Failure to Inform Residents About Medications and Obtain Informed Consent for Bed Rails
Summary
The deficiency involves failure to uphold residents' rights to be informed of and participate in their treatment decisions, specifically regarding medication administration and use of bed side rails. For one resident with chronic respiratory failure and age-related osteoporosis, whose MDS documented intact cognitive skills and partial/moderate assistance needs for ADLs, a nurse administered multiple medications, including midodrine, Senokot-S, Trelegy Ellipta, Miralax, Tylenol, and Systane eye drops, without informing the resident of the name and indication of each medication at the time of administration. When questioned, the nurse stated she was not aware that providing this information was required by facility policy. The DON confirmed that residents have the right to be informed about their care, including medications, and that not providing this information restricted the resident from exercising this right. The facility’s administrative manual stated that residents have the right to make decisions about their medical condition and to accept or refuse proposed treatment. The deficiency also includes failure to obtain informed consent for the use of bed side rails for another resident with hypertension and dysphagia, whose MDS also showed intact cognitive skills and partial/moderate assistance needs for ADLs. Review of the resident’s "Informed Consent for Bed Rail Use" form showed it was incomplete, lacking the resident’s or representative’s signature, the reason for side rail use, and the licensed nurse’s signature verifying that consent was obtained. The DON acknowledged that consent had not been obtained and no explanation was provided regarding the reason for side rail use. The facility’s bed rail policy required that, when the IDT determines bed rails are appropriate, the "Informed Consent for Bed Rail Use" form must be used prior to installation, with information presented in an understandable manner and consent given voluntarily and free from coercion.
Plan Of Correction
Joyce Eisenberg - Keefer Medical Center makes every effort to operate in substantial compliance with Federal and State laws and regulations. Nothing in this Plan of Correction is an admission otherwise. Joyce Eisenberg - Keefer Medical Center is submitting this Plan of Correction in compliance with its regulatory obligations and does not waive any objections it may have as to the merit or form of any allegations contained herein. Please note that the facility may contest the merits or form of any of the alleged deficient findings and may take reasonable steps to appeal them. This Plan of Correction constitutes Joyce Eisenberg - Keefer Medical Center's written credible allegation of compliance for the deficiencies noted. F-552 Corrective Action for Affected Residents: The Director of Nursing (DON) met with LVN involved to provide 1:1 education regarding requirement. LVN reviewed Resident 59's current medication regimen and ensured that Resident 59 received information regarding the name of each medication, its indication, and the right to refuse medications and resident confirmed she is aware of medications as above. RN Unit Manager completed a comprehensive review of Resident 101's bed rail use and obtained informed consent from Resident 101, including explanation of the reason for bed rail use, risks, benefits, and alternatives. The DON or designee ensured that the Informed Consent for Bed Rail Use form was completed with appropriate signatures including Resident 101 and the licensed nurse verifying that consent was obtained. 3/17/26 Identifying other Residents having the Potential to be Affected: As most residents have medications, DON or designee provided education to licensed nurses on the requirement to provide information regarding the name of each medication, its indication, and the right to refuse medications as applicable. DON educated residents during the 3/19/26 Resident Council meeting regarding their right to be informed on their medications.The Medical Records Manager conducted an audit of other residents currently utilizing bed rails. The RN Unit Managers reviewed the Informed Consent for Bed Rail Use forms to ensure that informed consent was obtained, forms are completed in their entirety including resident or resident representative signature, reason for use, and licensed nurse signature. For residents with incomplete consent forms, the RN Unit Managers or designee obtained proper informed consent including explanation of risks, benefits, and alternatives. Measures put into place or Systemic Changes: The DON or designee in-serviced LVNs and RNs on the requirement to inform residents of medication names and indications prior to administration, the resident's right to be informed of and participate in treatment decisions, and the resident's right to refuse medications. The in-service included review of the facility's Administrative Manual regarding resident rights to make decisions about medical treatment and to accept or refuse proposed treatment.The DON or designee in-serviced LVNs and RNs on the facility's Bed Rails policy and procedure, including the requirement to obtain informed consent prior to bed rail installation, proper completion of the Informed Consent for Bed Rail Use form including resident or resident representative signature, documentation of the reason for bed rail use, explanation of risks, benefits, and alternatives, and licensed nurse signature verifying consent was obtained. Plan to Monitor Performance: RN Unit Manager or designee will begin conducting medication administration observations for a sample of residents with intact cognitive skills for daily decision making. The observations will verify that nursing staff inform residents of medication names and indications prior to administration. These observations will be conducted weekly for four weeks, then monthly for three months. Medical Records department will begin auditing Informed Consent for Bed Rail Use forms for residents utilizing bed rails to ensure forms are completed in their entirety including resident or resident representative signature, reason for bed rail use, and licensed nurse signature. The audits will be conducted weekly. The "Stand Up Meeting Routine Questionnaire" form was updated to include verification of consent for bed rails. Medical Records Manager or designee will report monitoring plan results to the Quality Assurance and Performance Improvement (QAPI) committee. The Quality Assurance and Performance Improvement (QAPI) committee will monitor on an ongoing basis until substantial compliance of the set-forth protocol is achieved.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
Failure to Obtain Informed Consent Before Starting Duloxetine: The facility failed to obtain and document informed consent before starting Duloxetine for a resident with anxiety, depression, and chronic pain. The DON confirmed there was no informed consent for the medication, and the facility policy required informed consent before initiating psychotropic meds, including discussion of the target symptom, intended benefit, risks/side effects, and alternatives.
