Failure to Monitor Resident on Apixaban with Black Box Warning
Summary
A resident admitted with heart failure, atrial fibrillation, and mobility difficulties was prescribed apixaban, an anticoagulant with a black box warning (BBW) for significant risks such as bleeding and neurological impairment. The resident's Medication Administration Record (MAR) for two consecutive months was reviewed, and it was found that there was no documented monitoring for adverse effects associated with apixaban, despite facility policy and FDA recommendations requiring close monitoring for BBW medications. During an interview, the Assistant Director of Nursing confirmed that monitoring for adverse effects, such as bleeding, was not performed as indicated in the MAR. The facility's policy specifically required close monitoring for patients on BBW medications, and the manufacturer's insert for apixaban outlined the need for frequent monitoring for signs of bleeding and neurological compromise. The lack of monitoring constituted a failure to ensure the resident's drug regimen was free from unnecessary drugs and that adverse effects were adequately tracked.
Penalty
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Surveyors found that two residents did not receive medications in accordance with physician orders and drug administration guidelines. One resident on Metoprolol for hypertension and heart disease had the drug given nightly with blood pressure documented, but staff did not obtain or document the ordered apical pulse with hold parameters for HR <60 bpm. Another resident receiving weekly Fosamax for osteoporosis had the medication administered in the morning around the same time as breakfast service, despite orders to give it with a full glass of water on an empty stomach and drug information specifying administration at least 30 minutes before any food or other medications.
Surveyors found that multiple residents receiving PRN Ativan for anxiety had physician orders requiring non-pharmacological interventions such as relaxation, quiet room, massage, food, fluids, music, repositioning, activity involvement, toileting, and pain management to be used and documented for monitoring. Review of MARs and nursing progress notes showed that PRN Ativan was administered on several occasions without any documentation that these non-pharmacological measures were attempted beforehand. In an interview, the IDON acknowledged that staff did not complete or document the ordered non-pharmacological interventions prior to giving Ativan and noted there was no specific policy addressing this requirement, despite the need to follow physician orders.
A resident with a history of cerebral infarction and asthma was ordered Metoprolol Tartrate for HTN with instructions to hold the dose if SBP was below 110 or HR below 60, and to obtain and record vital signs to guide administration. Over an extended period, no SBP or HR values were documented on the MAR, and staff later confirmed that several doses should have been held but were not. This practice was inconsistent with the facility’s own medication administration policy requiring vital signs to be obtained and medications held when ordered parameters are not met, resulting in the resident receiving medication without adherence to prescribed hold parameters.
A resident without documented psychiatric diagnoses or anxiety symptoms was started on BuSpar and Trazodone following a psychiatric evaluation that relied on the resident’s self-reported sadness, anxiety, and sleep issues, while depression was still being ruled out. Nursing notes did not document the psychiatrist’s assessment or the new psychotropic orders on the day they were made, and there was no clear documentation that the responsible party was notified when BuSpar was initiated. The MAR showed BuSpar was entered and administered twice before being discontinued, and the responsible party later reported not understanding why the medications were started and expressed concern due to the resident’s prior adverse reactions to psychotropics. Interviews with ADONs revealed inconsistent accounts of when and how the responsible party was informed and showed that the rationale for Trazodone was not discussed, contrary to facility policy requiring immediate notification and documentation when there is a change in the resident’s status or treatment.
Surveyors found that two residents received antibiotics without adequate justification, documentation, or defined duration. One resident with multiple chronic conditions and an indwelling catheter was given Cephalexin twice daily for infection prevention over an extended period with an indefinite stop date, no supporting lab results, and no current UTI, and the prescribing specialist was unaware of the ongoing therapy. Another resident with severe cognitive impairment and total dependence for ADLs was started on Cefdinir for a UTI by an NP, but the record contained no abnormal urinary signs, symptoms, or test results, and no urine culture was obtained before treatment. These practices did not follow the facility’s antibiotic stewardship policy requiring clear indications, start/stop dates, and appropriate clinical information for antibiotic use.
