Failure to Obtain and Document Informed Consent for Psychotropic Medications
Summary
The deficiency involves the facility’s failure to obtain and document informed consent for psychotropic medications prior to administration, thereby failing to ensure residents or their representatives were informed in advance of the risks, benefits, alternatives, and options for treatment. For Resident #1, who had severe dementia with psychotic disturbance, anxiety disorder, and depressive disorder, the record showed extensive use of multiple psychotropic medications, including divalproex, lorazepam, olanzapine, quetiapine, sertraline, and trazodone over a defined period. The resident had an Office of Public Advocacy (OPA) guardian as medical decision-maker, yet there was no documented informed consent for any of these medications. Emails to the guardian referenced that Depakote and other psychotropics had been ordered or adjusted, but did not include information on risks, benefits, alternatives, or options, nor did they document that the guardian was given an opportunity to choose a preferred option. The guardian later stated the facility had never reviewed risks, benefits, alternatives, or options for any medications and that such information would have guided decision-making. For Resident #3, who had vascular dementia and cerebrovascular disease and also had an OPA guardian, the medical record showed long-term administration of valproic acid and a period of mirtazapine use, totaling hundreds of psychotropic medication administrations. The record contained no documented informed consent for these medications. A progress note indicated that a licensed nurse was unable to reach the resident’s representative and mailed a copy of notes, including the addition of mirtazapine, but there was no further documentation of efforts to contact the representative to discuss medications or obtain informed consent. The facility was unable to provide any proof of informed consent for Resident #3’s psychotropic medications, and the guardian similarly stated that information on risks and benefits would have guided decision-making. For Resident #4, who had Parkinson’s disease with dyskinesia, dementia due to Parkinson’s disease with behavioral disturbance, hallucinations, and Lewy body dementia with psychotic disturbance, the record showed an order and ongoing administration of pimavanserin, an antipsychotic, over approximately 90 days. The resident had a representative who made medical decisions, but there was no documented informed consent for this psychotropic medication, and the facility could not provide any proof when requested. For Resident #5, diagnosed with dementia with behavioral disturbance and Parkinson’s disease, quetiapine was ordered and first administered before the facility obtained a signed Psychotropic Risk/Benefits Verification of Informed Consent form; the consent was dated one day after the first dose was given. This demonstrated that consent was not obtained prior to initial administration. Interviews with nursing staff and leadership revealed confusion and inconsistency regarding responsibility for obtaining informed consent, when it should be obtained, and where it was documented. One licensed nurse believed physicians were ultimately responsible for obtaining consent and was unsure where signed consents were stored. Another nurse did not know who was responsible, when to obtain consent, or how to verify its presence before administering a new medication, and believed only antipsychotics required consent. A third nurse assumed that if a physician wrote an order, informed consent had already been obtained, and identified psychotropics and antipsychotics as requiring consent that included discussion of risks and benefits. The DON and LTC nurse manager stated that bedside nurses were trained to obtain informed consent before the first dose of medications needing consent and that the facility did not obtain new informed consent for psychotropics if a resident was already taking the same medication on admission, assuming the resident already knew the risks and benefits. The LTC nurse manager also stated that consents were sometimes obtained via email to representatives or guardians, but copies of those emails were not placed in the medical record, and audits of consents had not been done regularly. These practices conflicted with the facility’s resident rights document and its psychopharmacological drug use policy, both of which required that residents or their representatives be advised of potential risks and benefits of psychotropic medications and that this be documented.
Penalty
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Two residents with cognitive and behavioral disturbances received IM Haldol for acute episodes of agitation, paranoia, and physical aggression after refusing PO medications and nonpharmacological interventions were ineffective. In both cases, providers ordered one-time IM Haldol doses on multiple occasions, and family members were notified of the orders and involved in communication about the residents’ behaviors and treatment. One resident’s family later filed a grievance regarding IM Haldol use, and informed consent was documented only for Trazodone. Facility leadership confirmed there was no documentation that the risks or side effects of Haldol were discussed with either resident or their responsible parties prior to administration.
A resident with multiple medical conditions, including metabolic encephalopathy and Generalized Anxiety Disorder, was started on BuSpar 10 mg BID following a psychiatric evaluation, but the responsible party was not properly informed of this new psychotropic medication order. Nursing notes lacked documentation of the psychiatrist’s assessment or any notification to the responsible party, even though the MAR showed the resident received two doses. The responsible party later reported learning of the medication only during an in-person visit and expressed concern due to the resident’s prior adverse reactions to psychotropic drugs. Conflicting accounts from two ADONs about when and how the responsible party was notified, combined with the absence of required documentation, demonstrated noncompliance with the facility’s policy on notifying and documenting changes in a resident’s condition or treatment.
