West Virginia University Hospitals, Inc.

“DISPOSAL OF TRASH CFR(s): 482.41(b)(6) (4) The hospital must have procedures for the proper routine storage and prompt disposal of trash. This Standard is not met as evidenced by: 40269 Based on document reviews, observations, and interviews, it was determined the facility failed to follow policies by not properly disposing of trash and cleaning waste receptacles in three (3) waste receptacles in the Emergency Department (ED) waiting area, one (1) waste receptacle in the main lobby, one (1) waste receptacle in the Departure Lounge, one (1) waste receptacle in a surgery waiting area, and one (1) waste receptacle near the ninth (9th) floor elevators. This failure has the potential to negatively impact all patients and visitors at the facility. Findings include: A policy was reviewed titled, “Lobby-Public Area Cleaning,” last reviewed January 2019. The policy states in part, “PURPOSE: To detail the correct procedures for cleaning a lobby, waiting room, or other public area in order to maintain a clean environment for patients, visitors, and staff members ...PROCEDURE:...- Remove all trash from the area. Wipe inside and outside of receptacles with a microfiber cloth soaked in disinfectant before re-lining ...” A policy was reviewed titled, “Waste Receptacle Cleaning,” last reviewed January 2019. The policy states in part, “PURPOSE: To detail the correct procedures for cleaning waste receptacles in order to provide a clean and safe environment for patients, visitors, and staff members ...PROCEDURE: Daily cleaning: - Put on PPE [Personal Protective Equipment] (minimum gloves). - Remove the waist receptacle liner, and remove any debris that may have fallen inside the receptacle. - Wipe the inside of the receptacle with a disinfectant soaked microfiber cloth. - Wipe the exterior of the receptacle with the disinfectant soaked microfiber cloth. - If the receptacle has a lid and/or foot pedal, be sure to sanitize both. - Re-line the receptacle with a clean liner. DEEP CLEANING: Note: Do not let large amounts of water or chemicals to sit inside metal trash cans - this may cause them to rust. - Take the receptacle to the closest EVS closet equipped with a sink. - Put on PPE (long rubber gloves, a barrier gown, and goggles). - Remove the liner and any debris that may be inside the receptacle, then place the receptacle in the sink. - Fill the receptacle 1/4 [one fourth] to 1/3 [one third] full with disinfectant straight from the dispensing system. - Thoroughly scrub the inside of the receptacle with a green scrubbing pad or scrubbing brush. Allow to sit for the appropriate dwell time. - While the receptacle sits, wipe down the outside of the receptacle using a disinfectant soaked cloth. - Pour out the disinfectant and rinse the inside of the receptacle with fresh water. - Dry the receptacle inside and out using a clean cloth or paper towels. Re-line the receptacle and return it to its original location.” An observation was conducted in the facility Emergency Department (ED) waiting area on 04/13/26 at 10:45 a.m., accompanied by staff 11 and 12. A metal trash can (Waste Receptacle) was observed near the entry door. The staff lifted the plastic bag from the can, and underneath, was a soiled, soaked towel with debris. A second trash can was observed near an elevator. Upon lifting the plastic bag from the can, underneath was a soiled, soaked towel with a foul odor. A third trash can was observed around the side from the entry door. Upon lifting the plastic bag, underneath was a soiled, soaked blanket with black substance and a foul odor. The bottom of the can was noted to be rusted, and what was described to be an air freshener, was laying at the bottom of the can. In the ED, a trash can in the ED hallway, upon lifting the plastic bag, there was trash lying in the bottom of the trash can, with a foul odor. An observation was conducted in the facility first (1st) floor lobby on 04/13/26 at 10:53 a.m. A trash can observed near the emergency exit doorway, under the plastic bag, had liquid present and a foul odor. An observation was conducted in the facility second (2nd) floor on 04/13/26 at 11:00 a.m. A trash can observed in the Departure Lounge, under the plastic trash bag, had disposable paper chucks, which were soaked with liquid, and soiled. An observation was conducted in the facility’s fifth (5th) floor on 04/13/26 at 11:20 a.m. A trash can was observed in the surgery waiting area, under the plastic trash bag, to have soiled, soaked microfiber towels. An observation was conducted in the facility ninth (9th) floor on 04/13/26 at 12:06 p.m. A trash can was observed off the main elevators. Upon lifting the plastic trash bag, the metal trash can was observed to have soiled, soaked disposable paper chucks. An interview was conducted with staff 12 on 04/13/26 at 2:14 p.m. Regarding the soaked, soiled cloths, and debris under the plastic bags in the metal trash cans, staff 12 states, “The housekeeper should’ve cleaned it or let someone know immediately. If they couldn’t lift it to clean it, there are supervisors that can be contacted to help. They should’ve notified someone the plastic liner was missing from the cans.