**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on closed medical record review, hospital record review, review of a police and Emergency Medical Service (EMS) report, social media review, review of the Food and Drug Administration online medication information, policy review and interviews, the facility failed to timely respond and take appropriate action (e.g., suspending administration of an anticoagulant) in regard to an elevated International Normalized Ratio (INR) for Resident #11, who was receiving Warfarin (Coumadin) for atrial fibrillation. This resulted in Immediate Jeopardy and the potential for serious harm on 05/20/24 when the resident's INR, per laboratory testing, was abnormally high at 4.9 and staff failed to notify the physician or stop the administration of the medication, Coumadin. Staff continued to administer Coumadin 7.5 milligrams on 05/20/24 and 05/21/24 despite the high laboratory value, indicating the resident's blood was too thin and requiring a greater length of time to form a blood clot. On 05/22/24, Resident #11 reported he was having nose and gum bleeding. The resident subsequently called 911 for transport to the hospital for medical care. Upon Emergency Medical Service (EMS) arrival, EMS staff noted a large amount of bloody paper towels on the resident's bedside table. Upon arrival at the hospital (on 05/22/24 at 9:25 P.M.) the resident's chief complaint included nose and gum bleeding. Hospital emergency laboratory testing revealed the resident's PT was elevated at 63.4 seconds (reference range 9.7-13.0) and the INR was abnormally high at 7.2 (therapeutic range 2-3 with an anticoagulant planned INR of 2.5). The resident required treatment with Vitamin K (used to counteract the anticoagulant medication) intravenously and was hospitalized until 06/03/24 for ongoing care and treatment. This affected one resident (Resident #11) of five residents reviewed for Coumadin use. On 06/12/24 at 10:25 A.M. the Administrator, Director of Nursing (DON) and Regional Registered Nurse (RRN) #979 were notified Immediate Jeopardy began on 05/20/24 when the facility failed to monitor physician ordered laboratory results (INR) to ensure Resident #11's Coumadin was effective (by not allowing the resident's blood to clot too quickly or too slowly) and failed to notify the physician of an abnormally elevated INR result (4.9) to suspend the administration of Resident #11's Coumadin. Nursing staff continued to administer the Coumadin despite the elevated INR results placing the resident at significant risk for bleeding/continued blood loss. Resident #11 contacted EMS for emergent transport to the hospital for evaluation, received intravenous Vitamin K to counteract the effects of Coumadin and was subsequently admitted to the hospital for ongoing care and treatment. The Immediate Jeopardy was removed on 05/23/24 when the facility implemented the following corrective actions: • Resident #11 was discharged to the hospital on 5/22/24 at 9:00 P.M. • On 05/23/24 at 11:00 A.M. the Director of Nursing (DON), Assistant Director of Nursing (ADON) #918 and Registered Nurse (RN) Unit Manager (UM) #922 reviewed Resident #11's medical record, medication administration record (MAR), progress notes and laboratory results (labs) to identify the root cause related to the bleeding incident on 05/22/24. The facility identified the root cause as nursing staff including Licensed Practical Nurse (LPN) #883 and LPN #963 failed to check Resident #11's PT/INR level prior to administering Coumadin 7.5 mg to Resident #11 on 05/20/24 and 05/22/24 and failed to notify medical doctor (MD)/Certified Nurse Practitioner (CNP) #980 of Resident #11's abnormal INR level in a timely manner. • On 05/23/24 at 11:30 A.M. the DON, ADON #918, RN UM #922 and Regional RN (RRN) #979 completed an in house audit and confirmed four residents resided in the facility who receive Coumadin including Residents #38, #44 #76 and #82. Resident records for Residents #38, #44, #76 and #82 were reviewed which included the lab reports, medication administration records (MARs), progress notes and care plans to ensure that abnormal labs were reported to Nurse Practitioner (NP) #980 in a timely manner and that Coumadin was not administered to residents with a PT/INR greater than 3.0, without negative findings. T • On 05/23/24 at 12:00 P.M. the DON, RN ADON #918, RN UM #922 and Regional RN #979 completed assessments/skin checks on Residents #38, #44, #76 and #82 (receiving Coumadin) to ensure the residents did not have signs of bleeding or bruising. • On 05/23/24 at 1:00 P.M. RRN #979 completed competencies, in person with return demonstration, with the DON, ADON #918 and RN UM #922 to