F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
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Failure to Monitor Anticoagulation Therapy Leads to Resident's Death

Oak Ridge Care CenterUnion Grove, Wisconsin Survey Completed on 06-28-2024

Summary

The facility failed to ensure that a resident, identified as R2, who was receiving Coumadin, an anticoagulation medication, was monitored with ongoing laboratory testing to maintain a therapeutic dose. R2 was admitted with an order for Coumadin, which requires frequent lab tests to ensure proper dosing. However, the last test was conducted on a specific date, and no further tests were ordered. This oversight led to R2 developing multiple bruises, a sign of over anticoagulation, which went unnoticed by both nursing and pharmacy staff. R2's condition worsened, and he developed hematuria, indicating potential internal bleeding. Subsequent lab tests revealed critical low hemoglobin and hematocrit levels, along with critically high prothrombin time and INR, confirming over anticoagulation. Despite these alarming results, there was no evidence of a standing order for PT/INR tests, and the facility failed to monitor R2's condition adequately. This lack of monitoring and failure to act on the signs of over anticoagulation resulted in R2 being sent to the hospital, where he later died. Interviews with facility staff, including the Director of Nursing, Registered Pharmacist, Medical Director, and Advanced Practice Nurse Practitioner, revealed a systemic failure in monitoring and managing R2's Coumadin therapy. The staff acknowledged the absence of specific orders for monitoring Coumadin side effects and lab work, and the pharmacy's failure to notice the lack of lab tests. The Medical Director admitted that the incident was a system failure, and the facility had to revise their anticoagulation policy following the incident.

Removal Plan

  • The facility began an investigation and identified all residents in the building who could potentially be affected and ensured that all labs and medications were up-to-date and accurate.
  • The leadership team, including the NHA A, DON B, ADON L, ANHA F, MedDir K, Nurse Manager, and Quality Care Coordinator conducted an Ad-Hoc Quality Assurance and Performance Improvement (QAPI) meeting. The passing of the resident was reviewed.
  • The anticoagulation policy was reviewed and updated to ensure resident safety. The policy was adjusted to include standing orders for residents on Coumadin for weekly PT/INR draws upon admission to the facility.
  • The team decided to add new monitoring orders upon admission, including monitoring for signs or symptoms for bleeding.
  • A Coumadin log was initiated by the nurse manager team for daily review during clinical meetings. At each clinical meeting, the clinical team reviews all residents who are prescribed Coumadin.
  • The facility's pharmacy was contacted and a medication audit for all residents in the facility was completed. No other medication issues were discovered during this facility-wide medication audit. The pharmacy continues with monthly audits for all residents, and the residents on Coumadin are being monitored routinely by the pharmacy.
  • New admissions to the facility will have a prospective medication review completed by the pharmacy and the pharmacy will make note of medication that requires close monitoring. The consultant pharmacist will evaluate residents on Coumadin and clinically determine if INRs are being monitored routinely. Clinical judgement with regard to past stability of patient INR's will determine if consultant pharmacist recommends an INR for a resident for that month.
  • DON B began education on Coumadin with the nursing staff. All nursing staff were educated and provided with information about Coumadin. After reading and having a discussion, staff independently completed a quiz to show competency. The DON held small groups to complete this education with the nurses; additionally, the nurses were informed that if they had additional questions or concerns, they should seek out information from DON B or the ADON L accordingly. The staff were then informed about the changes being implemented regarding Coumadin.
  • The nursing staff's admission checklist and requirements include standing orders for weekly PT/INR draws for residents with Coumadin prescribed. Education began and all staff were educated before they began working their next shift on the floor. The nursing department had been educated about Coumadin and informed of the Anticoagulation policy and procedure. Upon hire, new staff members are now trained on this policy during their training period at orientation.
  • The team had contacted all parties involved to address the issue and make needed corrections. The plans put in place have thus far ensured that this mistake is prevented from occurring again. No other residents were affected, and the updated policy and procedure will keep residents safe. The facility made the necessary corrections and began monitoring immediately.

Penalty

Inspection fine: $28,8663 days payment denial
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

Resources

Below are regulatory guidelines relevant to this citation:

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F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
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No penalty information released
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
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No penalty information released
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
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F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
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No penalty information released
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Monitor Anticoagulant Therapy
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F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
Short Summary

Failure to monitor anticoagulant therapy: A resident with quadriplegia, seizures, and HTN was prescribed apixaban 5 mg BID, but the EMR did not include an order for anticoagulant monitoring and nursing documentation did not show daily monitoring for side effects with administration. The care plan called for monitoring, documenting, and reporting signs of anticoagulant complications, and the DON and ADM acknowledged the missing monitoring order in the EMR.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
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