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 40269 Based on policy reviews, medical record review, and staff interviews, it was determined the facility failed to follow policy and procedures for reporting patient safety events in two (2) adverse events for one (1) out of ten (10) patients, patient 1. This failure has the potential to negatively impact all patients receiving care at the facility. Findings include: A policy was reviewed titled “Cobe Optia Procedure Policy”, last reviewed 01/25. The policy states in part, “Purpose: give dialysis nurses proper guidance of how to setup and operate Cobe Optia apheresis machine. Policy: Staff assigned to or providing dialysis services will comply with the standards as outlined in the WVUH [West Virginia University Health)] Cobe Optia Policy and Procedure Manual as well as policies and procedures specific to the WVUH Dialysis Unit. Procedure: Scope of Care/Services: WVU Dialysis Unit provides inpatient and outpatient plasmapheresis services for both adult and pediatric clients ...Steps ...7. Monitoring the Patient and Adjusting the Procedure ...F. Possible Adverse Reaction (other than known citrate toxicity): 1. Touch the pause button to pause the system. 2. Assess patient. Activate rapid response team/code team if appropriate. 3. Notify the attending physician of the patient’s condition. 4. Follow physician orders. Stop or continue treatment per physician order. 5. If transfusion reaction is suspected, follow hospital Transfusion Practice Policy (P.026). 6. Document appropriate information in patient’s chart. 7. Enter patient safety report in hospital event reporting system...” A policy was reviewed titled “Sentinel and Patient Safety Event Policy”, last revised 02/10/25. The policy states in part, “...PROCEDURE: Types of Patient Safety Incidents to be reported: In addition to sentinel events, the following patient safety events shall be entered into the patient safety evaluation system: adverse events, no-harm events, close calls (good catches), hazardous conditions and unsafe conditions that involve patients and visitors ...Reporting Procedure: 1. The primary means of submitting safety reports are through a web-based reporting tool, Origami. If submitting a report for a particular patient, the reporting tool can be accessed in Epic within a patient’s chart on the left side bar by clicking ‘Patient Safety Report - Origami’ .Access to the reporting tool can also be located through the hospital’s intranet site CONNECT, then Safety Reports, then Origami - Enter Patient Safety Event ...Investigation of the Patient Safety Report: Upon Receipt of a safety report, the Location Manager must: 1. Assure that the report was accurately and thoroughly completed. 2. Complete the Department Manager Review including: a. Findings and Relevant Circumstances: an analysis of why the event occurred and corrective action plans to prevent similar events from happening again. b. Final degree and final duration of harm as experienced by the patient in relation to the patient safety event...” A review was conducted of patient 1’s electronic medical record (EMR). The patient presented to the facility’s Emergency Department (ED) on 09/29/25 with a chief complaint of throat swelling, voice change, and inability to swallow since last night.The patient has a history of Myasthenia Gravis (MG or MGUS), and recently had undergone IVIG (intravenous immunoglobulin) therapy treatments the day prior. The patient was admitted to the Neuro Critical Care Unit (NCCU) with a diagnosis of Myasthenia Gravis Exacerbation. On 09/30/25 at approximately 4:00 p.m. the patient was transferred to the dialysis unit for plasmapheresis therapy treatment. The treatment was initiated by staff 7, and completed by staff 3. Medication given prior to treatment by staff 7 included benadryl 25 (twenty-five) mg (milligrams) IV (intravenous) at 4:16 p.m., calcium gluconate 3000 (three thousand) mg IV at 4:17 p.m., albumin 5% (five percent) premix infusion 2900 (two thousand, nine hundred) mL (milliliters) IV at 4:17 p.m., tylenol 650 (six hundred fifty) mg PO (by mouth) at 4:16 p.m., and potassium chloride extended release tablet 20 (twenty) mEq (milliequivalent) PO at 4:18 p.m. A “Nurses Notes” by staff 3 on 09/30/25 at 5:50 p.m. states, “1700 [5:00 p.m.]- PT [patient] reporting hives and itching. NEPH [Nephrology] service call and instructed to give another 25 [twenty-five] mg of benadryl. 1720 [5:20 p.m.]- PLEX stopped per NEPH and pt rinsed back. PT still complaining of SOB [shortness of breath] and HR [heart rate] was elevated. Primary service was notified and or 5 [five] MG of valium to be given lV. 1730 [5:30 p.m.]- 5 [five] mg of Valium given. 