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Tag No.: C0270
Based on review of hospital policies, record review and interviews, the hospital failed to provide and implement current and updated policies and procedure to direct staff how to assess and care for patients with or at risk of venous thromboembolism including deep vein thromboembolism (DVT) and pulmonary embolism (PE).
See the example and citation at Tag C 275 regarding Patient #1 who was at high risk for thromboembolism based on a history of actual DVT, and was prescribed anticoagulant therapy. The therapy was discontinued for a nose bleed. Physician notes indicated that the medication had been restarted, but it had not. Ten days after the anticoagulant was discontinued the patient died. No autopsy was performed.
Medical, nursing and pharmacy staff failed to identify and report the need to restart the therapy. There was no procedure or protocol in place to direct staff when or how to comprehensively review the patient's medication and anticoagulant therapy status; or when to alert the physician for a possible need to restart the therapy. The omission may have resulted in the patient's death.
See example and citation at Tag C 275 Patient Care Policies for failure to have an effective procedure in place to direct staff and protect patients from omissions in care.
Due to the high risk of serious harm, injury, impairment or death due to the actual death of a patient and potential for actual harm or death for future patients, the Condition of Participation at 42 CFR 485.635 Provision of Services was NOT MET.
Tag No.: C0275
Based on record review, staff interview and review of hospital procedures, the hospital failed to have a standardized procedure in place to ensure patients on anticoagulant therapy treatment received comprehensive, timely periodic reviews by nursing, pharmacy and medical staff to ensure therapy was administered as intended based on the patient's care needs for 1 of 1 patients reviewed who received anticoagulant therapy (Patient #1).
Failure to have a procedure in place risked patient health and safety, and may have contributed to the death of Patient #1.
Findings were:
Patient #1 was a 25 year old male admitted to a hospital swingbed on 7/14/17 with chief complaints of strep viridans endocarditis, right lower extremity "acute on chronic" osteomyelitis now status post right below the knee amputation on 7/2/17. Review of the History and Physical identified a previous history of catheter associated infected deep venous thrombosis involving the right axillary and subclavian veins and MRSA. The anticoagulant drug, lovenox, was given during acute hospitalization. The physician documented, "..patient is at high risk of VTE (venous thromboembolism), and due to prior RUE DVT (right upper extremity deep vein thrombosis), one could consider risks vs benefit of continuation of lovenox during skilled swing bed hospitalization."
Review of physician progress notes evidenced that on 7/26/17, nursing reported the patient developed a nose bleed. The physician documented, "On rivaoxaban (anticoagulant medication), but since he is bleeding will hold for now." On 7/31/17, (5 days after holding the anticoagulant), the physician documented, "Right upper arm DVT. Improving. On rivaoxaban, but since he is bleeding will hold for now." The physician was also monitoring blood counts due to the patient's chronic anemia and documented, "His anemia is worse, probably from nose bleed. Cannot rule out GI blood loss..." and, "Nose bleed: controlled."
On 8/4/17, the physician documented, "Right upper arm DVT: Is on rivaoxaban." However, review of medication administration revealed the patient's anticoagulation therapy had not been resumed, as the physician documented.
On 8/6/17 at 3:30 A.M., the patient called for the nurse who then went to the room and found the patient unresponsive. A code was called. Cardio-pulmonary Resuscitation was performed, but the patient failed to revive, and was pronounced dead at 4:07 A.M.
The family was notified but refused an autopsy. The cause of death was not definitively identified.
Interview with administrative and nursing staff on 10/3/17 at 2:30 P.M. revealed the case had been reviewed, and that new triggers to alert nursing and pharmacy staff to review status of medications put "on hold" were being put in place. The investigation was still in progress, about 2 months after the patient's death.
Review of the hospital's procedure, "VTE Prevention Policy" was reviewed. It did not contain updated information related to the incident of Patient #1. The policy was a review of published medical and nursing intervention guidelines, and clinical study references. It did not address specific staff directions on when to re-visit a "hold" order. There was no direction when to notify the physician that a new order may be required in order to prevent a deep vein thrombosis or pulmonary embolism for patients at risk, as for Patient #1.
Review of nursing progress notes showed no evidence that nursing staff assessed the length of time the anticoagulant therapy had been discontinued, nor did they notify the physician to review the status of Patient #1 for resuming the therapy based on the patient's history and risks. There was no evidence that pharmacy reviewed the order to hold the anticoagulant, or documented recommendations to consider re-starting the therapy.
There was no standardized procedure in place to ensure that staff routinely reviewed patient status, and notified the physician regarding anticoagulant therapy for patients at risk to develop venous thromboembolism.