Thomas Memorial Hospital

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 40269 Based on document reviews and staff interviews, it was determined the facility failed to ensure all staff were adequately informed and trained on new medication dosage concentrations and new Intravenous (IV) pumps in the Intensive Care Unit (ICU) prior to their implementation. This failure has the potential to cause a delay in care and negatively impact all patients receiving care at the facility’s ICU. Findings include: A policy was reviewed titled “Competency and Education”, last reviewed on 12/14/2023. The Policy states in part, “... The policy contains Purpose: This competency and education establishes a systematic framework to ensure qualified, competent employees throughout the West Virginia University Health Systems (WVUHS) create uniformity, ensure the highest quality in patient care processes, and consistency in services. Procedure: ... B. Annual/Ongoing Competency and Mandatory Education, 1. Employees must complete all required competencies and mandatory education as defined by the department and organization on an annual basis., a. The system-wide mandatory annual/ongoing competency will be assigned in April of each year with a competition date in June of that calendar year ... C. Assessment of need for hire/annual competencies will be completed using a defined process ... E. Competency/Education Compliance ... 2. Compliance reports for annual/ongoing competencies will be the responsibility of each hospital., 3. Compliance reports for annual/mandatory education will be the responsibility of the system learning team.” A review was conducted of an Email dated 7/25/24 at 2:36 a.m. sent by Emp #12 to Emp #1 #2, and #4. The email states in part, “Subject: Education-Pumps and Drip Changes, Hi guys, Sorry to bring bad news, but I know the new pumps went live yesterday and with that came drip concentration changes, which people are complaining about; for various reasons, but mainly due to the lack of education done prior to going live with the changes. With the drip concentration changes occurring, that could easily be overlooked when programming the pumps. You have to type in the concentration after selecting the meds; for example, selecting fentanyl, you have to program the concentration. Also, another issue that occurred was changing to weight-based fentanyl without education on this. We have seen the papers hanging in the breakroom and bathroom, but several people do not pay attention to these or know what it is going to entail ...” A reply to the email was sent by Emp #1 on 07/25/24 at 5:33 a.m. and states, “I’m on my way now. I wish you had called me last night and I would have come in then.” An interview was conducted with Emp #1 on 08/05/24 at 1:31 p.m. Regarding education on new Intravenous (IV) pumps along with new medication dosage concentrations, Emp #1 states, “I got the training to be a superuser on July 9th. After that, I taught two (2) classes and whoever signed up for the class could attend. Nurses were supposed to sign up for the classes. They were all supposed to be trained prior to the pumps going to the floor. The education department was supposed to keep up with the training, however we did not have a sign in sheet for the classes that I taught. From my understanding, only percent (30%) of staff had the training after the rollout. If the staff had any questions after the rollout, they could always call whoever was on call for the department. On July 24th I was on call that night. No one called me. There’s an on-call sheet in the Staffing book and if any questions at all came up about anything, not just the pumps, they could call. When I got up that morning I saw an email was sent about having a problem programming the pump for fentanyl. I came in early. I looked at the pump and you just have to set the patient weight in kilograms and start. The new pumps and the new concentration of medication came out at the same time. The education was not mandatory prior to the pumps rolling out. The education department didn’t send any notices out to us to tell us that we needed to get the staff trained. I was not told until July 22nd that the new pumps were arriving on July 23rd.” An interview was conducted with Emp #2 on 08/05/24 at 1:54 p.m. Regarding education on new Intravenous (IV) pumps along with new medication dosage concentrations, Emp #2 states, “I received training to be a superuser sometime in July. I had used these pumps before at a previous job I had, so I was familiar with them. After I became a superuser I taught one (1) class. Anyone could attend my class, but no ICU staff attended. The training was not mandatory. The thought was that several staff had used the pump before, and enough staff would know how to use it to help with the ones who didn’t. I don’t believe there was any phone number to call with any concerns. The day the pumps rolled out; I stayed