1735 [5:35 p.m.] -PT was found slumped over in bed and unresponsive to stimuli. Code called.” An “Internal Medicine Code Blue” note by staff 13 on 09/30/25 at 6:06 p.m. states in part, “Paged for CODE BLUE @ [at] 1735 [5:35 p.m.] ASSESSMENT: [Patient 1] was noted by nursing to be unresponsive stimuli by nursing. A code was called. Presented to bedside to evaluate the patient. Upon initial assessment, the patient was minimally responsive; however, [he/she] was able to squeeze [his/her] bilateral hands. The patient also maintained a gag reflex and was protecting [his/her] airway. Was noted to be hypotensive with pressures ranging from 70s [seventies] over 40s [forties]. A 1 ([one] L [liter] bolus of fluids was ordered. Per nursing, the patient was noted to endorse itching and hives during [his/her] plasma exchange session. Due to a concern for anaphylactic shock, an IV epinephrine drip was started. Levophed was also started for vasopressor support. Patient became more responsive, able to respond to commands. The primary team updated [his/her] [significant other]. Once the patient’s blood pressure improved, [he/she] was transferred back to the Neurocritical Care unit ...” A Neurology Interval Progress Note on 09/30/25 at 6:00 p.m. by staff 8 states, “Received page regarding [patient 1] during PLEX session. Nursing staff reported that patient had broken out into hives midway through PLEX session. Nephrology was aware and patient and was given IV benadryl but was displaying signs of anxiety. [He/she] was given a one [1] time IV valium 5 [five] mg dose for anxiety at 1717 [5:17 p.m.]. Code blue was called at 1735 [5:35 p.m.] for unresponsiveness. Upon arriving to the scene, examiner was told that patient was found to be minimally responsive and hypotensive. [He/she] was able to follow commands during my assessment and answer questions appropriately. As [he/she] had been noted to be pruritic with hives during plex treatment, there was some concern for anaphylactic shock and IV epi [epinephrine] was started. Levophed was started for vasopressor support. Hypotension may have been side effect of plasmapheresis vs [versus] medication side effect vs anaphylactic shock. Patient was able to maintain airway and did not require intubation at this time. [He/she] was transferred to NCCU, and I called and notified [patient 1 significant other] of these developments.” An “INPATIENT NEUROCRITICAL HISTORY & PHYSICAL” was completed on 10/01/25 at 6:01 a.m. by staff 15 states in part, “...9/31.: Transferred to step down yesterday after PLEX line was placed. [He/she] broke into hives midway through first PLEX session, was given one time IV benadryl and one time valium 5 [five] mg for anxiety. A code blue was then called for unresponsiveness, and patient was started on IV epi for concerns of anaphylactic shock, and levophed for hypotension. [He/she] is off both this morning ...” A “Nurses Notes” by staff 6 on 10/02/25 at 4:35 p.m. states in part, “Post PLEX treatment, the client notified dialysis RN [Registered Nurse] of itching. Dialysis RN notified ICU [intensive care unit] RN’s. Upon assessment, urticaria was noted on the trunk [including upper back] and bilateral upper extremities. See photos/media. Neurology service notified. 1655-1700 [4:55 p.m.-5:00 p.m.]: Neurology service at bedside to assess patient. Orders received for lV Benadryl. See MAR for details ...” A “Discharge Summary” was completed on 10/14/25 at 11:31 a.m. and states in part, “...REASON FOR HOSPITALIZATION AND HOSPITAL COURSE:...9/31/25 was transferred to step down after PLEX line placed, following that patient had allergic reaction during PLEX session with concern for anaphylaxis. Received lV epinephrine and started on pressor for hypotension, transferred back to NCCU. Later improved and received further PLEX with pretreatment on 10/2/25, with plan for 5 [five] PLEX sessions. Completed all sessions without further concern for allergic reactions and had improvement in MG symptoms ...” The patient left the facility on 10/14/25 at 12:47 p.m. An interview was conducted with staff 3 on 11/17/25 at 2:18 p.m. Regarding patient 1, staff 3 states in part, “...The patient started complaining of shortness of breath, and was hyperventilating. We thought the patient was anxious. We contacted the physician and they ordered us to give five (5) mg of IV valium. We were getting ready to send the patient back to the floor and had called the bedside nurse to give report. We checked on the patient, and the patient was slumped over so we immediately called the code. The code team arrived. They hooked the patient up to the pads, but the patient had a heartbeat, no compressions or intubation was warranted. Respirations were shallow, but present and the patient never lost heartbeat. Within a couple minutes, the patient was awake and would answer questions, still a little bit lethargic...I did not fill out an incident report about the incident. I figured since the code was called that the code team would fill out some kind of report. I did document the incident in the patient’s medical record. I did not fill out a report in the safety report system...” A telephone interview was conducted with staff 6 on 11/18/25 at 9:04 a.m. Regarding patient 1, staff 6 states in part, “...I remember the patient having a rash after one of [his/her] PLEX treatments. [He/she] had had the same reaction previously. The dialysis nurse said [he/she] had a previous reaction. I documented the reaction, and I think that [he/she] got premedicated prior to this treatment... I just documented the reaction, since it was a known reaction, I didn’t fill out an incident report.” An interview was conducted with staff 7 on 11/18/25 at 9:30 a.m. Regarding patient 1, staff 7 states in part, “...