**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, interviews, and record review the facility failed to ensure the resident environment remained free of accident hazards as possible, and each resident received adequate supervision to prevent elopement for 1 of 5 residents (Resident #42) reviewed for accident hazards and supervision. 1. The facility did not ensure Resident #42 received adequate supervision to prevent exiting the facility without staff knowledge on 09/15/24. 2. The facility did not ensure exits accessible to residents who could exit unsupervised alarmed loud enough to allow staff to respond in a timely manner. An IJ was identified on 09/23/24. The IJ template was provided to the facility on [DATE] at 5:32 p.m. While the IJ was removed on 09/24/24, the facility remained out of compliance at a scope of isolated and a severity level of no actual harm with potential for more than minimal harm that is not immediate jeopardy due to the facility continuing to monitor the implementation and effectiveness of their Plan of Removal. These failures could place residents at risk of serious injury or harm. Findings included: Record review of Resident #42's face sheet, dated 09/26/24, indicated Resident #42 was admitted to the facility on [DATE] with diagnoses which included Alzheimer's (progressive disease that destroys memory and other important mental functions). Record review of the admission MDS assessment, dated 06/14/24, indicated Resident #42 made himself understood and understood others. Resident #42's BIMS score was 4, which indicated his cognition was severely impaired. Resident #42 did not have disorganized thinking, behaviors, wandering, or refusal of care. Resident #42 used a wheelchair. Record review of the comprehensive care plan, revised 07/19/24, indicated Resident #42 was a at risk for wandering. The care plan interventions included, distract resident from wandering by offering pleasant diversions, structured activities, food, conversation, television, book, identify pattern of wandering, if the resident is exit seeking, stay with the resident and notify the charge nurse by calling out, sending another staff member, call system, etc., monitor my location frequently through the day while I am up & out of bed, and wear owander alert bracelet in place (on w/c) & check for placement q shift. Record review of the comprehensive care plan, revised 09/15/24, indicated Resident #42 was at risk for elopement as evidenced by: resident history of exit seeking and exiting out of door of facility. The care plan interventions included, resident moved to secure care unit, assess/record/report to MD risk factors for potential elopement such as: Wandering, Repeated requests to leave facility, statements such as I'm leaving I'm going home, attempts to leave facility, elopement attempts from previous facility, home, or hospital, supervise closely, and make regular compliance rounds whenever resident is in room, determine the reason the resident is attempting to elope. Is the resident looking for something or someone? Does it indicate the need for more exercise? Intervene as appropriate, provide structured activities: for inside and outside, reorientation strategies including signs, pictures, and memory boxes, distract resident from elopement attempts by offering pleasant diversions, structured activities, food, conversation, television, books, and if the resident is exiting seeking, stay with the resident and notify the charge nurse by calling out, sending another staff member, call system, etc. Record review of the referral paperwork from a sister facility dated 06/05/24 revealed Resident #42 would be sent to a secure unit facility. Record review of Resident #42's elopement assessment, dated 06/05/24, reflected Resident #42 was at risk for elopement. Record review of the electronic medical records indicated Resident #42 was admitted to the secure unit on 06/05/24 but was moved off from the secured unit on 07/01/24. Record review of the MAR dated 09/01/24-09/31/24 indicated Resident #42 had a wanderguard and had been checked every shift for placement and function with a d/c date of 09/15/24. Record review of a progress note dated 07/01/24 at 4:05 p.m., completed by LVN D indicated Resident #42 attempted to exit door at the end of hall 5. Resident #42 was redirected, and alarm reset. No acute distress noted. Record review of a progress note dated 07/01/24 at 5:45 p.m., completed by LVN D indicated Resident #42 stated his truck got stole and he has been looking for his truck. Resident #42 tried to exit through the end of hall 5 door. Resident #42 stated, I don't know what the hell happened. Record review of Resident #42's elopement assessment, dated 07/01/24, reflected Resident #42 was at risk for elopement. Record of a progress note dated 07/10/24 at 4:10 a.m., completed by LVN E indicated Resident resting quietly in bed with eyes closed. Resident has been exit seeking this shift. Resident made out the door at the end of hall 5. When the staff was trying to redirect the resident, the resident became even more upset and was cursing yelling. Resident was finally distracted enough to come back in the building, by saying that it was to hot outside and the resident could be come dehydrated. Once the resident was back in the building. The resident made four other attempts to exit the building without success. However, each time his efforts did not produce the wanted outcome the resident became more and more upset. Re-direction was very difficult, with even stating that his truck was in the shop, offering food and Dr. Pepper, resident still remained upset for about 30-45 minutes. Resident filly calmed down approximately 10 p.m, while talking to female resident in the front lobby. Resident then went to his room and took a Dr. Pepper from his fridge and then went to bed at approximately 11:30 PM. Safety precaution met and call light and fluids within reach. Record review of Resident #42's elopement assessment, dated 07/20/24, reflected Resident #42 was at risk for elopement. Record review of the event nurses' note, dated 09/15/24, revealed Resident #42 was outside in the parking lot and was seen by Housekeeping Aide H as she was entering the parking lot via vehicle. Record review of the provider investigation report dated 09/15/24 indicated Housekeeping Aide H was pulling in the parking lot and saw Resident #42 outside. RN P had gone to get gloves when she heard the front door alarm, when she returned to the nurse's station, she asked about the door alarm. At that time LVN N was headed outside to assist Housekeeping Aide H with Resident #42. Resident #42 may have been outside for 2 minutes, no injuries. Record review of Resident #42's elopement assessment, dated 09/15/24, reflected Resident #42 was at risk for elopement. Record review of the electronic medical records indicated Resident #42 was moved on the secured unit 09/15/24. During an observation on 09/23/24 at 9:15 a.m., the front door had no locking mechanism or alarming system upon entrance to the building. The facility was located on a busy highway. During an observation and interview on 09/23/24 at 2:32 p.m., RN G and the state surveyor tested the alarm at the front door area which was not heard down the hallways by the other state surveyors. The front door wanderguard alarm was only audible to the front door area. RN G stated she had observed exit seeking behaviors in the past with Resident #42 on several different occasions, but he was able to be redirected easily. RN G stated interventions for residents at risk for elopement was redirection. During an observation and interview on 09/23/24 beginning at 4:54 p.m. with the Maintenance Supervisor he performed a door alarm check on all halls. 3 out of 7 facility exit doors did not alarm when opened by the Maintenance Supervisor. 2 out of 7 facility exit doors were attached to the wanderguard system. The Maintenance Supervisor stated the alarms should sound when the door was opened but was unsure why the door alarm was not activated. The Maintenance Supervisor stated he performed weekly door alarm checks. The Maintenance Supervisor stated the risk of the door alarms not been activated when the door opened would put residents at risk for elopement. Record review of sheet titled Task #317502 indicated the Maintenance Supervisor performed door alarm checks on all halls 09/12/24. During an attempted interview on 09/23/24 at 11:15 a.m. with Resident #42, indicated he was non-interview able. During an interview on 09/23/24 at 11:28 a.m., CNA O stated she was the CNA for the secured unit. CNA O stated Resident #42 was admitted on the secured unit but was removed off when there was an incident between him and another resident and him required to be transferred by hoyer lift. CNA O stated Resident #42 did have exit seeking behaviors prior to being removed off the unit but was able to be redirected. CNA O stated on 09/15/24 the day Resident #42 eloped she was in the kitchen getting cereal for another resident when Housekeeping Aide H came in and stated LVN N needed assistance with getting Resident #42 back in the building. CNA O stated when she went outside Resident #42 was halfway in the parking lot. CNA O stated she assisted LVN N with getting him back in the building. CNA O stated she could not recall the reason why Resident #42 stated he was outside. CNA O stated the front door wanderguard alarm did sound when Resident #42 was brought back in the building. CNA O stated Resident #42 was placed on 1:1 until the nurse obtained an order to place him on the secured unit. CNA O stated it was unsure how Resident #42 got out the building. During an interview on 09/23/24 at 12:46 p.m., Housekeeping Aide H stated she was coming into work on 09/15/24 and saw Resident #42 sitting in his wheelchair between 2 cars which was approximately 50 feet from the front door. Housekeeping Aide H stated she tried to redirect Resident #42 back in the building but was unsuccessful. Housekeeping Aide H stated she left Resident #42 in the parking lot by himself while she went in the facility to get assistance. Housekeeping Aide H stated she grabbed LVN N and told her Resident #42 was found outside in the parking lot. Housekeeping Aide H stated LVN N told her she needed a CNA, so she went back in the building to grabbed one while LVN N stayed with Resident #42. Housekeeping Aide H stated CNA O came out to assist LVN N with getting Resident #42 back in the building. During an interview on 09/23/24 at 2:54 p.m., RN P stated the day Resident #42 eloped she was down the hallway with CNA Q attempting to find the supply closet because she was new to the facility. RN P stated during that time she thought she