Deficiency in Informed Consent for Psychotropic Medications
Summary
The report identifies a deficiency in the facility's process of obtaining informed consent for the use of psychotropic medications for several residents. Resident 48 was admitted with diagnoses including major depressive disorder and congestive heart failure. Despite having the capacity to understand and make decisions, the informed consent forms for trazodone hydrochloride and temazepam were incomplete, lacking signatures from both the resident or their representative and the prescribing physician. This oversight was acknowledged by the RN and DON, who confirmed that the consent process was not followed, potentially leaving the resident unaware of the risks and benefits of the medications. Similarly, Resident 8, who was diagnosed with unspecified mood disorder and dementia, did not have completed informed consent forms for divalproex sodium and sertraline. The resident's capacity to understand and make decisions was impaired, necessitating consent from a representative. However, the forms were blank, and the medications were administered without documented consent. The MDS Nurse and DON both recognized the failure to obtain informed consent, which could result in the administration of psychotropic medications without the family's knowledge or agreement. The report also highlights deficiencies in the informed consent process for Residents 96 and 89. Resident 96, with diagnoses of anxiety disorder and major depressive disorder, had incomplete informed consent forms for sertraline and alprazolam, lacking documentation of who consented to the medication use. Resident 89, diagnosed with major depressive disorder and dementia, did not have a new informed consent obtained when the dosage of quetiapine was increased. The DON confirmed that the facility's policy was not followed, denying residents their rights to informed care and potentially leading to the use of unnecessary psychotropic drugs.
Penalty
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The facility did not obtain informed consent before starting antidepressant therapy for two residents. One resident with heart failure and anxiety received Citalopram without any signed informed consent on file. Another resident with a lumbar fracture, depression, and repeated falls received Sertraline before an informed consent form was signed, with the consent only completed several days after the medication was ordered. The RNC confirmed that, per facility policy, informed consent for antidepressant use should have been obtained prior to administration in both cases.
The facility failed to obtain and document informed consent for psychotropic medications for three residents. One resident with dementia and behavioral symptoms received quetiapine and divalproex, including a dose increase, without documented evidence that the responsible party was informed of risks and benefits or consented. Another resident with anxiety and depression, severe cognitive impairment, and disruptive behaviors was started on duloxetine and given multiple doses of PRN lorazepam, again without documentation that the responsible party was informed or consent obtained. A third cognitively intact resident with depression and anxiety received escitalopram 20 mg daily with no record that she was informed of the medication’s risks and benefits or that she consented. The Nurse Team Lead, identified as responsible for obtaining psychotropic consents, and the DON both confirmed that the expected notifications and consent documentation were not present in the medical records.
A resident with palliative care needs, CHF, and acute kidney disease had new PRN lorazepam oral concentrate orders for anxiety and terminal agitation entered without documented informed consent. Record review showed no evidence that the resident or representative was informed of the risks and benefits of lorazepam or that consent was obtained before the medication was added as an active order. A CRN confirmed that no signed consent documenting understanding of the lorazepam treatment risks and benefits was present, resulting in a deficiency related to informing residents about their care and treatments.
The facility failed to obtain and document informed consent, including discussion of risks and benefits, before initiating or increasing psychotropic medications for three residents receiving antianxiety and antidepressant drugs. Cognitively intact residents reported that no provider or staff discussed side effects or risks and benefits when their alprazolam, sertraline, Xanax, or Zoloft were started or increased, and a responsible party for a severely cognitively impaired resident did not recall any discussion when buspirone was initiated. Records lacked documentation of informed consent, while interviews with the NP, Medical Director, Rounding Nurse, DON, Informatics Nurse, and Consulting Pharmacist revealed that nursing staff were expected to handle psychotropic consents, but consents were only being obtained for new antipsychotic orders and not for residents admitted on psychotropics or for antidepressant and antianxiety medications, despite policy defining these as psychotropics.
A resident with COPD, depression, and cardiomegaly was started on Aripiprazole 5 mg daily without informed consent being obtained prior to initiation. Review of records showed that the psychoactive medication informed consent form, which included Aripiprazole along with Bupropion and Fluoxetine, was signed only after the medication had already been started. The CEO confirmed that a psychotropic medication acknowledgement consent should have been signed before Aripiprazole was administered but was not.