[He/she] had classic signs of anxiety. The patient also was itching, and possibly had hives...It might have been a reaction to the PLEX. I would not say it was an adverse reaction, like a transfusion reaction, as there was no difficulty in breathing. There was no problem with the patient’s vital signs. That’s why we premedicate prior to the PLEX treatment, there’s a possibility of itching afterwards. If anything happens, we call the physician. There’s so many things involved with the PLEX treatment: the premedication, the tubing, the gases in the tubing, the albumin...I wouldn’t have documented it in the Incident reporting system since the patient was premedicated and it’s expected that they have a reaction.” On 11/18/25 at 2:30 p.m. staff 1 confirmed there is only one (1) patient safety event in the system for patient 1. There are no events related to PLEX treatment reactions on 09/30/25 or 10/02/25.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 32177 Based on record review, document review and staff interview it was determined that Employee #8, failed to supervise the adolescent unit during a Code M. This failure has the potential to negatively affect all patients receiving services at the facility. Findings include: A review of the medical record for patient #1 revealed the patient was admitted to the hospital on 08/13/25, with a diagnosis of suicidal ideations. On 08/17/25 at approximately 9:30 p.m. A code M was activated the patient began to escalate over an earlier incident where the patient was placed on Close Visual (CV). The patient did not like being constantly watched. Two (2) MHS (Mental Health Specialist) tried to de-escalate the patient. A review of the staffing sheets for the 08/17/25, 7:00 p.m. to 7:00 a.m. shift revealed one (1) RN and two (2) MHS were scheduled. A review of the job description titled “RN III” with a date of last change 07/29/25. States in part, “Job Profile name: RN III ...Job Profile Summary This position has the authority, responsibility, and shift accountability for the delivery of nursing care through the use of the nursing process. The incumbent accepts accountability, applies competent clinical knowledge skills, and uses independent nursing judgment for care provided by self and by health care providers to whom care is delegated to achieve quality patient care outcomes. Performs the duties and responsibilities within the scope of a Registered Nurse (RN) ...” A review of a policy titled “CODE M (MORE ASSISTANCE) RESPONSE TEAM” with a last reviewed date of 06/07/23. States in part, “It is the policy of West Virginia University Hospitals (WVUH) to support a specially trained team to provide an effective and efficient response to any request for MORE ASSISTANCE (Code M) for a patient, visitor, or staff member, who may be emotionally and physically escalated ...All available staff from the primary unit and all available staff from near neighboring units will respond as show of support. Staffs educated in non-violent crisis intervention skills are to be the first responders. Roles: Staff nurse: communicates with patient and team. The response team will provide non-violent crisis intervention during events that occur in patient care areas ...” A telephone interview was conducted with employee #2 on 08/25/25 at 11:40 a.m. When asked to explain the incident with patient #1 on August 17th? They stated in part; “I came to the unit as part of the Code M team. When I got there, they were removing items from the patient’s room because they threatened self-harm. The patient began to get upset because they had a CV and me and another worker were explaining why they got the CV. The [states employee #8’s name] left the unit for a while ...” An interview was conducted with employee #5 on 08/26/25 at 6:45 a.m. When asked to explain the incident with patient #1 on August 17th? “I was at the door of [states patient #1’s name] trying to de-escalate them along with another MHS. [states employee #8’s name] was upset and we don’t know why they got so upset that night because they weren’t even on the unit when the patient started ripping the Velcro door off of the bathroom door and throwing it. They had left the unit to go find [states employee #7’s name]. When asked if there was another nurse on the unit? They stated, “No, [states employee #7’s name] was pulled to work another unit.” An interview was conducted with employee #6 on 08/26/25 at 7:46 a.m. When asked what the process is for a nurse to contact a charge nurse or a nursing supervisor? They stated in part, “The process is you start with the