 3:00 PM titled, “Medical Staff Rules and Regulations” that stated, “Patients shall be discharge only upon order of the attending physician ...”.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 38256 Based on review of medical records (MR), review of facility documents, and staff interviews, it was determined that the facility failed to ensure that nursing care plans were developed upon admission for nine of 16 medical records reviewed (Patient (P) 8, P9, P10, P11, P12, P13, P14, P15, and P16) (A0396). Cross Reference: 482.23(b)(4) Nursing Services: Nursing Care Plan”

“PHYSICAL ENVIRONMENT CFR(s): 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. This Condition is not met as evidenced by: 38289 Based on observation, review of facility documents, and staff interviews, it was determined that the facility failed to ensure 1.) the heating and ventilation system was maintained and functioning for the safety and well-being of the patients (A0701); and 2.) temperatures in the medication room were maintained within an acceptable level (A0724). This failure resulted in and Immediate Jeopardy (IJ), posing a serious risk of harm to the patients. On 8/16/24, at 3:05 PM, an IJ was identified due to the facility’s failure to ensure the maintenance of the building’s air conditioning and to activate the internal disaster plan for HVAC (Heating, Ventilation and Air Conditioning) failure in order to maintain the safety and well-being of the patients in the hospital. On 8/16/24 at 3:58 PM, the IJ template was presented to the administration and a removal plan was requested. On 8/19/24, at 11:05 AM, an acceptable removal plan was received. The facility implemented the following to address the IJ: Patients located on the behavioral health units were transferred out to accepting facilities; Patients on the 3 West Unit were transferred to the 2 West Unit where temperature readings were within normal range; the air chiller that controlled the HVAC for the Intensive Care Unit (ICU) was repaired; Temperatures were continued to be monitored on patient care units by the facility every four hours to ensure adequate cooling. The IJ was removed on 8/19/24, at 4:07 PM, after the State Survey Agency verified the full implementation of the removal plan, and the Condition level non-compliance remains (A0701). Cross Reference: 482.41(a) Physical Environment: Buildings 482.41(d)(2) Physical Environment: Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality”

“DISCHARGE PLANNING CFR(s): 482.43 The hospital must have in effect a discharge planning process that focuses on the patient goals and treatment preferences and includes the patient and his or her caregivers support person(s) in the discharge planning for post-discharge care. The discharge planning process and the discharge plan must be consistent with the patient’s goals for care and his or her treatment preferences, ensure an effective transition of the patient from hospital to post-discharge care, and reduce the factors leading to a preventable hospital readmissions This Condition is not met as evidenced by: 38256 Based on review of medical records, review of faciltiy documents, and staff interviews, it was determined the facility failed to ensure that discharge planning evaluations were included in nine of 16 medical records reviewed (Patient (P) 8, P9, P10, P11, P12, P13, P14, P15, and P16) (A0808). Cross Reference: 482.43(a)(3) Discharge Planning: Discharge Planning Evaluation”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 37656 Based on medical record reviews, staff interviews, and a review of facility documents, it was determined that the facility failed to ensure that nursing care plans were developed upon admission for nine of 16 medical records reviewed (Patient (P) 8, P9, P10, P11, P12, P13, P14, P15, and P16). Findings include: On 8/23/24, a review of the nine medical records of patients on the 5 West unit lacked documented evidence of nursing care planning for patient treatment goals while in the hospital and discharge planning for post-hospital needs. P8 was admitted on 8/8/24 for infective endocarditis. P9 was admitted on 7/26/24 to rule out angina, with history of atherosclerotic arteries. P10 was admitted on 7/26/24 for lower back pain, with history of cauda equina syndrome (nerve compression caused by a herniated disk) and spinal surgery. P11 was admitted on 7/25/24 as a transfer from another facility for an unspecified infection of the skin and subcutaneous tissue. Per the physician admission notes, P11 was sent to the facility for monitoring and continuum of care. P11 has a past medical history of cardiac issues, dementia, high blood pressure, AKA (above knee amputation), high cholesterol, paraplegia (paralysis of lower extremities), Thiamine deficiency, Type 2 Diabetes Mellitus (DM), urinary tract infection (UTI), and Vitamin D deficiency. P12 was admitted on 7/25/24 with a primary diagnosis of Multiple Sclerosis with limited mobility to lower extremities and was ordered physical therapy (PT) and occupational therapy (OT) services. P13 was admitted on 7/25/24 as a transfer from another facility for a local infection of the skin and subcutaneous tissue in the right axillary with a positive culture for MRSA (methicillin resistant staphylococcal aureus) which required contact isolation. P14 was admitted on 7/25/24 as a transfer from another facility for a history of anemia, anxiety, chronic suprapubic catheter with chronic UTI, constipation, depression, fatigue insomnia, left and right leg pain, polyneuropathy (nerve malfunction), and seizure. P14 was ordered PT and OT services. P15 was admitted on 7/25/24 with congestive heart failure, DM, dilated cardiomyopathy, gastroesophageal reflux disease (GERD), hypertension, high cholesterol, myocardial infarction, and other multiple health issues, including a wound to the right lower abdomen. P16 was admitted on 8/01/24 as a transfer from another facility with complaints of cramping, swollen legs and groin pain. P16 has a history of DM, GERD, and cerebrovascular accident (stroke), sacral decubiti stage II (wound), and atrial fibrillation (irregular heart beat). In an interview on 8/23/24 at 2:05 PM, Staff 36, Case Manager, stated that the Interdisciplinary Team was doing rounds on 5 West and was “working out” the process with the insurance company. A review of the facility policy titled, Nursing Standards of Care and Nursing Practice, reviewed July 2024, stated, “... Standard III - Plan of Care ... On admission a plan of care will be developed using the admission history information. ... The nurse will use the information to construct and apply an appropriate plan of care to ensure patient safety and reach discharge goals. Other disciplines will collaborate in forming patient goals as needed. ... The plan of care will work towards a common goal of a safe comfortable discharge. ...””

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 33557 Based on observation, document review, staff interviews, and review of facility documentation, it was determined that the facility failed to ensure the heating and air conditioning system is maintained and functioning for the safety and well-being of all patients. Findings include: On 8/16/24 at 11:00 AM, during a tour of the 5 West Unit, located on the 5th floor, the following room temperatures were measured and confirmed by Staff (S) 2, the Facility Manager: (Normal inpatient room temperatures 70-75 degrees Fahrenheit) Room #558, #563, #565, and #566: 76.0 degrees Fahrenheit (F) Room #561: 79.0 degrees Fahrenheit On 8/16/24 at 11:20 AM, during a tour of the Intensive Care Unit (ICU) located on the 5th floor, the following room temperatures were confirmed by S2: Room #511, unoccupied (available for patient use), Isolation Room: 81.9 Degrees Fahrenheit Room #524, occupied: 83.4 degrees Fahrenheit Room #523, occupied: 84.7 degrees Fahrenheit Room #517, occupied: 81.0 degrees Fahrenheit Room 500-1, occupied: 83 degrees Fahrenheit Room 500-6, occupied: 81.1 degrees Fahrenheit Nurses’ Station: 84.2 degrees Fahrenheit On 8/16/24 at 11:40 AM, during a tour of the Behavioral Health Unit 4 Main located on the 4th floor. Patients and staff were observed with visible sweat-stained clothing. The following room temperatures were confirmed by S2: Group Room: 86.6 degrees Fahrenheit Dining Room: 86.5 degrees Fahrenheit Behavioral Health Unit Corridor: 85 degrees Fahrenheit Room #405: 86.4 degrees Fahrenheit Seclusion Room #1: 87.0 degrees Fahrenheit Seclusion Room #2: 87.7 degrees Fahrenheit Room #406: 86.7 degrees Fahrenheit Room #408: 87.0 degrees Fahrenheit Quiet Room: 88.5 degrees Fahrenheit Nurse’s Station: 87.0 degrees Fahrenheit Room #410: 86.1 degrees Fahrenheit Room #412: 87.4 degrees Fahrenheit Room #413: 88.7 degrees Fahrenheit Room # 414: 89.6 degrees Fahrenheit Room #415: 88.7 degrees Fahrenheit Activity Room: 86.1 degrees Fahrenheit Medication Room: 91.2 degrees Fahrenheit On 8/16/24 at 12:40 PM, during a tour of the 3 Main Unit (Medical/Surgical) located on the 3rd floor, the following room temperatures were confirmed by S2: Room #312: 82.5 degrees Fahrenheit Room #318: 78.0 degrees Fahrenheit Room #327: 88.7 degrees Fahrenheit Room #329: 89.7 degrees Fahrenheit Room #330: 88.4 degrees Fahrenheit Room #331: 89.7 degrees Fahrenheit Room #336: 85.6 degrees Fahrenheit Room #338: 86.0 degrees Fahrenheit Medication Room: 87.1 degrees Fahrenheit A review of work orders from the HVAC contractor dated 5/14/24, 5/22/24, and 8/7/24 identify the reason for the visit as a “repair.” During an interview on Friday, 8/16/24 at 11:00 AM, S2 stated the HVAC Contractor was on-site working on the air conditioning and that the repairs to the air conditioning system would not be completed until Monday or Tuesday of next week. S2 added, temperatures on patient care units have been elevated since 8/4/24. Portable air conditioning units were dispersed throughout the hospital but were not alleviating the high temperatures based on a review of the facility provided temperature logs. Temperatures of patient care areas were taken every four (4) hours by the facility’s maintenance staff. During an interview with S2 on 8/19/24 at 1:30 PM, he/she confirmed the routine preventative maintenance is not preformed on the HVAC system. S2 confirmed the contractor was only called to make repairs as needed. During a review of facility provided temperature logs dated 8/4/24, elevated temperatures were found on the following patient care units: 7:00 AM: 5-West: Between 76 and 78 degrees Fahrenheit, 4-Main: 78-81 degrees Fahrenheit, ICU 5th Floor: 78-80 degrees Fahrenheit, 3:00 PM: 2 West: 77-79 degrees Fahrenheit, 5-West: 77-78 degrees Fahrenheit, 4-Main: 76-78 degrees Fahrenheit, 4-West: 77-78 degrees Fahrenheit, 11:00 PM:2 West: 77-78 degrees Fahrenheit, 5-West: 76-77 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/5/24, elevated temperatures were found on the following patient care units: 7:00 AM: 2 West: 76-78 degrees Fahrenheit, 4-Main: 76-79 degrees Fahrenheit, 3:00 PM: 2 West: 76-77 degrees Fahrenheit, 5-West: 78-79 degrees Fahrenheit, ICU 5th Floor: 77-78 degrees Fahrenheit, 4-Main: 76-79 degrees Fahrenheit, 4-West: 76-78 degrees Fahrenheit, 11:00 PM:2 West: 76-78 degrees Fahrenheit, 5-West: 78-79 degrees Fahrenheit, ICU 5th Floor: 77-78 degrees Fahrenheit, 4-Main: 78-79 degrees Fahrenheit, 4-West: 77-78 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/6/24, elevated temperatures were found on the following patient care units: 7:00 AM: 2 West: 76-78 degrees Fahrenheit, 4-Main: 79-81 degrees Fahrenheit, 4-West: 76-78 degrees Fahrenheit, 3:00 PM: 4-Main: 76-79 degrees Fahrenheit, 11:00 PM: 2 West: 76-78 degrees Fahrenheit, 5-West: 77-78 degrees Fahrenheit, ICU 5th Floor: 77-78 degrees Fahrenheit, 4-Main: 77-78 degrees Fahrenheit, 4-West: 77-78 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/7/24, elevated temperatures were found on the following patient care units: 11:00 PM 2 West: 76-78 degrees Fahrenheit, 5-West: 78-79 degrees Fahrenheit, 4-Main: 77-78 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/8/24, elevated temperatures were found on the following patient care units: 3:00 PM: 2 West: 76-78 degrees Fahrenheit, 4-Main: 81-82 degrees Fahrenheit, 11:00 PM 2 West: 76-78 degrees Fahrenheit, 5-West: 76-78 degrees Fahrenheit, 4-Main: 77-78 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/9/24, elevated temperatures were found on the following patient care units: 7:00 AM: 4-Main: 79-81 degrees Fahrenheit, ICU 5th Floor: 77-79 degrees Fahrenheit, 3:00 PM: ICU 5th Floor: 78-82 degrees Fahrenheit, 4-Main: 81-83 degrees Fahrenheit, 11:00 PM: ICU 5th Floor: 79-81 degrees Fahrenheit, 4-Main: 79-82 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/10/24, elevated temperatures were found on the following patient care units: 7:00 AM: 4-Main: 81-83 degrees Fahrenheit, ICU 5th Floor: 80 degrees Fahrenheit, 3:00 PM: ICU 5th Floor: 78-84 degrees Fahrenheit, 4-Main: 78-84 degrees Fahrenheit, 5-West: 77-78 degrees Fahrenheit, 11:00 PM: 4-Main: 78-79 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/11/24, elevated temperatures were found on the following patient care units: 7:00 AM: 2 West: 76-78 degrees Fahrenheit, 4-Main: 80-83 degrees Fahrenheit, 5-West: 77-79 degrees Fahrenheit, 3:00 PM: ICU 5th Floor: 78-84 degrees Fahrenheit, 4-Main: 77-78 degrees Fahrenheit, 5-West: 77-78 degrees Fahrenheit, 11:00 PM 4-Main: 78-79 degrees Fahrenheit, 4-Main: 76-78 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/12/24, elevated temperatures were found on the following patient care units: 7:00 AM: 2 West: 76-78 degrees Fahrenheit, 4-Main: 80-83 degrees Fahrenheit, 5-West: 77-79 degrees Fahrenheit, ICU 5th Floor: 77-78 degrees Fahrenheit, 3:00 PM: ICU 5th Floor: 78-84 degrees Fahrenheit, 4-Main: 77-79 degrees Fahrenheit, ICU 5th Floor: 77-78 degrees Fahrenheit, 11:00 PM 4-Main: 77-79 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/13/24, elevated temperatures were found on the following patient care units: 7:00 AM: 4 West: 79-80 degrees Fahrenheit, 4-Main: 81-82 degrees Fahrenheit, 3:00 PM: 4-Main: 81-83 degrees Fahrenheit, 11:00 PM 4-Main: 77-79 degrees Fahrenheit, During a review of facility provided temperature logs dated 8/14/24, elevated temperatures were found on the following patient care units: 7:00 AM: 4-Main: 82-85 degrees Fahrenheit, 5-West: 76-78 degrees Fahrenheit, ICU 5th Floor: 77-78 degrees Fahrenheit, 3:00 PM: 3-Main: 78-85 degrees Fahrenheit, ICU 5th Floor: 78-84 degrees Fahrenheit, 4-Main: 84-86 degrees Fahrenheit, ICU 5th Floor: 77-83 degrees Fahrenheit, 5-West: 76-78 degrees Fahrenheit,”

