**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of clinical records, hospital records, facility documentation, facility policies, FDA (Food and Drug Administration) guidelines, and interviews with staff, it was determined the facility failed to provide care and services that meet the professional standards of quality and as outlined in resident's plan of care for one of 13 residents reviewed (Resident R17). The facility failed to accurately and timely notify the physician after Resident R17 who was on blood thinner medication, sustained a fall in the bathroom. The facility failed to conduct comprehensive assesment of Resident R17 in a timely manner after the resident showed abnormal blood pressure levels following the fall and after the administration of a routine anti-coagulant medication. The facility's failure resulted in Resident R17 not receiving emergency medical care for approximately 10 hours after the fall, sustaining a subdural hemorrhage which required transfer to the hospital and expiring in the hospital. This failure placed Resident R17 in an Immediate Jeopardy situation. (Resident R17) Findings Include: Review of facility policy Notification of Changes in Resident's Status dated March 2020, revealed Purpose: To assure that each resident and/or resident representative is notified timely of accidents that result in injury and have the potential for physician intervention; significant changes in status; significant changes in treatment; abnormal lab, radiology or other diagnostic test results; transfer or discharge associated with the health or safety of the resident; change in roommate status or change in resident rights under Federal or State law or regulations. Further review of facility policy revealed Pennswood Village shall provide timely notification to each resident and/or resident representative of accidents that result in injury and have the potential for physician intervention, significant changes in condition, significant change in treatment, transfer/discharge status related to health or safety of the resident or other individuals in the facility, roommate status or change in resident rights under Federal or State law or regulations. The Community will notify the physician in person, by telephone or in writing of the following changes or events: a. An accident which results in injury and has the potential for requiring physician intervention. b. A significant change in physical, mental, or psychosocial status. Significant change is a deterioration in health, mental, or psychosocial status in either life-threatening conditions or clinical complications. c. Abnormal lab, radiology or other diagnostic test results may be communicated to the ordering clinician. d. A need to alter treatment significantly. Significant alteration is the need to discontinue or change an existing form of treatment due to adverse consequences, or to commence new form of treatment. e. A decision to transfer or discharge a resident related to health or safety of the resident or other individuals in the facility. Review of FDA guidelines for the medication Xarelto revealed that XARELTO increases the risk of bleeding and can cause serious or fatal bleeding. In deciding whether to prescribe XARELTO to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Bleeding Risks -advise patients to report any unusual bleeding or bruising to their physician. Inform patients that it might take them longer than usual to stop bleeding, and that they may bruise and/or bleed more easily when they are treated with XARELTO [see Warnings and Precautions (5.2)]. If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs (non-steroidal anti-inflammatory) or platelet inhibitors, advise patients to watch for signs and symptoms of spinal or epidural hematoma, such as back pain, tingling, numbness (especially in the lower limbs), muscle weakness, and stool or urine incontinence. If any of these symptoms occur, advise the patient to contact his or her physician immediately. Increased risk of bleeding: XARELTO can cause bleeding which can be serious and may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. You may have a higher risk of bleeding if you take XARELTO and have certain other medical problems. Review of facility reported incident dated November 25, 2024, revealed Resident R17 was noted on November 25, 2024, at approximately 3:00 a.m. observed sitting on the floor in the bathroom with the resident's back against the wall. The resident's pants were down, and the floor was wet with urine. Resident R17 stated, I hit my head. The resident was awake and alert, speech was clear and answered appropriately. Neuro checks initiated and was within normal limits. Resident was able to move all extremities and denied pain. [Resident R17] was noted with increased blood pressure post fall, which was discussed with [Nurse Practitioner, Employee E4], as well as current clinical presentation offering no other complaints at this time and no visible signs of injury, recommended to continue current plan of care and give morning medications. Morning medications given including Furosemide and Cardizem. In the early afternoon around 12:30 p.m. the resident was noted with complaint of head pain, left eye pain, nausea, as well as vomiting. The physician was called, and ordered to send the resident to the hospital for evaluation. Resident was transferred to the hospital. Upon arriving to the emergency room, a CT (computed tomography) scan was completed and Resident R17 was noted with a 16 millimeter (mm) subdural hematoma (pool of blood between the brain and its outermost covering) with a 6 mm midline shift (displacement of