Failure to Monitor Drug Interactions Leads to High INR
Summary
The facility failed to adequately monitor a resident's drug regimen, leading to adverse consequences. The resident, who had a diagnosis of Atrial Fibrillation and was on Coumadin, was prescribed Bactrim, an antibiotic known to potentiate the effects of Coumadin. The facility did not complete the necessary monitoring for symptoms of drug interactions, which resulted in the resident being sent to the hospital with a supratherapeutic INR of 4.5, significantly higher than the therapeutic range of 2-3. The facility's policy on Warfarin monitoring requires that all residents receiving Warfarin therapy be monitored for efficacy through observation and PT/INR testing. However, the facility did not follow this policy when the resident was placed on Bactrim. There was no indication that the facility informed the physician or the anticoagulation clinic about the resident's Coumadin therapy when Bactrim was prescribed. Consequently, the resident's INR was not monitored during the course of Bactrim treatment, leading to a critically high INR level. Interviews with the Director of Nursing revealed that the facility should have contacted the anticoagulation clinic and checked the INR within 1-3 days after starting the antibiotic. However, this process was not followed, resulting in the resident's increased risk for bleeding due to the high INR. The lack of communication and monitoring contributed to the deficiency in ensuring the resident's drug regimen was free from unnecessary drugs and adverse consequences.
Penalty
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Surveyors found that the facility did not prevent duplicate medication orders or ensure monitoring for medication side effects for two residents. One resident on palliative care with CHF and acute kidney disease had two PRN orders for lorazepam oral concentrate written for the same dose and frequency, one for anxiety and one for terminal agitation, with no documented monitoring for sedation, respiratory status, cognitive changes, or other adverse effects despite FDA guidance. Another resident with diabetes, CHF, and mild cognitive impairment had two overlapping PRN orders for bisacodyl suppositories, which the CRN acknowledged were in error.
A resident with a history of hematuria, renal failure, anemia, and recent blood transfusions was readmitted from the hospital with discharge instructions to pause apixaban, but the facility failed to obtain admission orders and did not clarify the incomplete anticoagulant order. The resident’s care plan did not address anticoagulant use or monitoring, and staff administered multiple doses of apixaban after readmission. Nursing notes documented blood in the nephrostomy drainage bag on two days without provider notification or intervention, followed by worsening weakness, poor intake, and hypoxia that led to hospital transfer. Hospital records showed the resident had gross hematuria, hypotension, respiratory distress, acute kidney injury, and a critically low Hgb requiring transfusion, and a late entry note acknowledged that the discharge order to hold apixaban had been overlooked.
A resident with dementia, chronic pain, COPD, and other comorbidities was converted from scheduled hydrocodone-acetaminophen to a fentanyl 25 mcg/hr transdermal patch despite not meeting FDA-defined opioid-tolerant criteria, and without documented risk assessment for advanced age and chronic lung disease. The resident’s actual morphine equivalent (ME) exposure was significantly below the 60 mg/day threshold required for initiating this fentanyl dose. Later, after several days without a patch and variable PRN opioid use, the fentanyl dose was doubled to 50 mcg/hr soon after the resident received Norco and lorazepam 0.5 mg for restlessness and anxiety, contrary to manufacturer titration guidance and the facility’s own policy to avoid or closely monitor opioid–benzodiazepine combinations. The resident subsequently developed acute shortness of breath, hypoxia, somnolence, slow shallow respirations, and pinpoint pupils, required naloxone by EMS, and was diagnosed in the ED with accidental opiate overdose and hypoxia.
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 intact decision-making ability and a history of depression was given a combination of IM haloperidol, lorazepam, and diphenhydramine for agitation, a "B52" regimen the DON acknowledged is typically used in ER settings and rarely in this facility. Despite AGS Beers Criteria and Epocrates identifying these drugs and their combination as high risk for older adults, the record lacked documentation of recent behaviors before or after administration, non-pharmacologic interventions, or ongoing monitoring that night. There was no behavior-focused care plan, no IDT review, and informed consent forms for each drug listed only "severe agitation" without specific behaviors or alternative treatments and risks, contrary to facility policies on psychotropic use, behavioral assessment, informed consent, and change-in-condition assessment.