review PT/INR blood work prior to administering Coumadin and education was provided on reporting of abnormal labs to CNP #980 of the specific resident by the end of the shift. • On 05/23/24 at 2:00 P.M., LPN #883 and LPN #963 (two nurses who were out of compliance related to the Immediate Jeopardy) were educated (in person) by the DON, with return demonstration, on checking residents PT/INR blood work prior to administering Coumadin and on reporting of abnormal labs to CNP #980 of the specific Resident by end of shift. • On 05/23/24 beginning at 2:00 P.M. through 4:35 P.M., RRN #979 completed an audit of the lab work for Residents #38, #44, #76 and #82. NP #980 was notified of all lab results. The audit revealed Resident #76's PT/INR lab work dated 05/23/24 had an INR of 3.6 and the NP was notified on 05/23/24 and ordered to hold the Coumadin dose and repeat the INR on 05/24/24. • On 05/23/24 at 2:15 P.M., the DON, ADON #918 and RN UM #922 completed competencies with LPN #883 and LPN #963, in person with return demonstration, on checking residents PT/INR prior to giving Coumadin and to ensure that the lab results are reported to CNP #980 of the specific Resident by end of shift. • On 05/23/24 at 3:30 P.M. the facility held an emergency Quality Assurance Performance Improvement (QAPI) meeting. The QAPI meeting was held to review the root cause, reviewed the facility abatement plan due to the nurses administering Coumadin prior to checking Resident #11's PT/INR labs and not notifying NP #980 responsible for Resident #11's care, by the end of the shift. Medical Director #669, the Administrator, the DON, ADON #918, Environmental Services Director (ESD) #805, Pharmacist #1012 (participated over the phone), RRN #979, Social Services Designee (SSD) #931, Activity Director (AD) #930 and Rehab Director #1024 participated in the QAPI meeting. • On 05/23/24 at 6:00 P.M. the DON developed and implemented a PT/INR Coumadin flow sheet. ADON #918 and RN UM #922 were educated on the form, how to implement the form, when to use the form and what to do for abnormalities identified on the form. Both nurses would print Coumadin lab reports five days a week at Clinical Morning Meetings to review any changes in orders due to any abnormal lab results & to ensure the CNP of the specific resident was notified of the results by the end of the reporting shift. • On 05/23/24 at 6:30 P.M. the Coumadin flow sheet was implemented by ADON #918 and RN UM #922. The form would be completed each time a blood draw was ordered with results received for each resident on Coumadin. The abnormal results would be reported to CNP #980 of the specific resident by end of the reporting shift. • On 05/23/24 at 11:45 P.M. the DON, ADON #918 and RN UM #922 completed education in person and via phone to all 17 staff LPNs and all six staff RNs on checking residents' PT/INR results prior to giving Coumadin and to ensure that the lab results were reported to NP #980 of the specific resident by the end of the reporting shift. In addition, all 37 staff State Tested Nursing Assistants (STNA) were educated on observing for abnormal effects of Coumadin including bleeding, bruising and black tarry stools and reporting abnormalities to the nurse. The facility also used agency staffing including four agency RN's (to be educated from 05/23/24 to 06/04/24), eight agency LPN's (to be educated from 05/27/24 to 06/11/24) and five agency STNA's (to be educated from 05/24/24 to 06/09/24) who work as needed in the facility. RRN #979 confirmed the agency staff members were educated over the phone and would not work in the facility from 05/23/24 to 06/14/24, unless they had received the education prior to their next scheduled shift. The facility indicated all new hires would receive the education during orientation. • On 05/23/24 at 11:45 P.M. the DON, ADON #918 and RN UM #922 completed competencies to ensure 17 LPNs and six RNs were checking residents PT/INR prior to giving Coumadin and to ensure that the lab results are reported to NP #980 in a timely manner. • To ensure ongoing compliance, the DON/ADON/UM/Designee would audit PT/INR lab results and timely notification of the residents' NP four times a week for three weeks. The audits would be completed beginning on 06/06/24 and the facility would then continue a monthly audit for the next two months, during clinical morning meetings, for verification the PT/INR results were reviewed and reported to the residents' NP as needed. The results of the audits would be forwarded to the facility QAPI committee for additional review and recommendations. Although the Immediate Jeopardy was removed on 05/23/24, the facility remained out of compliance at a Severity Level 