over till about 8:00 p.m. to help with the new pumps. They had a problem in the ED, and I helped them with a blood transfusion there. I did not stay over on the 24th. On the 25th, I stayed over until about 9:00 (p.m.) after we had received the information that the night shift didn’t know how to program the pump on the previous night. I haven’t received any calls about staff having pump problems when I’m on call on night shift.” An interview was conducted with Emp #4 on 08/05/24 at 2:03 p.m. Regarding education on new Intravenous (IV) pumps along with new medication dosage concentrations, Emp #4 states in part, “When it was determined that we were going to get new IV pumps, it was in several phases ... The third phase was training for staff. There were workday modules assigned to the staff to complete. They were assigned to all nurses with a deadline of one (1) to two (2) months. The CNO (chief nursing officer) did not make the training mandatory. The education department and the CNO felt that the Superuser training was sufficient for the departments. For the training of the staff, we should have kept better track and we should have made sure all the staff was trained but we didn’t ... We were notified about a week prior about the time and day that the pumps would be rolled out. They also asked for assistance to help roll out the new IV pumps for that day and we had staff sign up. We have a clinical coordinator that works afternoon shift and stays until 9:00 or 10:00 p.m. If the staff would have had any problems with the pumps on any shift, they could have notified Pharmacy, they could have called the supervisor, or they could have called our clinical coordinator on call. None of that happened. We just received an email the next day that they had a problem with the pump the night before. After this, we resent education to everyone via email. We made sure the communication binder had information about the new pumps and the medication concentrations. After we received the email, we spoke with the pharmacy manager. We also spoke with the staff member that sent the email. We also went around and looked at the pumps and found that two (2) of the pumps weren’t updated because they weren’t plugged in. Looking at this incident (with Patient #1) the patient did get what they needed, there was just a slight delay. After we received the email about the incident, [Emp #1] came in early and immediately addressed it with [Emp #12].” An interview was conducted with Emp #5 on 08/05/24 at 3:30 p.m. Regarding education on new Intravenous (IV) pumps along with new medication dosage concentrations, Emp #5 states in part, “The training was to be rolled out initially in Workday. We couldn’t roll out the CBLs (Care based learning) though until July 1st, and then it took a couple weeks to get the class started- on July 11th. We did in person training in the meantime until the roll out. The super users were trained, and they were to train the staff in their department. A lot of the staff had exposure to this kind of pump in the past and so they could help other staff as well. The last I checked two hundred twenty-five (225) out of three hundred (300) nurses were trained. I wasn’t aware that all the ICU nurses had not been trained. I round out on the units every morning, and asked how the new pumps were going and didn’t have any complaints from the staff. The new pumps with the weight based programming were pre-staged on July 22nd with a rollout of July 23rd. This date was announced back in June, and the staff should have been fully aware when this was happening. We pushed training and encouraged the staff to do either the Workday training or the training in person ...” A telephone interview was conducted with Emp #6 on 08/05/24 at 4:16 p.m. Regarding an incident with programming the new IV pumps in ICU on 07/25/24, Emp #6 states, “We got new pumps. They tried to enter the new bags with the new fentanyl concentration. The dosage was weight-based, and they determined that the patient would not get the medication until several hours later. No one knew how to reprogram the pumps to work since it was weight-based. I know the charge nurse was trying to call people I’m not sure who. Anesthesia was there and couldn’t help us. They gave the patient another drug instead, I think, to make the patient more comfortable. They delayed the process of intubation about twenty (20) to twenty-five (25) minutes. I’m unsure if the nursing supervisor came. I do know the charge nurse was trying to help. There was a bunch of Staff in the room trying to figure it out, a couple respiratory techs (technicians) and a bunch of Nursing staff. Two (2) of the nurse practitioners were there too and they didn’t know about the dosage concentration change or the new pumps either.” A telephone interview was conducted with Emp #8 on 08/05/24 at 6:04 p.m. Regarding an incident with programming the new IV pumps in ICU on 07/25/24, Emp #8 