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 38289 Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure temperatures in the medication room were maintained within the acceptable temperature range (68-77 degrees Fahrenheit). Findings include: On 8/16/24 at 12:00 PM, during a tour of the 4 Main Unit, the counter in the medication room was observed to have medications labeled with patient’s names for distribution. The medication Invega Sustenna, an antipsychotic medication, was on the counter. The box of the medication stated, “Store at room temperature (77 degrees Fahrenheit, 25 degrees Celsius); excursions between 59 degrees Fahrenheit and 86 degrees Fahrenheit (15 degrees Celsius and 30 degrees Celsius) are permitted.” The temperature in the medication room, per the wall thermostat, read 89.4 degrees Fahrenheit. Staff (S) 2, the Facility Manager, confirmed the finding at the time of discovery and used his/her infrared thermometer device (a handheld device for temperature measurement) to determine the accuracy of the wall thermostat. The temperature reading per the infrared thermometer was 91.2 degrees Fahrenheit. The medication room also contained an Omnicell, a medication storage system. At 12:11 PM, upon request, the door to the Omnicell was opened and a temperature was recorded at 93 degrees Fahrenheit. A paper temperature log was observed hanging on the side of the Omnicell for the month of August 2024. The log indicated “MedRoom Temp Range: (normal 68-77 degrees Fahrenheit).” Each day, the temperature was checked at 7 AM, 3 PM, and 11 PM. Per the log, temperatures in the medication room were documented to have been out of range starting on 8/1/24 at 3 PM. Forty-five temperature checks were completed for August 2024, 39 out of 45 temperature checks were documented above the normal range. Documentation next to the abnormal value stated “notified” in the column of the log marked “DOP [Director of Pharmacy] notified when out of normal room temp range.” An interview was conducted on 8/19/24 at 12:11 PM with S14, Director of Pharmacy, regarding the above findings. S14 stated that he/she had not received any notifications regarding the abnormal temperatures on 4 Main. S14 stated that the staff of the unit documents on the log and he/she was not sure where the notifications went. S14 stated that the pharmacy staff has monthly inspections in the units and that the inspection for August 2024 had not been completed yet. S14 further stated that the inspections are not on specific days or at regular intervals, just that they have to occur once a month. S14 stated that on 8/16/24, upon notification of the out of range temperatures, S14 did an inspection of the medication room on the 4 West/4 Main Unit and removed all medications from the room and the Omnicell for destruction. The medication room and Omnicell was then set up on the 4 East Unit to accommodate the patient’s needs on the 4 West and 4 Main Units. S14 confirmed that if medications are stored outside of the the acceptable temperature range for an extended duration of time then the medications could be potentially unsafe for use. On 8/19/24 at 1:25 PM, an interview was conducted with S13, Chief Nursing Officer, who stated that there was no definitive process in place and that the facility should have one. S13 confirmed that without a process for monitoring and accountability of the temperature logs, the result could be harmful to patients. Facility policy titled, “Pharmacy - Medication Management - Storage” stated, “... Medications, biologicals, and devices shall be stored to ensure their integrity, stability, and effectiveness ... STORAGE OF MEDICATIONS BETWEEN RECEIPT AND ADMINISTRATION ... The drug should not be left on or in any area exceeding 25 degrees C [Celsius] (80 degrees Fahrenheit) for any extended period of time. The Pharmacy Director will engage Facility Services to mitigate any heat liability ... STORAGE CONDITIONS ... Medications shall be stored under the proper conditions of sanitation, temperature, light, moisture, ventilation, organization, segregation, safety, and security. Temperatures and ventilation in the work areas shall ensure the integrity of medications ... Room temperatures in medication storage areas shall be monitored twice daily (minimum 8 hour interval) including documentation on an appropriate temperature log displayed in the room itself ...””

“DISCHARGE PLANNING EVALUATION CFR(s): The discharge planning evaluation must be included in the patient’s medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient’s representative). This Standard is not met as evidenced by: 37656 Based on medical record reviews, staff interviews, and a review of the facility documents, it was determined the facility failed to ensure that discharge planning evaluations were included in nine of 16 medical records reviewed (Patient (P) 8, P9, P10, P11, P12, P13, P14, P15, and P16). Findings include: On 8/23/24, a review of nine medical records on the 5 West, Medical/Surgical Unit, revealed that nine of nine medical records lacked documented evidence that a discharge planning evaluation was conducted and that case management interdisciplinary rounds were conducted on a daily basis in accordance with the facility policy: P8 was admitted on 8/8/24 for infective endocarditis. P9 was admitted on 7/26/24 to rule out angina, with history of atherosclerotic arteries. P10 was admitted on 7/26/24 for lower back pain, with history of cauda equina syndrome (nerve compression caused by a herniated disk) and spinal surgery. P11 was admitted on 7/25/24 as a transfer from another facility for an unspecified infection of the skin and subcutaneous tissue. Per the physician admission notes, P11 was sent to the facility for monitoring and continuum of care. P11 has a past medical history of cardiac issues, dementia, high blood pressure, AKA (above knee amputation), high cholesterol, paraplegia (paralysis of lower extremities), Thiamine deficiency, Type 2 Diabetes Mellitus (DM), urinary tract infection (UTI), and Vitamin D deficiency. P12 was admitted on 7/25/24 with a primary diagnosis of Multiple Sclerosis with limited mobility to lower extremities and was ordered physical therapy (PT) and occupational therapy (OT) services. P13 was admitted on 7/25/24 as a transfer from another facility for a local infection of the skin and subcutaneous tissue in the right axillary with a positive culture for MRSA (methicillin resistant staphylococcal aureus) which required contact isolation. P14 was admitted on 7/25/24 as a transfer from another facility for a history of anemia, anxiety, chronic suprapubic catheter with chronic UTI, constipation, depression, fatigue insomnia, left and right leg pain, polyneuropathy (nerve malfunction), and seizure. P14 was ordered PT and OT services. P15 was admitted on 7/25/24 with congestive heart failure, DM, dilated cardiomyopathy, gastroesophageal reflux disease (GERD), hypertension, high cholesterol, myocardial infarction, and other multiple health issues, including a wound to the right lower abdomen. P16 was admitted on 8/01/24 as a transfer from another facility with complaints of cramping, swollen legs and groin pain. P16 has a history of DM, GERD, and cerebrovascular accident (stroke), sacral decubiti stage II (wound), and atrial fibrillation (irregular heart beat). In an interview on 8/23/24 at 2:05 PM, Staff (S) 35, Social Worker, and S36, Case Manager, stated that interdisciplinary (IDT) rounds were not being done on 5 West. S6 stated that he/she performs utilization review by reading the physician notes and sending each patient’s clinical information to the insurance company. When asked for documentation of communication to the insurance company, both S35 and S36 were unable to provide the documentation. A review of the facility policy titled, “Discharge Planning and the Continuum of Care,” reviewed July 2024, stated, “It is the policy of (name of the facility) ... to maintain an interdisciplinary service that facilitates the continuity of patient care for medical and surgical patients which takes into consideration the unique contributions of all disciplines and departments providing patient care services. The discharge planning process is coordinated by the Continuing Care Department. ... PURPOSE: 1. To ensure that patients have a plan for post-hospital care that addresses their medical, nursing, psychosocial, functional, and financial needs, and that provides them ... with maximum information ... and other support services. ... SCOPE: Members of the interdisciplinary healthcare team include but not limited to the patient, the medical staff, the department of nursing, case management staff, physical rehabilitation, pharmacy, radiological services and food and nutrition. QUALIFICATION/RESPONSIBLE PARTIES: Continuing Care staff including case managers, social workers, and discharge planners. ... PROCEDURE: 1. All patients will be assessed to determine which patients are at risk to experience adverse health consequences without a discharge plan. ... 3. All patients are assessed and reassessed as applicable, and identify discharge planning needs including the need for specialized medical equipment or environmental modifiers. 4. Members of the interdisciplinary healthcare team responsible for patient care discuss the care of patients on a regular basis. 5. Each member of the interdisciplinary healthcare team determines the type of continuing care services to be provided and documents the plan in his/her progress notes. The social worker/care manager facilitates the recommendations of the healthcare team in the development of an overall discharge plan. ...” A review of the facility policy titled, “Interdisciplinary Rounds,” reviewed March 2024, stated, “Case Management interdisciplinary rounds will be held on all medical and surgical units on a daily basis ...””