A resident with acute osteomyelitis of the left ankle and foot had PRN orders for acetaminophen for mild pain and Percocet for moderate to severe pain. Documentation showed acetaminophen was given only once for a pain level of 4 and then not administered for several days, while Percocet was administered multiple times for documented pain levels of 3, below the ordered indication for moderate to severe pain. The facility’s pain management policy required pain assessment every shift with documentation of the pain scale and type of pain, and the DON reported that physicians had moved away from relying on the numeric pain scale because residents might underreport their pain.
Failure to Prevent Duplicate Medication Orders and Monitor PRN Sedative Side Effects
Penalty
Summary
The facility failed to ensure residents were free from unnecessary drugs by allowing duplicate medication orders and not implementing monitoring for medication side effects. For one resident with diagnoses including palliative care encounter, congestive heart failure, and acute kidney disease, the medical record contained two separate PRN orders for lorazepam oral concentrate 2 mg/mL, each directing administration of 0.5 mL by mouth every 8 hours as needed, one for anxiety and one for terminal agitation. Despite FDA prescribing information indicating the need to monitor for adverse effects such as respiratory depression, cognitive impairment, paradoxical reactions, and dependence or withdrawal symptoms, the resident’s care plan and physician orders did not include any documented monitoring parameters for lorazepam use, including monitoring for sedation, respiratory status, or cognitive changes. The DON confirmed that the record lacked monitoring interventions for lorazepam. Another resident, admitted with multiple diagnoses including diabetes, congestive heart failure, and mild cognitive impairment, had duplicate PRN orders for bisacodyl suppositories. One order directed insertion of a 10 mg bisacodyl suppository rectally as needed for constipation if there were no results within 24 hours from a bisacodyl tablet, and a second order directed insertion of a 10 mg bisacodyl rectal suppository every 24 hours as needed for no bowel movement after the prior bowel protocol regimen. On interview, the CRN acknowledged that the resident had two bisacodyl suppository orders in error. These findings showed the facility did not prevent duplicate medication orders or ensure appropriate monitoring for medication side effects for the residents reviewed.
Failure to Clarify Anticoagulant Orders Leads to Unnecessary Drug Administration and Hospitalization
Penalty
Summary
The deficiency involves the facility’s failure to ensure a resident’s drug regimen was free from unnecessary drugs when nursing staff did not clarify and correctly implement anticoagulant orders upon the resident’s readmission. The resident had been hospitalized for hematuria, renal failure, and anemia, received multiple blood transfusions, and was discharged back to the facility with an After Visit Summary instructing that apixaban (an anticoagulant) be paused, with no restart date specified. Despite this, the facility’s admission documentation for the readmission date showed no admission orders, and the apixaban order was not clarified with the physician. The medication was restarted and administered after readmission, even though the hospital documentation indicated it was to be paused and later discontinued. Following readmission, the resident’s Medication Administration Record showed that seven doses of apixaban were given. The resident’s care plan, initiated on the readmission date, did not identify any problems, goals, or interventions related to anticoagulant use, safety, or monitoring for side effects. Nursing progress notes documented that the resident had a right-sided nephrostomy with yellow urine drainage on the day of readmission, and then documented blood in the nephrostomy drainage bag on two consecutive days. However, there was no documentation that the provider was notified about the hematuria or that any action was taken in response to this change. Subsequently, nursing notes described the resident as weak, not eating, unable to maintain a sitting position, and having low oxygen saturation that did not adequately improve with increased supplemental oxygen, leading to transfer to the emergency department. Hospital records from that visit showed the resident presented with hypoxia, hypotension, profound weakness, respiratory distress, gross hematuria, acute kidney injury, and a critically low hemoglobin of 6.9 g/dL, and that the resident had received an anticoagulant and required blood transfusions. A late entry nursing note at the facility later documented that the hospital discharge summary had been overlooked, the order to hold apixaban was not implemented, and the resident continued to receive apixaban until readmission to the hospital. The facility’s root cause analysis attributed the event to ambiguity in discharge communication and medication reconciliation workflow and noted that the apixaban order was incomplete and not clarified before administration.