Failure to Obtain Informed Consent for Psychotropic Medications: Two residents receiving psychotropic medications, including antidepressants, antipsychotics, and mood stabilizers, did not have documented informed consent in their records before the medications were administered. One resident had diagnoses including depression, bipolar disorder, and schizophrenia, and the other had traumatic brain injury, schizoaffective disorder-bipolar type, major depressive disorder, and paraplegia. The DON could not provide consent documentation for one resident, and the other resident's record lacked consent explaining the risks and benefits of the medications. The NP stated the facility is responsible for obtaining medication consents when residents are admitted on psychotropics or when doses or medications change.
A resident with diabetes, dementia, and CHF was started on Diazepam for anxiety, but the clinical record lacked evidence that the resident and/or representative were informed in advance of the medication’s risks, benefits, and alternative treatments. The DON confirmed the missing documentation, and the facility policy required RN-obtained consent and notification of the resident’s representative regarding desired effects and potential side effects.
A resident with intact cognition and diagnoses including renal dialysis dependence, type 2 DM, and insomnia was prescribed clonazepam and temazepam, but the medical record lacked evidence of informed consent for either psychotropic medication. The DON was unable to locate signed consent, and stated that residents admitted on psychotropic meds needed a consent form signed on admission day.
The facility failed to document and offer nonpharmacological treatment options when obtaining consent for psychotropic medications for several residents. A resident with PTSD, anxiety, and depression; a resident with severe cognitive impairment and dementia; and two residents with dementia-related behaviors received antipsychotic, antianxiety, and/or antidepressant medications, and consent forms were completed, but the records did not show that alternate treatment interventions were presented. The DON confirmed the facility had no evidence that these options were provided with the psychotropic medication consents.
Failure to obtain informed consent for psychotropic medications: two residents were prescribed medications for mental health-related conditions, but the EMR did not show education or consent for all ordered drugs. One resident with intact cognition had orders for Depakote and gabapentin without documented education on risks, benefits, side effects, or alternatives. Another resident with severe cognitive impairment had consent for Celexa, but not for hydroxyzine or risperidone; the DON stated residents and/or families should know the risks and side effects before deciding to take the medication.
Failure to Obtain Informed Consent Before Starting Duloxetine
Penalty
Summary
The facility failed to ensure that Resident #7 was informed in advance, by the physician or other professional, of the risks and benefits of proposed care, treatment alternatives, and the option to choose the preferred treatment before Duloxetine was started. Resident #7 was admitted with diagnoses including unspecified anxiety disorder, unspecified depression, and chronic pain. Record review showed an order for Duloxetine HCl 30 mg, and the medication record indicated that Duloxetine was initiated on 4/15/26, later discontinued and reordered, and remained active as of 7/8/26. During interview on 8/13/26, the DON stated there was no informed consent for Resident #7’s Duloxetine and said, “We are working on it now.” The facility’s Informed Consent policy stated that no treatment, procedure, or service requiring informed consent is to be initiated without informed consent from the resident or representative, and that psychotropic medications require documented informed consent before initiation. The policy also required discussion of the target symptom or condition, intended benefit, potential risks and side effects, and available alternatives before starting a psychotropic medication.
Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure informed consent was obtained before psychotropic medications were administered to Resident #4. A record review on 8/12/26 showed physician orders for Paroxetine 40 mg daily for depression, Trazodone 100 mg daily for depression, Divalproex 500 mg twice daily for bipolar disorder, and Risperidone 2 mg three times daily for schizophrenia. Resident #4 was admitted with diagnoses including major depressive disorder, depression, bipolar disorder with manic severe psychotic features, and paranoid schizophrenia. When the DON was asked to provide documentation of informed consent for these psychotropic medications, she was unable to provide evidence that the resident or resident representative had been informed of and consented to their use prior to administration. The same issue was identified for Resident #11, who was admitted with diagnoses including traumatic brain injury, schizoaffective disorder-bipolar type, major depressive disorder, and paraplegia. The resident was receiving Haldol 10 mg three times daily, Olanzapine 10 mg at bedtime, and Divalproex sodium 500 mg every 12 hours for schizoaffective disorder and bipolar disorder, but the record did not contain consent for psychotropic medication use explaining the risks and benefits prior to administration. During interview, the DON stated the NP obtains medication and treatment consents when she visits residents, while the NP stated it is the facility's responsibility to obtain medication consents when a resident is admitted on psychotropic medications and when there is a dosage increase, decrease, or medication change. The facility policy stated residents receiving psychotropic medication are to have the risks and benefits reviewed and consent completed prior to initiation of the medication.