2 (no actual harm with potential for more than minimal harm that is not Immediate Jeopardy) as the facility is still in the process of implementing their corrective action plan and monitoring to ensure on-going compliance. Findings include: Review of Resident #11's closed medical record revealed the resident was admitted to the facility on [DATE] with diagnoses including pain in the left leg, end stage renal disease with dependence on renal dialysis and paroxysmal atrial fibrillation (intermittent irregular heartbeat in the upper chambers of the heart). The resident was transferred to the hospital on [DATE] and did not return to the facility. Review of Resident #11's baseline care plan dated 05/15/24 revealed the resident would be monitored for abnormal bleeding due to anticoagulation treatment. The care plan revealed the resident would receive anticoagulant therapy as ordered; would be observed for any signs and symptoms of abnormal bleeding including bruising, tarry stools, nose bleeds, bleeding gums and/or hemorrhage; would receive education on the risks and benefits of anticoagulant therapy if needed; be monitored as ordered for lab tests to monitor coagulation factors and have any abnormal findings reported to the provider including the physician, nurse practitioner or physician assistant. Review of Resident #11's physician orders revealed an order dated 05/16/24 for Warfarin (Coumadin) 7.5 mg one tablet to be administered orally once daily (scheduled to be administered between 7:00 P.M. to 11:00 P.M.); and an order dated 05/18/24 to obtain a Prothrombin Time (PT) and International Normalized Ratio (INR) (The INR is a standardized number that measures how long it takes blood to clot. It's calculated using the results of the PT test, which measures how quickly the liquid portion of a person's blood clots. The INR is used to monitor people who take blood thinners, also known as anticoagulants, like Coumadin, to help ensure the medication is working properly. The higher the INR, the longer it takes the person's blood to clot) two times per week on Monday and Thursday. Further review of the medical record revealed no specific parameters for changes to the resident's Coumadin dosage or parameters for contacting/notifying the physician related to the INR results. Record review (also dated 05/16/24) revealed nursing staff were to initial for anticoagulant monitoring every shift (ensuring the PT/INR results were reviewed/available and the daily dose of Coumadin was available in the medication cart for the evening/night administration). This was documented on the medication administration record for the respective dates and shifts during the resident's stay. Review of Resident #11's laboratory testing revealed the resident's bloodwork was collected on (Thursday) 05/16/24 at 7:10 A.M. and reported on 05/16/24 at 3:57 P.M. The results of the PT and INR dated Thursday, 05/16/24 revealed the PT was 19.3 seconds and the resident's INR was 1.9. There was no evidence of any changes to the Coumadin order at this time. Review of Resident #11's laboratory testing revealed a PT/INR was drawn on (Monday) 05/20/24 at 2:50 P.M. and reported on 05/20/24 at 5:47 P.M. The resident's PT was 47.1 seconds (elevated), and the resident's INR was 4.9 (elevated). This laboratory form indicated the standard anticoagulant was 2.0 to 3.0 range for the INR and aggressive anticoagulant treatment was 2.5 to 3.5 INR range. Record review revealed no evidence the physician, nurse practitioner or physician assistant were notified of this abnormally high laboratory test result on 05/20/24. Review of Resident #11's medication administration records (MAR) and treatment administration records (TAR) from 05/20/24 to 05/22/24 revealed on 05/20/24 during the dayshift, Licensed Practical Nurse (LPN) #935 documented on the MAR, the INR was not applicable (NA); on 05/20/24 during the nightshift, LPN #883 documented on the MAR that the INR was 1.9 (however, these were the INR results obtained in 05/16/24). On 05/21/24 during the dayshift, LPN #935 documented the INR on the MAR as NA; On 05/21/24 during the nightshift, LPN #963 documented the INR on the MAR as 4.9; and on 05/22/24 during the dayshift, RN #812 documented the INR on the MAR as 4.9. Review of Resident #11's MAR from 05/15/24 to 05/22/24 revealed the resident was not administered the ordered Coumadin 7.5 mg on 05/15/24 (date of admission). The comment indicated it was a new order. The MAR revealed the resident was administered Coumadin 7.5 mg on 05/16/24, 05/17/24, 05/18/24, 05/19/24, 05/20/24 and 05/21/24. The medication was scheduled to be administered daily from 7:00 P.M. to 11:00 P.M. The record noted the Coumadin was