Failure to Follow Up on Subtherapeutic Phenytoin Level Leading to Status Epilepticus
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.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
A resident with severe dementia, psychiatric comorbidities, and protein-calorie malnutrition had a physician order for weekly weights, but the facility failed to consistently obtain and document these weights over several months. Although the resident appeared adequately nourished and was observed eating most of a meal, multiple ordered weekly weights were missing from the treatment records. Facility leadership, including the DON and ADON, were unaware that the weekly weight order had not been followed, despite policies requiring adherence to physician orders and documentation of weights in the EHR.
Two residents did not receive care in accordance with professional standards. One resident on warfarin for a valve replacement had invalid initial PT/INR labs, an order to hold warfarin pending results, and later dose changes, yet MAR entries showed warfarin was administered on days it should have been held, including when INRs were elevated and critically high, with no evidence the physician was contacted or that ordered follow-up INRs were drawn as prescribed. Another resident’s medication pass was observed where an LPN correctly administered six oral medications and held insulin for a blood sugar of 109, but later documented on the MAR that a polyethylene glycol 3350 dose had been given when it had not; after being questioned, the LPN retrieved the medication from the supply room and administered it after signing for it.
Surveyors found that staff failed to follow physician orders for several residents, including not documenting required physician notification and new insulin orders after a critically high blood glucose, not consistently obtaining or recording ordered daily weights, and administering antihypertensive and midodrine medications despite blood pressure readings outside ordered hold parameters. Documentation on the MAR and related records included unexplained "NA," "X," and blank entries for required weights, and cardiac and BP-related medications were given when systolic blood pressure was below or above specified thresholds, contrary to written orders and facility policy.
The facility failed to document assessment and monitoring of a resident’s bruising and post-procedure condition, and failed to follow ordered medication hold parameters for two residents. One resident returned from an outpatient spinal injection with no nursing note or assessment, another had persistent bruising with no documentation, and two residents received Metoprolol and midodrine despite pulse or BP values outside ordered limits. A separate resident was observed with purple discolorations and a black scab, but the skin record did not reflect assessment or monitoring.
Failure to Assess and Document Changes in Condition: A resident with repeated falls, hypoxia, lethargy, and later hospital transfers had multiple episodes where assessments, vital signs, or follow-up documentation were missing or delayed. Another resident with COPD and impaired gas exchange was observed in respiratory distress without oxygen and was later transferred for respiratory failure, with no transfer documentation on the progress notes. A third resident with dementia and a history of falls had incomplete post-fall assessments and was later sent to the hospital after additional falls and pain. A fourth resident with a Foley catheter had cloudy, low, and absent output, pain, and family requests for transfer; the catheter was later found to have caused traumatic injury and hematuria.
Failure to maintain heel offloading for a resident with a reopened DFU. A resident with dementia and dependence for mobility had a left heel wound that had healed and then reopened; the wound care provider recommended heel floating and pressure relieving boots at all times, but observations showed the resident in bed with heels on the mattress and later reclined in a wheelchair with the heel resting on the footrest strap and no boots in place. Staff stated the resident had not refused the boots or heel floating, and the care plan was not updated after the wound reopened.
Failure to Follow Physician Orders for Weekly Weights
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document weekly weights as ordered by the physician for one resident with significant nutritional risk factors. The resident was an elderly female with severe dementia with agitation, depression, schizoaffective disorder–bipolar type, and protein-calorie malnutrition. Her Quarterly MDS showed a BIMS score of 0, indicating severe cognitive impairment, and documented a weight of 120 pounds. A physician order dated 05/14/26 directed that weekly weights be obtained every Wednesday starting 01/21/26. Record review showed that, despite this standing order, multiple weekly weights were not obtained or recorded over several months. The Treatment Administration Records from 01/01/26 through 05/13/26 reflected missing weekly weight assessments on at least six ordered dates: 01/28/26, 02/11/26, 03/11/26, 03/25/26, 04/08/26, and 04/22/26. Progress notes documented weights on some dates (01/19/26, 01/21/26, 02/23/26, and 03/18/26), but these did not fulfill the requirement for consistent weekly weights as ordered. The facility’s own policy on Physician Orders stated that such orders are essential for comprehensive care, and the Weight Assessment and Intervention policy required that weights be recorded in the electronic health record. During observations, the resident appeared well-groomed, did not appear underweight or emaciated, and was seen consuming approximately 75% of a meal with staff assistance. However, interviews with the DON, ADON, and Administrator confirmed that they were not aware that the weekly weight orders had not been consistently followed for this resident. The ADON reported that the resident had significant cognitive impairment and often refused to be weighed, but there was no documentation in the report that these refusals were linked to the missed ordered weight dates or that alternative measures were taken to comply with the physician’s order. The deficiency centers on the facility’s failure to follow the physician’s weekly weight order and to ensure weights were consistently obtained and recorded in accordance with professional standards, the care plan, and facility policy.