had heard an alarm going off but only for a short time. RN P stated she started coming up the hallway when Housekeeper Aide H had come up saying LVN N needed help with Resident #42 who was found outside in the parking lot. RN P stated she went outside, and Resident #42 was easily redirected into the facility. RN P stated the Administrator, and the Regional Compliance Nurse were notified, and she was instructed to sit 1:1 with him until an order was obtained for the secured unit. RN P stated multiple elopement drills were completed the day of the incident, in-servicing was performed on abuse/neglect and elopement prevention and response. RN P stated that no other staff members had heard an alarm during the investigation, so she assumed she was just hearing things. RN P stated that when Resident #42 was brought inside the facility the wander guard system on his wheelchair set the front door alarm off, so they knew the door alarm was working. RN P stated that when Resident #42 was back inside the facility, an assessment was completed. RN P stated Resident #42 had no visible issues. During an interview on 09/23/24 at 3:20 p.m., CNA R stated she was in a room down the hall and did not hear any door alarms going off while in the room when Resident #42 was found outside. During an interview on 09/23/24 at 3:53 p.m., the ADON stated Resident #42 was admitted to the facility on [DATE] to the secured unit because the facility he was at he was having exit seeking behaviors. The ADON stated Resident #42 was removed off on 07/01/24 due to an incident with another resident and requiring a hoyer lift for transfer. The ADON stated if a resident required a hoyer lift they did not meet the secured unit requirement. The ADON stated Resident #42 did have exit seeking behaviors but was easily redirected. The ADON stated he would always state he was looking for his truck. The ADON stated when Resident #42 tried to elope on 07/01/24 and 07/10/24 the only interventions she was aware was the wanderguard and redirection. The ADON stated she did not reassess Resident #42 after the attempted elopements back in July. The ADON stated the DON was on medical leave at this time and she did not know if she reassessed the resident to ensure safety. The ADON stated the ADO came in the week on 09/02/24 and saw Resident #42 exit seeking and asked her why he was not on the unit. The ADON stated after she told her the reason why he was not she stated a hoyer lift transfer could be on the unit. The ADON stated after the conversation with the ADO, Resident #42 was not placed on the because when he started to exhibit exit seeking behaviors, he was able to be redirected so putting him back on the unit was never brought back up until he eloped on 09/15/24. The ADON stated the risk for residents eloping was a serious injury. During an interview on 09/23/24 at 4:14 p.m., LVN D stated she was on the unit passing medications when Resident #42 was found outside in the parking lot. LVN D stated Housekeeping Aide H came and told her Resident #42 was outside in the parking lot and LVN N was with him. LVN D stated she was unable to leave the residents by themselves on the secured unit, so she had to wait until CNA O came back on the unit. LVN D stated once CNA O came to relieved her, she went out and completed a head-to-toe assessment on Resident #42. LVN D stated all the responsible parties were notified and Resident #42 was moved to the secure unit when an order was obtained. LVN D stated she had observed exit seeking behaviors from Resident #42 when he was on Hall 5 off the secured unit. LVN D stated Resident #42 would state he was looking for his white ford truck or his big rig. LVN D stated Resident #42 was easily redirected at times, but she has had to reset the alarm before because Resident #42 would get close to the door and set the alarm off. LVN D stated interventions for Resident #42 been at risk for elopement was redirection and the wandergaurd system. During an observation on 09/23/24 at 6:10 p.m., the speed limit sign in front of the facility changes from 45 to 55 miles per hour. During an interview on 09/24/24 at 11:38 a.m., LVN N stated she was at the end of Hall 2 when Housekeeping Aide H came in hollering Hey, Someone Help Me. LVN N stated Housekeeping Aide H stated Resident #42 was found outside in the parking lot when she arrived at work. LVN N stated when her and Housekeeping Aide H went outside Resident #42 was by a tree beside the facility that was approximately 150 feet from the front door entrance. LVN N stated when she asked Resident #42 where he was going, he stated, I'm going home. LVN N stated she was able to redirect Resident #42 back in the building. LVN N stated when Resident #42 was brought inside the facility the wander guard system on his wheelchair set the front door alarm off. During a telephone interview on 09/25/24 at 10:21 a.m., Administrator S stated she was the Administrator for the facility when Resident #42 eloped back in July. Administrator S stated Resident #42 was moved off the unit because she was told by the DON Resident #42 was not exhibiting exit -seeking behaviors. Administrator S stated she could not remember the incidents on 07/01/24 or 07/10/24. Administrator S stated she did not remember Resident #42 exit seeking when she was there. Administrator S stated if resident tried to elope on 07/01/24 and 07/10/24 he should have gone back to the unit because he was still at risk for elopement. Administrator S stated the risk for residents eloping was a serious injury. During an interview on 09/26/24 at 11:22 a.m., Administrator T stated she had observed Resident #42 exit seeking while sitting at her desk in the front lobby, but he was easily redirected. Administrator T stated she thought the wandergard system was enough to be safe since he was easily to be redirected. Administrator T stated the front door remained unlocked all day and felt like it was just fine. Administrator T stated she monitored resident safety by discussing any incidents during morning meetings, rounds and collaborating with the DON/ADON. Administrator T stated the risk for residents eloping was a serious injury. Record review of the facility's policy titled, Elopement Prevention, revised 10/27/10, indicated, Every effort will be made to prevent elopement episodes while maintaining the least restrictive for residents who are at risk for elopement .Physical Plan (1) All facility exits that residents have access to will have a device in place to alert staff of possible elopement attempts . (2) All other exits not considered fire exits will be locked when not occupied by staff members . This was determined to be an IJ on 09/23/24 at 5:30 p.m. The Administrator was notified. The Administrator was provided with the IJ template on 09/23/24 at 5:32 p.m. The following plan of removal submitted by the facility was accepted on 09/24/24 at 1:00 p.m. and included the following: Interventions: 1. On 9/23/24, Resident #42 resides on the secure unit inside the facility. 2. All door alarms were checked for proper functioning and alarming by the maintenance director on 9/23/24. All doors are alarming properly. 2 of 2 doors with wander guard volume increased on 9/23/24. All other doors with locking mechanism are at a volume that is audible throughout the facility on 9/23/24. 3. All residents with wander guards had their devices checked for proper functioning by ADON and Charge Nurses on 9/23/24. All devices are functioning properly. Front door Wander guard alarm volume increased on 9/23/24. 4. Elopement risk assessments for all residents in the facility were completed and reviewed by the DON/ADON/Designee on 9/23/24. No additional concerns were identified. 5. All elopement risk care plan interventions were reviewed on 9/23/24 by the Regional Compliance Nurse, DON, and ADON. All interventions are in place and care planned. 6. The Administrator and ADON were in-serviced 1:1 by the ADO and Regional Compliance Nurse on 9/23/24 on the following: a. Elopement Prevention Policy to include implementing interventions for residents at risk for elopement. b. Elopement Response Policy c. Abuse and Neglect Every effort will be made to prevent elopement episodes while maintaining the least restrictive environment for residents who are at risk for elopement. The Elopement Risk Assessment will be completed upon admission by the charge nurse. The assessment will be completed by reviewing the resident's medical history and social history. Information may be obtained by reviewing current medical records, if available, interview with resident/family, or conference with the interdisciplinary team member. The Elopement Risk Assessment is to be completed at least quarterly, after an elopement attempt, upon new exit seeking behavior, and upon change of condition. The Elopement Risk Assessment will be completed by the charge nurse or designee. The DON/ADON will be responsible for ensuring the completion and review of the assessment. This will begin 9/23/24. All residents who are at risk for elopement will be assessed by the interdisciplinary team. This will begin 9/23/24. The resident's care plan will be modified by the DON, MDS Coordinator, or designee to indicate the resident is at risk for elopement with appropriate interventions to prevent elopement attempts. This will begin 9/23/24. 7. Medical Director notified of the immediate jeopardy on 9/23/24. 8. An ADHOC QAPI meeting was conducted on 9/23/24 to discuss the immediate jeopardy citation and subsequent plan of correction. In-services: 1. The Regional Compliance Nurse, Administrator and ADON will in-service all staff on the following topics below. All staff not present for the in-services will not be allowed to work their next shift until the in-services are complete. All new hires will be in-serviced during orientation prior to working their shift. All agency staff will be in-serviced prior to assuming scheduled shift. a. All staff were in-serviced on the elopement response policy by the Compliance Nurse, Administrator and ADON on 9/23/24. b. All staff were in-serviced on elopement prevention by Compliance Nurse, Administrator and ADON on 9/23/24. c. All staff were in-serviced on Abuse and Neglect by the Compliance Nurse, Administrator, and ADON on 9/23/24. d. Charge Nurses in-serviced on 9/23/24 on Checking door alarms and wander guard alarms 2 times daily at change of shift. On 09/24/24 the survey team confirmed the facility implemented their plan of removal sufficiently to remove the Immediate Jeopardy (IJ) by: 1. During an observation on 09/24/24 at 11:01 a.m., Resident #42 was observed on the secure unit inside the facility. 