charge nurse, and you contact them by either texting them or calling them on their phone.” When asked if the unit should be left with no registered nurse (RN)? They stated in part, “No, they should be using their phones to contact them instead of leaving the unit.” A telephone interview was conducted on 08/26/25 at 8:00 a.m. with employee #7. When asked to describe their involvement with patient #1 on August 17th? They stated in part, “I was on another unit when [states employee #8’s name] came to the unit and wanted me to come back to the unit to see ‘inappropriate behavior’ between two [2] MHS workers and a patient. I went to the unit where the MHS workers were calmly explaining the CV order to the patient. When asked if there was another RN on the unit while employee #8 was off the unit? They stated in part, “No other RN was on the unit when they went left the unit to get me.” A telephone interview was attempted on 08/26/25 at 9:20 a.m. with employee #8. A Voice message was left to please return this surveyor’s phone call. It should be noted the employee never contacted this surveyor back.”

“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: 32177 Based on document review, medical record review, and staff interview it was determined the Nurse Manager failed to ensure patient safety checks were completed as ordered on seven (7) our of ten (10) medical records reviewed (Patient #1,2,4,5,6,7,and 8). This failure has the potential for all patients to be at risk for self-harm. A review of the policy titled “CRC [Chestnut Ridge Center] Special Precautions and Room Check Policy”. With a last revised date of 01/2022, states in part, “Policy: Chestnut Ridge Center inpatient staff will use the level of precautions deemed necessary to provide the appropriate level of safety. The acute patient will be evaluated on admission and daily by the attending physician or covering physician and placed on the least restrictive precaution level to maintain the patient’s safety ...A. Admission/Transfer: 1. Upon arrival to the unit, the patient’s belongings are secured and the patient is placed on a minimum, precautions that require 15 [fifteen] minute location/safety rounds record special precautions form. A higher level of precaution may be indicated to meet each individual patient safety needs based upon clinical assessment and ASQ [Ask Suicide-Screening Questions.] ...3. The clinical therapist will complete the SAFE-T [Suicide Assessment Five-Step Evaluation and Triage] protocol and the C-SSRS (Columbia Riska and Protective Factors) recent with the patient within 72 [seventy-two] hours of admission ...B. Precaution levels ...2. (CVs) Constant Visual-Line of sight, Maintaining patient within a designated staff person’s visual field is used when a patient gives specific evidence that a suicide/homicide attempt, or self/other-harm act is considered imminent ...3. (SP) Suicide/Self-Harm Precautions (Eps) Escape Precautions (HPs) Homicide Precautions- The area of risk is specified, and the patient is placed on 15 [fifteen] minute checks. Used when a patient is judged to be at risk for specific impulsive acts. Patient will be restricted to unit and visually monitored at least every 15 [fifteen] minutes. 15 [fifteen] minute checks are approximations and may be completed plus or minus three [3] minutes every quarter of an hour ...C. For patient safety, room and unit checks will be completed by unit staff at least every shift and documented on the Q15 [fifteen] check sheet ...” A review of the medical record for patient #1 revealed the patient was ordered fifteen (15) minute safety checks. The patient had no documentation of safety checks on 05/21/25 from 9:00 p.m. through 9:22 p.m. A review of the medical record for patient #3 revealed the patient was ordered CV. The patient had no documentation of safety checks or CV on 05/21/25 from 9:08 p.m. through 9:45 p.m. A review of the medical record for patient #4 revealed the patient was ordered CV. The patient had no documentation of safety checks or CV on 05/21/25 from 9:09 p.m. through 9:45 p.m. A review of the medical record for patient #5 revealed the patient was ordered fifteen (15) minute safety checks. The patient had no documentation of safety checks on 05/21/25 from 9:00 p.m. through 9:22 p.m. A review of the medical record for patient #6 revealed the patient was ordered fifteen (15) minute safety checks. The patient had no documentation of safety checks on 05/21/25 from 9:09 p.m. through 9:45 p.m. A review of the medical record for patient #7 revealed the patient was ordered fifteen (15) minute safety checks. The patient had no documentation of safety checks on 05/21/25 from 9:12 p.m. through 9:32 p.m. A review of the medical record for patient #8 revealed the patient was ordered fifteen (15) minute safety checks. The patient had no documentation of safety checks on 05/21/25 from 9:10 p.m. through 9:45 p.m. An interview was conducted on 06/04/25 at 9:55 a.m. with employee #1. They concurred that no safety checks were completed for patient #1,3, 4, 5, 6, 7, and 8.”