A resident returned from the ED with new pain and muscle relaxant prescriptions entered as verbal orders from an outside prescriber that were never signed, and there was no documented communication with any facility provider or in-house visit to review these medications, yet staff administered them along with multiple existing antianxiety, muscle relaxant, and analgesic drugs until the resident fell and was later diagnosed in the ED with polypharmacy. Another resident with hypotension had midodrine ordered with instructions to hold the dose when SBP exceeded a specified threshold, but nursing staff repeatedly administered the drug despite SBP readings above that level over several months, contrary to the written parameters. A third resident with ESRD, HTN, and multiple comorbidities was ordered clonidine with hold parameters tied to SBP and pulse, but there was no evidence that BP or HR were obtained for evening doses or that HR was monitored at all during the review period, and the regional nurse confirmed the parameters in the order itself were incorrect, while facility policy required medications to be administered as prescribed.
Failure to Follow Medication Parameters and Fasting Requirements for Two Residents
Penalty
Summary
The deficiency involves the facility’s failure to ensure that residents’ drug regimens were free from unnecessary drugs by not following specific physician orders and administration parameters. For one resident with hypertensive heart disease with heart failure, atrial fibrillation, and hypertension, the physician ordered Metoprolol Succinate ER 25 mg to be given nightly at bedtime with parameters to hold the medication if the systolic blood pressure was less than 100 mmHg or the heart rate was less than 60 bpm. Review of the MARs for March and April showed the medication was administered at 9:00 P.M. with blood pressures documented prior to administration, but there was no documentation that an apical pulse was checked before giving the medication, despite the order including heart rate parameters. Further review of the resident’s EMR, including the vital signs tab, revealed no evidence that an apical pulse was obtained and recorded at times corresponding to the administration of Metoprolol. This lack of documentation was confirmed by the DON, who was unable to locate any record of apical pulse checks prior to the nightly doses. The DON acknowledged that the resident’s heart rate should have been checked because Metoprolol is known to slow the heart rate. The deficiency also includes the facility’s failure to administer an osteoporosis medication in accordance with physician orders and recommended administration guidelines. Another resident, diagnosed with age-related osteoporosis, had an order for alendronate sodium (Fosamax) 70 mg once weekly on Fridays, to be given with a full glass of water and on an empty stomach. The MAR and a 30-day medication administration audit showed that the Fosamax was administered between 8:25 A.M. and 8:53 A.M., while breakfast on that hall was served at 8:30 A.M. in the dining room or at 8:50 A.M. in the resident’s room. An LPN confirmed that the resident typically ate breakfast at those times and acknowledged that, based on the administration times, the medication was not being given on an empty stomach, which would result in poor absorption according to the drug information cited from Medscape.
Plan Of Correction
1. Resident #12 had their order for Fosamax clarified with the physician on 4/8/26 by a licensed nurse to administer the medication on an empty stomach. Resident #12 was assessed by the Director of Nursing on 5/7/26 with no ill effects noted. Resident's Fosamax was discontinued by the physician on 4/30/26. Resident #100 had their order for Metoprolol updated to include monitoring of their pulse on 4/14/26 by the Director of Nursing. Resident #100 was assessed by the Director of Nursing on 5/7/26 with no ill effects noted. 2. Like Residents are identified as residents who utilize bisphosphonate medications for the treatment of osteoporosis. An audit will be completed by the Director of Nursing or designee for like residents utilizing the Medication Audit Tool which was created on 4/20/26 by the Director of Nursing for the purpose of this POC, to ensure residents who utilize medication for osteoporosis receive them on an empty stomach and/or according to physician orders. This audit along with identified corrections will be completed on or before 5/13/26. Like Residents are identified as residents who utilize betablocker medications with specific orders to monitor their pulse for the treatment of hypertension. An audit will be completed by the Director of Nursing or designee for like residents utilizing the Medication Audit Tool which was created on 4/20/26 by the Director of Nursing for the purpose of this POC, to ensure residents who utilize beta blocker medication for hypertension have their pulse monitored when the physician indicates specific parameters within the order. This audit along with identified corrections will be completed on or before 5/13/26. 3. The Director of Nursing or designee will re-educate licensed nurses on the Physicians Order Policy to ensure orders include and are transcribed with the information that is necessary and accurate to carry out the order correctly. This education will be completed on or before 5/13/26. 4. Utilizing the Medication Audit Tool which was created on 4/20/26 by the Director of Nursing for the purpose of this POC, the Director of Nursing or designee will complete an audit 4-6 residents weekly for four weeks, beginning 5/14/26 to ensure residents who utilize medication for osteoporosis receive them on an empty stomach and/or according to physician orders and to ensure residents who utilize beta blocker medication for hypertension have their pulse monitored when the physician indicates specific parameters within the order. Discrepancies noted during the audits will be corrected with physician orders clarified. Negative findings to be addressed immediately and negative trends or system wide issues will be reported to the QAPI committee, and the action plan will be adjusted as needed.