A resident with Lewy Body Dementia and severe cognitive impairment was started on risperidone 0.5 mg twice daily for a mood disorder without documented informed consent from the responsible party regarding the risks and benefits of the psychotropic medication. Record review showed no consent documentation in the electronic medical record, and interviews with the social services staff and the NP revealed that the prior process for obtaining psychotropic consents had lapsed after a former social worker left. The DON confirmed that the system for notifying the NP to obtain informed consent for new psychotropic medications had failed, resulting in the medication being initiated without proper informed consent.
Failure to Obtain Informed Consent Before Initiating Antidepressant Medications
Penalty
Summary
The facility failed to obtain informed consent prior to initiating psychotropic (antidepressant) medications for two residents reviewed for unnecessary medications. The facility’s Medication Therapy policy required that each resident’s medication regimen include only necessary medications and that medication use be consistent with the individual’s condition, prognosis, values, wishes, and responses to treatment. Resident #1, admitted and later readmitted with multiple diagnoses including heart failure and anxiety, had a physician order dated 3/1/26 for Citalopram Hydrobromide 20 mg by mouth once daily, but the Resident Nurse Coordinator (RNC) confirmed on 4/13/26 that there was no signed Informed Consent for Use of Antidepressant Medications for this order. Resident #35, admitted and later readmitted with multiple diagnoses including a stable lumbar vertebra fracture, depression, and repeated falls, had a physician order dated 4/1/26 for Sertraline HCl 200 mg by mouth at bedtime; the medical record contained an informed consent for use of antidepressant medication signed and dated 4/10/26, and on 4/13/26 the RNC stated that this informed consent should have been signed before the resident received the medication but was not.
Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent for psychotropic medications prior to initiation or dose changes for multiple residents. For one resident with unspecified dementia, anxiety disorder, depression, and delusional disorder, the physician ordered quetiapine for anxiety and agitation and later ordered divalproex for dementia with aggression and agitation, with a subsequent dose increase. The resident’s MDS showed moderate cognitive impairment, use of antipsychotic, antidepressant, and anticonvulsant medications, and behavioral symptoms including rejection of care. Record review showed these medications were administered as ordered, but there was no documentation that the responsible party was informed in advance of the risks and benefits of starting or increasing these psychotropic medications or that consent was obtained. Another resident with anxiety disorder and depression was started on duloxetine for depression and later had PRN lorazepam ordered for daytime and bedtime anxiety with agitation. The MDS indicated severe cognitive impairment, behavioral symptoms that interfered with social interactions and disrupted care, and use of anti-anxiety and antidepressant medications. The MAR confirmed that duloxetine was given as ordered and lorazepam was administered on multiple days. However, the electronic medical record contained no documentation that the responsible party was informed in advance of the risks and benefits of initiating duloxetine or lorazepam or that consent was obtained. The Nurse Team Lead, who was responsible for obtaining psychotropic consents, could not locate any consent forms for this resident and could not recall whether the responsible party had been called. A third resident with major depressive disorder and generalized anxiety disorder, and intact cognition per the MDS, had an active order for escitalopram 20 mg daily for depression and anxiety. The MDS showed no behavioral symptoms and receipt of antidepressant medication. Review of the medical record revealed no documentation that this resident was informed in advance of the risks and benefits of initiating escitalopram and consented to the treatment. In interviews, the Nurse Team Lead consistently stated she was responsible for obtaining psychotropic consents when new orders were received from providers, but she was unable to find consent forms for the involved residents or explain what had occurred. The DON described a process in which providers communicated new or changed psychotropic orders to the Nurse Team Lead, who was expected to notify residents or responsible parties and document the notification, but acknowledged that for these residents the required documentation and consent forms were missing.
Failure to Obtain and Document Informed Consent for Lorazepam Use
Penalty
Summary
Surveyors found that the facility failed to ensure a resident was informed in advance of care and treatment, including the risks and benefits, before initiating a new medication. One resident with multiple diagnoses, including palliative care encounter, congestive heart failure, and acute kidney disease, had physician orders for lorazepam oral concentrate 2 mg/mL, to be given 0.5 mL by mouth every 8 hours as needed for anxiety and every 8 hours as needed for terminal agitation for 180 days. Record review showed no documentation that the resident or the resident’s representative had been informed of the risks and benefits of lorazepam or had provided consent prior to lorazepam being added as an active order. In an interview, the clinical resource nurse confirmed that neither the resident nor the representative had signed a consent documenting understanding of the risks and benefits of the lorazepam treatment. This failure to obtain and document informed consent for lorazepam use for this resident, whose record was reviewed for informed consent, was identified as a deficiency related to ensuring residents are fully informed and understand their health status, care, and treatments.
Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent, including discussion of risks and benefits, before initiating or increasing psychotropic medications for multiple residents. For one cognitively intact resident with panic disorder, depression, and anxiety, the NP increased alprazolam from twice daily to three times daily and later increased sertraline in two separate dose changes. Physician orders and MARs showed these medications were administered as ordered over several months, but the medical record contained no documentation that the resident was informed in advance of the risks and benefits of these dose increases. In an interview, this resident reported that no provider at the facility had discussed side effects or the risks and benefits of taking or increasing alprazolam or sertraline. Another resident, who was severely cognitively impaired and admitted with anxiety disorder and major depressive disorder, was started on buspirone per physician order, and the MAR confirmed ongoing administration. The record contained no evidence that the responsible party was informed in advance of the risks and benefits of initiating buspirone. In a telephone interview, the responsible party did not recall any discussion with the provider or facility staff about the risks and benefits of this antianxiety medication at the time of admission. A third cognitively intact resident with anxiety disorder and major depressive disorder had orders for Xanax three times daily and Zoloft at bedtime, with MARs confirming administration, but the medical record lacked documentation that the resident was informed in advance of the risks and benefits of initiating either medication. This resident also did not recall any discussion with providers or staff about side effects or risks and benefits. Interviews with facility staff and leadership showed systemic gaps in the process for obtaining psychotropic medication consents. The NP stated that psychotropic consents were handled by nursing, and the Consulting Pharmacist confirmed that antidepressants and antianxiety medications are psychotropics requiring consent when initiated or increased but did not review consents during monthly medication reviews. The Medical Director reported not recalling discussions of risks and benefits for residents admitted on psychotropics and believed floor nurses and the Rounding Nurse notified residents and representatives of medication changes, expecting consents to be completed when psychotropics were initiated or increased. The Rounding Nurse stated she was responsible for obtaining psychotropic consents but only did so for residents started on antipsychotics after admission, not for residents admitted on psychotropics or for antidepressant and antianxiety medications, as she did not know these were considered psychotropics. The DON confirmed the Rounding Nurse’s role, acknowledged that all entered orders are new orders (including pre-admission medications), and stated she did not know antianxiety and antidepressant medications required consent when initiated or increased. The Informatics Nurse indicated the psychotropic policy definition, which includes antidepressants and antianxiety medications, had not changed and that nurses should know which medications are psychotropics, while the Administrator stated an expectation that psychotropic consents be obtained.
Failure to Obtain Informed Consent Before Initiating Psychotropic Medication
Penalty
Summary
The facility failed to obtain informed consent prior to initiating a psychotropic medication for one resident reviewed for unnecessary medications. The resident, who had diagnoses including COPD, depression, and cardiomegaly, was ordered Aripiprazole 5 mg by mouth once daily on 11/27/25. Record review showed that the resident’s Psychoactive Medication Informed Consent form, which listed Aripiprazole 5 mg along with Bupropion 150 mg and Fluoxetine 40 mg, was not signed until 1/16/26, after the medication had already been started. In an interview, the CEO acknowledged that the resident should have signed a Psychotropic Medication Acknowledgement Consent prior to administration of Aripiprazole but had not done so.
Failure to Obtain Informed Consent for Initiation of Psychotropic Medication
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent for the initiation of a psychotropic medication. A resident with Lewy Body Dementia and severe cognitive impairment, as documented on the admission MDS, had no behavioral symptoms and was receiving antidepressant medications during the assessment look-back period. The December 2025 MAR showed a physician order dated 12/04/25 for risperidone 0.5 mg twice daily for a mood disorder. Review of the resident’s electronic medical record revealed no documentation that the resident’s Responsible Party was informed in advance of the risks and benefits of starting risperidone or that consent to this treatment was obtained. Staff interviews further clarified the breakdown in the facility’s process for obtaining informed consent for psychotropic medications. The Social Worker and Social Worker Assistant, both of whom started in August 2025, reported they were not responsible for obtaining informed consents and stated that the NP was responsible for this task. The NP reported that he had previously been given forms to sign monthly by the former Social Worker, but that this practice stopped when the former Social Worker left, and he acknowledged he was not obtaining informed consents before initiating psychotropic medications, instead only reviewing medications generally during rounds and documenting in progress notes. The DON explained that the prior system relied on the Social Worker to notify the NP when informed consent was needed for new psychotropic medications and stated that this system failed when the last Social Worker left, resulting in the lack of informed consent for the psychotropic medication initiated for this resident.
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