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 33557 Based on document review and staff interview on 8/22/24, it was determined that the facility failed to review and update the Emergency Preparedness Program at least annually. Findings include: During a review of the Emergency Preparedness Program at 1:50 PM, the last documented review date was 1/1/2019. At 2:00 PM, during an interview with Staff (S)3, the VP of Operations, who oversees the Emergency Preparedness Program, S3 confirmed the Emergency Preparedness Program was last reviewed and approved on 1/1/2019. S3 further stated, “The Emergency Preparedness Program is currently under review and undergoing updating.””

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 33557 Based on document review and staff interview, it was determined that the facility failed to ensure policies and procedures are developed to ensure the safe evacuation of patients from the facility. Findings include: During a review of the facility Emergency Preparedness Plan (EPP) on 8/23/24, it was identified that the plan failed to address how an evacuation would be handled, to include communication with receiving facilities, coordination of transportation, or clear triggers for staff to activate the evacuation plan. During a review of the EPP plan for Utility Failure, no guidance or triggers were identified to tell staff when to enact the policies and procedures related to the emergency transfer of patients to other hospitals. On 8/19/24 at 1:30 PM, Staff (S1), Director of Quality and Informatics was interviewed concerning the sustained elevated temperatures that were not controlled despite the facility’s use of portable air conditioning units in the patient care areas. S1 was asked if the EPP was activated due to the air condition failure and extreme temperatures in the building and S1 stated, “No.” S1 was then asked when would the facility activate their EPP and relocate patients to appropriate facilities and S1 was unable to state what triggers would initiate the evacuation of patients under the utility failure EPP.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 46468 Based on review of Medical Records (MR), review of facility documents and interview with Staff (S) it was determined the facility failed to ensure freedom from pain and abuse of one patient as evidenced by: failing to implement their processes and policies on Workplace Violence and Abuse Reporting (A0145). This failure resulted in an Immediate Jeopardy, posing a serious risk of abuse and harassment to the patients, staff, and visitors. During a review of the 3/29/24 video surveillance, an incident was noted between security officers and a discharged patient. It was observed that one officer forcefully placed his/her knee on the individual’s head. On 4/23/24, upon interview with a security officer present during the event, the officer stated that one officer hit the individual in the face multiple times. Three officers involved were terminated. The facility was unable to provide the evidence of staff education after the 3/29/24 event. On 4/24/24 at 2:18 PM, the facility submitted an acceptable removal plan. Verification of the removal plan was conducted to include interviews with staff, and review of the educational documents and sign in sheets from each unit in the hospital, noting who received the Workplace Violence and Abuse Reporting re-education. Upon interview with two registered nurses, five security guards, and one unit secretary, it was confirmed that the refresher education; regarding Workplace Violence and Abuse Reporting, and the updated documents. They were able to speak to the communication that needs to be made for any suspected abuse and where to find or who to ask for more explanation if needed. The staff reinforced the need to document any event, especially with suspected abuse, in the incident reporting system. Upon verification of the implementation of the removal, the IJ was lifted on 4/24/24 at 4:30 PM. Cross Reference: 482.13(c)(3) Patient Rights: Free From All Forms of Abuse or Harassment.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 46468 Based on staff interview, review of facility documents, review of the security surveillance video, and review of one of one Medical Record, it was determined the facility failed to implement their policy and re-educate staff on Workplace Violence and Abuse Reporting; thus posing a serious risk of abuse or harassment to patients, staff and visitors. Findings include: On 4/22/24 at 10:20 AM, an entrance conference was conducted with Staff (S)1, the Director of Quality and Informatics. The facility policies, documents, medical record review, and a tour were requested. At 12:35 PM, the Incident Report Log was reviewed, and the following was revealed: The Incident Report log entry dated “3/29/2024 4:52:52 PM” and titled, “Hospital, Behavior (Assault/Abuse/Neglect) Threat, Emergency Department” stated, “...The patient, [P1’s name] had earlier resisted being discharged from the ER (Emergency Room). Security managed to convince the patient leave the ER. At the waiting [he/she] turned aggressive towards the security insisting to be let back into the ER .... The patient left the ED (Emergency Department) and came back armed with 3 rocks and shattered the ED entrance. [Name of Police Department] responded and took [him/her] into custody ....” P1’s Medical Record was reviewed in the presence of S1 and revealed the following: On 3/29/24 at 2:32 PM, a Nurse Practitioner (NP) progress note indicated P1 arrived at the ED as a walk-in with complaints of being physically, emotionally, and mentally exhausted; not compliant with his/her medication. The NP note stated, “ ...Patient selective with care, refused chest x-ray and blood to be drawn ... Patient made aware of all abnormal lab result and cleared for discharge by crisis and medically cleared. Patient instructed to follow-up with PMD [Primary Medical Doctor] after discharge. Patient agreed and verbalized understanding ....” On 3/29/24 at 2:34 PM, S13’s (ED Nurse) Nursing progress note stated, “Patient for discharge, written instructions given, advised to follow up with outpatient psych [psychiatric] as per crisis, patient refused to sign discharge instructions.” On 3/29/24 at 3:31 PM, S13’s Nursing progress note stated, “ ...Patient refusing to leave ED treatment area after being discharged, Security called, and patient escorted out of ED ....” On 4/22/24 at 2:57 PM, the Security surveillance video [from 3/29/24] was reviewed in the presence of Staff (S)1, Director of Quality and Informatics, and S9. The following was revealed: On 3/29/24 at 3:55 PM, Patient (P)1 walked away from the Emergency Department (ED) main entrance, towards Central Avenue. At 3:56:36 PM, P1 returns into view, approaches the ED main entrance, and throws three objects at the ED main entrance doors, shattering the glass. At 3:56:58 PM, S12, Interim Security Manager, S15, a Security Officer (SO), and S20, a SO, were viewed restraining P1 by securing his/her left and right arms, and waist. P1 falls to the ground and at 3:57 PM, S19, a SO, uses his/her knee to push P1’s head to the ground, forcefully. At 3:58 PM, P1 was brought back inside to a chair at the end of the ramp, by the ED main entrance. The chair was not able to be viewed on the Security surveillance video. Upon interview, S9 stated this part of the ED main entrance is a “blind spot” and cannot be viewed on surveillance video. The police report filed on 3/29/24 at 3:10 PM state, “... The officer spoke with the suspect[male/female] who was later identified as [P1] who stated [he/she] damaged the window to get the hospital staff attention because [he/she] still needs more help after being discharged ... [P1] stated that after [he/she] broke the glass the security guard jumped on [him/her] causing [him/her] to have a cut on [his/her] left ear and left eye. EMS [emergency medical services] responded to prisoner intake to treat [P1] for injuries.” On 4/22/24, a tour of the ED was conducted with S1 and S2, the ED Nurse Manager. During the tour, the following was revealed: At 11:04 AM, upon interview with S6, a Security Officer (SO), S6 explained that the nurse manager, security supervisor, or any witness to a violent act can call the police, and the manager of security documents all calls to the police in the Security Shift Report. S6 indicated he/she was not debriefed, nor did he/she receive any re-education regarding Abuse Reporting, Handle With Care (HWC: de-escalation and restraint training) and/or the policy regarding Workplace Violence (after the incident of 3/29/24). On 4/23/24, the Workplace Violence (WPV) Committee meeting minutes from November 2023 to April 2024, were reviewed and the following was revealed: The WPV Committee’s meetings for January and February 2024 were “canceled.” The discussion regarding Handle With Care (HWC) was “tabled” (not discussed), due to a lack of time. On 4/23/24 the following staff members were interviewed, and the following was revealed: At 10:34 AM, S7, Security Supervisor, stated he/she “contacted the EOPD, many times due to the aggressive behavior of [P1].” S7 indicated that P1 was considered trespassing, because he/she was discharged from the ED at that time. S7 stated that S12 filed an incident report with the police report number, and informed him/her to go home, it was the end of the shift. S7 informed surveyors that he/she did not receive any re-education regarding Abuse Reporting, HWC, and/or regarding Workplace Violence (after the incident of 3/29/24). At 11:13 AM, S13, a Registered Nurse (RN) stated that on 3/29/24, “[P1] refused to leave ED Bay 13, after being discharged.” S13 indicated that P1 did not meet the criteria for drug detoxification, which he/she requested. S13 stated that he/she “was unable to verbally redirect [P1] and he/she informed the SO in the ED that assistance was needed.” S13 explained that following an incident all witnesses were supposed to fill out a witness statement to go along with the incident report. S13 did not receive any re-education regarding Abuse Reporting, HWC, and/or regarding Workplace Violence (after the incident of 3/29/24). At 12:02 PM, S15, a SO, indicated that towards the end of his/her shift on 3/29/24, he/she was alerted (via overhead page) that assistance was needed with an aggressive patient in ED Bay 13. S15 explained that when he/she arrived at ED Bay 13, ED staff were surrounding P1, and [S15] instructed staff to step away and provide P1 with space. S15 stated that he/she and ED staff were able to verbally re-direct P1 into a wheelchair, and then P1 was escorted out of the ED waiting room. P1 sat in a chair at the end of the wheelchair ramp, and S15 returned to his/her post. S15 stated he/she returned to the ramp, where he/she observed S12, S18 and S20 with P1. S15 indicated that S12 had moved the chair in which P1 was sitting, out of the camera view, and S18 struck P1 in the head and face, with closed fists and S12’s elbow. P1’s nose began to bleed, and this was right when the EOPD came in. S15 stated that he/she “wrote, not typed, a witness statement, when I returned to work the next day,” regarding the incident with P1 on 3/29/24. S15 indicated he/she did not receive any re-education regarding Abuse Reporting, HWC, and/or the policy regarding Workplace Violence (after the incident of 3/29/24). At 2:08 PM, S16, a SO, indicated he/she was watching the security cameras and observed the SOs standing outside of the ED main entrance, and went to help. S16 indicated he/she did not assist in physical de-escalation/restraint, because P1 was already on the ground and “it didn’t feel right to do that to someone that was already on the ground.” S15 indicated he/she did not receive any re-education regarding Abuse Reporting, HWC, and/or the policy regarding Workplace Violence (after the incident of 3/29/24). At 2:22 PM, an interview with S9, Director of Operations, confirmed that the DOH was not notified of the alleged excessive force used on P1. S9 further stated that no one was debriefed regarding the incident with P1 on 3/29/24, and re-education of HWC and workplace violence “would probably begin within the next two weeks.” S9 indicated he/she attended a Workplace Violence Committee meeting on 4/19/24, and “the discussion of re-educating staff [Abuse Reporting, HWC and Workplace Violence] was initiated.” S9 stated, “I don’t know which department specifically would receive the education.” S9 also explained that witness statements were not necessary when incident reports are filed. S9 explained that S7 and/or S12 did not make him/her aware that there was a physical incident between P1 and S12, S18, and S19 on 3/29/24. S9 stated that the investigation of the incident was initiated “after I heard rumors of the incident from facility staff.” The investigation began on 4/4/24 and was concluded on 4/8/24. S9 confirmed the alleged excessive force used on P1 was not reported to the local police department. Review of the facility policy titled, “Responding to Adverse Events,” dated 2017 stated, “ ... 7. All individuals who witnessed or participated in the occurrence will be part of the debrief. It is required that all the individuals involved participate in the debrief if at all possible. ... 8. The RCA meeting is the next step. ... 9. ... The purpose of this meeting is to finalize the root causes and establish a corrective action plan as appropriate. 10. The Quality Team will partner with the Operations Team to implement, document, and measure the corrective actions.” It was determined that the facility practice was not in accordance with the facility policy.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 38289 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure an effective governing body that is responsible for the conduct of the hospital. The facility failed to have an overall institutional plan and budget (Cross refer Tag A-0073), failed to maintain a contract for patient medical transport (Cross refer Tag A-0083), failed to maintain and have available diagnostic radiological services (Cross refer Tag A-0529), failed to ensure diagnostic services were available for patients presenting to the emergency department with a medical emergency (Patient (P) 2) (Cross Refer Tag A-1101), and failed to ensure oversight and direction of the respiratory care services department (Cross refer Tag A-1151). This failure resulted in three Immediate Jeopardy (IJ) situations, posing a serious risk of harm to patients. Findings include: On 3/7/24 at 3:28 PM, three IJ’s were identified for the facility’s failure to ensure the maintenance of a contract for patient medical transport for patients requiring diagnostic radiological services for both inpatient and in the emergency department, and for the failure of the facility to ensure the maintenance and availability of diagnostic radiological services for a patient with a medical emergency. On 3/7/24 at 5:40 PM, the three IJ templates were presented to administration and removal plans were requested. On 3/8/24 at 12:48 PM, an acceptable removal plan was received for the IJ corresponding to Tag A-0529. The facility implemented the following for this removal plan: Borrowed IV contrast from another local hospital for use at the facility until their shipment comes in; Confirmed the shipment order that was placed was changed to overnight shipping to ensure reception of the ordered contrast on 3/8/24; Re-education to radiologic staff and administration for the protocol for ordering supplies when they fall below par levels. A tour was conducted of the Radiology Department to confirm that education was received, the protocol for ordering was posted and visible to staff, and visual confirmation that the shipment of contrast dye had been received. The IJ for Tag A-0529 was resolved on 3/8/24 at 3:00 PM, after the State Survey Agency verified full implementation of the removal plan. On 3/13/24 at 1:45 PM, an acceptable removal plan was received for the IJ corresponding to Tag A-0083 and Tag A-1101. The facility implemented the following for this removal plan: Procured a transport contract with a local hospital to include medical transport for patients requiring services from the facility; a signed contract included the designation of an onsite ambulance to remain at the facility for BLS [Basic Life Support] transfers. In the event of need for ALS [Advanced Life Support] transport services, facility has plan to contact with a second ambulance provider for assistance with ALS transfer of patients on an as needed basis; and the education of Emergency Department (ED) staff of new transfer protocol. The IJ’s for Tags A-0083 and Tag A-1101 were resolved on 3/14/24 at 3:45 PM, after the State Survey Agency verified full implementation of the removal plan. Cross Reference: 482.12(c) - Contracted Services 482.12(d) - Institutional Plan and Budget 482.26 - Radiologic Services 482.55 - Emergency Services 482.57 - Respiratory Services”