2. During an observation on 09/24/24 with the Maintenance Supervisor and a state surveyor beginning at 2:50 p.m., the door alarms were checked for proper functioning and alarming. All other doors with locking mechanism were at a volume that was audible throughout the facility. No additional concerns were identified. 3. During an observation on 09/24/24 with the Maintenance Supervisor and a state surveyor beginning at 2:50 p.m., a wanderguaard device was checked for proper functioning by attempting to go out the front door entrance. Front door Wander guard alarm volume increased. 4. Record review of the elopement risk assessments audit, were completed on 09/23/24, revealed all residents were assessed for elopement. No additional concerns were identified. 5. Record review of the elopement risk care plan interventions audit, were completed on 09/23/24, revealed all care plan interventions were in place and care planned. 6. Record review of the in-service form dated 09/23/24 revealed the Administrator/ADON had received 1:1 in-service training with the ADO and Regional Compliance Nurse on elopement prevention, elopement response policy and abuse and neglect. 7. During a telephone interview on 09/24/24 at 1:52 p.m., the Medical Director stated he was notified of the immediate jeopardy situation and attended a QAPI meeting via phone over the immediate jeopardy and subsequent plan of removal on 09/23/24. 8. Record review of the ADHOC QAPI meeting, dated 09/23/24, revealed a meeting was conducted on 09/23/24 to discuss the IJ citation and subsequent plan of correction. 9. During interviews conducted on 09/24/24 between 2:10 p.m. and 3:10 p.m., revealed LVN D, RN G, Housekeeping Aide H, [NAME] L, LVN N, CNA O, RN P, CNA Q, CNA R, CNA V, Housekeeper Aide W, Activity Director, Human Resource Coordinator, Dietary Manager, Floor Maintenance, Housekeeping Supervisor, Maintenance Supervisor, Social Worker, PT Assistant, Rehab Director, OT, Marketing/Admissions, from all shifts were in serviced on elopement response policy, elopement prevention, abuse/neglect policy and checking the door alarms and wander guard alarms 2 times daily at change of shift. The Administrator was informed the IJ was removed on 09/24/24 at 3:36 p.m. The facility remained out of compliance at a severity level with potential for more than minimal harm with a scope identified as isolated due to the facility's need to evaluate the effectiveness of the corrective systems that were put into place.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, observation, and record review, the facility failed to provide pharmaceutical services, including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals, to meet the needs of each resident for 8 of 15 residents (Resident #2, Resident #10, Resident #20, Resident #23, Resident #25, Resident #28, Resident #29, and Resident #31) and 2 of 4 medication carts (Hall 5 and Hall 6) reviewed for pharmacy services. The facility failed to ensure Resident #29 received Ribavirin (An antiviral medication that is used to treat chronic hepatitis C. Ribavirin is not effective when used alone) and Epclusa (a medication that contains a combination of sofosbuvir and velpatasvir antiviral medications that prevent hepatitis C virus from multiplying in your body it may sometimes be used with another antiviral medication, Ribavirin), as ordered by the physician, medications for treatment of his hepatitis C to prevent liver failure. The facility failed to have a process in place to ensure Epclusa was received and administered as ordered to Resident #29. The facility failed to monitor Resident #29 for side effects of the Ribavirin. An Immediate Jeopardy (IJ) situation was identified on 07/27/2023 at 5:00 PM. The IJ template was provided to the facility on [DATE] at 5:29 PM. While the IJ was removed on 07/28/2023 at 5:15 PM, the facility remained out of compliance at actual harm that is not immediate jeopardy with a scope identified as isolated due to the facility's need to complete in-service training and evaluate the effectiveness of the corrective systems. The facility failed to ensure LVN C, LVN K, and LVN L had a witness when wasting controlled medications for Resident #2, Resident #10, Resident #20, Resident #23, Resident #28, and Resident #31. The facility failed to ensure LVN H and LVN E notified the DON when the controlled medication count for Resident #20's Lorazepam (controlled medication used for anxiety) was not correct. The facility failed to ensure LVN C, LVN E, and LVN M notified the DON when there was a discrepancy with the count of Resident #25's whiskey. The facility failed to ensure LVN F and LVN M counted controlled drugs every shift change. These failures could place residents at risk for harm or death related to inappropriate medication therapy, not having medications available for use, and drug diversion. Findings included: 1. Record review of a face sheet dated 07/28/2023, indicated Resident #29 was a [AGE] year-old male initially admitted to the facility on [DATE] and readmitted on [DATE] with diagnoses which included acute and subacute hepatic failure without coma (acute liver failure symptoms include yellowing of the skin and eyeballs, swollen belly, nausea, vomiting, disorientation, confusion, tremors, sleepiness), chronic obstructive pulmonary disease (chronic inflammatory lung disease that causes obstructed airflow from the lungs), hemiplegia unspecified affecting left nondominant side (paralysis of the left side of the body). Record review of the Comprehensive MDS assessment dated [DATE] indicated Resident #29 was able to make self-understood and understood others. The MDS assessment indicated Resident #29 had a BIMS score of 11, which indicated his cognition was moderately impaired. The MDS assessment indicated Resident #29 required extensive assistance with bed mobility, transfer, dressing, toilet use and personal hygiene. The MDS assessment indicated Resident #29 had an active diagnosis of acute and subacute hepatic failure without coma. Record review of the care plan with date initiated 03/20/2023, last revised 07/28/2023, indicated Resident #29 was at risk of complications related to liver disease due to a diagnosis of hepatitis C (a viral infection that causes inflammation of liver that leads to liver inflammation). Resident #29's care plan indicated he would be free from signs and symptoms of liver complications including infection, abnormal or unexplained bleeding, malnutrition, anemia, cognitive decline, or mental status changes. Resident #29's care plan indicated he had an appointment scheduled on August 22, 2023, with an infectious doctor and his family member would take him to the appointment and all records would be sent with his family member, and labs would be forwarded to the infectious doctor and medical director, monitor labs as needed and as prescribed by infectious doctor and medical director. Record review of Complaint #402920 indicated on 01/31/2023, the Complainant said on 10/22/2022 the disease specialist doctor prescribed two medications to be administered for Resident #29's hepatitis C. The Complainant said the facility received one of the prescriptions called Ribavirin (200 mg capsule to be administered twice daily) and the facility started this medication. The Complainant said this medication had a black box warning that it was not supposed to be administered by itself. That it should be administered with another medication. The Complainant said for approximately three months, Ribavirin had been administered to Resident #29 by itself. The Complainant said during Resident #29's hospitalization in January of 2023 the liver doctor had stated Resident #29's hepatitis C was very active, and the nursing facility was supposed to be treating Resident #29 for hepatitis C. The complainant said the facility had administered the Ribavirin without reading the black box warning. The complainant said the Ribavirin and Epclusa were supposed to be administered simultaneously to kill the hepatitis virus. The complainant said the nursing facility failed to administer the Epclusa medication and as a result Resident #29 was delusional and experienced side effects. The complainant said the liver doctor said the facility had dropped the ball, and the Ribavirin and Epclusa had to be restarted and administered simultaneously to treat Resident #29's hepatitis C on 01/26/2023. Record review of Ribavirin's Important Warning on Medline Plus (medlineplus.gov) indicated, Ribavirin will not treat hepatitis C (a virus that infects the liver and may cause severe liver damage or liver cancer) unless it is taken with another medication. Your doctor will prescribe another medication to take with ribavirin if you have hepatitis C. Take both medications exactly as directed . If you experience any of the following symptoms, call your doctor immediately: excessive tiredness, pale skin, headache, dizziness, confusion, fast heartbeat, weakness, shortness of breath, or chest pain . Record review of the Order Summary Report with order date range from 10/01/2022-07/31/2023, indicated Resident #29 had a discontinued order for Ribavirin Tablet 200 MG give 1 tablet by mouth two times a day for Hepatitis C with a start date of 10/22/2022, no end date. Resident #29's Order Summary Report did not indicate there was an order for Epclusa Oral Tablet 400-100 mg (Epclusa is a medication that contains a combination of sofosbuvir and velpatasvir antiviral medications that prevent hepatitis C virus from multiplying in your body it may sometimes be used with another antiviral medication, Ribavirin) to take with the Ribavirin on 10/22/2022. The Order Summary Report for Resident #29 had a discontinued order for Ribavirin Oral tablet 200 mg give 1 tablet by mouth two times a day for Hepatitis C give with food with a start date of 01/26/2023, the discontinued date was not indicated on the order summary report. Resident #29's Order Summary report indicated a discontinued order for Epclusa Oral Tablet 400-100 MG give 1 tablet by mouth one time a day for Hepatitis C take with food with a start date of 01/26/2023, the discontinued date was not indicated on the order summary report. Record review of Resident #29's October 2022 MAR indicated he had an order for Ribavirin tablet 200 mg give 1 tablet by mouth two times a day for hepatitis C with a start date of 10/22/20223 and discontinued date of 01/12/2023. The October 2022 MAR indicated Resident #29 received the Ribavirin as ordered from 10/22/2022 to 10/31/2022. The October 2022 MAR did not indicate an order for Epclusa, and it did not indicate Epclusa had been administered. Record review of Resident #29's November 2022 MAR indicated he had an order for Ribavirin tablet 200 mg give 1 tablet by mouth two times