“OUTPATIENT SERVICES PERSONNEL CFR(s): 482.54(b) The hospital must -- (1) Assign one or more individuals to be responsible for outpatient services. (2) Have appropriate professional and nonprofessional personnel available at each location where outpatient services are offered, based on the scope and complexity of outpatient services This Standard is not met as evidenced by: 49464 Based on observation, document review, and staff interview, sleep lab management failed to ensure that physicians were not signing blank documents for staff to copy and complete, including the prescription area, for the initiation of obtaining medications for the treatment for Narcolepsy at the Sleep Lab; affecting one (1) Patient (Patient #1) of five (5) reviewed, who were ordered Xywav and/or Xyrem. This failure has the potential to affect all patients being treated medically for Narcolepsy or Idiopathic Hypersomnia. (Refer to 482.54) Findings include: A review of the medical record for Patient #1 was completed, and revealed a “Xywav and Xyrem REMS Prescription Form,” (form) dated 03/27/24, that appeared to be completed in it ’ s entirety, including the prescription dose, by Employee # 6. The form was signed by Employee #13. Six (6) of these blank forms signed by Employee #13 located in a file cabinet in the control room in the sleep lab. A telephone interview was conducted on 07/16/24 at 9:50 a.m. with Employee #13 regarding the forms. Employee #13 stated: “The form is filled out to initiate the process of obtaining the medication for the patient. The MA fills out the top of the form and I fill out the dosage information. The medications are given for Narcolepsy and Idiopathic Hypersomnia. They are a controlled substance, and it is a process that we have to go through to get the medication. The patient will come to the clinic after their sleep studies, and options are discussed. The medications have interactions with alcohol and other medications and may have psychotic side effects. The patient will fill out an enrollment form, and we fill out our forms. The forms are sent with medical records to the only pharmacy that handles the medication] and the insurance. It is a process, and sometimes we have to resubmit documentation. Once it is approved, we can send the prescription through Epic [computer e-pharmacy]. It all has to go through me. Any time I make a dosage change, we follow the same process.” An interview was conducted on 07/18/24 at 12:33 p.m. with Employee #13. Employee #14 examined the pre-signed form found in the control room and confirmed that it was their signature on the blank form. Employee #13 then examined the form filled out for Patient #1, dated 03/27/24. Employee #13 confirmed that the MA had filled out the entire form, including the prescription, and it appeared to be a copy of the blank pre-signed form. Employee #13 stated: “I recall this. I had been talking to [Patient #1] about starting the medication, and [he/she] was on the fence. I had submitted the paperwork last November, and [he/she] decided against it. [The November documentation was reviewed, and the prescription area was completed by the physician, and the physician signature was not the same as the blank copies]. In March, [he/she] was contemplating starting it again. I signed the paper to get the process started, waiting to hear back from the patient. I told the MA I would fill out the rest later. I frankly had forgotten about it. I had discussed it with the MA, who said they would fill in the paperwork if they heard back from the patient. The prescription is the standard starting dose. I ’ m not sure where the MA got it from. I do not give verbal orders for medications to an MA. I am responsible for filling out the prescription area and should not have done that [left a blank signed form]. I had absolutely no idea that the blank form was copied - especially six (6) times. I only have four (4) patients on the medication at this time. I am very upset that I left a blank signed form, and that copies were made. I have no idea who would have copied it. The company has changed the process just this week where the entire process will be completed online, so this will never happen again.” A zoom interview was conducted on 07/18/24 at 10:45 a.m. with Employee #11 regarding pre-signed forms. Employee #11 stated: “I oversee the medical staff of the sleep lab. I found out about the pre-signed forms on Monday.” Employee #11 then viewed the blank form with Employee #13 ’ s signature, and confirmed that it was an old form that was no longer in use; and that the process just recently changed, and will be completed electronically without the use of the documents. Employee #11 concurred the forms should not be pre-signed. Employee #11 stated: “I complete the medication dosage area, and would never give a verbal order for medication to an MA. The MA fills out the top portions, pulls the appropriate medical records from Epic, and sends them to [specific pharmacy]. I call and coordinate everything with the pharmacy.” A zoom interview was conducted on 07/18/24 at 11:05 a.m. with Employee #12, who stated: “I do not have direct oversight of the sleep clinics. Employee #1 reports to me in the leadership meetings.” Regarding the pre-signed forms, Employee #12 stated: “There should be no pre-signed forms of any kind anywhere. That is totally unacceptable.” An interview was conducted on 07/16/24 at 10:35 a.m. with Employee #1 regarding the pre-signed blank copied forms that were found in the control room. Employee #1 confirmed that the form for Patient #1, dated 03/27/24, looked like it was completed entirely by Employee #6, except for the signature, which matched the copies in found in the drawer, and signed by Employee #13.”