Failure to Follow Anticoagulation Orders and Accurate Medication Documentation
Penalty
Summary
The deficiency involves failures in anticoagulation management and medication administration/documentation for two residents. For one resident with a history of valve replacement, the physician ordered warfarin (5 mg every other day) and associated PT/INR and CMP labs. Initial PT/INR labs were reported as invalid, and the physician subsequently ordered warfarin to be held pending INR results. When INR results were later received, the physician adjusted the warfarin dose to 2.5 mg on one day and 5 mg daily on subsequent days. The MAR showed nurses initialed administration of 5 mg doses on multiple days, even though the order to hold warfarin remained in effect until a later date. Nursing documentation reflected elevated INRs of 3.38 on two days and a critically elevated INR of 9.12 on another day, yet warfarin was still administered and there was no evidence the physician was contacted for guidance when these elevated INRs were obtained. When the INR was critically elevated at 17.63, the physician ordered vitamin K 10 mg injection and daily INR labs for two days, but there was no evidence the ordered labs were drawn or that staff followed up with the lab; labs were not completed until several days later, by which time the resident’s condition had deteriorated, including becoming nonresponsive and not eating, and the resident was transferred to the hospital. Pharmacy records showed 21 warfarin 5 mg tablets were dispensed and 20 were returned at discharge, despite MAR entries indicating four doses (one 2.5 mg and three 5 mg) had been administered, and the DON confirmed there were no warfarin tablets taken from the emergency kit and no other residents on warfarin. For a second resident, a medication pass was observed with a licensed nurse who prepared and administered six oral medications, which the surveyor verified by name and dose. The nurse confirmed that no additional medications were to be given at that time other than insulin, which was held due to a blood sugar of 109. However, on the MAR, the nurse documented that she had also administered polyethylene glycol 3350 powder, 17 g twice daily, even though this medication was not given during the observed pass. When questioned, the nurse acknowledged she had signed for administering the polyethylene glycol despite not having given it. She then searched the medication cart, found no polyethylene glycol, went to the supply room to retrieve a bottle, and administered the medication after the fact. The nurse stated she must have obtained the medication from another cart when she administered the morning dose, since none was available on the current cart at the time of the evening pass.
Plan Of Correction
Preparation and/or execution of this plan does not constitute admission or agreement by the provider of the truth of the facts alleged or conclusions set forth in the Statement of Deficiencies; this plan of correction is prepared and/or executed solely because it is required (1) What corrective action(s) will be accomplished for those residents found to have been affected by the deficient practice? A. On [R] resident #1 was discharged from facility to Lawnwood Regional Medical Center. B. On [R] Physician was notified of prior events and current conditions for resident discharged to Lawnwood Regional Medical Center on [R] . No additional residents were affected at this time. C. On [R] , comprehensive medication and lab review for resident #1 was completed to ensure all physician orders and current and being followed; resident transferred to hospital prior to additional interventions being implemented. D. As of [R] , the licensed nursing staff identified in the deficient practice are no longer employed by the facility. (2) How you will identify other residents having potential to be affected by the same practice and what corrective actions will be taken: A. On [R], the Director of Nursing/Designee identified and reviewed current residents receiving [R]. The review included verification of current physician orders, review of [R] INR results and therapeutic ranges, confirmation of timely laboratory draws, and verification of appropriate medication and documentation. At the time of the review, there were no residents in the facility receiving [R] [R] therapies were reviewed. Any discrepancies identified during the review were immediately corrected, including physician notification and clarification orders. (3) What measures will be put into place or what systematic changes you will make to ensure A. By [R], the facility implemented system changes, including the establishment of an [R] Management Protocol outlining INR critical value parameters, required interventions for elevated INR levels, and mandatory physician notification guidelines. A Lab Tracking Log was also implemented to ensure all ordered laboratory tests are completed as scheduled, reviewed in a timely manner, and escalated appropriately when not obtained. In addition, High-Risk Medication Audits [R] tool for [R] monitor compliance and medication safety practices. Education was completed with licensed nursing staff regarding the administration, monitoring, [R] management of [R] including therapeutic INR ranges, timely physician notification, documentation requirements, and appropriate interventions for abnormal lab values. B. By [R], Licensed Nursing Staff will have been educated by Director of Nursing/Designee on the components of F684 with an emphasis on medication administration safety, documentation accuracy, and appropriate clinical decision-making and escalation protocols. C. Newly hired licensed nursing staff will receive education by the Director of Clinical/Designee on the components of F684 with an emphasis on medication administration safety, documentation accuracy, and appropriate clinical decision-making and escalation protocols. (4) How the corrective action(s) will be monitored to ensure the practice will not recur, i.e., what quality assurance program will be put in place: A. The Director of Nursing/Designee will conduct audits on 5 residents on weekly x 4 weeks, then biweekly x 4 weeks, then monthly x 1 month. Audits will include medication administration accuracy, lab completion and follow up, physician notification compliance. The findings of these quality monitoring's to be reported to the quality Assurance/Performance Improvement Committee monthly until the committee determines substantial compliance has been met.