a day for hepatitis C with a start date of 10/22/20223 and discontinued date of 01/12/2023. The November 2022 MAR indicated Resident #29 received the Ribavirin as ordered from 11/01/2022 to 11/30/2022. The November 2022 MAR did not indicate an order for Epclusa, and it did not indicate Epclusa had been administered. Record review of Resident #29's December 2022 MAR indicated he had an order for Ribavirin tablet 200 mg give 1 tablet by mouth two times a day for hepatitis C with a start date of 10/22/20223 and discontinued date of 01/12/2023. The December 2022 MAR indicated Resident #29 received the Ribavirin as ordered from 12/01/2022 to 12/31/2022. The December 2022 MAR did not indicate an order for Epclusa, and it did not indicate Epclusa had been administered. Record review of Resident #29's January 2023 MAR indicated Epclusa Oral Tablet 400-100 MG (Sofosbuvir-Velpatasvir) give 1 tablet by mouth one time a day for hepatitis c take with food with a start date of 01/26/2023 and a discontinued date of 04/19/2023. The Epclusa was administered as ordered from 01/26/2023 to 01/31/2023. Record review of Resident #29's January 2023 MAR indicated Ribavirin tablet 200 mg give 1 tablet by mouth two times a day for hepatitis c take with food with a start date of 01/26/2023 and discontinue date of 04/19/2023. The Ribavirin was administered as ordered from 01/26/2023 to 01/31/2023. Record review of Resident #29's visit with the infectious disease doctor dated 09/07/2022 indicated in the assessment/plan that he had a history of hepatitis C, and once the infectious disease doctor had all labs available, he would start the process for approval of medication to treat Resident #29's hepatitis C. The infectious disease doctor indicated it took about 3-4 months for the medication to be approved, and the medication would be sent directly to his nursing facility. Record review of Resident #29's progress notes beginning on 10/14/2022 did not indicate there was an order to start Ribavirin or Epclusa. The progress notes did not indicate when the Ribavirin was started or monitoring of Resident #29 after the start of the Ribavirin. The progress notes indicated on 10/24/2022 at 8:41 PM an entry by LVN S indicated, Resident #29 was sitting up on his bedside commode and became nonresponsive for approximately 7 min due to a possible TIA. Resident #29 then became responsive and was assisted back to his bed with the assistance of 3 attendants. Resident #29 had no complaints of any pain or discomforts after getting him back to his bed. The progress notes indicated an entry on 10/31/2022 at 7:00 AM by the ADON that Resident #29 was confused that morning and the CNA was in the room to get Resident #29 up and he did not know where he was at. Resident #29 thought he was on the highway running. The ADON noted twitching to his right upper extremity and face/head, and he was incontinent of urine that morning. Resident #29 stated, he did not know he had urinated. Resident #29 was transferred via Hoyer lift due to him having weakness. The ADON indicated she would notify the doctor of changes and would continue to monitor. Record review of an entry in the progress notes made by LVN R on 11/02/2022 at 8:35 AM indicated Resident #29 was to start Rocephin and Cipro (both antibiotic medications) for a urinary tract infection. Record review of an entry in the progress notes made by RN N on 11/15/2022 at 10:58 AM indicated Resident #29 was lethargic and did not eat breakfast. He was not answering simple questions and his behavior appeared to be different. The Medical Director was notified of this by the ADON. Record review of an entry in the progress notes made by the facility's Medical Director on 12/13/2022 at 3:44 PM indicated Resident #29 was doing a little better an assessment included on peripheral neuropathy (a disease that causes weakness, numbness and pain in the feet and hands), allergic rhinitis, chronic back pain, coronary artery disease, chronic obstructive pulmonary disease, traumatic brain injury, seizures, left hemiplegia, left foot drop. The Medical Director's progress note did not address the Ribavirin or the hepatitis C treatment. Record review of an entry in the progress notes by the ADON on 12/28/2022 at 2:31 PM, indicated Resident #29 had vomited and reported nausea the Medical Director was notified, and he was started on Zofran (medication used for nausea) 4mg one tab by mouth every 4 hours as needed for 14 days. Record review of an entry in the progress notes by LVN H on 01/06/2023 at 5:22 PM indicated upon entering the room, LVN H observed Resident #29 laying in a prone (face down) position in the bathroom his wheelchair was directly behind him in the doorway. Resident #29 denied having pain, blood was noted on the floor, he was not moved, and 911 was called at this time the Medical Director was notified and a new order was received to send to the ER for evaluation. Record review of Resident #29's hospital records dated 07/27/2023 indicated he was admitted on [DATE] with diagnoses of syncope and liver failure and discharged on 01/12/2023.The hospital records indicated Resident #29 was admitted to the hospital for further stabilization of life-threatening conditions which included liver failure. During an attempted interview on 07/24/2023 at 3:07 PM, the complainant did not answer the phone. During an interview on 07/25/2023 at 3:19 PM, Resident #29 said all he knew was that he was supposed to be taking medications for his hepatitis C, but he did not know about when he was supposed to start it or anything. Resident #29 did not know what the medications to treat his hepatitis C were. Resident #29 was unable to provide details regarding his hospitalizations. During an interview on 07/27/2023 1:41 PM, LVN T, the infectious disease doctor's nurse, said on 10/19/2022 she had received notice from the pharmacy that Resident #29's Epclusa and Ribavirin had been approved and would be sent to the nursing facility. LVN T said on 10/19/2022 she called the nursing facility and spoke with the ADON. LVN T said she gave the ADON verbal orders for both the Epclusa and Ribavirin and instructed her both medications had to be administered at the same time. LVN T said for nursing facility patients she gave verbal orders to the nurses at the facility, and faxed the doctors order for the medications to the pharmacy. LVN T said she provided the ADON the pharmacy's number for her to call and check on the medications. LVN T said the Ribavirin should not be taken alone because it would not treat the hepatitis C if taken alone. LVN T said on 10/22/2022 the ADON called her and notified her that Resident #29 had started the Ribavirin. LVN T said she was not informed by the ADON that Resident #29 did not start the Epclusa. LVN T said on 01/16/2023 the ADON called her to notify her Resident #29 was about to complete the Ribavirin and informed her Resident #29 had never started the Epclusa. LVN T said the ADON informed her that Resident #29 had been discharged from the hospital with a diagnosis of liver failure and the Ribavirin had been discontinued. LVN T said the hepatitis C was not treated effectively due to not receiving both medications. LVN T said the infectious disease doctor had given orders to restart both the Epclusa and Ribavirin on 01/26/2023 and Resident #29 had completed both medications on 04/18/2023. LVN T said the infectious disease doctor was currently out of the country and unable to be reached for interview. During an interview on 07/27/2023 at 2:03 PM, the ADON said Resident #29 was seeing the infectious disease doctor and she was notified by LVN T that Resident #29's Epclusa and Ribavirin would arrive to the facility by mail from the pharmacy. The ADON said the Ribavirin arrived at the facility by mail, and she put the physician's order in Resident #29's electronic health record for the Ribavirin to be started. The ADON said she called the infectious disease doctor and notified LVN T that Resident #29 had started the Ribavirin. The ADON said she did not notify LVN T that the Epclusa had not been received and it was not started. The ADON said she did not notify LVN T the Epclusa had not been received because LVN T should have asked her if they had received the Epclusa. The ADON said LVN T had given verbal orders for both the Ribavirin and the Epclusa. The ADON said she did not remember if the Ribavirin came with a black box warning. The ADON said she did not remember if when she put in the physician's order for the Ribavirin the black box appeared in the electronic health record. The ADON said if a medication had a black box warning, when the physician's order was entered the black box warning automatically appeared and had to be dismissed to continue entering the physician's order. The ADON said if a black box warning appeared in the electronic health record when she input Resident #29's order for Ribavirin, she was supposed to notify the doctor for further instructions. The ADON said she was not aware that Ribavirin had a black box warning, and that it should not be administered alone for the treatment of hepatitis C. The ADON said when she did not receive the Epclusa she should have called and checked on the medication. The ADON did not specify why she had not followed up with the pharmacy after the Epclusa was not delivered. The ADON said if a medication was ordered to be delivered by mail and it did not arrive, she was supposed to call the pharmacy to follow up on the medication and notify the doctor. During an interview on 07/27/2023 at 3:25 PM, the DON said she was not employed at the facility in October 2022. The DON said if the ADON was aware Resident #29 was supposed to take both the Ribavirin and Epclusa, when the Epclusa was not delivered the ADON should have called the infectious disease doctor's office and notified them. The DON said when a physician's order was entered into a resident's electronic health record, if the medication had a black box warning it would pop up before allowing the staff to continue. The DON said if a black box warning appeared when inputting an order the physician should be notified of the warning for further instructions, and it should be documented in the resident's progress notes. The DON said the black box warning associated with the Ribavirin indicated the Ribavirin would not treat hepatitis C unless taken with another medication, and it could cause liver damage or liver cancer if taken alone. During an interview on 07/28/2023 at 10:10 AM, Pharmacist Consultant V said he reviewed Resident #29's medication orders in October 2022, November 2022, and December 2022. Pharmacist Consultant V said he was aware of the black box warning for the Ribavirin. Pharmacist