HospitalInspections.org

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.