held on 05/22/24 because the resident was in the hospital. Review of Resident #11's medical record revealed no evidence the physician, nurse practitioner or physician assistant were notified of the PT/INR result of 4.9 on 05/20/24 or 05/21/24. Review of Resident #11's Minimum Data Set (MDS) 3.0 assessment dated [DATE] revealed the resident exhibited intact cognition and the resident was on an anticoagulant. Review of Resident #11's progress note dated 05/22/24 at 7:32 P.M., authored by Registered Nurse (RN) #812, revealed the resident notified RN #812 that he blew his nose and blood clots were coming out of his nose and a small amount in his mouth. Vital signs were stable, and the nurse practitioner was notified of the resident's INR level with a new order to hold Coumadin dose until further notice. The resident was made aware. There was no indication an order was obtained to check the resident's PT/INR at that time. Review of an Incident/Offense Report form dated 05/22/24 at 8:48 P.M., authored by Police #506 and Police #507, revealed Resident #11 had called 911 due to bleeding from his mouth and nose. The resident stated he had been bleeding from his nose and gums all day. The resident reported he was on a blood thinner and was taken by stretcher to the hospital. Review of Resident #11's progress note dated 05/22/24 at 9:00 P.M., authored by LPN #963, revealed LPN #963 was exiting another resident's room when EMS staff were observed going into Resident #11's room with a stretcher. The note indicated the resident called them (EMS) himself without letting the nurse know. A face sheet and medication list were sent with the resident to the hospital. Review of Resident #11's social media (Facebook) posts/documentation dated 05/22/24 between 7:00 P.M. and 8:00 P.M. revealed the resident had posted information to the social media site related to his status and health care. This information included when the resident's blood was drawn a few days ago in dialysis, the resident personally delivered the tube of blood to the nurse for the lab to pick up (at the facility). The resident had a hard time clotting at the end of the (dialysis) treatment. Later in the evening, the resident asked LPN #983 if she had the results of the blood work because the resident was reluctant to take the 7.5 mg of Coumadin because he felt his blood was thin. The social media post revealed LPN #983 argued with the resident and said the INR was 1.8. The resident said that it was the bloodwork from 05/16/24 and LPN #983 stated it was the current bloodwork. An unidentified person responded on the resident's social media on 05/22/24 between 7:00 P.M. to 8:00 P.M. to call 911 and to tell them his bleeding would not stop, and his INR was 4.9. (The content of the social media/Facebook post was verified through telephone interview with Resident #11 on 06/13/24 at 3:05 P.M.) Review of a police report dated 05/22/24 (incident number 24-01975) revealed upon arrival, the police department observed a large amount of bloody paper towels on Resident #11's bedside table. The resident explained that since his arrival on 05/15/24, he had not received proper care and had documented the improper care on social media to keep track of the lack of care and keep a record to advocate for himself and others in the facility that may not be able to (advocate for themselves). Review of hospital documentation revealed the resident presented to the emergency room (on 05/22/24) with a chief complaint of spontaneous bleeding. The resident had called the squad himself for concerns of spontaneous bleeding. The resident reported he had been having nosebleeds and bleeding from the mouth for the past few days and was concerned about his INR being high. The resident had an admission diagnosis of coagulopathy (bleeding disorder; a condition in which the blood's ability to coagulate (form clots) is impaired. This condition can cause a tendency toward prolonged or excessive bleeding (bleeding diathesis) which may occur spontaneously or following an injury or medical and dental procedures. The resident received Vitamin K intravenously to counteract the effects of the Coumadin and assist in stabilizing his INR levels and was admitted to the hospital from [DATE] through 06/03/24 for continued medical care and monitoring. The resident did not return to the facility upon discharge from the hospital. On 05/29/24 at 6:36 A.M. interview with Licensed Practical Nurse (LPN) #963 revealed she was the nurse working and assigned to care for Resident #11 on 05/21/24 during the nightshift from 7:00 P.M. to 7:00 A.M. LPN #963 revealed she did not notice the PT/INR for Resident #11 was out of range until after she had administered