Consultant V said the black box warning indicated the Ribavirin was not supposed to be taken alone. Pharmacist V said he did not make any recommendations to the facility regarding the Ribavirin because he thought it was what the doctor had ordered according to the physician's order. Pharmacist Consultant V said he was not aware that the Ribavirin had to be taken with the Epclusa. During an interview on 07/28/2023 at 1:20 PM, the Medical Director said he was aware Resident #29 was started on Ribavirin and Epclusa. The Medical Director said since that was a special medication, and it was prescribed by the infectious disease doctor he was not familiar with the medications. The Medical Director said if there was a black box warning associated with the Ribavirin the nurses should have contacted the infectious disease doctor for further instructions. Record review of the facility's policy titled, Pharmacy Services Overview, last revised April 2019, indicated, The facility shall accurately and safely provide or obtain pharmaceutical services, including the provision of routine and emergency medication and biologicals, and the services of a licensed consultant pharmacist. Policy Interpretation and Implementation 1. Pharmaceutical services consists of: a. the processes of receiving and interpreting prescriber's orders; acquiring, receiving, storing, controlling, reconciling, compounding (e.g. intravenous antibiotics), dispensing, packaging, labeling, distributing, administering, monitoring responses to using and/or disposing of all medications, biologicals, chemicals; b. the provision of medication-related information to health care professionals and residents; c. the process of identifying, evaluating, and addressing medication-related issues including the prevention and reporting of medication errors; and d. the provision, monitoring and/or the use of medication-related devices. 2. The facility shall contract with a licensed consultant pharmacist to help it obtain and maintain timely and appropriate pharmacy services that support the residents' needs, are consistent with current standards of practice, and meet state and federal requirements . 4. Residents have sufficient supply of their prescribed medications and receive mediations (routine, emergency, or as needed) in a timely manner .5. Nursing staff communicate prescriber orders to the pharmacy and are responsible for contacting the pharmacy if resident's medication is not available for administration . Medications are received, labeled, stored, administered and disposed of according to all applicable state and federal laws and consistent with standards of practice . The consultant pharmacist, in collaboration with the dispensing pharmacy and the facility, oversees the development of procedures related to pharmacy services, including (but not limited to): a. acquisition and availability of medications: (1) receipt, labeling, and storage of medications; (2) reconciliation of medications from the pharmacy; (3) control of medications from point of receipt to secured storage areas; and (4) facility staff roles and responsibilities during the receipt and storage of medication. b. medication packaging and dispensing systems; c. administration of medications; d. disposition of medications; e. authorization, training and competency of personnel; and f. documentation of processes, as applicable. Record review of the facility's policy titled, Medication and Treatment Orders, last revised July 2016, indicated, . only authorized, licensed practitioners, or individuals authorized to take verbal orders from practitioners, shall be allowed to write orders in the medical record. 3. Drugs and biological orders must be recorded on the physician's order sheet in the resident's chart. Such orders are reviewed by the consultant pharmacist on a monthly basis . verbal orders must be recorded immediately in the resident's chart by the person receiving the order and must include prescriber's last name, credentials, the date and the time of the order . The Administrator was notified on 07/27/2023 at 5:19 PM that an Immediate Jeopardy situation was identified due to the above failures. The Administrator was provided the Immediate Jeopardy template on 07/27/2023 at 5:29 PM. The facility's Plan of Removal was accepted on 07/28/2023 at 1:45 PM and included: Plan of Removal: Immediate Actions Taken: Resident #29 is no longer taking antiviral medications as of 4/18/2023, which was the conclusion of the 12 week treatment plan. The original order was to begin antiviral medications on 1/25/2023 and stop on 4/19/2023. The facility has implemented the following process, as of 07/27/23 to ensure medications are received and administered as ordered. Licensed nursing staff and medication aides will be in-serviced on 07/28/23 on the below process. Staff will not be allowed to work unless they have completed the in-services. o Order received. o Order entered into PCC. o If Black Box Warning Notification - physician will be contacted, and order verified; physician will make the decision to continue with the order or to change to a different drug regimen. Response of physician will be documented in the clinical record. o Medication is ordered. o If Medication is being ordered through a mail order process, physician will be contacted and give order to administer medication once received or change the order to a different drug regimen. o When medication is ordered the resident will be placed on daily charting until medication received. o Follow up with physician will be conducted every 7 days to verify continuance of current plan or change to different drug therapy. Resident #29 is no longer on antiviral medications. Side effects for antiviral medications will be entered into PCC and monitored by nursing staff. Resident #29's care plan was updated on 03/20/23 to reflect diagnosis of hepatitis. Resident #29's care plan was updated on 7/28/2023 to reflect chronic hepatitis C diagnosis. Resident #29 is no longer on antiviral medication. The care plan was updated on 07/28/2023 by MDS Coordinator. All resident care plans are being reviewed to ensure all chronic conditions/medications are documented. This audit will be completed on 7/28/2023. Review of all resident medication orders revealed no residents are currently receiving antiviral medications. DON and/or Designee pulled a list of all residents that are on medications that have a black box warning and we will notify physician of this warning and orders will be verified, physician specific response will be documented in the clinical record. The audit will be completed on 7/28/2023, the DON and/or Designee will complete the audit. All licensed nurse staff and medication aides will be in-serviced on the following topics. The in-service will be completed by 11 AM on 7/28/23. The DON and ADON will be responsible for providing the in-service training. Black Box Warning Notification - the in-service will include the following process - physician will be contacted, and order verified; physician will make the decision to continue with the order or to change to a different drug regimen. Response of physician will be documented in the clinical record. Documentation of the reason for giving a medication and documentation of complications or side effects. Rights of Medication Administration Antiviral Medications and Side Effects Mail order medications - delivery and administration. If Medication is being ordered through a mail order process, physician will be contacted and give order to administer medication once received or change the order to a different drug regimen. When medication is ordered the resident will be placed on daily charting until medication received. Follow up with a physician will be conducted every 7 days to verify continuance of current plan or change to different drug therapy. On 7/27/23, on 2nd shift, the DON under the guidance of the Regional Nurse Consultant initiated an in-service with all licensed nurses on duty to cover the topics of: Black Box Warning Notification - physician will be contacted, and order verified; physician will make the decision to continue with the order or to change to a different drug regimen. Response of physician will be documented in the clinical record. Documentation of the reason for giving a medication and documentation of complications or side effects. Rights of Medication Administration Antiviral Medications and Side Effects Mail order medications - delivery and administration. If Medication is being ordered through a mail order process, physician will be contacted and give order to administer medication once received or change the order to a different drug regimen. When medication is ordered the resident will be placed on daily charting until medication received. Follow up with a physician will be conducted every 7 days to verify continuance of current plan or change to different drug therapy. In-servicing of all nursing staff will be completed by 11 AM on 7/28/23. Demonstration of and acknowledgement that all licensed nurses are aware of the above- The DON/ADON Designee will contact all licensed nurse staff and get a verbal acknowledgement as a return demonstration of understanding that- Medications must be received and administered as ordered by physician. Side effects of antiviral medication must be monitored. Nursing staff that aren't available for training will be in-serviced before they are allowed to work their next scheduled shift. On 7/27/23, the facility Administrator, DON, and Regional Nurse Consultant held an ad hoc QAPI meeting with Medical Director via phone. Impromptu agenda items were: IJ (Immediate Jeopardy) was cited on 7/27/23 as evidenced by facility's failure to: F755 Pharmacy Services o The facility failed to ensure Resident #29 received Epclusa 400-100 mg by mouth one time per day as prescribed by the physician. o The facility failed to have a process in place to ensure medications were received and administered as ordered. o The facility failed to monitor Resident #29 for side effects of the antiviral medication. o The facility failed to have a care plan for Resident #29's chronic hepatitis C and antiviral medication. The pharmacy consultant has been notified of the IJ (Immediate Jeopardy). Training for all licensed nurse staff and newly hired staff will include: Black Box Warning Notification - physician will be contacted, and order verified; physician will make the decision to continue with the order or to change to a different drug regimen. Response of physician will be documented in the clinical record. Documentation of the reason for giving a medication and documentation of complications or side effects. Rights of Medication Administration