Failure to Implement Non-Pharmacological Interventions Before PRN Psychotropic Use
Penalty
Summary
Surveyors identified a deficiency related to the requirement that each resident’s drug regimen be free from unnecessary drugs, specifically regarding the use of PRN psychotropic medications without prior non-pharmacological interventions. For one resident with hip fracture, dementia, anxiety, and bipolar disorder, the record showed a physician’s order for non-pharmacological interventions (such as relaxation, quiet room, massage, food, fluids, music, repositioning, activity involvement, pain medication, and other measures documented in progress notes) to be used for monitoring, and a separate order for PRN Ativan 0.5 mg for anxiety. The MAR documented multiple administrations of PRN Ativan over several days, but review of the MAR and nursing progress notes showed no documentation that non-pharmacological interventions were attempted prior to giving the medication on any of those occasions. Another resident with Alzheimer’s disease and anxiety had physician orders for non-pharmacological interventions similar to those above, as well as an order for PRN Ativan 0.25 mg for anxiety. The MAR showed several PRN Ativan administrations over a three-day period, but the MAR and nursing progress notes lacked documentation of non-pharmacological interventions before the medication was given. A third resident with dementia, hypertension, and incontinence had an order for non-pharmacological interventions and subsequent orders for scheduled and PRN Ativan for anxiety. Review of this resident’s MAR and nursing notes showed PRN Ativan was administered without any documented alternate non-pharmacological interventions beforehand. In an interview, the Interim DON confirmed staff failed to complete or document non-pharmacological interventions prior to administering Ativan and stated there was no specific facility policy requiring such interventions before psychotropic medications, though physician orders were to be followed.
Failure to Follow Ordered Vital Sign Parameters for Antihypertensive Medication
Penalty
Summary
The facility failed to ensure a resident’s drug regimen was free from unnecessary drugs by not following physician-ordered parameters for administration of Metoprolol Tartrate. The resident, admitted with diagnoses including cerebral infarction, unspecified and unspecified asthma, uncomplicated, had a physician order dated 01/30/26 for Metoprolol Tartrate 25 mg, 1.5 tablets by mouth twice daily for HTN, with instructions to hold the medication if systolic blood pressure (SBP) was below 110 or heart rate (HR) was below 60. Review of the medication administration record showed no documented SBP or HR from 01/30/26 through 02/26/26, despite the order requiring these parameters to determine whether the medication should be given or held. Pharmacy reiterated the same hold parameters on 02/26/26, yet vital signs were still not documented for the earlier period, and staff interviews confirmed that the medication should have been held for specific doses on 03/10/26 and 03/11/26 but was not. Review of the facility’s Medication Administration Policy dated 08/22/22 showed that staff were required to obtain and record vital signs when applicable or per physician orders and to hold medications when vital signs fell outside prescribed parameters, which was not followed in this case. This deficiency was identified for one resident out of five reviewed for unnecessary medications, with a facility census of 92, and was investigated under Complaint Number 2696141.