“RADIOLOGIC SERVICES CFR(s): 482.26 The hospital must maintain, or have available, diagnostic radiological services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications. This Condition is not met as evidenced by: 38289 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to maintain and have available diagnostic radiologic services (Cross refer Tag A-0529), and the facility failed to ensure that a qualified staff member was appointed to the Director of Radiology position (Cross refer Tag A-0547). The failure to maintain and have available diagnostic radiological services (Tag A-0529) resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to patients. Findings include: On 3/7/24 at 3:28 PM, an IJ was identified for the facility’s failure to ensure the maintenance and availability of diagnostic radiological services for a patient with a medical emergency. On 3/7/24 at 5:40 PM, the IJ template was presented to administration and a removal plan was requested. On 3/8/24 at 12:48 PM, an acceptable removal plan was received. The facility implemented the following for the removal plan: Borrowed IV (intravenous) contrast from another local hospital for use at the facility until their shipment comes in; Confirmed the shipment order that was placed was changed to overnight shipping to ensure reception of the ordered contrast on 3/8/24; Re-education to radiologic staff and administration for the protocol for ordering supplies when they fall below par levels. A tour was conducted of the Radiology Department to confirm that education was received, the protocol for ordering was posted and visible to staff, and visual confirmation that the shipment of contrast dye had been received. The IJ was resolved on 3/8/24 at 3:00 PM, after the State Survey Agency verified full implementation of the removal plan. Cross Reference: 482.26(a) - Scope of Radiologic Services 482.26(c)(2) - Qualified Staff”

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 38289 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that the emergency needs of patients are met. The failure to maintain and have available diagnostic radiological services and to maintain a contract for patient medical transport for an Emergency Department patient with a medical emergency (Cross refer Tag A-1101) resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to patients. Findings include: On 3/7/24 at 3:28 PM, an IJ was identified for the facility’s failure to maintain and have available diagnostic radiological services and to maintain a contract for patient medical transport for an Emergency Department patient with a medical emergency. On 3/7/24 at 5:40 PM, the IJ template was presented to administration and a removal plan was requested. On 3/13/24 at 1:45 PM, an acceptable removal plan was received for the IJ (Tag A-1101). The facility implemented the following for this removal plan: Procured a transport contract with a local hospital to include medical transport for patients requiring services from the facility; a signed contract included the designation of an onsite ambulance to remain at the facility for BLS [Basic Life Support] transfers. In the event of need for ALS [Advanced Life Support] transport services, facility has plan to contact with a second ambulance provider for assistance with ALS transfer of patients on an as needed basis; and the education of Emergency Department (ED) staff of new transfer protocol. The IJ was resolved on 3/14/24 at 3:45 PM, after the State Survey Agency verified full implementation of the removal plan. Cross Reference: 482.55(a) - Organization and Direction 482.55 (a)(2) - Integration of Services”

“RESPIRATORY CARE SERVICES CFR(s): 482.57 The hospital must meet the needs of the patients in accordance with acceptable standards of practice. The following requirements apply if the hospital provides respiratory care services. This Condition is not met as evidenced by: 38289 Based on staff interview and review of facility documents, it was determined that the facility failed to ensure oversight and direction of the respiratory care services department. Findings include: The facility failed to ensure there was a qualified director of respiratory care services (Cross refer to Tag A-1153). Cross Reference: 482.57(a)(1) - Director of Respiratory Care”

“INSTITUTIONAL PLAN AND BUDGET CFR(s): 482.12(d) The institution must have an overall institutional plan that meets the following conditions: (1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles. (2) The budget must include all anticipated income and expenses. This provision does not require that the budget identify item by item the components of each anticipated income or expense. (3) The plan must provide for capital expenditures for at least a 3-year period, including the year in which the operating budget specified in paragraph (d)(2) of this section is applicable. (4) The plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of $600,000 (or a lesser amount that is established, in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located) that relates to any of the following: (i) Acquisition of land; (ii) Improvement of land, buildings, and equipment; or (iii) The replacement, modernization, and expansion of buildings and equipment. This Standard is not met as evidenced by: 38289 Based on staff interview, it was determined that the facility failed to have an overall institutional plan and budget. Findings include: On 3/14/24 at 12:11 PM, the facility’s institutional plan and budget for the year 2023 and 2024 was requested from Staff (S) 1, Director of Quality and Informatics. S1 reviewed the federal guidelines in this surveyor’s presence to ensure what was being asked. At 1:19 PM, S1 returned and introduced S16, interim Chief Financial Officer, to speak about the institutional plan and budget. S16 stated that the facility does not have a budget for the year 2024, but stated that the facility is following the “Go Forward Plan.” S16 explained that the plan focuses on looking at what it looks like for the future of the facility and the focus is not on creating a budget but rather looking at the service lines at the facility. S16 stated that by looking at the service lines, the focus is on what is provided, what is needed and what is not needed. S16 stated that Senior leadership meet every other week to discuss. S16 was asked about an operational budget and expenses for the daily operations at the facility. S16 reconfirmed that there was no budget and stated, “when something is needed, that needs to be fixed, then we will deal with it.” When asked to provide the Budget and institutional plan for the year 2023 for review, S1 and S16 stated the facility did not have one and confirmed that neither of them had seen a budget or plan for the year 2023. When asked to provide documentation of the “Go Forward Plan,” S1 and S16 stated that it was not written down anywhere and could not provide evidence of the plan.”