“PATIENT RIGHTS: GRIEVANCE PROCEDURES CFR(s): 482.13(a)(2)(i) [At a minimum:] The hospital must establish a clearly explained procedure for the submission of a patient’s written or verbal grievance to the hospital. This Standard is not met as evidenced by: 40269 Based on medical record review, document reviews, and staff interviews, it was determined the facility failed to follow policy and procedures for filing and responding to a grievance, in one (1) out of one (1) patient elopement, patient #1. This failure has the potential to negatively impact all patients receiving care at the facility. Findings include: A medical record review was conducted for patient #1. The patient was presented to the facility’s Emergency Department (ED) on 10/24/23 at 10:34 p.m. accompanied by the Police Department. A “Note” by Employee (emp) #3 on 11/01/23 at 4:42 p.m. states, “Paging service to notify of patient escaped unit and was found off of Hospital property by security.” A “Discharge Summary’’ on 11/01/23 at 5:12 p.m. by emp #4 states in part, “ ... Today pt eloped without notifying nurse or physician team of [patient #1] intentions or concerns about leaving. No one was able to counsel [patient #1] or redirect [patient #1] to stay in the hospital. Per unit, pt was spotted off of Hospital property and security is not able to apprehend at this stage. Security notified the local authorities that the patient is missing. [HCS (Healthcare Surrogate)] was notified of patient’s elopement.” A “Note” by emp #5 on 11/01/23 at 5:31 p.m. states, “Informed by care manager [emp #1] that patient had eloped. Call approximately 425p [4:25 p.m.] Simultaneously heard overhead page for this patient’s elopement during call. Later 443p [4:43 p.m.] [Emp #1] called again. Informed security reported patient had been off property, and they were not permitted to force patient to return since [patient #1] was no longer on Hospital property per report. [Emp #1] unsure if security had contacted police. I contacted security dispatch. Spoke to an officer [emp #6]. Explained the patient lacks DMC and was a ward of the state. [Emp #6] stated [emp #6] would call local police. I contacted [HCS] to informed [HCS] of elopement. I informed [HCS] security reported they would now call police. Reportedly, the patient was last seen a little past the Varsity Club on Willowdale Rd [Road] per security.” Emp #6 gave the following written statement regarding patient #1, “I was able to review video footage and find patient [patient #1] exiting the main Ruby visiting elevators at approximately 16 :20:19 [4:20:19 p.m.] hours. The patient then exited the Ruby main canopy @ [at] approximately 16:21:09 [4:21:09 p.m.] hours and made [patient #1’s] way through the C-lot [parking area] and onto University property at approximately 16:24:37 [4:24:37 p.m.] hours. The initial phone call from the staff from 7 West came in at approximately 16:24:49 [4:24:49 p.m.] hours and was immediately given out to the officers. At approximately 16:25:01 [4:25:01 p.m.] the officers at the main canopy of Children’s Hospital located the patient as [patient #1] made [patient #1’s] way up the service road to the stadium and cut across the F 3-4 [parking area] lot where [patient #1] then exited the lot and crossed Willowdale Road at approximately 16:29:46 [4:29:46 p.m.]. Due to the patient leaving hospital property, law enforcement was notified. Officers were never able to make contact with the patient.” A policy was reviewed titled, “Patient Complaints and Grievances,” last revised 08/14/23. The policy states in part, “... Definitions: ... Grievance - A Formal or informal written or verbal complaint that is made to the hospital by a patient, or the patient’s representative, regarding that patient’s care (when the complaint is not resolved at the time of the complaint by staff present), abuse or neglect, issues related to the hospital’s compliance with CMS Patient’s Rights CoPs [Conditions of Participation], or a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489 ... Procedure: ... Once a grievance has been filed, a patient advocate, or designee, will respond to the complaint in writing, within seven [7] calendar days. This written response shall, at a minimum, acknowledge the patient’s concerns. If the resolution will take longer than seven [7] days, the acknowledgment letter will inform the patient or