Failure to Ensure Appropriate Indication and Notification for New Psychotropic Medications
Penalty
Summary
The facility failed to ensure a resident’s drug regimen was free from unnecessary medications by not establishing and documenting appropriate indications for new psychotropic drugs. A resident admitted with metabolic encephalopathy, peripheral vascular disease, urinary tract infection, kidney calculus, and osteonecrosis of the left femur had no documented history of generalized anxiety disorder, depression, or other psychiatric conditions in the medical record. Review of progress notes over several days showed no signs or symptoms of anxiety and no documentation of referral to psychiatric services. During an admission psychiatric evaluation, the consulting psychiatrist documented the resident’s self-reported sadness, depression, poor sleep, anxiety, and restlessness, diagnosed generalized anxiety disorder, ordered BuSpar 10 mg orally twice daily for anxiety, and Trazodone 25 mg orally every evening while depression was still being ruled out and not listed as a confirmed diagnosis. The nursing documentation did not reflect the psychiatrist’s assessment or the new orders for BuSpar and Trazodone on the date they were made, and there was no documentation of notification of the resident’s responsible party regarding the initiation of BuSpar. The MAR showed the BuSpar order was entered the day after the psychiatric evaluation, and the resident received two doses before discontinuation. The responsible party later reported that the medications were started for an unknown reason, stated the resident had prior adverse reactions to psychotropic medications, and did not want medications that cross the blood-brain barrier. Interviews with the ADONs revealed conflicting accounts about whether and when the responsible party was notified of the new orders, with one ADON stating she did not notify the family by phone and that all communication was in person, and acknowledging that nothing was discussed regarding the rationale for Trazodone. The facility’s policy required immediate notification of the resident and authorized representative, consultation with the practitioner, and documentation in the medical record when there is a change in mental, physical, or psychosocial status, which was not consistently followed in this case.
Unjustified and Poorly Documented Antibiotic Use for Two Residents
Penalty
Summary
The facility failed to ensure residents’ drug regimens were free from unnecessary antibiotics, resulting in antibiotic use without adequate indications, monitoring, or defined duration. One resident with hemiplegia, type 2 diabetes, bladder dysfunction, hypertension, and an indwelling urinary catheter had a physician order for oral Cephalexin 500 mg twice daily “for prevention of infection” with an indefinite end date. A pharmacy note requested clarification of a stop date, but the medication was administered continuously for several months. The medical record contained no documentation justifying extended use of Cephalexin, no related laboratory results, and the resident did not currently have a UTI. The Infection Preventionist confirmed the antibiotic had been ordered and administered for an extended period, had not appeared on the ordered antibiotic list, and that the urology office had not ordered or been aware of the ongoing Cephalexin use, with no documented justification for its continual use. Another resident with cerebral palsy, profound intellectual disabilities, seizures, hypertension, dysphagia, severe cognitive impairment, and total dependence for ADLs received Cefdinir suspension ordered by a nurse practitioner for a UTI. Nursing documentation noted the NP visit and the new Cefdinir order, and the medication was administered as ordered. However, the medical record lacked documentation of abnormal urinary signs or symptoms or any test results to support the antibiotic use. The Infection Preventionist confirmed there was no documentation to support Cefdinir as treatment for a UTI and that a urine culture was not obtained prior to starting the antibiotic. These practices were inconsistent with the facility’s “Antibiotic Stewardship” policy, which requires complete antibiotic orders including indication and duration, and specific clinical information to be communicated when a nurse contacts a prescriber about a suspected infection.