“CONTRACTED SERVICES CFR(s): 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 38289 Based on staff interview, vendor interview, and review of facility documents, it was determined that the facility failed to ensure an effective services contract for patient medical transport for patients requiring medical care not available at the facility. Findings include: On 3/7/24, Patient (P) 2 presented to the facility Emergency Department (ED) at 8:32 AM for a complaint of dizziness, back pain, and palpitations. P2 required medical transport to a local hospital for Stat (Immediate) diagnostic radiologic services that were not available at the facility. The order was place for the Stat Computed Tomography (CT) Scan on 3/7/24 at 11:13 AM. An interview with Staff (S) 10, Medical Director of the ED, on 3/7/24 at 1:20 PM, was conducted. S10 indicated that he/she was still waiting for a transfer for P2. S10 stated that S13, Chief Nursing Officer, was made aware that a transfer was needed for P2 at 11:30 AM. When S10 was asked what was causing the delay, S10 stated that the transport service refused transfer due to non-payment. S10 stated that S13, was made aware, and that alternate means of transportation were being looked into and there was no approximate time for which the transfer may take place. S10 confirmed at this time that he/she had not been made aware of any downtime or scheduled downtime for any radiological services. On 3/7/24 at 11:17 AM, S6, Radiologic Technologist, stated that there was scheduled preventative maintenance of the Computed Tomography (CT) scanner to start at approximately 12:00 PM until about 4:00 PM. S6 stated that S13 would have known about the scheduled maintenance and would have sent out a mass email to the facility’s providers to let them know that the service would not be available. On 3/7/24 at 1:59 PM, S13 confirmed that he/she would send notification to the facility’s providers regarding scheduled downtime, or issues that would cause an interruption in service, such as lack on IV (Intravenous) contrast dye. S13 was asked for documentation of the notification to the facility’s providers regarding the CT Scanner downtime. S13 was unable to provide this documentation, stating that it hadn’t been sent yet. S12, Director of Operations, and S13 were asked if there had been issues with transport. S12 stated that issues with the transport service were recent, and the transport service has been resistant due to short staff and availability of crews. S12 and S13 confirmed that there was an issue the previous week where the contracted transport service refused a patient transfer to a local hospital. S12 states that the contracted service administration has different viewpoints on whether to accept or refuse transfer services from the facility. S12 stated that he/she is in the process of signing a contract with another transport company, but it has not been finalized yet. 49075 Upon request, S1, Director of Quality and Informatics and S13 provided the contract with [Transport Company A] for review. The contract, titled “Medical Transportation Service Agreement,” dated March 1st, 2020, stated, “... Provider shall provide emergency and non-emergency medical transportation services to facility twenty-four hours a day, seven days a week, three hundred and sixty-five days a year.” A second contract with [Transport Company A] titled “Dedicated Lower Mode Van Agreement,” dated March 8th, 2024, was provided by the S1 and S13. Upon review of this document, it was determined that the contract was not signed by the facility or the transportation provider. S1 and S13 provided a third contract with [Transport Company B] titled “Dedicated Medical Transportation Services Agreement,” effective February 23rd, 2024. This contract lacked signatures from the facility and Transport Company B. After reviewing the facilities transfer log, it was determined that there were no patient transfers completed by Transport Company B from December 2023 to March 2024. On 3/7/24 at 3:03 PM, a call was made to the current contracted transport company to speak with the interim administrator, S19. S19 stated that the owner, S20, was on vacation and S19 was in charge at the moment. S19 stated that he/she refused a transfer today from the facility due to continued non-payment from the facility, and confirmed a refused transfer last week from the facility for the same reason. S19 stated that “it has been some time” since the facility has paid the invoices, and that the transport can’t continue to offer services if they do not get paid. At 3:10 PM, a call was held with S20 of the transport company. S20 stated that he/she can’t keep resources at the facility, an onsite ambulance, when the company is not getting paid. S20 stated that the last payment made by the facility was a couple of years ago. S20 states that he/she had received a text message from S12 on 3/6/24 that the facility’s CT was going down, and then another text on 3/7/24 at 11:30 AM from S12 to confirm that S20 had received the message. S20 is on vacation and S19 was making the decisions at the transport company. S20 stated that he/she will let S19 know to not refuse services, as S20 does not want to “leave patients hanging when they need care”. S20 restated that he/she would not leave an ambulance onsite at the facility waiting, but stated that the transport company would respond within 30 minutes for an emergent transfer. S20 stated that he/she was not aware a patient needed transfer this day and was refused. Upon request, S1, provided the facility policy titled, “Emergency Management of Cerebrovascular (CVA) Patient,” Reviewed July 2015. The policy stated, “... F. transport the patient for a non-contrast CT of the head. Door to CT Scan must be completed within 25 minutes. CT Scan must be interpreted within 20 minutes of completion ...” This policy was reviewed with S1 and S13 on 3/8/24 at 3:05 PM. When asked how the facility would ensure timely transport of a patient that presented with symptoms of stroke, either inpatient or to the emergency department, during CT downtime, S1 and S13 confirmed that if no ambulance was onsite, they could not ensure the timeliness of transport to CT Scan.”

“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: 38289 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to ensure that an adequate supply of intravenous (IV) contrast dye needed for stat (immediate) diagnostic radiological exams for patients that present to the Emergency Department (ED) with a medical emergency, in three of three medical records reviewed (Patient (P) 2, P3, and P5. Findings include: On 3/7/24 at 10:40 AM, when asked about supply and staffing issues in the Radiology Department, Staff (S) 10, ED Medical Director, stated that he/she was not aware of any downtime in radiology recently, but was aware that the department was short on contrast dye “last week.” S10 then stated that he/she was just made aware that the facility was completely without IV contrast “about two hours ago.” When S10 was asked how he/she was notified, S10 responded that he/she had found out when he/she had placed an order for a Computed Tomography (CT) Scan with contrast and called to follow-up on the exam. A tour was conducted of the Radiology Department on 3/7/24 at 11:07 AM. S6, Radiologic Technologist, stated that there was no contrast to do CT scans if needed. S6 stated that he/she was made aware on 3/6/24 at 4:00 PM by the previous day’s technician that there would not be enough contrast for 3/7/24. S6 stated that he/she was told that S13, Chief Nursing Officer (CNO), was made aware of the low supply, but S6 was unaware of any follow-up to the issue. S6 stated that he/she was unsure of why the contrast dye had run out and that this surveyor would need to speak with someone in the facility’s purchasing department. Four orders for STAT CT scans with contrast were observed on the desk of CT technician’s monitor room for Patient (P) 2, P3, P5, and P11. S6 stated that P11 was too unstable to come for CT scan and was waiting to hear from the inpatient unit for when the patient may be ready. P2, P3, and P5 were patient’s in the ED. S6 stated that P3 and P5’s providers were notified of the contrast supply issue, and new orders for P3 and P5 were received to perform the CT’s without contrast. At 11:30 AM, S6 took a phone call, with this surveyor present, from P2’s ED provider. P2’s provider was inquiring the status of the availability of the contrast dye. S6 responded that the facility still was without dye and S6 was unsure of when a new supply would be available. Upon request to S1, the medical records of P2, P3, and P5 were provided for review. P2 presented to the ED on 3/7/24 at 8:32 AM with complaints of dizziness, back pain, and palpitations. P2’s order for the CT of the Chest with contrast to rule out (r/o) a Pulmonary Embolism (PE, clot in the lung) was placed on 3/7/24 at 11:13 AM. An interview with S10 on 3/7/24 at 1:20 PM, noted that S10 was still waiting for a transfer for P2. During the time of this interview, S10 noted that P2’s lab had resulted, thus changing the treatment plan for the patient. S10 confirmed that the suspicion was lower for a PE and the labs pointed toward a thyroid issue instead. The order for the Stat CT of the chest with contrast was discontinued at 1:29 PM. The time between the Stat CT order and it’s discontinuation was 2 hours and 16 minutes. P2 was admitted for observation and had bilateral lower extremity ultrasounds ordered instead. P3 had an order for a Stat CT of the Abdomen/Pelvis with contrast placed on 3/7/24 at 7:20 AM. The medical record lacked evidence of an order to transfer the patient out to have the test completed. At 11:35 AM, the order was changed to Stat CT Abdomen/Pelvis without contrast. The scan was conducted at 11:51 AM. The time between the Stat order with contrast and the order change was 4 hours and 15 minutes. These findings were confirmed with S13 on 3/8/24 at 4:01 PM. P5 had simultaneous orders for a CT Head/Neck and a CT Angio of the Head/Neck placed on 3/7/24 at 9:39 AM for r/o Stroke. The medical record lacked evidence of an order to transfer the patient out to have the test completed. P5’s order for the CT Angio Head/Neck was discontinued at 11:21 AM. The CT was not completed within 25 minutes in accordance with the facility stroke policy. The time between the Stat order and the discontinuation of the order was 1 hour and 42 minutes. Review of P5’s medical record revealed that the patient had a history of seizures and was post-ictal (a period of time that begins when a seizure subsides and ends when the patient returns to baseline) from a seizure upon arrival to the ED, therefore the CT Angio Head/Neck was not indicated at that time. This finding was confirmed with S10, Medical Director of the ED, at the time of discovery. P5 was admitted to the facility. On 3/7/24 at 12:48 PM, and interview was conducted with S11, Purchasing Manager. S11 explained the process for ordering supplies when they are below par levels. S11 stated that the technician in the department monitors the departments supplies, if a certain supply falls below par level then the technician enters an order for the supply. This order, called a purchase order, is then reviewed by the purchasing department. If the order is okay, then the order is sent to the vendor. When asked the last time IV contrast dye was ordered, S11 stated sometime this week. S11 confirmed that there was an issue with credit and the order had been put on hold but has now been shipped. S11 stated that the order was shipped yesterday but was unsure of the date of delivery to the facility. Upon request, the purchase order and correspondence with the vendor was provided for review. The order was dated March 4, 2024, but was noted that the order was not released until 3/5/24 with a request for payment details. On 3/7/24 at 2:10 PM, when asked if he/she was aware when the IV contrast had run out, S13 stated “Sometime today.” S13 stated that he/she was aware on Monday (3/4/24) that the facility was running low and S13 followed-up with the finance department to determine the hold up. S13 stated that a second order for IV contrast was placed on Monday (3/4/24) “sometime after noon.” S13 stated that he/she was made aware on 3/6/24 at 4:00 PM by the CT technologist that there was only one bottle of contrast remaining. When ask what guidance was given to staff regarding this low supply, S13 stated that he/she told the CT technologist to let him/her know when they ran out. S13 confirmed that a memo to notify all physicians at the facility that there was no contrast dye was not drafted or sent out. S13 also stated that he/she was unsure of when the shipment would be coming in. S13 confirmed that diagnostic radiologic exams requiring contrast dye would not be able to be performed at the facility at this time. S13 stated that those patients would have to be transferred out to have those tests completed. P2, P3, and P5 did not have the ordered CT with contrast due to lack of contrast availability. The facility was without contrast for CT scans until 4:00 PM. At 4:39 PM, upon visual verification of the contrast dye, S1 confirmed that the contrast dye had arrived at 4:00 PM, as it had been borrowed and just delivered from a local hospital. Facility policy titled, “[Facility Name] Radiology Internal Escalation Policy,” Effective December 12, 2018, stated, “... Delay - Exams are expected to complete the workflow, Ordered to Final, within the following time frames. Anything outside of these ranges is considered a delay. -STAT - 1 hour ...”. Facility policy, titled, “Emergency Management of Cerebrovascular Accident (CVA) Patients,” Reviewed - July 2015, stated, “... F. ... Door to CT scan must be completed within 25 minutes. CT scan must be interpreted within 20 minutes of completion ...””