the patient’s representative that the hospital is still working to resolve the grievance and will include the current progress and the time frame for future updates. WVUHS [West Virginia University Health System] strives to resolve all grievances as soon as possible. Steps in the grievance investigation process include, but are not limited to interviewing the patient, interviewing the complainant (if different than the patient), reviewing relevant medical records, interviewing staff with potential knowledge of the situation, researching applicable laws, regulations, policies, and procedures, identifying measures, including those already taken, to resolve the problem ...” The Grievance/Complaint Log, titled “OFLAC Report” was reviewed for 11/01/23 through the present. The event involving patient #1’s elopement was not listed on the log. A review of the policy, titled “Abuse and Neglect of Incapacitated Adults and Facility Residents,” reviewed 12/21/21. The policy states, in pertinent part, “... Procedure: ... B. Reporting Mechanism 1. Reporting Responsibility: Any medical, dental or mental health professional or social service worker who has reasonable cause to believe that an incapacitated adult or facility resident is, or has been neglected, abused or placed in an emergency situation, or who observes an incapacitated adult or facility resident being subjected to conditions that are likely to result in abuse, neglect or an emergency situation must immediately report the circumstances by telephone to the WV Abuse and neglect hotline at 1-800-352-6513. The telephone report must be followed by a written report within 48 [forty-eight] hours. The reporter may request that [patient #1] or her name be removed from the report before APS forwards it to the appropriate law enforcement agency, prosecuting attorney, or medical examiner. The Care Management Department can assist with facilitating this process ...” An interview was conducted with emp #9 on 11/06/23 at 12:40 p.m. Regarding the incident with patient #1, emp #9 states, “I was present when this happened. I had seen this patient right before 4:00 p.m. that day. After the incident we had discussed it in Daily shift huddles. I had not been asked to do any formal investigation into the incident yet.” An interview was conducted with emp #1 and emp #5 on 11/06/23 at 12:50 p.m. Emp #5 explained that [emp #5] filed the APS due to the fact that the patient was incapacitated and was going to be out in cold weather. “The team made the decision to file the APS the next day. The decision was made since the APS form stated that any incapacitated adult that could be at risk, you should file an APS. The intent was not to allege neglect against the hospital.” An interview was conducted with emp #12 on 11/06/23 at 3:22 p.m. Emp #12 confirmed an incident report was filed in the Event Monitoring System (EMS) on 11/01/23. An investigation began on 11/01/23 and was still in process. The event was not considered a grievance. An interview was conducted with emp #13 and emp #14 on 11/07/23 at 8:51 a.m. Regarding the incident of patient #1 eloping, emp #13 and #14 state, “We look at the incident log first thing in the morning. We would have received this on 11/2. We start fact finding and working with events that could be a sentinel event. The fact-finding process begins the process. We start with the medical record and create a timeline of events. We reach out to the leadership afterwards to get additional details. When we reach out to leadership, we try to have some sort of resolution by the end of the day. There’s no resolution yet to this as we are still in the fact-finding process. Ideally, we would complete our investigation in less than forty-five (45) days. We usually have thirty (30) events per day that need to be investigated and we have two (2) coordinators that review the events. If an event needs to be immediately investigated, leadership or Administration would let us know. Otherwise, all events go through the same process.” A telephone interview was conducted with emp #19 on 11/08/23 at 10:26 a.m. Regarding the incident involving patient #1 eloping, emp #19 states in part, “I felt that no immediate intervention or investigation was necessary as did the chief quality officer. We did not report this as a grievance as there was no indication of neglect on the part of the staff.””