Antiviral Medications and Side Effects Mail order medications - delivery and administration. If Medication is being ordered through a mail order process, physician will be contacted and give order to administer medication once received or change the order to a different drug regimen. When medication is ordered the resident will be placed on daily charting until medication received. Follow up with a physician will be conducted every 7 days to verify continuance of current plan or change to different drug therapy[TRUNCATED]

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview and record review, the facility failed to ensure each resident's drug regimen was free from unnecessary drugs with inadequate monitoring for one (Resident #4) of 7 residents reviewed for medications. The facility failed to adequately monitor Resident #4's PT/INR levels at least monthly while taking Coumadin (anticoagulant medication) 4 mg daily since 03/23/22. Resident #4's last lab dated 03/22/22 reflected Pro Time (PT) was 26.5 and INR was 2.5. On 06/08/22, Surveyor notified the facility of Resident #4's PT/INR lab not being completed since 03/22/22. Facility ordered a Stat PT/INR lab to be drawn on 06/08/22. Resident #4's PT was 44.3 and INR was 4.5 (high out of therapeutic range) on 06/08/22. Resident #4's INR was 4.5 which placed her at a greater risk for bleeding while on Coumadin medication and on 06/09/22 physician ordered Resident #4's Coumadin medication to be held at least 2 days and when INR level is 3 or below. Resident #4's physician ordered PT/INR labs be drawn next 2 days. Pharmacy Consultant did not have access to residents' labs to ensure PT/INR labs were completed for residents on Coumadin medication. There was not a system in place to ensure and monitor resident's physician orders like PT/INR labs to have a specific timeframe and the immediacy is based on the need for surveyor intervention. An Immediate Jeopardy (IJ) was identified on 06/09/22. While the IJ was removed on 06/10/22, the facility remained out of compliance at a severity level of no actual harm with potential for more than minimal harm that is not immediate jeopardy at a scope of isolated due to facility continuation of in-servicing and monitoring of the plan of removal. This failure placed residents on anticoagulant medications with inadequate monitoring, at risk of major or fatal bleeding, hospitalization or death. Findings included: Review of Resident #4's face sheet dated 06/09/22 reflected she was an [AGE] year-old-female admitted to the facility on [DATE] and readmitted on [DATE] with diagnoses of type 2 diabetes mellitus, hypothyroidism, hypertension, atherosclerotic heart disease, generalized muscle weakness, unsteadiness on feet and lack of coordination Review of Resident #4's admission MDS assessment dated [DATE] reflected she had diagnoses of atherosclerotic heart disease, hypertension, diabetes mellitus and thyroid disorder. She had a BIMS of 10 indicating she was moderately cognitively intact. Resident #4 required supervision with ADLs of transfers, dressing, toileting, personal hygiene with one-person physical assistance. Resident #4 was on anticoagulant and diuretic medications. Review of Resident #4's Comprehensive Care Plan date initiated and last revised 05/24/22 reflected the following: -Resident #4 was on anticoagulant therapy (Coumadin) related to disease process of Coronary Artery Disease. Interventions initiated on 03/01/22 included the following: to monitor/document/report to MD prn s/sx (signs and symptoms) of anticoagulant complications: blood tinged or frank blood in urine, black tarry stools, dark or bright red blood in stools, severe headaches, nausea, vomiting, diarrhea, muscle joint pain, lethargy, bruising, blurred vision, SOB (shortness of breath), loss of appetite, sudden changes in mental status, significant or sudden changes in v/s (vital signs). Revised on 06/08/22 reflected PT/INR labs monthly. Report abnormal lab results to the MD. -revised on 02/02/22 reflected Resident #4 had a fall and at risk for further falls due to unsteady gait. Resident #4 had falls on 02/01/22 and 02/02/22 with no injury. Review of Consolidated physician orders dated 06/08/22 reflected Resident #4 had the following current physician orders: - start date of 03/02/22 of Coumadin tablet 4 mg give 1 tablet by mouth of one time a day related to Atherosclerotic Heart Disease. - start date of 03/19/22 for PT/INR. There was no frequency or timeframe noted. Review of Resident #4's PT/INR lab collected on 03/22/22 at 10:53 am and received on 03/22/22 at 4:14 pm reflected Resident #4 had a PT (pro time) level of 26.5 and INR of 2.5 (therapeutic range of 2.0 to 3.0). Dated and time signed 0600 am - Nurse signed waiting for doctor's response. Then written on lab Continue with Warfarin 4 mg Recheck PT/INR with physician signature. Review of Resident #4's labs from 03/23/22 to 06/09/22 revealed there were no PT/INR levels completed since 03/22/22. Review of Resident #4's Nurse note by LVN K dated 03/23/23 reflected PT/INR reported to [Physician G]. No change in dose at this time. No bleeding episodes noted. Record Review of Nurse's MAR for March to June 2022 reflected the following for Resident #4: March 2022 - Resident #4 was administered Coumadin tablet 4 mg (Warfarin sodium) 1 tablet at 5 pm from 03/02/22 to 03/14/22, 03/16/22 to 03/31/22. 03/15/22 was blank. April 2022 - Resident #4 was administered Coumadin tablet 4 mg (Warfarin sodium) 1 tablet at 5 pm on 04/01/22, 04/05/22 to 04/26/22, 04/30/22. On 04/02/22, 04/03/22, 04/28/22 and 04/29/22 Resident #4 was out on pass. May 2022 - Resident #4 was administered Coumadin tablet 4 mg (Warfarin sodium) 1 tablet at 5 pm from 05/01/22 to 05/04/22, 05/06/22, 05/09/22 to 05/20/22, 05/22/22 to 05/31/22. On 05/07/22, 05/08/22, and 05/21/22 resident was out on pass. June 2022 - Resident #4 was administered Coumadin tablet 4 mg (Warfarin sodium) 1 tablet at 5 pm from 06/01/22 to 06/08/22. Review of Resident #4's PT/INR lab collected at 06/08/22 at 11:30 PM and received on 06/09/22 at 6:42 AM revealed PT was 44.3 and INR was 4.5. DON wrote on lab to hold x 2 days PT/INR tomorrow and next day. Record Review of Pharmacy Consultant recommendations for April and May 2022 reflected no pharmacy recommendations for Resident #4. She was reviewed for medications. Record Review of Resident #4's Pharmacy Consultant recommendation printed 02/01/22 reflected Resident #4 was receiving warfarin 3 mg without routine lab monitoring. Due to potential bleeding problems with INR is above range, please consider a protime lab with INR to be done monthly. This pharmacy recommendation had no physician/prescriber response. Observation and Interview on 06/08/22 at 4:15 PM revealed Resident #4 was sitting in her recliner with no bruising or bleeding. Resident #4 stated she was on Coumadin and had been on coumadin for 10 years. She stated she did not have any bruising or bleeding. She denied any bleeding in her gums. She stated in the past she had bruises but currently had no bruising at this time. She stated she bleeds easily. She stated she was not aware the facility had not drawn her PT/INR labs to check her coumadin since March 2022. She stated her physician at previous facility checked her PT/INR lab levels every 2 weeks. She stated she would like her PT/INR labs drawn to check her levels since she took Coumadin medication. Resident #4 stated she had no recent falls. Interview on 06/08/22 at 4:08 PM with Resident # 4's physician (Physician G) revealed Resident #4 should be checked for PT/INR labs once a month since her last INR was stable (2.5) and facility should have a protocol of how often PT/INR labs should be drawn for residents on Coumadin. Resident #4's physician stated the facility should have been redrawn Resident #4's PT/INR monthly after 03/22/22. He stated coumadin medication is the drug which levels fluctuate frequently and resident's eating and other medications she took can affect it. He stated the risk of PT/INR labs not being drawn are that Coumadin levels can go up and go down and it can put you more at risk for bleeding. Interview on 06/08/22 at 4:20 PM with ADON A revealed the facility did not have a standing order or protocol for coumadin and how often PT/INR levels should be checked. She stated at minimum PT/INR levels should be checked at least monthly for Resident #4 and last time it was checked was on 03/22/22. She stated they reviewed physician orders and check physician orders daily. She stated she did not put a specific lab order timeframe for the PT/INR to be checked for Resident #4 and it was up to physician to determine how often it needed to be checked. She stated in the past we had trouble with physician asking for it to be re-checked earlier than the routine lab order so when PT/INR results are given to doctor the nurse needs to find out from doctor when next time it needs to be ran. ADON A stated she was aware that the pharmacy consultant did not review lab orders of PT/INR levels and requirements for Coumadin medication. She stated Resident #26 is the only other resident who was on Coumadin at the facility. Interview on 06/08/22 at 4:30 PM revealed DON and ADON A stated there was not anything in electronic record that would catch if a resident's physician order like the PT/INR lab did not have a specific timeframe on it. ADON A stated Resident #26's physician ordered her PT/INR checks to be done weekly. DON stated Resident #4's PT/INR labs were not being completed since 03/22/22 and should have been done monthly. DON stated they had contacted Resident #4's physician after becoming aware of PT/INR levels not being completed after surveyor intervention to have it drawn tomorrow to check Resident #4's PT/INR levels. DON stated they can contact Resident #4's physician to do the PT/INR order STAT so Resident #4's results will be available in the morning. They were not aware of any facility policy on Coumadin or lab monitoring. Follow-up interview on 06/09/22 at 9:20 AM with Physician G revealed Resident #4's PT/INR lab was higher and his concern was the INR being at 4.5. He stated he ordered Resident #4's Coumadin 4 mg daily to be held at least for next 2 days and have labs redrawn the next 2 days. Physician G stated Resident #4's Coumadin medication will be held until INR is below 3 and will start her back on a lower dose of Coumadin once it gets below 3. He stated the nurse will contact him with the PT/INR results. He stated residents on Coumadin should have PT/INR checked at least monthly or more often depending on the results. He stated residents on coumadin should be monitored for falls and are at risk for falls, bleeding and skin tears. Physician G stated