Failure to Follow Physician Orders for Insulin, Daily Weights, and BP-Related Medications
Penalty
Summary
The deficiency involves multiple failures to follow physician orders for medication administration and monitoring. For one resident with type 2 diabetes, peripheral vascular disease, and failure to thrive, a physician’s order directed use of Humalog insulin per a specific sliding scale and required physician notification if blood glucose exceeded 400. A blood sugar of 470 was recorded on one date, and the Medication Administration Record (MAR) showed that 5 units of Humalog were given, but there was no documentation in the MAR, assessment tab, or progress notes that the physician was contacted or that new insulin orders were obtained, despite the DON later stating that an additional 5 units had been ordered. Two residents with orders for daily weights did not have those weights consistently obtained or documented as ordered. One resident with heart failure, hypertension, and chronic kidney disease had a physician’s order for daily weights on dayshift, but on multiple dates in February, March, and April, the MAR/TAR and related documentation showed entries marked as “NA,” “X,” or left blank, with no recorded weights, no physician notification, and no explanation for the missing data. Another resident with hypertension, anxiety disorder, and severe protein-calorie malnutrition also had a daily weight order, yet on numerous dates in April and May, weights were marked “NA” without corresponding weights, physician notification, or explanatory documentation; one weight entry was crossed out and the re-weight was not obtained until the following day. LPNs provided differing explanations for “NA” and “X,” indicating inconsistent understanding of documentation practices. Additional deficiencies occurred in the administration of cardiac and blood pressure–related medications contrary to ordered hold parameters. One resident with hypertension had orders for amlodipine, hydralazine, and losartan potassium, each with instructions to hold the medication if systolic blood pressure (SBP) was less than 110, yet the MAR showed these medications were administered on specific dates when the SBP was below the ordered hold threshold. Another resident with hypertension and systolic and diastolic congestive heart failure had been hospitalized for severe hypotension and returned on midodrine with an order to hold the medication if SBP was greater than 110; however, the MAR showed multiple doses were given on various dates when SBP was outside the ordered hold parameter. These actions were inconsistent with the facility’s own policies requiring medications to be administered only as prescribed and weights to be accurately obtained and documented, and they formed the basis of the cited quality of care deficiency.
Failure to document assessments and follow medication parameters
Penalty
Summary
The facility failed to provide care according to orders and documented parameters for multiple residents. One resident with diagnoses including stroke, dementia, and osteoarthritis had an outpatient medial branch block at a surgery center, but there were no nursing progress notes documenting the procedure, the time the resident left the facility, the time the resident returned, or any assessment of the bandage or the resident’s condition on return. The Director of Nursing stated there was no documentation or assessment when the resident came back from the outpatient procedure. Another resident was observed with a dark purple bruise to the left antecubital area on multiple observations, but the record contained no documentation of that bruising. The resident’s diagnoses included anxiety disorder, major depressive disorder, diabetes, heart failure, high blood pressure, and acute kidney failure. The resident had care plan entries related to bruising and bleeding risk from anticoagulant use and bruising from needle sticks, and weekly skin observations documented no bruises. The DON stated the resident had a blood draw, but there was no documentation regarding the bruise to the left arm. Two residents had medications administered outside ordered parameters. One resident received Metoprolol Tartrate 50 mg twice daily for high blood pressure with instructions to hold if pulse was less than 60, but the MAR showed doses given when the pulse was below 60 on several occasions. Another resident on hospice care received midodrine 5 mg three times daily with instructions to hold if systolic blood pressure was greater than 110, but the MAR showed the medication was administered multiple times when systolic blood pressure exceeded that limit. In addition, a resident was observed with purple discolorations and a black scab on the left forearm, wrist, and hand, but the weekly skin assessment documented no bruising and there was no documentation that the discolorations were assessed or monitored.
