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:

See other F0757 citations
Inadequate Monitoring for Resident on Furosemide
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F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
Short Summary

Inadequate monitoring was identified for a resident receiving furosemide, a high-risk diuretic. The resident had CAD with angina, HTN, hyperlipidemia, cognitive impairment, and dementia, but the record lacked orders for weights or edema monitoring and did not include clear provider-notification parameters for changes in weight or edema. Although the care plan referenced monitoring edema and weight, weights were done monthly instead of weekly, and an eight-pound weight fluctuation was not documented as reported to the provider. Staff and the DON stated they expected weekly weights and regular edema checks for residents on diuretics.

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.
Failure to Follow Ordered Medication Parameters
D
F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
Short Summary

Failure to follow ordered medication parameters led to unnecessary drug administration. One resident with DM, HTN, and schizophrenia received rapid-acting insulin even when BS was below the ordered hold parameter on multiple occasions, and another resident with HTN, major depressive disorder, and schizoaffective disorder received antihypertensive meds without documented BP or pulse readings despite hold parameters. A third resident with DM had an insulin order without BS parameters, and a nurse later updated the EMR with parameters.

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.
Failure to Follow BP Hold Parameters for Antihypertensive Medications
D
F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
Short Summary

Failure to Follow BP Hold Parameters for Antihypertensive Medications: A resident with hypertensive heart disease received ordered BP medications despite BP readings below the physician's hold parameter of systolic BP less than 100. The MAR showed Isosorbide Mononitrate ER, Losartan, and Atenolol were administered when BP was 86/54, 94/57, and 77/52, and the DON confirmed the medications were given when the ordered parameters were not met.

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.
Unordered Narcan Administration to Hospice Resident
G
F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
Short Summary

A hospice resident with COPD, opioid dependence, chronic pain, and anxiety received Narcan nasal spray from staff without a physician order or standing order after being found unresponsive. After the dose, the resident developed flailing and jerking movements, respiratory distress, and signs consistent with opioid withdrawal, and was transported to the hospital where she received lorazepam and morphine and was admitted.

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.
Missed Blood Glucose Monitoring for Residents Receiving Insulin
E
F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
Short Summary

Two residents receiving insulin did not have ordered blood glucose checks completed, including missed checks when one resident was sleeping and a documented shortage of test strips. One resident with type 2 DM had multiple missed BG checks and no documentation that the provider was contacted when BG exceeded the ordered threshold, while another resident with type 2 DM, CHF, chronic respiratory failure, and obesity also had missed q4h BG checks and no provider notification documented for BG readings over 400 mg/dL.

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.
Unnecessary Medication Use and Duplicate PRN Orders
D
F0757 F757: Ensure each resident’s drug regimen must be free from unnecessary drugs.
Short Summary

A facility failed to follow provider parameters for an antihypertensive medication when a resident’s metoprolol was given even though SBP was below the hold threshold on multiple occasions. The facility also allowed two active PRN ondansetron orders for another resident, and both orders were available in the EHR and used. RNs and the DON confirmed the medication parameters and duplicate-order review process were not followed.

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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