Failure to Follow FDA Fentanyl Patch Dosing Guidelines Resulting in Opioid Overdose
Penalty
Summary
The deficiency involves the facility’s failure to follow FDA Black Box Warnings and manufacturer dosing specifications for a fentanyl transdermal patch in an elderly resident with COPD and multiple comorbidities. The resident, in her late 70s, had diagnoses including dementia, chronic pain, vertebral compression fractures, bipolar disorder, anxiety disorder, COPD, and cerebral infarction. Prior to fentanyl initiation, the resident was receiving hydrocodone-acetaminophen (Norco) 5-325 mg on a scheduled basis, with a regimen that allowed for up to five tablets per day, but the MAR showed multiple instances where doses were refused or held due to sedation. Based on the consultant pharmacist’s review and morphine equivalent (ME) calculations, the resident’s actual opioid exposure at the time fentanyl was started was approximately 20–25 mg ME per day, below the FDA-defined threshold of at least 60 mg oral morphine daily for at least one week to qualify as opioid-tolerant. The record contained no documented justification for switching from Norco to a fentanyl patch or any risk assessment addressing the resident’s advanced age, COPD, and sub-threshold opioid exposure in relation to the FDA Black Box Warning and manufacturer guidance. On 11/26/25, an order was written for a fentanyl (Duragesic) 25 mcg/hr transdermal patch to be applied every 72 hours for chronic pain, and Norco was changed to PRN two days later. The consultant pharmacist later confirmed that, according to the Duragesic dosing guidelines, a 25 mcg/hr starting dose should only be used in patients already receiving at least 60 mg oral morphine equivalents daily for a minimum of seven days, which this resident did not meet. The facility’s own pain management policy stated that pain medications should be selected based on pertinent treatment guidelines, that the lowest possible effective opioid dose should be used with ongoing monitoring, and that combining opioids and benzodiazepines should be avoided or closely monitored for respiratory depression. Despite these standards and the resident’s COPD and geriatric status, the fentanyl patch was initiated without documentation that the resident was opioid-tolerant as defined by the FDA labeling, and without a documented risk assessment. Subsequently, the resident’s fentanyl dose was increased from 25 mcg/hr to 50 mcg/hr on 1/30/26, after a period in late January when the 25 mcg/hr patch had been removed and not replaced for several days due to unavailability. During January, the resident’s PRN Norco use ranged from one to three tablets per day, with nine days of no Norco administration, and pain scores varied from 0 to 9. On 1/29/26, nursing documentation showed the resident was restless and unable to be consoled, leading to a new order for lorazepam 0.5 mg for anxiety, which was administered at 5:20 p.m., following a Norco dose at 4:00 p.m. The next day, the fentanyl patch dose was doubled to 50 mcg/hr. The consultant pharmacist verified that, at the time of this dose increase, the resident was receiving only 5–15 mg of supplementary morphine equivalents per day, far below the 45 mg ME per day that the manufacturer’s titration guidelines associate with a 12.5 mcg/hr increase, and that lorazepam and Norco had been administered shortly before the fentanyl dose escalation, creating a potential for respiratory depression. On 2/1/26, nursing notes documented that the resident began screaming for help and reported, “I can’t breathe, I can’t talk, I can’t swallow.” The nurse applied supplemental oxygen, but the resident’s oxygen saturation dropped to 77%, and her temperature was 100.1°F. The medical director was notified and ordered transfer to the emergency department. ED triage documentation indicated shortness of breath, slow shallow respirations, pinpoint pupils, and a positive response to naloxone administered by EMS, with the fentanyl patch removed by EMS. The ED history and physical described somnolence presumed due to opioid overdose and shortness of breath, and the ED physician’s note characterized the event as an iatrogenic occurrence requiring re-evaluation of the resident’s pain management strategy. The ED diagnoses included accidental or unintentional opiate overdose and hypoxia. Throughout interviews, the consultant pharmacist confirmed that both the initial fentanyl dose and the subsequent dose increase did not meet FDA and manufacturer criteria for opioid tolerance and dose titration, while the medical director stated he believed he had followed fentanyl dosing guidelines but could not identify the cause of the resident’s respiratory distress.
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.