Failure to Assess and Document Changes in Condition
Penalty
Summary
The facility failed to provide appropriate treatment and care according to orders, resident preferences, and goals for four residents who experienced changes in condition. For resident #1, the record showed multiple episodes where the resident was found after falls, had low oxygen saturations, became lethargic, or was unresponsive, yet there was no evidence of timely assessments, vital signs, or follow-up documentation at several of those events. The record also showed a late entry note for a 3/5/26 incident was added 62 days after the event. The resident was later transferred to the hospital for respiratory failure, pneumonia, acute heart failure, dry gangrene, hyponatremia, metabolic encephalopathy, pulmonary edema, critical electrolyte abnormalities, atrial fibrillation with RVR, and acute kidney injury. For resident #69, the resident had diagnoses including chronic myeloid leukemia, CAD, seizure disorder, traumatic brain injury, and COPD, and the care plan addressed impaired gas exchange. On 5/4/26, the resident was observed sitting on the edge of the bed with a respiratory rate of 30-40 breaths per minute, grey pallor, and no oxygen in place. The resident was later sent to the hospital for respiratory failure, but the progress notes for the transfer did not show documentation on 5/5/26. A later facility note stated the resident had been found with oxygen saturation of 60% on 4 lpm NC, difficulty breathing, and lethargy, and the LPN reported she had been asked to come in on her day off to document the assessment and transfer. For resident #81, who had severe cognitive impairment, dementia, COPD, atrial fibrillation, CAD, diabetes, and a history of falls, the record showed repeated falls and incomplete assessments. After a fall on 4/20/26, the assessment section was left blank. Another note dated 4/23/26 documented pain, confusion, and unsteadiness but stated there were no safety risks. After a fall on 4/25/26, staff documented vital signs and a normal assessment but did not know whether the resident hit his/her head, and there was no evidence of follow-up assessments. After a fall on 4/30/26, the resident was found on the floor with pain, and the interdisciplinary review identified impaired cognition, weakness, and self-transfers as the root cause, with a new skin tear noted. The resident's representative reported the resident was in significant pain, not at baseline, disheveled, saturated with urine, had neck swelling, and was missing a pain patch, and stated no vital signs or assessment had been done before the resident was sent to the hospital. For resident #6, who had moderate cognitive impairment, cancer, CAD, heart failure, renal disease, dementia, and an indwelling catheter, the care plan identified UTI risk related to the Foley catheter. After a recent hospitalization for sepsis related to UTI/prostate cancer, the record showed thick cloudy catheter output, complaints of pain, and periods of no catheter output. The resident's family repeatedly requested hospital transfer, and the catheter was changed after the resident had no output since the prior shift; the catheter then drained but had bloody urine. The resident later had cloudy grayish-yellow urine, was not getting up for breakfast, and was transferred to the ED. The ER report stated the Foley had caused traumatic injury and hematuria because the balloon was inflated in the prostatic urethra, and the resident also had AKI with creatinine elevated above baseline. The DON stated she expected transfer documentation to include resident condition, vital signs, notifications, and immediate or within-24-hour documentation, and confirmed that only vital signs were completed and ongoing assessment was not completed as expected.
Failure to Maintain Heel Offloading for Reopened DFU
Penalty
Summary
The facility failed to consistently implement pressure reducing strategies for a resident with a left heel diabetic foot ulcer that had reopened. The resident was admitted with diagnoses including left hip fracture with surgical repair, a blood clot of the left lower leg, and dementia, and was dependent on staff for mobility and unable to make needs known. The baseline care plan and care plan both included heel offloading interventions, and the wound care provider initially recommended heel floating with pillows or wedge and pressure relieving boots. The wound later resolved, but a weekly skin assessment documented that the left heel wound reopened and was very painful to touch. After the wound reopened, the contracted wound care provider documented that the DFU to the left heel had reopened and recommended the resident wear pressure relieving boots at all times. The current care plan reviewed after the wound reopened did not include new interventions related to the reopened wound. Observations showed the resident seated in a reclined wheelchair with the left foot/heel resting on the footrest strap and no pressure relieving boots in place, and later lying in bed with both heels directly on the mattress without being floated and without boots. Staff interviews indicated the resident had not refused the boots or heel floating, and the LPN/CC and DON stated the resident should have been assessed and the plan of care updated when the wound reopened.
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