states, “A couple different things happened at the same time. The patient needed an emergent intubation. The pumps were new, and the concentration of the drips changed. Neither I nor the staff knew that the dose concentration had changed or how to use the IV pumps. Later, one (1) of the staff members found a paper in the bathroom with the new dose concentrations on it. They brought it up with the clinical educator in the morning and got no response. They spoke with a pharmacist and [Emp #9] said education was sent out earlier. I was told the clinical coordinator should have trained the staff and that didn’t happen. I don’t know if the nursing supervisor that night was called. I did call the pharmacy at that time for help with the order and they helped us through it. Pharmacy explained you have to give an initial bolus due to the concentration so high and it would take three (3) to five (5) minutes for the medication to start getting to the patient. The incident was brought up the next morning with the day shift coordinator.” A telephone interview was conducted with Emp #15 on 08/05/24 at 6:13 p.m. Regarding an incident with programming the new IV pumps in ICU on 07/25/24, Emp #15 states in part, “ ... There were no problems with programming the pump. It was okay, but the rate was so slow that it wouldn’t get to the patient. I don’t remember ever getting any email for any kind of classes for training. That night was my first night with these pumps and I did not have any training prior to this. [Emp #2] was there the next night and stayed a couple hours and helped. I did not know if there was any training for these pumps or the dosage changes on workday.” An interview was conducted with Emp #9 on 08/06/24 at 9:03 a.m. Regarding education on new Intravenous (IV) pumps along with new medication dosage concentrations, Emp #9 states in part, “We were getting new pumps at this hospital. They wanted the pumps to be standardized across the system. The medication dosages were also to be standardized and they were changing to weight based and a lot of them were higher concentration. I sent the education to [Emp #1] and [Emp #2] ahead of time. The medication concentration changes were sent to the ICU medical team (vendors) who relayed the information and in person training. I provided an entire PowerPoint with highlighted areas. I told everyone that when the pumps go live, the medication concentration would change. The date was set for July 22, 2024. We knew the final date sometime at the end of June ...” A telephone interview was conducted with Emp #12 on 08/06/24 at 2:45 p.m. Regarding an incident with programming the new IV pumps in ICU on 07/25/24, Emp #12 states in part, “That night the patient in bed twenty-three (23) needed to be intubated. The problem with us programming the pumps caused the small delay. Everyone had come into the room to try to help. There was a change in the pumps and the medication concentrations at the same time. We found a printout with the new medication concentrations posted on the bathroom wall ... We had to call the pharmacy because the nurse practitioner didn’t know how to order the fentanyl, the rate was so slow, everything was different. After that incident, I sent emails to our director, our educator, and our two (2) clinical coordinators about the lack of communication. I did not remember receiving any email to sign up for classes. I talked to the pharmacist afterwards and [Emp #9] said the education was provided a while back, but [Emp #9] was happy to provide it to me. I didn’t know any classes were sent via email. I was never told that and did not see it in my email. The other charge nurse who works Night Shift wasn’t aware of any classes either. After I sent my email to our four (4) coordinators, one (1) educator responded and came in early that morning. The pharmacist had already told me that [Emp #9] included the education in that class, but like I said, I didn’t know about any class. [Emp #9] went ahead and forwarded me the drip concentration PowerPoint and told me to spread it out through the unit. That night, when I came back to work, the information still was not in our communication binder. I printed it out and put it at the nurse’s station, in the binder, and several places throughout the unit... I didn’t know that they were holding any kind of classes ... After this happened I found out that there was an e-learning module on Workday related to this. I did not know prior. I shared that with the other staff members that there was a class on Workday. We still have not received any education on our unit other than what I had provided with everyone with the PowerPoint print out. When [Emp #1] came in early in the morning, after I sent the email, [Emp #1] showed us how to use the pump, but [Emp #1] still did not talk about the medication concentration changes. We have a white binder at the desk which is called a clinical communication