F0684

J

Failure to Follow Up on Subtherapeutic Phenytoin Level Leading to Status Epilepticus

Vidor, Texas Survey Completed on 02-27-2026

Penalty

Fine: $26,685

Summary

The deficiency involves the facility’s failure to ensure that a resident received treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the resident’s choices, specifically related to management of an anti-seizure medication (phenytoin/Dilantin) and associated lab monitoring. The resident was an adult male with anoxic brain damage, epilepsy with status epilepticus, and severe cognitive impairment. His care plan identified a seizure disorder and directed staff to administer seizure medication as ordered, monitor and document side effects and effectiveness, monitor labs, report any subtherapeutic or toxic results to the physician, and obtain and follow up on lab/diagnostic work as ordered.

The resident had an order for phenytoin, initially at 250 mg daily, with phenytoin levels to be checked every three months. After a critically high phenytoin level of 23.4, the physician decreased the dose from 250 mg to 200 mg daily and increased lab monitoring to every two months. A subsequent phenytoin lab result showed a level of 5.6 ug/ml, below the therapeutic range of 10.0–20.0 ug/ml. This low result was documented on the lab report and in the record, including a medication regimen review noting the low level and recommending a redraw and possible dose adjustment, with the physician checking a box agreeing with the recommendation. Progress notes indicated that the NP reviewed the resident’s BMP, CBC, and phenytoin labs and documented “no new orders” at that time.

Despite the documented subtherapeutic phenytoin level of 5.6, there was no evidence in the record that nursing staff implemented additional assessments, obtained repeat labs in a timely manner, or followed up beyond notifying the NP. Interviews with the DON and nursing staff confirmed that the NP was contacted twice regarding the abnormal lab value and that no new orders were received, with no further escalation to the attending physician or medical director. The DON stated that the lab value was low but not critical and that it was beyond the nurse’s scope to question the NP’s response. The NP later stated she had missed the low level and that, given the resident’s seizure history and low level, she would normally have ordered a repeat lab and subsequent dose adjustment. The resident continued to receive 200 mg of phenytoin daily as documented on the MAR, and there was no documentation of seizure symptoms prior to his transfer to the hospital for screaming in severe pain, where he was diagnosed with status epilepticus and a subtherapeutic/undetectable Dilantin level.

Interviews with family members indicated they were told by a hospital neurologist that the hospitalization and seizures were preventable and related to the decrease in medication and low phenytoin levels. The attending physician acknowledged that the first recheck level after the dose decrease was “5 something,” which he described as on the low side, and stated that the NP had missed the lab. He also stated he did not recall being notified of this specific lab value and that he would not “chase the numbers” in the absence of symptoms. Another physician interviewed stated that changes in phenytoin dosing or lab values should be followed by more frequent lab monitoring and that changes should not be based on old labs. The facility had a policy requiring physician notification of abnormal labs and documentation of such notifications and interventions, but there was no documentation that the low phenytoin level was escalated beyond the NP or that any clinical interventions or additional monitoring were implemented in response to the subtherapeutic result prior to the resident’s hospitalization.

An Immediate Jeopardy (IJ) was identified related to this failure, based on the facility’s lack of follow-up after notifying the NP twice about the subtherapeutic phenytoin level and the absence of interventions or assessments in response to that abnormal lab value. The IJ was later removed, but the facility remained out of compliance at a lower severity level while it continued to monitor implementation and effectiveness of its corrective actions.

Removal Plan

• Transferred Resident #1 to the hospital for treatment of status epilepticus and subtherapeutic Dilantin level.
• Completed a 100% audit of anticonvulsant medications to ensure therapeutic lab values and communicated any abnormal findings to the attending physician.
• Notified the provider of an abnormal lab identified during the audit, awaited new orders, and monitored the resident for signs/symptoms of seizures.
• Provided 1:1 in-service to the DON and ADON by the Regional Compliance Nurse on provider notification of abnormal lab values, documentation of provider notification for changes in condition including abnormal labs, escalation process when the NP/attending does not address non-therapeutic labs, and abuse/neglect implications of failure to intervene on abnormal labs.
• Notified the Medical Director of the Immediate Jeopardy.
• Completed an ad hoc QAPI meeting with the interdisciplinary team including the Medical Director.
• Initiated facility-wide in-services for all charge nurses and ensured staff not present would not be permitted to work until in-serviced, new hires would be in-serviced during orientation, and agency staff would be in-serviced prior to working floor assignment, covering provider notification of abnormal labs, documentation of provider notification for changes in condition including abnormal labs, escalation process when the NP/attending does not address non-therapeutic labs, and abuse/neglect implications of failure to intervene on abnormal labs.
• Reviewed the facility-wide anticonvulsant audit, reviewed documentation of Resident #2’s follow-up to an abnormal lab, reviewed in-service documentation for the ADON/DON/all staff, and ensured any incomplete in-services would be completed before the staff member’s next shift.
• Conducted individual staff interviews across shifts/weekends/PRN to confirm staff understanding of training and reporting requirements for lab results including reporting to the DON, MD, and family.