“QUALIFIED STAFF CFR(s): 482.26(c)(2) Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures. This Standard is not met as evidenced by: 38289 Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that a qualified staff member was appointed to the Director of Radiology position. Findings include: On 3/7/24 at 9:33 AM, Staff (S) 1, Director of Quality and Informatics, stated that the Director of the Radiology Department left the position about two weeks ago, and that S13, Chief Nursing Officer, was filling the position in the interim. The job description for the Director of Radiology was requested along with S13’s personnel file. On 3/8/24 at 11:43 AM, the documents were provided for review. The job description for the Director of Radiology stated, “...Director Diagnostic Imaging and Cardiovascular Services ... The minimum education and certification ... requires a bachelor’s degree in Radiology or Business Administration, he/she must be certified by the American Registry of Radiological Technologies or possess another preferred radiological certification ...” Upon review of the personnel file for S13, the file lacked evidence of education and training required for the position of the Director of Radiology. 49075 This finding was shared with S13 on 3/8/24 at 4:01 PM, in the presence of S1. S13 confirmed that he/she was not qualified for the position. S1 stated that it has been hard to fill the gaps and that the facility was still trying to find an Administrator Consultant to assist at the facility.”

“ORGANIZATION AND DIRECTION CFR(s): 482.55(a) Organization and Direction. If emergency services are provided at the hospital -- This Standard is not met as evidenced by: 38289 Based on medical record review, staff interview, and review of facility documents, it was determined that the facility failed to provide critical care transport for a patient that needed a diagnostic radiological exam, that could not be completed at the facility to rule out a medical emergency, in one of one medical record reviewed (Patient (P)2). Findings include: P2 presented to the Emergency Department (ED) on 3/7/24 at 8:32 AM with a complaint of dizziness, back pain, and palpitations. P2 was triaged at 8:40 AM as a level 3 urgent. Vital signs were taken indicating the patient’s heart rate was abnormal above 100 beats per minute. Lab (laboratory) work was sent which resulted in an elevated D-Dimer test, and an order for a CT with contrast to rule out (r/o) a Pulmonary Embolism (PE, clot in the lung) was placed at 11:13 AM. At 11:30 AM, P2’s ED provider was made aware that the facility still did not have contrast dye needed to perform the diagnostic study. An interview with S10 on 3/7/24 at 1:20 PM, noted that S10 was still waiting for a transfer for P2. When S10 was asked what was causing the delay, S10 stated that the transport service refused transfer due to non-payment. S10 stated that S13, Chief Nursing Officer, was made aware, and that alternate means of transportation were being looked into. On 3/7/24 at 1:59 PM, S13 confirmed that he/she would send notification to the facility’s providers regarding scheduled downtime or for any issues that would cause and interruption in service, such as lack of IV contrast dye. S13 was asked for documentation of the notification to the facility’s providers regarding the CT Scanner downtime and/ or the lack of contrast dye, S13 was unable to provide this documentation, stating that it hadn’t been sent yet. S12, Director of Operations, and S13 were asked if there had been issues with transport. S12 stated that issues with the transport service were recent, and the transport service has been resistant due to short staff and availability of crews. S12 and S13 confirmed that there was an issue the previous week where the contracted transport service refused a patient transfer to a local hospital. This was unable to be confirmed by surveyors. S12 states that the contracted service administration has different viewpoints on whether to accept or refuse transfer services from the facility. S12 stated that he/she is in the process of signing a contract with another transport company, but it has not been finalized yet. Upon request, S1 and S13 provided the contract with [Transport Company A] for review. The contract, titled “Medical Transportation Service Agreement”, dated March 1st, 2020, stated, “... Provider shall provide emergency and non-emergency medical transportation services to facility twenty-four hours a day, seven days a week, three hundred and sixty-five days a year.” A second contract with [Transport Company A] titled “Dedicated Lower Mode Van Agreement,” dated March 8th, 2024, was provided by the S1 and S13. Upon review of this document, it was determined that the contract was not signed by the facility or the transportation provider. S1 and S13 provided a third contract with [Transport Company B] titled “Dedicated Medical Transportation Services Agreement,” effective February 23rd, 2024. This contract lacked signatures from the facility and Transport Company B. After reviewing the facilities transfer log, it was determined that there were no patient transfers completed by Transport Company B from December 2023 to March 2024. On 3/7/24 at 3:03 PM, a call was made to the current contracted transport company to speak with the interim administrator, S19. S19 stated that the owner, S20, was on vacation and S19 was in charge at the moment. S19 stated that he/she refused a transfer today from the facility due to continued non-payment from the facility and confirmed a refused transfer last week from the facility for the same reason. S19 stated that “it has been some time” since the facility has paid the invoices, and that the transport can’t continue to offer services if they do not get paid. At 3:10 PM, a call was held with S20 of the transport company. S20 stated that he/she can’t keep resources at the facility, an onsite ambulance, when the company is not getting paid. S20 stated that the last payment made by the facility was a couple of years ago. S20 states that he/she had received a text message from S12 on 3/6/24 that the facility’s CT was going down, and then another text on 3/7/24 at 11:30 AM from S12 to confirm that S20 had received the message. S20 is on vacation and S19 was making the decisions at the transport company. S20 stated that he will let S19 know to not refuse services, as S20 does not want to “leave patients hanging when they need care.” S20 restated that he/she would not leave an ambulance onsite at the facility waiting but stated that the transport company would respond within 30 minutes for an emergent transfer. S20 stated that he/she was not aware a patient needed transfer this day and was refused. 49075”

“DIRECTOR OF RESPIRATORY SERVICES CFR(s): 482.57(a)(1) There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge, experience and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis. This Standard is not met as evidenced by: 38289 Based on staff interview and review of facility documents, it was determined that the facility failed to ensure that there was a Director of Respiratory Care services who is a doctor of medicine or osteopathy. Findings include: On 3/14/24 at 11:36 AM, Staff (S) 1, Director of Quality and Informatics, when asked who the director of respiratory services was, stated that the facility does not have a director, but has a manager, S18. The personnel file for S18 was requested for review. Upon review of the personnel file, S18 was noted to have a job description that stated, “Lead Respiratory Therapist” and was signed by the department manager on 1/23/15 and by the human resources executive on 1/27/15. The personnel file lacked evidence that S18 was a Doctor of Medicine or osteopathy. This finding was shared with S1 at the time of discovery. S1 provided a list of position vacancies for the facility. This list was reviewed and did not include an open position for a director of respiratory care services. This finding was shared with S1 at the time of discovery. When asked, S1 stated that he/she would look into it. On 3/14/24 at 2:17 PM, the job description for director of respiratory care services was requested for review. The facility was unable to provide a copy of this job description.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 41646 Based on random observation, staff interviews, and review of facility policy and procedure, it was determined that the facility failed to ensure that signage indicating the rights of individuals under EMTALA law, is conspicuously posted in areas likely to be seen by individuals requesting emergency care. Findings include: Reference: Facility policy, “Emergency Medical Treatment and Active Labor” revised December 2023 states, “ ...VII. Signs. 1. [Name of Facility] will post one or more signs conspicuously or in a place or places likely to be noticed by all individuals entering and obtaining treatment in the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area). In general, the sign(s) shall be visible from anywhere in the area or distance of twenty (20) feet, whichever is less.” On 3/13/24 at 11:18 AM, a tour of the Emergency Department (ED) was conducted in the presence of Staff (S)6, ED Nurse Manager. At 11:20 AM, during a tour of the walk-in and ambulance entrances, there was no EMTALA signage displaying the rights of individuals under EMTALA law in the entrance hallway. S6 confirmed that all patients requesting emergency treatment, including walk-in patients and patients arriving via ambulance, will enter through that hallway, and that there was no signage posted. At 11:24 AM, signage for EMTALA was observed posted in the hallway leading to the fast track area of the ED. The signage was not visible from all of the fast track bays. A second sign was posted on the wall of the main ED hallway treatment area. The signage was not visible from all of the treatment bays. These findings were confirmed by S6 upon discovery.”

“EMERGENCY SERVICES CFR(s): 482.55 The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. This Condition is not met as evidenced by: 43214 Based on staff interviews and review of facility documents it was determined the facility failed to meet the emergent needs of patients in accordance with acceptable standards of practice, consistent with the designation as a primary stroke center by failing to adequately integrate emergency services with radiology services as evidenced by documented gaps in staffing coverage and the inability to ensure the availability of radiology services and personnel (1103) and failed to establish and implement a policy and procedure for diverting when services are unavailable (1104).”