Plan Of Correction
F757 Unnecessary drugs The PoC will what corrective action(s) will be accomplished for those residents found to have been affected by the deficient practice. Resident # 39 has been reviewed by physician on March 14, 2026, for ongoing use of antibiotic with justification of use to prevent UTI. Resident # 40 as of Feb 22, 2026, is no longer receiving this antibiotic. How you will identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken. Residents in the facility who have antibiotics without stop dates being used as a prophylactic treatment would be like residents. The sweep completed by the infection preventionist on 3/25/26 of current residents did not identify such residents. Any residents receiving antibiotics require documentation of the reason for antibiotic use. What measures will be put into place or what systemic changes you will make to ensure that the deficient practice does not recur. Inservice for nurse managers and licensed nurses to follow the antibiotic stewardship protocol a. Drug name; b. Dose; c. Frequency of administration; d. Duration of treatment: (1) Start and stop date; or (2) Number of days of therapy; route of administration; and f. Indications for use. The policy also stated that when the nurse calls a physician/prescriber to communicate a suspected infection, he/she would have the following info: when symptoms first observed, the resident's hydration status, current medication list, and the infection type. Inservice per DON/designee and completed by 4-9-2026. Residents with antibiotics ordered must have reason for the antibiotic identified. How the corrective action will be monitored to ensure the deficient practice will not recur. Daily audit of orders for antibiotics without stop dates began 3/25/26 by infection preventionist all antibiotic orders and will be audited weekly x 4 weeks by DON/designee to ensure all antibiotics have automatic stop dates Results are submitted to QAPI committee weekly. Concerns identified will be corrected at the time of audit, and education of nurses will be done to remind them that we need to have a stop date for any antibiotics ordered.
Failure to Ensure Physician Oversight and Adherence to Medication Parameters
Penalty
Summary
The deficiency involves failures in medication management and physician oversight, resulting in residents receiving unnecessary or improperly monitored drugs. One resident with dementia, muscle weakness, adult failure to thrive, and poly osteoarthritis was admitted with moderate cognitive impairment and required assistance with activities of daily living. After an emergency department visit, this resident was prescribed a lidocaine topical patch and tizanidine for pain and muscle spasms. These new medications were entered as verbal orders from an outside certified nurse practitioner but were never signed, and there was no documented communication with any facility provider about the new medications. Despite the lack of provider sign-off or documented oversight, nursing staff administered these medications along with multiple other antianxiety, muscle relaxant, and pain medications already ordered for the resident. Over several days, the resident received Xanax, baclofen, hydroxyzine, tramadol, Tylenol, lidocaine patch, and tizanidine. Subsequently, the resident experienced a fall and was noted to be slower to respond, with slurred speech. The on-call physician was notified, and the resident was sent to the emergency department, where documentation indicated a diagnosis of polypharmacy with muscle relaxants held and mental status improvement. Review of the medical record confirmed that the emergency room orders from the earlier visit were never signed by the ordering nurse practitioner, there was no documentation of communication with any facility provider regarding the new medications, and no in-house provider visits were documented during that period. The regional nurse confirmed that no documentation could be provided to show provider awareness or oversight of the new medications. A second resident with dementia, hypotension, anxiety disorder, mood disorder, major depressive disorder, and paraphilia had an active care plan for altered cardiovascular status related to hypotension, including medication as ordered by the physician. The physician ordered midodrine 15 mg three times daily with instructions to hold the medication if systolic blood pressure was greater than 110 mmHg. Review of multiple months of MARs showed that midodrine was repeatedly administered when the resident’s systolic blood pressure exceeded 110 mmHg at various morning, afternoon, and evening doses. The regional nurse verified that the resident had systolic blood pressure readings greater than 110 mmHg throughout the review period and that midodrine was not held as ordered. Facility policy required medications to be administered in a safe and timely manner and as prescribed, but the ordered parameters were not followed. A third resident with end-stage renal disease on dialysis, type 2 diabetes, major depressive disorder, opioid dependence, anxiety disorder, and long-term antibiotic use had a care plan for hypertension that included providing antihypertensive medication as ordered, monitoring for side effects, monitoring blood pressure as clinically indicated, and reporting signs of malignant hypertension. The physician ordered clonidine 0.1 mg, three tablets by mouth twice daily, with instructions to hold the medication for systolic blood pressure above 110 mmHg and pulse above 60 bpm. Review of the MAR and vital signs over a one-month period showed that clonidine was scheduled for administration at 10:00 a.m. and 10:00 p.m., but there was no evidence that blood pressure was checked for the evening dose and no evidence that heart rate was obtained at any time during the review period. The regional nurse later verified that the parameters in the order were incorrect and that the medication should have been held for systolic blood pressure below 110 mmHg and pulse below 60 bpm. The facility’s medication administration policy required medications to be administered in accordance with orders, but the required monitoring parameters were not followed or correctly applied.
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