binder. There was no information in this binder prior to me putting in the PowerPoint presentation from the pharmacist the night after this happened.” A telephone interview was conducted with Emp #14 on 08/06/24 at 5:10 p.m. Regarding an incident with programming the new IV pumps in ICU on 07/25/24, Emp #14 states, “The programming of the pumps wasn’t a huge issue, but I feel a lot of people were left in the dark. Any education provided would have been beneficial, and we didn’t get any. We were notified by email that the pumps were coming out, but no education was provided. A couple staff even asked for education and did not get it. The biggest issue I felt was the medication concentration changing. It was switched to a weight-based program in the new pumps. Some of the medication included vasopressors, Lasix, and medication we use for sedation. The only education we received is some printouts that were on the bathroom door. We got an email saying the changes were being made but never any education provided. After this incident happened, our charge nurse contacted the educators. We have a director, a coordinator and two (2) educators so there’s four (4) people. [Emp #12] sent an email to them, and the one (1) educator came in early that day. The educator made a crappy comment about if the nurse killed somebody by programming the pump wrong, then they would just lose their license. [Emp #12] contacted the pharmacist, and the pharmacist gave [Emp #12] the education that was provided previously to the coordinators. [Emp #9] also sent us information on who to contact if we have any problems. [Emp #12] printed off the PowerPoints that [Emp #9] sent [Emp #12] and placed them throughout the unit and in the communication binder. The next night, [Emp #2] was there at the beginning of the shift and [Emp #12] had to ask [Emp #12] for education for the pumps. [Emp #2] didn’t offer formal education about any of the medication dosages, [Emp #2] just did a pump demonstration to a couple of staff. I don’t recall receiving any email about classes to sign up for regarding the pump changes and medication dosage concentration changes. I don’t remember seeing a module in workday related to this either. That night when all this happened, I know [Emp #12] had sent the email, but I don’t know if [Emp #12] called the supervisor. I don’t remember seeing any paper with contact information for the pump vendors. I don’t remember any information being brought up in the shift huddle. They may have talked about the medication being changed and the new pumps but nothing in detail. The coordinators or director do not participate in the shift huddle only the charge nurses do the shift huddle. I have not once seen the director, or the coordinators participate or be near the shift huddle when it happens either at the start of day shift or at the start of night shift.” A review was conducted of the staffing for 07/24/24 7:00 p.m. through 07/25/24 7:00 a.m. A document was provided to this surveyor with all the ICU staff who had been assigned the Workday module for the new ICU Medical IV pumps and medication concentration changes. Eight (8) RNs were on staffing for the ICU. Two (2) of the Eight (8) staff had been assigned the modules, and one (1) of the two (2) staff had completed the module. Six (6) staff had not been assigned the module. An email was reviewed dated 08/06/24 at 3:46 p.m. by Emp #1 (After being interviewed by this surveyor on 08/05/24) to all ICU staff which states, “All, There is ICU medical pump Plum 360 education loaded in workday and some of you have emailed me asking for an access code. It is 657. IF YOU DO NOT HAVE THE EDUCATION, IT IS OKAY. For some reason some people have it, and some don’t. We have a ticket in and are working on figuring out why. Thank you.” An interview was conducted with Emp #16 on 08/07/24 at 11:00 a.m. Emp #16 explained the additional six (6) staff listed on the night shift in ICU on 07/24/24 did not have the online modules assigned to them in Workday. Emp #16 confirmed no email was sent to Nursing staff in the ICU to sign up for in-person classes for training related to the new medication dosage concentrations and the new IV pumps. An additional interview was conducted with Emp #4 on 08/07/24 at 11:20 a.m. Emp #4 confirmed the only email sent to staff regarding the pumps and medication changes which had a link for sign -up was one that asked for volunteers to help with the roll out on 07/22/24. No email was sent to ICU staff with a link to sign up for classes. The clinical educator was to train the staff in person. Not all staff received a notification in Workday to sign up for online modules and not all staff were assigned the modules.