“INTEGRATION OF EMERGENCY SERVICES CFR(s): 482.55(a)(2) [If emergency services are provided at the hospital --] (2) The services must be integrated with other departments of the hospital. This Standard is not met as evidenced by: 43214 Based on staff interviews and review of facility documents, it was determined that the facility failed to integrate emergency services with radiology services, as evidenced by documented staffing coverage gaps, thus the facility is unable to assure the immediate availability of radiology services and personnel consistent with acceptable standards of practice for a facility designated as a primary stroke center. Findings include: Reference #1: Facility website accessed on 3/12/24 at https://carewellhealth.org/emergency-department/ states “ ...We are staffed 24 hours a day, 365 days a year by a highly trained team of emergency medicine physicians, who are board certified and assisted by other emergency medicine professionals. CareWell Health is a Primary Stroke Center and recognizes that time is essential in an emergency. Our entire staff is dedicated to treating patients as quickly as possible and our experienced team of medical professionals is focused solely on your health, with the facilities and technology necessary to treat you best. ...” Reference #2: The State of New Jersey, Department of Health, Acute Stroke Service, Complete List of Designated Stroke Center Hospitals in New Jersey [pdf] accessed on 3/12/24 at Designated_Stroke_Centers_2024.pdf (nj.gov) lists Carewell Health Medical Center as a Primary Stroke Center. Reference #3: 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). Reference #4: NJ Administrative Code 8:43G states, “ ... 12.7 (w) Radiology services for emergency needs shall be available to the emergency department 24 hours a day. ... .” During the entrance conference conducted on 1/30/24 at 9:40 AM, in the presence of Staff (S)1 (Senior Director of Nursing), S2 (Quality Nurse Coordinator), and S3 (Medical Director), S3 stated there have been “gaps” in CT services due to staffing shortages. S3 stated the previous Radiology Director left the organization at the end of December (2023) and would “cover gaps in the schedule” prior to his/her departure. During an interview on 1/30/24 at 10:00 AM, S2 stated, “Honestly, we are not sure if we are a primary stroke center. We used to be.” On 2/1/24, the facility was identified as a Primary Stroke Center on the New Jersey Department of Health website. During an interview on 1/30/24 at 10:45 AM, S4 (Radiology Director) stated the Radiology Department currently has three open positions for x-ray technicians and three open positions for CT technicians. The facility has a contract with an agency to fill staffing gaps with contracted x-ray technicians. The facility does not have any contracted CT technicians. When asked if he/she covers gaps in radiology services, S4 stated that he/she is not “CT certified.” Upon review of the CT and x-ray staffing schedule on 1/30/23 at 2:15 PM, in the presence of S1, it was revealed that CT services were unavailable 11 times and x-ray services were unavailable 4 times from 12/17/23 until 1/30/24. During an interview conducted on 1/31/24 at 10:27 AM, S19 (ED Medical Director) stated, “I have made multiple requests in December alone to place the hospital on divert due to the CT scan not being available. If a patient develops stroke-like symptoms while in our facility, they will get transferred out.” On 1/30/24 at 2:30 PM, S3 confirmed that CT and x-ray services were not available at the facility for patients 24 hours a day, seven days a week, for patients exhibiting signs and symptoms of a stroke. On 2/1/24 at 2:47 PM the on-call schedule for the Radiology Department was requested and reviewed. Due to the facility having staffing shortages in the CT and x-ray departments, the Radiology on-call list for November 2023 through February 2024 was requested and reviewed. Review of the “[Name of Radiology Group] Month by Assignment,” Radiology on call schedule, revealed there were no physician or group name listed for on-call coverage on the following dates: every Saturday and Sunday; Thursday, November 23, 2023; Friday, November 24, 2023; Monday, December 25, 2025; and Monday, January 1, 2024. The last page of the call schedule is an addendum that states “*[Name of Contracted Radiology group] Radiology extends coverage beyond regulare [sic] hours*”. On 2/1/24 at 2:50 PM, during interview with S6 (Director of Informatics), he/she explained that the radiology service is provided by contract through [name of Radiology group]. S6 stated [name of Radiology group] has a contract with [name of contracted Radiology group] to take call for them and do their readings after hours. Both contracts were requested for review. S6 was able to provide the facility’s contract with [name of Radiology group], but after multiple requests, was unable to provide the contract between [name of Radiology group] and [name of contracted Radiology group].”

“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: 47131 Based on staff interviews and review of facility documents, it was determined the facility failed to establish a policy and procedure to implement when CT (computerized tomography) and x-ray services are unavailable, and the department diverts radiology services to another facility. Findings include: During the entrance conference conducted 1/30/24 at 9:40 AM, in the presence of S1, S2, and S3, it was confirmed the facility has experienced gaps in CT and x-ray services due to staffing shortages. On 1/30/24, review of the CT staff roster determined that six CT technicians are currently employed at the facility. The facility does not currently have any agency CT technicians. Review of the x-ray staff roster determined that eight x-ray technicians are currently employed at the facility and cover the radiology and ED departments. On 1/30/24 at 2:15 PM, during review of the CT and x-ray staffing schedules in the presence of S1, he/she confirmed that no technicians were identified on the CT and x-ray staffing schedules from 12/17/23 until 1/30/24 for the following shifts: CT: 12/25/23 (4PM-12AM); 12/30/23 (8PM-12AM); 1/5/24 (12PM-4PM); 1/6/24 (5PM-12AM); 1/8/24 (12AM-8AM); 1/9/24 (4PM-8PM); 1/14/24 (8PM-12AM); 1/16/24 (4PM-12AM); 1/20/24 (4PM-12AM); 1/21/24 (8PM-12AM); 1/28/24 (4PM-8PM). X-ray: 1/1/24 (8AM-3PM); 1/9/24 (12AM-8AM); 1/16/24 (4PM-6PM); 1/20/24 (4PM-8PM). The radiology department experienced lapses in CT services 11 times and lapses in x-ray services four times, from 12/17/23 until 1/30/24, due to lack of staffing. Upon interview on 1/31/24 at 10:30 AM, S3 stated, “We never went on divert for CT services. We do not have equipment issues so there was no reason to put the services on divert.” Upon request of the facility’s “Divert Policy,” S1 stated, “We do not have any divert policy when CT services are not available here.” On 1/31/24 at 11:00 AM, S6 (Director of Informatics) confirmed the facility does not have a policy to follow when radiology services are unavailable and CT and x-ray services are diverted to another facility.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 39223 Based on documentation review, interviews, and observations, it was determined that the governing body failed to demonstrate that it is effective in ensuring that hemodialysis services offered by the hospital are provided to hemodialysis patients. It did not provide necessary oversight and leadership as evidenced by the lack of compliance with the Condition of Participation: 482 CFR 482.13 Patient Rights”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 39223 Based on medical record review, review of facility documents, and staff interviews, it was determined that the hospital failed to protect and promote the rights of each patient by: 1. failing to ensuring the portable Reverse Osmosis (RO) machines utilized to provide hemodialysis treatment to patients are determined to be free of possible contamination prior to use on patients scheduled for hemodialysis treatments 12/29/23 through 1/11/24 (A-144); and 2. failing to ensure that hemodialysis treatments are provided to patients in renal failure who are admitted to the hospital (A-144). Findings include: The above findings resulted in an Immediate Jeopardy (IJ) on 1/12/24 at 3:32 PM. The IJ template was provided to Staff (S)4, Director of Risk Management, on 1/12/24 at 3:39 PM and a removal plan was requested. An IJ Removal Plan was provided by the facility on 1/12/24 at 4:00 PM, and was accepted. On 1/12/24, it was determined that the facility took the following steps to remove the immediacy of the IJ: Education to all direct patient care staff on the removal from service of portable RO 9 until further notice from the administrator and a sign placed on portable RO 9 indicating that it was out of service. It was determined that the IJ removal plan was successfully implemented and the IJ was removed on 1/12/24 at 4:15 PM. Cross Reference: 482.13(c)(2) Patient Rights: Care in Safe Setting”