Resident #4's INR was 2.5 which was in stable range on 03/22/22 and should have been checked monthly. He stated the INR of 4.5 was high which placed Resident #4 at a greater risk of bleeding. Interview on 06/09/22 at 9:30 AM with Pharmacy Consultant revealed monthly she reviewed new physician orders on all residents, reviewed medications to ensure appropriate, checking medication allergies of residents and blood pressure and vitals required for medications. She stated she checked residents' controlled drug documentation including prn controlled drug medications. She stated she reviewed resident psychotropic meds for dosage reduction. She stated she had not checked Resident #4's labs to see if PT/INR labs were completed for resident on coumadin in April or May 2022. She stated PT/INR labs should be checked monthly at least or more often if ordered from physician. She stated PT/INR levels fluctuate could go too low and higher which places residents at risk for bleeding. She stated if she had reviewed Resident #4's clinical record for PT/INR labs and reviewed the lab orders she would have recommended to physician about a timeframe for routine lab orders for PT/INR. She stated she had not reviewed labs for PT/INR lab levels for Resident #4 or any residents on Coumadin medication. She stated she did not have access to resident's labs to review the labs. Interview on 06/09/22 at 1:48 PM revealed DON was not aware of facility's policy for Coumadin and lab order monitoring until today. She did not know the facility had a policy for Coumadin and lab order monitoring. Interview on 06/09/22 at 3:35 PM with Administrator revealed the communication between Physician G and the nurse was not very clear about when next time the PT/INR lab should be drawn for Resident #4. Administrator stated the nurse who reported Resident #4's PT/INR results on 03/23/22 was an agency nurse and should have found out when Physician G wanted the PT/INR labs to be redrawn. He further stated nurse should have put a physician order of next PT/INR lab for Resident #4. He stated he expected his staff to follow the policy on Coumadin and lab monitoring. Review of facility's policy Coumadin dated 02/17/20 reflected the facility was to monitor residents receiving anticoagulant therapy. Under procedure 1. Residents on Coumadin will be monitored for signs and symptoms of bleeding. 2. PT/INR will be checked as ordered by the physician. 3. Licensed Nurse will notify the physician of the PT/INR results and document any new orders. 4. If applicable physician orders will be followed for any diet restrictions. Review of facility's policy Lab Monitoring dated 03/08/20 reflected the policy was that physician ordered laboratory services will be provided and monitored. Under procedure 1. Lab monitoring requires a physician order. 2. Lab orders will be obtained for all drugs that require therapeutic monitoring. Follow these steps: a. Request an order from the physician for a baseline order b. Request ongoing (therapeutic) lab orders. c. Notify lab of new orders following center's laboratory service procedure. d. Complete a lab requisition: hard copy or enter online depending on lab used. e. Enter orders into clinical software assign and document in progress notes. f. Enter the lab on the lab tracking form at the front of the book to enter lab to be drawn, date drawn, return receipt of the results and the physician notification g. Licensed nurse will continue to document on the lab tracking form until steps of tracking are complete. 3. When physician does not choose to order labs for baseline or therapeutic levels, documentation of same will be noted in the resident's clinical software in the progress notes. 4. All lab results will be reviewed by a nurse. The nurse will date and document the time the result was reviewed or confirm results in the clinical software. 5. Lab results at are within normal limits will be reported to the physician. 6. Critical lab results will be called to the physician or on-call physician immediately. Initial, date and time the lab result. Note if new orders were received. Document same in resident's clinical software progress notes. 7. Abnormal lab results will be sent to the physician. Note any medications the resident is taking that could affect the lab value and note all treatments that have been done (i.e., UA), date and signature of nurse .The following is a list of medications for therapeutic lab tests. Warfarin (coumadin) medication required prothrombin time for frequency of every month for the purpose to monitor therapy range. Review of facility's policy Lab Orders dated 03/08/20 reflected the facility was to provide or obtain laboratory services to meet the needs of its residents. [Facility] is responsible for the timeliness of the services. [Facility] must notify the attending physician of the lab results. Procedure 1. Lab orders will be entered in the clinical software and assigned to the appropriate flow sheet. 2. The Director of Nursing/designee will be responsible to monitor lab orders to ensure that a ordered labs have been drawn as ordered by the physician. 3. Lab personnel will be responsible to report to the charge nurses all labs that have been drawn that day. Charge nurse will be responsible to initial date lab is drawn on the MAR/TAR. The Director of Nursing/designee will be responsible to notify the lab when a lab result is not received in a timely manner. 5. The attending physician will be notified promptly of lab results. 6. Laboratory results will be maintained in the resident's clinical record. Review of Coumadin - FDA prescribing information, side effects and uses from https://www.drugs.com/pro/coumadin.html#content retrieved on 06/09/22 reflected under Coumadin Dosage and Administration the following: The dosage and administration of Coumadin must be individualized for each patient according to the patient's International Normalized Ratio (INR) response to the drug. Adjust the dose based on the patient's INR and the condition being treated. Consult the latest evidence-based clinical practice guidelines regarding the duration and intensity of anticoagulation for the indicated conditions. Recommended Target INR Ranges and Durations for Individual Indications An INR of greater than 4.0 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding. Atrial Fibrillation .In patients with non-valvular AF, anticoagulate with warfarin to target INR of 2.5 (range, 2.0-3.0). The Administrator and DON were notified of the Immediate Jeopardy on 06/09/22 at 1:49 pm due to the above failures and provided the IJ template. The facility was asked to provide a Plan of Removal to address the Immediate Jeopardy. The Facility's Plan of Removal for Immediate Jeopardy was accepted and RDCO was notified on 06/10/22 at 2:13 PM. The accepted Plan of Removal for the Immediate Jeopardy included the following: The Texas Department of Health and Human Services Committee (TXHHSC) entered facility for annual survey. During their investigation an IJ (Immediate Jeopardy) was cited in regard to Coumadin Management on 6/9/2022. -Resident(s) found to be affected: Resident #4 Immediate interventions: 6/8/22 1604: Provider was notified that the orders were received 1604: STAT PT/INR ordered 1625: Resident was assessed, found no bruising, bleeding or injury. 1943: DON called facility to check statis of lab draw 2127: DON called facility to check statis of lab draw 2140: DON called facility to check statis of lab draw 2150: DON called facility to check statis of lab draw 2153: Nurse returned DON's call saying the tech has not arrived 2200: CCL called about STAT Lab 2220: Nurse returned DON saying tech has not arrived 2318: Nurse returned DON saying tech has not arrived 2245: Notified Tech on the way o 2346: Phlebotomist at facility for STAT lab- sample acquired Immediate interventions: 6/9/22 0642: Lab results reported to provider with new orders obtained*INR 4.5 Physician G was called. Left a message 0659: Physician G returned the call: gave a new order to hold coumadin for 2 days, repeat PT/INR on 6/10 and 6/11. 0800: Resident assessed for petechiae along with any signs of bleeding or bruising, none noted. Vital signs, stools, urination, weights, ADL, activities are consistent with baseline. Resident is stable, thriving and happy with care. 0915: Physician G came in to assess resident- unremarkable o 1015: Received new orders from Physician G: PT/INR daily until INR is below 3.0, then start coumadin 3mg by mouth 1 tab daily. Then PT/INR weekly o 1215: Physician completed assessment note and spoke to the survey team. Asked ADON A to contact Resident #4's cardiologist to see if it would be safe to change Coumadin to Eliquis. ADON A called Resident #4's cardiologist but spoke to his nurse. The nurse said that per cardiologist, Resident #4 has a diagnosis of Atrial Fibrillation and that is why she is on Coumadin, but she knew the doctor prefers Eliquis. 1215: RDCO emailed Consultant Pharmacy regarding the pharmacy consultant failing to note the missing PT/INR for Resident #4's Coumadin, o 1604: Cardiologist nurse called back and said he recommends discontinuing coumadin and change to Eliquis. The dosage depends on her kidney function so PCP Physician G will provide the appropriate order. 16:33 RDCO emailed Consultant Pharmacy again asking for an immediate in-service to the consultant on monitoring for labs required for medication management and safety. Then followed up with a call for expediency. A plan was set in motion for the consultant's supervisor to provide an in-service as asked and a different consultant will complete an audit of the facility's medications requiring lab monitoring. PCC log in and lab portal access was provided. Expected to be completed by 6/10/22 3PM 1723: Physician G gave orders to draw CMP for 6/10 and he will decide on the dose once he has received the results. 2030: Pharmacy Consultant received in-service from her supervisor on the requirements of monitoring therapeutic lab values as it relates to Medication management and safety. 6/10/22 Interventions completed 0930: RDCO re-educated the DON/ADON A and Medical Records tech on medication management, and the policy and procedures of Consolidation of Monthly Orders. 0930: RDCO re-educated the DON that she is ultimately responsible for the accurate completion of the Consolidation of Monthly Orders. 0930: RDCO re-educated the DON that she is ultimately responsible for ensuring the pharmacy consultant has reviewed the lab monitoring by reviewing the pharmacy consultant recommendations report. 