brain tissue that occurs when the brain is pushed to one side of its natural centerline. It can be caused by a number of things, including traumatic brain injury). Family wished for conservative management per trauma team and no surgical intervention, goal was comfort. Resident R17 passed away at the hospital. Review of facility incident report dated November 25, 2024, revealed that Resident R17 was found sitting on the floor. Resident stated, I hit my head, The time of the incident was documented as 2:05 a.m. Further review of the incident report revealed that the physician notification time was 3:40 p.m. There was no documentation of mode of communication and physician response. There was no documented evidence that physician responded to the notification. Review of medication administration record for Resident R17 for November 2024 revealed that the resident received Xarelto 15 milligrams (mg) every evening at 6 p.m. and the resident received a dose on November 24, 2024. Review of care plan for Resident R17 dated November 8, 2024 revealed that resident was on anticoagulant therapy Xarelto related to Atrial fibrillation (irregular and rapid heartbeat) with care plan intervention including monitor/document/report as needed adverse reactions of anticoagulant therapy: blood tinged or red blood in urine, black tarry stools, dark or bright red blood in stools, sudden severe headaches, nausea, vomiting, diarrhea, muscle joint pain, lethargy, bruising , blurred vision, shortness of breath, loss of appetite, sudden changes in mental status, significant or sudden changes in vital signs. Review of neurological assessment dated [DATE], at 2:15 a.m. revealed that resident's blood pressure (BP) after the fall was 190/80 (normal blood pressure is 120/80). It was also documented that the resident complained of pain of on a scale, 3 out of 10. There was no documentation of the pain location or type of pain. Review of neurological assessment dated [DATE], at 2:30 a.m. revealed that the blood pressure (BP) was 178/78. Review of neurological assessment dated [DATE], at 2:45 a.m. revealed that the blood pressure (BP) was 170/78. Review of neurological assessment dated [DATE], at 3:00 a.m. revealed that the blood pressure (BP) was 178/72. Review of neurological assessment dated [DATE], at 3:30 a.m. revealed that the blood pressure (BP) was 180 /78. Review of neurological assessment dated [DATE], at 4:00 a.m. revealed that the blood pressure (BP) was 177/78. Review of neurological assessment dated [DATE], at 5:00 a.m. revealed that the blood pressure (BP) was 180/80. Review of neurological assessment dated [DATE], at 6:00 a.m. revealed that the blood pressure (BP) was 170/80. Review of neurological assessment dated [DATE], at 6:55 a.m. revealed that the blood pressure (BP) was 181/83. Review of neurological assessment dated [DATE], at 7:55 a.m. revealed that the blood pressure (BP) was 185/80. Review of neurological assessment dated [DATE], at 11:55 a.m. revealed that the blood pressure (BP) was 186/80. Review of neurological assessment dated [DATE], at 12:15 p.m. revealed that the blood pressure (BP) was 192/80. Review of Resident R17's clinical record failed to reveal documented evidence the physician was notified of Resident R17's high blood pressure levels and the use of anticoagulant medication until November 25, 2024 approximately 7:30 a.m. Review of hospital record dated November 25, 2024, revealed Resident R17 presented for evaluation of the ground-level fall sustained at 2:00 a.m. 10 hours later resident developed headache, nausea, vomiting. In emergency room resident received Kcentra for reversal of Xarelto coagulopathy and seizure prophylaxis. CT scan revealed cerebral hemorrhage (16 mm subdural hematoma and 6 mm midline shift). Family chosen conservative management and comfort measures were initiated. Resident died on November 26, 2024, and the reason was documented as subdural hematoma. Interview with Nurse Practitioner, Employee E4 on December 2, 2024, at 12:07 p.m. stated she was not on call on November 25, 2024. She came to the facility around 7:00 a.m. and heard that the resident had a fall, later around 7:30 a.m. she became aware the resident was having high blood pressure. Employee E4 stated resident was due for (his/her) morning medication and she asked staff to give the medication. She did not order any other medication. She was not aware of resident's status until around 12 noon on November 25, 2024. Employee E4 stated staff were expected to recheck the blood pressure an hour or two after the medications were given and notify the provider to see response of the blood pressure or to initiate additional interventions. Interview with Registered Nurse, Employee E5 on December 2, 2024, at 12:28 p.m. stated she was the supervisor on duty for November 25, 2024. She asked the nurse to give the morning medication after the resident was noted with high blood pressure. She was not sure if the charge nurse rechecked Resident R17's blood pressure or if the blood pressure came down in response to the medication. Employee E5 stated later when she assessed the resident around 12 or 1 p.m. resident was vomiting and had nausea. Interview with Registered Nurse, Employee E6 on December 3, 2024, at 9:33 a.m. stated she was the night shift supervisor when the resident fell at 2:05 a.m. She created the incident report. She sent an e-mail (electronic communication) to physician around 3:40 a.m. to notify of the fall. Employee E6 stated she was not sure if any physician saw the e-mail or responded to the e-mail. Employee E6 stated she was aware that the resident hit her head during the fall. Employee E6 