“CARE OF PATIENTS - RESPONSIBILITY FOR CARE CFR(s): 482.12(c)(4) [ ...the governing body must ensure that the following requirements are met:] A doctor of medicine or osteopathy is responsible for the care of each Medicare patient with respect to any medical or psychiatric problem that-- (i) Is present on admission or develops during hospitalization; and (ii) Is not specifically within the scope of practice of a doctor of dental surgery, dental medicine, podiatric medicine, or optometry; a chiropractor; or clinical psychologist, as that scope is-- (A) Defined by the medical staff; (B) Permitted by State law; and (C) Limited, under paragraph (c)(1)(v) of this section, with respect to chiropractors. This Standard is not met as evidenced by: 39223 Based on medical record review, staff interviews, and review of facility documents, it was determined that the governing body failed to demonstrate that it is effective in ensuring that hemodialysis services offered by the hospital are provided to hemodialysis patients. Findings include: A review of the facility’s reverse osmosis machines indicated that all seven machines were removed from service due to machine alarms and high calcium test results on 12/19/23. This left the facility unable to provide hemodialysis to patients. A review of medical records for hemodialysis patients at the facility from 12/19/23 through 12/29/23 indicated that Patient (P) 1 was not able to receive two hemodialysis treatments prior to transferring out to a rehabilitation facility on 12/21/23. (Cross refer to Tag A-144) During an interview on 1/11/24 at 10:05 AM, Staff (S) 5, a Hemodialysis Registered Nurse (RN), stated that the portable reverse osmosis (RO) machines have been “suffering” as of late and that for two weeks (12/19 through 12/29/23), the hospital was not able to provide hemodialysis treatments to patients. S5 stated that patients in the Emergency Department were transferred to other facilities that were able to provide hemodialysis treatments during this time. S5 stated that this was the first time that a problem like this occurred. During an interview on 1/11/24 at 10:44 AM, S6, the Hemodialysis Charge RN, stated that when the problem was reported, he informed S3, the Senior Director of Nursing, in addition to the nephrologists. During an interview on 1/11/24 at 1:26 PM, S16, the Biomedical Technician, stated that in December 2023, six of the seven portable RO machines tested for calcium levels resulted with high levels. One portable RO was not functioning due to a “no water” alarm. S16 stated that he sends out the needed lab samples and S17, the Unit Director of Biomedical, would perform any repairs or maintenance. As per S16, the membranes for three RO machines (RO 6, RO 9, and RO 10) were replaced on 1/2/24 and retested for calcium levels. The machines were then released back for use after passing calcium levels were received. When asked who reviews and oversees his work, S16 indicated that S3, the Director of Nursing, was responsible for reviewing his work and lab results. A review of S16’s education indicated that S16 was trained on a different Machine System in 2005. Upon request for further verification of competency in maintaining and fixing the portable reverse osmosis machines, S16 was unable to provide. During an interview on 1/12/24 at 2:35 PM, S17 stated that he repairs the machines and performs maintenance as recommended by manufacturer. S17 stated that the hospital staff complete regular disinfections, collect samples for water quality, and report the results of testing to him. When the RO’s reported a high calcium multiple times, S17 consulted with the manufacturer on treatment, which consisted of a pH treatment to try and clear out any build up within the system. S17 stated that if the pH treatments do not work, then the membranes would need to be replaced. Upon request, S17 was able to provide data reports provided to the Governing Body that indicated a knowledge of multiple repeat results of high calcium with pH treatment interventions as follows: Portable RO 4 had a high calcium reported for August, September, October, and November 2023. Interventions reported were pH treatments. Documented lab results for 12/7/23 indicated a high calcium result. Portable RO 5 had a high calcium reported for June, August, September, October, and November 2023. Interventions reported were pH treatments. Documented lab results for 12/7/23 indicated a high calcium result. Portable RO 6 had a high calcium reported for November 2023 with a high and low pH treatment completed. Documented lab results for 12/18/23 indicated a high calcium result. Portable RO 7 had a high calcium reported for August 2023 with a high pH treatment completed. Documented lab results for 12/7, 12/15, and 12/26/23 indicated high calcium results. Portable RO 8 had a high calcium reported August and September 2023 with a disinfection treatment completed. Documented lab results for 12/18 and 12/26/23 indicated high calcium results. Portable RO 9 had a high Calcium reported in June and July 2023 with a low pH treatment and disinfection treatment completed. Documented lab results for Portable RO 10 on 12/9 and 12/30/23 indicated high calcium results. Upon request for documentation for which machines had membranes replaced and on what days, S17 was only able to provide documentation that membranes had been ordered. A review of S17’s education file revealed that he was trained on a centralized RO system on 5/5/21. During an interview on 1/11/24 at 2:47 PM, S3 stated that he was new to this position and started on 12/23/23. S3 is in charge of the inpatient hemodialysis unit. S3 stated that the lack of usable portable RO machines was reported to senior management during the daily morning huddle meetings and patient treatment plans were discussed. A review of the “AOC Daily Huddle Checklist” dated 12/22/23 through 12/28/23, documented a row labeled, “Dialysis” with check marks indicating that the dialysis patients were discussed at the meetings on 12/22, 12/26, 12/27, and 12/28/23. When asked what was the plan to ensure that hemodialysis services would continue to be provided to patients, uninterrupted, S3 responded that a plan had not been discussed until the day of survey. Upon request, S3’s training on portable Reverse Osmosis machines and their operation could not be provided. During an interview on 1/12/24 at 12:20 PM, S1, the Chief Medical Officer, and S10, the Chief Executive Officer, stated that when the portable RO machines were unusable, all attending physicians were made aware and they were encouraged to transfer their patients more immediately. S1 and S10 stated that they expedited transfers through Case Management personnel. S10 stated that if any service provided by the hospital is not available then they should transfer the patient out. Upon request for Governing Body Meeting Minutes related to the dialysis machines not being available for patient treatments, S1 and S10 were only able to provide the above listed documentation. There was no documentation of a plan to ensure dialysis services are continued to be provided to patients.”

“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: 39223 Based on medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure that: 1. The portable Reverse Osmosis (RO) machines utilized to provide hemodialysis treatment to patients are determined to be free of possible contamination prior to use on five of five hemodialysis patients scheduled for hemodialysis treatments 12/29/24 through 1/11/24; and 2. Hemodialysis treatments are provided to patients in renal failure for one of five patients (Patient (P) 1) admitted to the hospital 12/19/23 through 12/29/23. Findings include: 1. On 12/19/23, RO 9, a Millennium HX Reverse Osmosis Unit, was placed out of service on 12/19/23 due to a “no water” alarm. The RO membrane was replaced on 1/2/24. There was no culture or endotoxins sample drawn after the replacement to ensure the machine was safe to use, in accordance with the manufacturer’s instructions for use, and before patients received hemodialysis treatments. RO 9 was returned to service on 12/29/23. A review of the In-Patient Hemodialysis Schedule for December 2023 and January 2024, and individual patient treatment flowsheets revealed RO 9 was used for eleven hemodialysis treatments as follows: On 12/29/23, P3 received hemodialysis treatment through RO 9 starting at 5:55 PM through 8:00 PM. On 12/30/23, P3 received hemodialysis treatment through RO 9 starting at 9:50 AM through 12:50 PM. On 12/30/23, P12 received hemodialysis treatment through RO 9 starting at 4:35 PM through 6:35 PM. On 12/31/23, P12 received hemodialysis treatment through RO 9 starting at 11:35 AM through 2:35 PM. On 12/31/23, P13 received hemodialysis treatment through RO 9 starting at 3:35 PM through 6:35 PM. On 1/2/24, P12 received hemodialysis treatment through RO 9 starting at 9:00 AM through 12:00 PM. On 1/3/24, P13 received hemodialysis treatment through RO 9 starting at 9:20 AM through 12:20 PM. On 1/3/24, P14 received hemodialysis treatment through RO 9 starting at 4:50 PM through 7:50 PM. On 1/3/24, P15 received hemodialysis treatment through RO 9 starting at 1:05 PM through 4:05 PM. On 1/4/24, P12 received hemodialysis treatment through RO 9 starting at 9:30 AM through 12:35 PM. On 1/6/24, P12 received hemodialysis treatment through RO 9 starting at 9:00 AM through 12:00 PM. On 12/19/23, RO 6, a Millennium HX Reverse Osmosis Unit, was placed out of service due to a high calcium. A portable RO membrane was replaced on 1/2/24. Culture and endotoxin lab samples were sent out from the facility on 1/6/24 and results were received on 1/11/24. A review of the In-Patient Hemodialysis Schedule for January 2024, and individual patient treatment flowsheets revealed RO 6 was used for P 10’s hemodialysis treatment on 1/9/24 starting at 9:46 AM through 12:40 PM. Interview with the Biomedical Technician on 1/11/24 starting at 1:26 PM revealed that three RO’s received new membranes on 1/2/24 (RO 6, RO 9, and RO 10). The machines were retested and once he saw the calcium was within range, he communicated with the facility that the machines were available for use. A review of the Mar Cor Purification Millennium HX Reverse Osmosis Unit Operation and Maintenance Manual, published March 25, 2020, stated, “ ... 5.2.3 Membrane Replacement ... Warning: Ensure that TDS/uS [Total Dissolved Solids / microsiemens] and membrane performance (& rejection) are normal for the regions water quality. Consult your facility physician. An appropriate AAMI [Association for the Advancement of Medical Instrumentation] and bacteria/Endotoxin test meeting AAMI or CSA requirements of the product water must be obtained and interpreted before using the RO unit for hemodialysis treatment ...” 2. A review of P1’s medical record indicated that he/she was admitted to the facility on 12/16/23 with a diagnosis of weakness, dizziness, lethargy and recurrent hypotension. P1 was transferred to a physical therapy rehabilitation facility on 12/21/23. The physician’s history and physical note on 12/16/23 at 10:32 AM stated, “... ESRD [end stage renal disease] on dialysis ...” A physician’s order, dated 12/18/23 at 10:37 AM stated, “... Hemodialysis treatment ...” “Hemodialysis Treatment Settings, order details: Monday/Wednesday/Friday, 3.5 hours, 400 ml [milliliters]/minute, 1 liter as tolerated, 2K [potassium] 2.5 Ca [calcium], 138 sodium, 36 degrees, 700 dialysate flow rate...” A review of P1’s hemodialysis treatments indicated that P1 did not receive hemodialysis treatment as ordered on 12/18/23 and 12/20/23. A Registered Nurse’s note, dated and timed for 12/18/23 at 12:00 PM, stated, “... Hemodialysis not done due to reverse osmosis poor water quality. Nephrologist on consult and primary nurse aware ...”. A Registered Nurse’s note dated 12/19/23 at 11:15 AM stated, “... Hemodialysis not performed due to reverse osmosis poor water quality. Nephrologist on consult and primary nurse aware.” A Registered nurse’s note dated 12/20/23 stated, “... hemodialysis unavailable today ...” A note written by Staff (S) 14, a Social Worker, on 12/21/23 at 2:19 PM, stated, “... DP [Discharge Planner] also reached out to ___ [name] HD [Hemodialysis] Center and [name redacted] the facility manager was made aware that patient was not dialyzed in the hospital due to broken hemodialysis machines. DP made her aware that as per nephrologist, [name redacted], patient is to be dialyzed on 12/22 as early as possible. Facility liaison is aware and will make arrangements. ...” During an interview on 1/11/24 at 12:51 PM, S14 stated that when the hemodialysis machines were down, there may have been some patients that missed more than one hemodialysis treatment. When asked why P1 was not transferred to a facility that could complete hemodialysis treatments, S14 stated that insurance delayed the patient’s transfer and that the physicians were aware. During an interview on 1/11/24 at 1:26 PM, S12, a Case Manager, stated that the normal process to discharge or transfer a patient on hemodialysis would be to reach out to the nephrologist and the attending physician in an effort to facilitate discharge and get the patient to their established hemodialysis clinic. S12 stated that it was not safe to discharge P1 home as he/she needed to go to a physical therapy rehabilitation facility. Since P1 was a new placement into a physical therapy rehabilitation facility, the insurance approval process took time and delayed P1’s discharge to a place where he/she could receive hemodialysis treatments. During an interview on 1/12/24 at 3:04 PM, S15, the Nephrologist, stated, “... I don’t remember details of why hemodialysis was not being done. I requested the patient to be transferred to another hospital but the patient was stable, labs looked okay, not fluid overloaded, patient was talking. The patient was not critical so no hemodialysis was needed emergently.” During an interview on 1/12/24 at 12:50 PM, S1 and S11, both administrators, stated that if any service provided by the hospital was not available then patients should be transferred out to where the service can be provided. Review of facility policy titled, “Patient Rights and Responsibilities,” revised January 2022, stated, “... As a patient in a New Jersey hospital, you have the right to: Transfers ... Be transferred to another facility only if the current hospital is unable to provide the level of appropriate medical care ...””