Coumadin 7.5 mg on 05/21/24. The LPN verified she did not report the elevated lab to the NP or the fact she had administered the resident's Coumadin without checking the INR first during her nightshift 05/21/24. LPN #963 stated on 05/22/24 at 7:00 P.M., when she came on shift to work, she was notified in the nursing shift to shift report by RN #812 that the NP was made aware of Resident #11's nose and mouth bleeding and the NP then gave an order to hold the Coumadin. LPN #963 stated the resident called for an ambulance to go to the hospital (on 05/22/24) while she was in another room. She stated she was unaware of any concerns until she had observed the squad with a stretcher going into Resident #11's room. LPN #963 stated she printed a face sheet and orders to send with the resident to the hospital and let the NP know the resident requested to be transported to the hospital. LPN #963 stated she was busy on her shift and did not think to call the physician after administering the Coumadin on 05/21/24 when she found out the PT/INR was elevated. Interview on 05/29/24 at 10:02 A.M. with Registered Nurse (RN) #812 revealed she worked dayshift from 7:00 A.M. to 7:00 P.M. on 05/22/24. RN #812 stated she talked to Resident #11 close to shift change around 7:00 P.M. to 7:30 P.M. about his Coumadin dosage and the NP orders to hold the Coumadin on 05/22/24. RN #812 stated the resident did not have concerns when she left the room, and the resident did not request to be sent to the hospital during her shift. She also stated she was not aware of the resident's nosebleed until she went in the room around 6:30 P.M. to answer the resident's call light and had observed the resident's bloody nose and several bloody tissues on his overbed table along with a bloody tissue in his hands RN #812 stated she immediately called the NP at that time and received new orders to hold the Coumadin. The RN denied knowledge of the resident's INR level until he (the resident) reported the bloody nose, and she reviewed the INR value. RN #812 denied an increase in monitoring Resident #11's condition because she stated she was not aware of the resident receiving the Coumadin with a high PT/INR. Telephone interview on 06/04/24 at 6:42 P.M. with Nurse Practitioner (NP) #980 revealed she was not aware of Resident #11's high PT/INR until the resident had the nosebleed and she ordered to hold the resident's Coumadin. The staff notified her the resident had gone out to the hospital (on 05/22/24). She indicated staff did not call her about the resident's abnormally high PT/INR result and they should have notified her (on 05/20/24) so the Coumadin could have been adjusted or held as necessary. Telephone interview on 06/10/24 at 6:03 P.M. with LPN #883 revealed she had administered Resident #11's Coumadin dose on 05/20/24 during the nightshift based on the lab work dated 05/16/24 (and not the lab work from 05/20/24). The LPN indicated the dayshift nurse told her the 05/16/24 lab work was the current lab work available for the resident and stated she did not physically check the lab system to see what the PT/INR was on the lab work obtained on 05/20/24. Telephone interview on 06/10/24 at 6:31 P.M. with Resident #11 with the Administrator and RRN #979 present revealed on 05/22/24, he had reported to RN #812 between 2:00 P.M. and 3:00 P.M. that his nose and gums were bleeding. Resident #11 stated RN #812 assessed his mouth and stated that he must have broken one of his teeth which caused bleeding. She provided a saltwater rinse for the resident. Resident #11 stated between 6:30 P.M. and 6:34 P.M., RN #812 came in and told him that his PT/INR was 4.9 and that his Coumadin was to be held. He stated at that point, he called his friends at the fire department and decided to call EMS for transport to the hospital. He stated he was hospitalized from [DATE] to 06/03/24 to get his INR stabilized which included the administration of Vitamin K shots. The resident indicated the hospitalization would not have been necessary if the nursing staff had monitored his lab work closely and reported the abnormal labs to the physician before giving him his Coumadin. Interview on 06/12/24 at 10:30 A.M. with RRN #979 revealed the facility policy was for the dayshift nurses to check the medication cart to ensure Coumadin doses were available for resident administration and the nightshift nurses were responsible to check the PT/INR results and administer Coumadin as ordered. Telephone interview on 06/12/24 at 1:33 P.M. with Laboratory Staff (LS) #502 revealed their company did not call high labs and only called critical labs. When further questioned, she stated it was a different critical level result for each