Use of High-Risk Sedating Drug Combination Without Required Assessment or Monitoring
Penalty
Summary
The deficiency involves the facility’s failure to ensure a resident’s drug regimen was free from unnecessary medications when a combination of three drugs—intramuscular haloperidol 5 mg, lorazepam 2 mg, and diphenhydramine 50 mg—was ordered and administered nearly simultaneously for agitation. The resident was an older adult with a diagnosis including depression and a BIMS score of 15/15, indicating intact decision-making ability. On the identified night, the Medication Administration Record showed that diphenhydramine and lorazepam were given at 1:01 a.m. and haloperidol at 1:02 a.m. The DON confirmed this was a "B52" combination commonly used in emergency room settings for severe agitation and acknowledged she had never seen it used in this skilled nursing facility. The facility pharmacist stated that this combination should generally be avoided in the skilled nursing setting. The facility’s own policies and nationally recognized clinical resources highlighted concerns with this medication regimen. The AGS 2023 Beers Criteria listed haloperidol, lorazepam, and diphenhydramine as medications best avoided in most older adults, with haloperidol associated with increased stroke risk, lorazepam with increased falls and fractures, and diphenhydramine with increased confusion and falls. Epocrates indicated that using these three medications together should be avoided due to risks of respiratory depression and psychomotor impairment. Facility policies on psychotropic medication use and behavioral assessment required that pertinent non-pharmacological interventions be attempted and documented, that staff observe and document the effectiveness and adverse consequences of psychotropic medications, and that physicians change or stop problematic medications or clearly document why benefits outweigh risks. Despite these requirements, the resident’s record lacked documentation of behaviors in the days immediately before or after the medication administration, and there was no documentation of non-pharmacological interventions attempted prior to giving the three medications. The progress note from the night of administration described the resident screaming, yelling, blocking the room entrance with his wheelchair, wheeling to the nursing station, and glaring at staff and other residents, and stated that the medications were effective, but there was no further monitoring documented for the remainder of the night. There was no care plan addressing behavior monitoring or the use of haloperidol, lorazepam, or diphenhydramine, and no documentation of an IDT meeting to discuss this medication use. Informed consent forms for each of the three medications listed only "Severe Agitation" as the diagnosis or signs and symptoms, without specifying behaviors to be monitored or alternative treatments and risks as required by the facility’s informed consent policy. The DON also acknowledged that a change in condition assessment was not completed following the resident’s behaviors and the administration of the three medications, contrary to the facility’s policy requiring documentation and comprehensive assessment when there is a significant change in a resident’s physical or mental condition. The Medical Director stated that the combination of haloperidol, lorazepam, and diphenhydramine is standard for enforced sedation for people who are out of control and confirmed that it was intentionally used in this case in the skilled nursing setting rather than transferring the resident to the emergency room. A subsequent progress note by the Medical Director several days later documented that the resident had been administered the three medications once that night and "has been fine ever since." However, there was no contemporaneous documentation of monitoring for efficacy and adverse consequences as required by the facility’s behavioral and psychotropic medication policies, and no evidence in the record that the physician documented why the benefits of this high-risk combination outweighed the known risks in an older adult. Collectively, these omissions and the use of a high-risk drug combination without required assessments, non-pharmacologic attempts, monitoring, care planning, and complete informed consent constituted the deficiency in ensuring the resident’s drug regimen was free from unnecessary drugs.
Inadequate Assessment and Indication for Opioid Pain Medication
Penalty
Summary
Surveyors identified a deficiency related to unnecessary medications when the facility failed to ensure appropriate assessment and indications for opioid pain medication use for one resident with other acute osteomyelitis of the left ankle and foot. The facility’s Pain Management policy dated 12/2/25 required that pain be assessed every shift, recorded on the eMAR, with the pain scale used and the type of pain documented, and that pain management be consistent with professional standards of practice and the resident’s care plan, goals, and preferences. For this resident, there was a physician order for acetaminophen 325 mg, two tablets by mouth every 8 hours as needed for mild acute pain, not to exceed 3000 mg/day. The record showed acetaminophen was administered once on March 8 at 0837 for a pain level of 4, with no further documented administration of acetaminophen from March 9 through March 16. The same resident also had a physician order for Percocet 5-325 mg (oxycodone with acetaminophen), one tablet by mouth every 4 hours as needed for moderate to severe acute pain related to the osteomyelitis diagnosis. However, the medical record documented that Percocet was administered on three occasions—March 13 at 0707, March 15 at 0621, and March 16 at 0625—each time for a documented pain level of 3, which is below the ordered indication of moderate to severe pain. During an interview on March 17 at 12:58 PM, the DON stated that physicians had moved away from using the pain intensity number scale because some residents might report a pain level of 3 when it is really a 6 or 7, indicating a discrepancy between the documented pain scores and the ordered criteria for opioid use.
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