0930: RDCO re-educated DON/ADON A on monitoring for lab documentation and follow up. -Potential residents to be affected by identified practice: o The facility has reviewed all coumadin orders and has identified one resident who is on coumadin. The resident has received coumadin management in accordance with provider orders. No further action needed at this time. Corrective action implemented so identified practice will not recur with root cause analysis: 5/27/22 a certified letter by overnight carrier notice of contract termination with Central Clinical Labs and Xray services to be complete on July 26, 22. On 6/9/22 RDCO has re-educated the DON/ADON on PT/INR procedures and lab process per the Coumadin management policy. On 6/9/22 RDCO has re-educated on the STAT lab requirements of 4 hours to draw and 2 hours to result. On 6/9/22 DON has educated the nurses on STAT lab requirements of 4 hours to draw lab and 2 hours to receive results. On 6/9/22 The DON/designee educated all nurses on Policy for Coumadin management. o On 6/9/22 RDCO has re-educated DON/ADON that the nurse on duty at the time of receipt of lab results and STAT lab results is responsible to notify the physician and orders resulting. Then DON/ADON will verify the next morning that those lab results have been processed properly and it will be discussed in IDT. On 6/9/22 DON educated the nurses that the nurse on duty at the time of receipt of lab results and STAT lab results is responsible to notify the physician and orders resulting. On 6/9/22 The DON created a PT/INR binder that contains the policy for reference and the log sheets and educated the nurses on the expectations of completion and follow up. DON/ADON will monitor this binder daily. On 6/9/22 Lab login is posted at the nurse's station o On 6/9/22 A PT/INR flow sheet has been developed to track labs, therapeutic range, and orders- to be managed by DON/designee and place in a binder at the nurse's station. Nurses have been educated by the DON and placed in a binder. On 6/9/22 The Regional Director of Clinical Operations (RDCO) has re-educated the Inter-Disciplinary Team (IDT) to follow-up with orders post-test results of PT/INR, system changes and processes. o Any nurse on vacation or that works PRN or new nurse or agency nurse will receive this reeducation prior to working their next schedule shift. The nurse will demonstrate competency by passing the designated quiz. This re-education will be provided either by DON/ADON and/or other additional designees. o If the staff nurse does not properly demonstrate understanding, they will receive continued education prior to working their shift. On 6/10/22 Pharmacy Regional Director of Clinical Operations has arranged for a consultant to perform a full audit of all medications requiring lab monitoring. On 6/10/22 Pharmacy Regional Director of Clinical Operations will conduct an in service to the current pharmacy consultant who failed to note a missing PT/INR and monitoring therapeutic lab values. On 6/9/22 The physician has been re-educated on carefully reviewing consolidated orders to include needed therapeutic values via phone. Will obtain official signature 6/10/22. On 6/10/22 received the history and physical from the cardiologist that includes the diagnosis of Atrial Fibrillation. He defers to the PCP (Physician G) to decide about ordering Eliquis or not. Tracking and Monitoring: The DON/ designee will audit the nurse's return demonstration of proper coumadin/ PT/INR process. Findings will be reported to IDT and to monthly QAPI x3 months at which time the QAPI Committee will determine if further monitoring is needed. The DON/ designee will audit the Coumadin flow sheets and process. Audit findings will be reported to IDT and to monthly QAPI x3 months at which time the QAPI Committee will determine if further monitoring is needed. The DON/ designee will conduct random audit of IDT staff knowledge for monitoring PT/NR results and orders. Audit findings will be reported to IDT and to monthly QAPI x3 months at which time the QAPI Committee will determine if further monitoring is needed. Pharmacy Consult will perform monthly audits for therapeutic lab values for appropriate medications. This will be reviewed monthly in QAPI until compliance is met. Pharmacy consultant completed a new recommendation audit of Resident #4. The facility's implementation of the IJ Plan of Removal for pharmacy services was verified through the following: Record Review of List of Residents on anticoagulants revealed Residents #4 and #26 were the only 2 residents on Coumadin medications. Record Review of Resident #26's clinical record revealed Resident #26 had a current PT/INR lab order to be drawn weekly. Reviewed Resident #26 lab orders, progress notes and physician orders revealing Resident #26 did have PT/INR levels drawn weekly, were communicated to the physician and nurse followed physician orders of medication changes. Record Review of five of five residents for medications revealed no concerns with significant medications or lab orders. Interview on 06/10/22 at 03:21 PM with DON revealed she had looked and was unable to find Resident #4's pharmacy recommendation with physician's response. She did not know what happened or if it even got to the physician. Record Review on 06/09/22 to 06/10/22 of Resident #4's clinical record revealed Resident #4's Coumadin was placed on hold on 06/09/22 and 06/10/22. Facility did Resident #4's PT/INR labs, notified physician and followed physician orders. Record Review of In-services dated 06/09/22 PT/INR test follow up by RDCO reflected IDT will list and discuss each resident on anticoagulants in the IDT meeting and minutes. This will include the resident name, drug and next lab draw day. Notes will be written and validated lab results, new orders/physician orders in chart and including discussion by IDT. Staff in-serviced were IDT members. Observation and Interview on 06/10/22 at 12:05 PM with Corporate Pharmacy Consultant revealed he was at facility to do a full complete on residents who have medications that require therapeutic lab monitoring and especially residents on anticoagulant medications. He stated going forward the facility's assigned pharmacy consultant would be reviewing these medications which require therapeutic lab monitoring including coumadin, physician orders and the labs on their monthly visits. Record Review of In-service dated 06/08/22 and 06/09/22 Lab process, PT/INR procedure and Coumadin Management revealed MDS Coordinator, LVN B, LVN C, LVN F, LVN H, LVN I, LVN J and RN Weekend Supervisor. Interviews on 06/10/22 from 1:48 PM to 3:03 PM with 5 of 5 LVN (LVN B, LVN C, LVN F, LVN H and LVN I) including facility and agency nurses from all shifts revealed they had been in-serviced on protocol for Coumadin and lab monitoring of PT/INR for residents on Coumadin. All five LVNs were knowledgeable that any residents on Coumadin should be receiving at least monthly or more frequently if ordered by physician. They were in-serviced on when discussing resident 's PT/INR lab results with physician to find out if any changes in dosage, when next the physician wants the PT/INR ordered and to put a lab order along with physician order of PT/INR lab to next be drawn. They were knowledgeable of facility starting a system of lab monitoring including PT/INR binder at nurse's station. Interview on 06/10/22 at 2:36 PM with RN Weekend Supervisor revealed she had been in-serviced on the protocol and facility policy for residents on Coumadin and lab monitoring. She stated residents on Coumadin medication must have a PT/INR ran monthly or more frequently if physician ordered. She stated when they receive PT/INR lab results, they contact physician immediately with PT/INR lab results and put in any new medication changes' physician orders for Coumadin and the lab order for PT/INR monitoring. Record Review of In-service provided by consultant pharmacy group dated 06/09/22 reflected pharmacy consultant was in-serviced on medication monitoring guidelines including warfarin (coumadin) and on monitoring of lab results. She was in-serviced on consultant role of recommending routine labs and follow-up on results) and steps to taken when additional facility follow up needed. Interview on 06/10/22 with 02:34 PM revealed Pharmacy Consultant was in-serviced to look at residents with Coumadin to ensure PT/INR lab orders are being completed and PT/INR physician lab orders have frequency of when PT/INR should be checked. She stated she was provided access to resident labs now and if a resident is missing lab orders find them she will be contacting DON to check on labs. She knew types of medications like Lasix, Digoxin, Depakote and could go over what labs are required of each. She stated PT/INR should be checked at least monthly or more often if physician order states it. She stated when she reviews resident medication each month she will be reviewing medication orders and lab orders to ensure they are being completed. Follow-up interview on 06/10/22 at 5:57 PM revealed Pharmacist Consultant stated the pharmacy recommendations she did monthly went to DON, physician and Administrator. She could not recall the pharmacy recommendation for Resident #4 dated 02/01/22. Record Review of facility's in-services for DON and ADON A by RDCO on 06/09/22: -PT/INR - Coumadin process DON/ADON A will do the following: All residents on Coumadin will be entered on the Coumadin flow sheet including PT/INR, Dose and next scheduled lab. Lab PT/INR - will be drawn in accordance with doctor orders. DON/ADON A will also list each resident in the IDT meeting minutes with their drug and next lab draw. IDT will discuss and validate it on flow sheet. DON/ADON A will ensure a note is placed in the medical record when lab results are received, Doctor notified, order changes and next scheduled lab draw was discussed. Policy for Coumadin Management reviewed. - DON/ADON ensure nurses understand they are responsible for processing all lab results STAT or otherwise when they are received to include calling the lab if not received timely, notify physician, any new orders or dose changes. DON/ADON A will validate this process and discuss in IDT meeting. Interview on 06/10/22 at 03:34 PM with ADON A revealed she was in-serviced and was aware of the facility's policy on Coumadin protocol and PT/INR lab monitoring. She stated residents on coumadin medication should have PT/INR lab orders to include when to be checked and/or frequency of lab. She stated she or the DON will review PT/INR lab orders Monday through Friday daily to ensure nurse put in PT/INR order correctly as a physician order and in lab system. She stated they will review any changes to anticoagulant medications and ensure physician order was put in the system. She stated the facility has initiated a PT/INR flowsheet [TRUNCATED]