facility and their computer told them when to call the results to the facility. LS #502 revealed their company faxed Resident #11's lab results to the facility on [DATE] at 1:49 P.M., 4:49 P.M. and 5:54 P.M. When asked why the lab faxed the lab results three different times, LS #502 stated multiple lab staff members worked on the labs with high results and that was probably why the results were faxed to the facility three times. Interview on 06/14/24 at 7:11 A.M. with RRN #975 revealed the nurse who was assigned to care for a resident receiving Coumadin was responsible for calling in the lab work for the PT/INR to the physician/NP. She stated all residents on Coumadin had orders to monitor for signs and symptoms of bruising or bleeding and any adverse effects of anticoagulant therapy. RRN #975 stated the expectations of each physician of those residents on Coumadin were different but in general, all nurses should call immediately for a PT/INR of greater than 3.0 (standard 2.0 to 3.0). RRN #975 confirmed Resident #11's lab work results for his PT/INR were received by the facility (via fax) around 5:30 P.M. on 05/20/24 and LPN #935, who worked dayshift on both 05/20/24 and dayshift on 05/21/24, should have called the physician with the PT/INR results for Resident #11 as well as LPN #883, who worked nightshift on 05/20/24, and LPN #963, who worked nightshift on 05/21/24, should have called the physician/NP regarding Resident #11's elevated PT/INR results. RRN #975 stated Resident #11's NP was notified on 05/22/24 and did not indicate she wanted the resident transported to the hospital. RRN #975 stated the NP wanted the resident's Coumadin held on 05/22/24, but the resident did not feel comfortable with that order and requested his own emergency transport to the emergency room Interview on 06/14/24 at 8:18 A.M. with Fire Department #311 revealed he had responded to Resident #11's 911 call on 05/22/24 and their squad was on scene for 21 minutes. He stated he had observed Resident #11 with bloody towels on the table, bloody tissues, blood in cups and blood down the front of him. Fire Department #311 shared that upon arrival, three staff members were at the end of the hall laughing and talking on their cell phones while the squad team was in the building. No staff were present in the room helping Resident #11. Further interview revealed fire department staff asked the staff members for a mechanical lift to get the resident on a cot for transport and no staff members brought the mechanical lift or even talked to them and/or assessed the resident while the squad was in the room. He stated the resident's room was in deplorable condition with bloody towels/tissues and the floor was sticky (from the resident's blood). Fire Department #311 indicated the entire 21 minutes the squad was in the building, not one staff member had come in to assess, monitor or assist Resident #11 in any way. Fire Department #311 indicated he asked for Resident #11's resident information and the nurse handed him the form without talking to the squad about the resident or resident's care. Review of the undated facility Labs policy revealed the nightshift nurse was responsible for double checking the lab draw list and assuring all residents that were due for scheduled labs were on the requisition. Review of the facility Anticoagulation policy revised 05/27/21 revealed on admission, nursing would identify individuals who were currently anticoagulated. Residents would be monitored for possible complications associated with anticoagulation and providers would be promptly notified of any such complications. Anticoagulation therapy and monitoring would be included in the care plan. The nurse would obtain and verify anticoagulation orders from the provider. In the event there was a change in the dosage of the medication, all changes to the dosage would be made on the MAR. Supplemental orders for anticoagulated residents include antibiotic check, PT/INR frequency check, dose check, check (to verify the) dose in the medication cart was correct and monitor bleeding. Review of the Resident Change in Condition policy revised 11/10/20 revealed the charge nurse would notify the physician/provider/family of significant changes in condition. Review of Food and Drug (FDA) Highlights of Prescribing Information webpage www.fda.com revised 10/2011 revealed to adjust Warfarin (Coumadin) dose to maintain a target INR of 2.5 with an INR range of 2.0 to 3.0 for all treatment durations (related to treatment of atrial fibrillation). This deficiency represents non-compliance investigated under Master Complaint Number OH00154752 and Complaint Numbers OH00154261, OH00154253 OH00153950 and OH00153809.