stated she was aware of the high blood pressure and confirmed the physician was not notified in a timely manner. Review of an e-mail message sent to the providers on November 25, 2024, at 3:45 a.m. revealed that Hello, (Resident R17) fell last night in (Resident R17)'s bathroom, no apparent injuries at this time. Further review of the email notification failed to reveal evidence the staff notified the provider of resident hitting head, being on anticoagulant medication, pain level of 3, or high blood pressure after the fall. Interview with Nursing Home Administrator and Registered Nurse, Clinical Service Director, Employee E3 on December 3, 2024, at 9:33 a.m stated staff should call physician if there is a change in condition. Employee E7, Licensed Nurse, who provided care to the resident on November 25, 2024 when resident fell was not available for an interview. Interview with Physician, Employee E8 on December 3, 2024, at 2:00 p.m. stated staff should call the physician via phone if there an emergency or urgent care need that necessitates a physician response regardless of the time. Staff could e-mail for non-emergency notifications that require physician response but should complete a follow up call if no response received in an hour. Physician stated he was the physician for Resident R17. He stated that staff should notify the physician immediately after the fall via phone of a resident who sustain a fall with suspected head injury such as hitting head during fall. Staff should also make the physician aware if the resident is taking anticoagulant medication which increases risk for brain injury. The physician should also made aware of the high blood pressure or vital signs changes after a fall when resident hit their head. Physician, Employee E8 also stated that staff should re-check the blood pressure at least in two hours after a medication was given for high blood pressure. A follow up interview with Nurse Practitioner, Employee E4 on December 3, 2024, at 2:30 p.m. stated she was not aware the resident was on blood thinner medication when the staff notified them about Resident R17's high blood pressure after the fall. Employee E4 stated she would have looked at the resident's condition in a different way and would have changed her decision if she was aware of Resident R17 being on Xarelto. Employee E4 stated Xarelto increased the risk of head injury and bleeding after falls involving hitting the head. Interview with Nursing Home Administrator and Registered Nurse, Clinical Service Director, Employee E3 on December 3, 2024, at 2:40 p.m. confirmed the staff did not notify the physician in a timely and appropriate manner after Resident R17 sustained a fall in which the resident hit his/her head and observed with pain, high blood pressure. Nursing Home Administrator and Employee E3 confirmed there was no documented evidence that the staff notified the resident's physician of high-risk anticoagulant medication which the resident was taking. Nursing Home Administrator and Employee E3 also confirmed there was no documented evidence the staff re-checked Resident R17's blood pressure in timely manner after medication was administered for high blood pressure. An Immediate Jeopardy situation was identified to the Nursing Home Administrator on December 4, 2024, at 1:16 p.m. for the facility's failure to provide care and services that meets the professional standards of quality and as outlined in resident's plan of care. Failure to accurately and timely notify the physician after Resident R17 who was on a blood thinner medication, fell in the bathroom and hit he/her head. Failure to re-assess Resident R17 in a timely manner after the resident experience in abnormal high blood pressure levels following the fall and after routine medication was administered. These failure placed Resident R17 at risk for serious harm including death. The facility submitted a written plan of action on December 4, 2024, and implemented a plan of action which included the following: - Facility will immediately and accurately communicate with the physician/provider any pertinent change in condition of a resident. - Notification of Changes in Resident's Status Policy has been reviewed and revised to include that the phone should be utilized or in person for all communication regarding significant change in status with physician/provider. Documentation to include physician/provider response. - Education has been implemented of all RNs (Register Nurse) and LPNs (Licensed Practical Nurse) regarding the revised facility policy of Notifying Changes in Resident's Status. This education includes assessing residents after change in condition, appropriate and complete notification of the physician/provider and method of notification. 85% of all RNs and LPNs will have completed education by the end of the day 12/4/24. 100% of RNs and LPNs will have completed education by the end of the day 12/5/24. If staff are not available, they will be educated prior to the start of their next shift in facility. - Every fall incident will be audited by interdisciplinary team to assure that appropriate and complete physician/provider notification has occurred. The audit will be reported on at Quality Assurance and Performance Improvement (QAPI) for four quarters. On December 4, 2024, at 3:47 p.m. the action plan was reviewed, additional clinical records were reviewed, policy verified, interviews were conducted with staff to confirm that the in-service education was completed. The Immediate Jeopardy was lifted on December 4, 2024, at 4:02 p.m. 201.14(a) Responsibility of licensee 201.18(b)(1) Management 211.12(d)(1)(2)(3)(5) Nursing services