Failure to Inform Resident/Representative Before Diazepam Use
Penalty
Summary
The facility failed to inform Resident R11 and/or the resident’s representative in advance of the risks, benefits, and treatment alternatives before starting Diazepam, a psychotropic medication. The facility policy on Psychotropic Medications stated that the resident’s representative would be informed of the need for the desired effects and potential side effects of the medication, and that the RN would obtain consent verbally or in person and complete a Psychotropic Medication Consent form. Resident R11 was admitted with diagnoses including diabetes, dementia, and CHF. The clinical record showed physician orders for Diazepam 5 mg by mouth twice daily for 90 days, followed by a later order for Diazepam 5 mg by mouth daily and 10 mg at bedtime. The record lacked evidence that the resident and/or representative were informed in advance of the risks, benefits, and alternative treatments prior to administration of Diazepam. During interview, the DON confirmed that the record lacked evidence of this notification.
Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to obtain informed consent, including risk and benefit information, for one resident who was reviewed for psychotropic medications. The resident had intact cognition on the comprehensive MDS, was admitted with diagnoses including dependence on renal dialysis, type 2 diabetes, and insomnia, and was prescribed clonazepam 1 mg by mouth daily on Monday, Wednesday, and Friday for dialysis days, as well as temazepam 30 mg by mouth at bedtime. The medical record did not contain evidence of informed consents for either medication, and the DON attempted to locate signed consent without success. During interview, the DON stated that any resident admitted with a psychotropic medication in use needed a consent form signed for that medication on admission day. The facility policy stated that a consent form must be signed for use of an antipsychotic medication and that the Permission for use of Psychotropic Medications form would be used to obtain consent.
Failure to Inform Residents of Nonpharmacological Options for Psychotropic Medications
Penalty
Summary
The facility failed to fully inform residents and/or their resident representatives by not documenting and offering nonpharmacological treatment options when obtaining consent for psychotropic medications. The deficiency involved 4 of 5 sampled residents, including residents with diagnoses such as dementia, anxiety, depression, PTSD, stroke, and severe cognitive impairment. Facility policies stated that residents and/or representatives would be educated on medications and that consent forms would be completed with new psychotropic orders and dose increases, but the records reviewed did not show alternative nonpharmacological interventions were presented with the consents. Resident 4 was cognitively intact, independent with several activities of daily living, and had diagnoses including diabetes, stroke, anxiety, depression, and PTSD. The resident received aripiprazole, buspirone, fluoxetine, and trazodone, and consent forms were completed for each medication. Resident 25 had severe cognitive impairment, required staff assistance with dressing, toileting, transfers, and hygiene, and had diagnoses of dementia, anxiety, and depression. The resident received bupropion and venlafaxine, and consent forms were completed for both medications. For both residents, the record contained no evidence that nonpharmacological treatment options were documented and offered. Resident 21 had severe cognitive impairment, delusions, and other behaviors 1-3 days weekly, with diagnoses of dementia, anxiety, and depression, and received mirtazapine, citalopram, quetiapine, and lorazepam. Resident 1 had severe cognitive impairment, rejected care, wandered 1-3 days in the prior 7 days, required assistance with hygiene, dressing, and bathing, and received lorazepam and quetiapine for anxiety and behavior disturbance associated with dementia. For both residents, consent forms were present for the psychotropic medications, but there was no evidence that alternative nonpharmacological treatment intervention options were documented and offered. The DON confirmed during interview that the facility did not have evidence that such alternatives were provided when obtaining consent.
Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure residents were informed of and consented to medications prescribed and given for mental health intervention for 2 of 5 residents reviewed for unnecessary medications. One resident had a significant change assessment showing intact cognition and diagnoses of Parkinson’s disease, anxiety, insomnia, and bipolar disorder. That resident’s care plan addressed behavior related to bipolar disorder and anxiety, and provider orders included Depakote 250 mg by mouth twice daily for bipolar disorder and gabapentin 300 mg by mouth three times daily for anxiety. The resident’s EMR did not contain evidence that the resident had been educated on the risks, benefits, side effects, and alternatives for either medication. A second resident had diagnoses including Parkinson’s disease, polyneuropathy, depression, and anxiety, and the MDS identified severe cognitive impairment, dependence on staff for activities of daily living, and receipt of antianxiety medications, opioids, and anticonvulsants. The resident’s order summary included Celexa 20 mg daily for major depressive disorder, hydroxyzine 10 mg twice daily for hallucinations/delusions related to Parkinson’s disease, and risperidone 0.25 mg at bedtime for hallucinations related to major depressive disorder. The EMR showed consent for Celexa, but not for hydroxyzine or risperidone. The DON stated that residents and/or their families should know the side effects and risks of the medication to decide if the risk was worth taking the medication.
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