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 46199 Based on review of policies and medical record review it was determined that the facility failed to provide an appropriate medical screening examination to one (1) of twenty (20) 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 “Emergency Medical Treatment and Labor Act (EMTALA)” date reviewed 2/1/23. This policy has a section titled “Policy” which states, in part, “West Virginia University Hospitals (WVUH) will comply with the requirements of the Emergency Medical Treatment and Active Labor Act (EMTALA) by ensuring that when an individual comes by him or herself or with another person to WVUH or its premises and a request is made by the individual or on the individual’s behalf for medical examination or treatment, WVUH or a department thereof will provide for an appropriate Medical Screening Examination within the capability of the WVUH Emergency Department, including ancillary services routinely available to the Emergency Department, to determine whether or not an emergency medical condition exists ...” This policy contains a section titled “Medical Screening Examination Procedure 1. When a Medical Screening Examination (MSE) is Required” which states, in part, “B. An individual in a non-WVUH-owned ambulance, which is on WVUH property or premises, is considered to have come to the WVUH Emergency Department.” A document titled “WVU Medicine Thomas Hospitals Medical Staff Bylaws 2024”, revised 2024. This document has a section titled ‘Emergency Room Coverage’ which states, in part, “B. Every patient who presents to Thomas Memorial Hospital Emergency Department will have a screening exam beyond the initial triage, performed by an Emergency Department Physician or Physician Assistant to determine whether or not an emergency medical condition exists. Emergency medical condition means that any medical condition that manifests itself by acute symptoms of sufficient severity, including severe pain, psychiatric disturbances, and/or symptoms of substance abuse, such that the absence of immediate medical attention could reasonably be expected to result in 1. Serious jeopardy to the health of the individual, pregnant woman or her unborn child. 2. Serious impairment of any bodily function or serious dysfunction of any organ part..” A medical record review was conducted for Patient #1. The patient arrived in the Emergency Department (ED) via Emergency Medical Services (EMS) at 2:29a.m. on 6/17/24. The medical record contains an entry titled “ED Triage Note entered by Emp #19 on 6/17/24 at 2:37a.m. which states, in part, “Patient called 911 for blood sugar (BS) check for feeling like [he/she] was going to pass out. According to EMS they check on [him/her] frequently and [he/she] is currently altered compared to normal. Glucose on scene two hundred eighty-four (284). Patient does have a history (hx) of schizophrenia. Current BS two hundred seventy-five (275). Denies any pain. Patient (Pt) very hard to talk to, talking all over the place.” The medical record contains a section titled “ED Primary Provider Note” entered by Emp #6 at 2:29a.m. on 6/17/24, which states, in part, “Chief Complaint Patient presents with altered mental status. Arrival: The patient arrived by ambulance [he/she] presenting to the ED via EMS for complaints of elevated blood sugar. EMS was contacted because [his/her] blood sugar check. Patient apparently told them that [they] felt like [they] was [sic] going to pass out ...Patient has EMS to check on [him/her] rather frequently, they report that [he/she] seemed to be acting a little different than typical ...They do report a strong aroma of marijuana. Patient’s glucose was two hundred eighty-four (284) when they arrived. [It should be noted that the facility’s Latest Reference and Units for Glucose is seventy (70) - one hundred (100) milligrams per deciliter (mg/dl)]. Patient does have a history of schizophrenia. They declined that patient had any suicidal or homicidal thoughts or comments to them ...The patient is extremely tangential on thoughts [he/she] has no reported suicidal or homicidal thoughts ...[He/She] is uncertain of why [he/she] is here but [he/she] reports that [he/she] may want checked out, but [he/she] is uncertain.” This entry has a section titled “Physical Exam” which states, in part, “Constitutional: Alert and oriented and patient responds with questions in tangential thought and speech, strong aroma of marijuana ...Psych: The patient’s mood and manner are tangential thoughts unable to remain still continuously moving.” The medical record contains an entry titled “ED Nurse Notes” entered by Emp #7 on 6/17/24 at 3:53a.m. which states, “Patient walked out of EC [sic]. [He/She] stated that a family member was coming to get [them].” May it be noted that no additional mental health testing or laboratory work was ordered or completed, and the elopement documentation is not contained within the medical record. The entry has a section titled “Patient Data” which states, in part, “Labs Ordered / Reviewed - No data to display. No orders to display.” This entry has a section titled “Disposition’ which states, “Eloped.””