A resident with multiple medical and psychiatric diagnoses, who was cognitively intact, repeatedly requested to be transferred to the hospital during episodes of acute symptoms such as chest pain, low blood sugar, and gastrointestinal distress. Despite these requests, nursing staff deferred to the PCP, who typically ordered in-house treatment and monitoring rather than approving a hospital transfer. Staff interviews confirmed that the resident's right to self-determination and participation in care decisions was not honored, in violation of facility policy and resident rights regulations.
A resident with severe cognitive impairment sustained a skin tear during a mechanical lift transfer, but the responsible party was not notified of the incident or new wound care orders. Staff interviews revealed confusion about notification responsibilities, and the facility's policy requiring timely notification of the resident's representative was not followed.
A resident's court-appointed guardian was not notified about the initiation or charges for therapy services, nor was informed consent obtained for dental services after the resident switched to private pay. The resident, who had significant cognitive and medical issues, received multiple therapy and dental services without proper guardian notification or updated consent documentation.
A resident with a history of respiratory issues expressed concerns about having pneumonia and requested a chest x-ray, but the facility did not facilitate this due to the resident's body habitus and did not send him to the hospital. The resident was not examined by the physician during his stay, leading to dissatisfaction with the facility's handling of his health concerns. This situation highlights a failure to support the resident's right to self-determination in medical care.
Lack of Informed Consent for IM Haldol Use in Two Residents
Penalty
Summary
The deficiency involves the facility’s failure to ensure residents and/or their responsible parties were informed of the risks of antipsychotic (Haldol) use prior to administration. For one resident with muscle wasting, difficulty walking, chronic venous hypertension with ulcers, CHF, and moderate cognitive impairment, behavior notes documented episodes of severe agitation, paranoia, physical and verbal aggression, refusal of oral medications, and rejection of care. In response, an NP ordered a one-time IM dose of Haldol, and later that same day a physician ordered a second one-time IM dose after the resident again became severely agitated and refused oral medications, including PRN Ativan. The resident’s son was notified of the orders and was present during some of the episodes, but there was no documentation that the risks of Haldol use were discussed with either the resident or her son. Subsequent documentation for this same resident showed continued severe paranoia, delusions, refusal of medications and care, and combative behavior, leading to additional IM Haldol administrations. Notes indicated that attempts had been made to initiate oral antipsychotic medication but were unsuccessful due to refusals, and that non-pharmacological interventions were not effective. The facility informed the family that there were no other interventions staff could initiate in the nursing setting and that the resident would benefit from transfer to a geriatric psych facility. Despite multiple Haldol injections and ongoing communication with the family about the resident’s condition and care needs, the corporate nurse later verified there was no documentation that the risks of Haldol had been discussed with the resident or her son. For a second resident with diagnoses including a left humerus fracture, metabolic encephalopathy, abnormal gait and mobility, history of falls, heart disease, and parkinsonism, the care plan identified risk for complications related to psychoactive medication use. The resident had intact cognition and required assistance with ADLs. Behavior notes documented episodes of paranoia, belligerence, attempts to crawl out of bed, physical aggression toward staff, refusal of PO medications, and belief of being held without permission, leading an NP to order IM Haldol on two separate occasions for safety after nonpharmacological measures were ineffective. A grievance was later filed by the family regarding the use of IM Haldol for an acute change in behavior, and an informed consent form for Trazodone was signed by the resident’s wife with potential side effects reviewed. However, there was no documentation that Haldol side effects or risks were discussed with the wife prior to either IM Haldol administration, and the corporate nurse confirmed the absence of such documentation.
Failure to Notify Responsible Party of New Psychotropic Medication Order
Penalty
Summary
The deficiency involves the facility’s failure to ensure a resident’s responsible party was fully informed of and understood a change in the resident’s medication regimen. A resident admitted with metabolic encephalopathy, peripheral vascular disease, urinary tract infection, kidney calculus, and osteonecrosis of the left femur underwent an admission psychiatric evaluation by a consulting psychiatrist, who diagnosed Generalized Anxiety Disorder and ordered BuSpar 10 mg orally twice daily. The nursing progress notes for the period surrounding this evaluation contained no documentation of the psychiatrist’s assessment or of any notification to the resident’s responsible party about the new BuSpar order. The MAR showed the BuSpar order was entered and that the resident received two doses. The facility’s policy required immediate notification of the resident and authorized representative, with documentation in the medical record, when there was a change in the resident’s mental, physical, or psychosocial status. The resident’s responsible party reported that the facility started the resident on BuSpar and Trazodone for reasons unknown to her, and that she did not learn about the BuSpar until a nurse mentioned it during a visit. She stated the resident had previously experienced adverse reactions to psychotropic medications and that she did not want him on medications that cross the blood-brain barrier. One ADON stated she believed another ADON had notified the responsible party by phone and that she later met in person with the responsible party to discuss the BuSpar order, acknowledging the resident received two doses before discontinuation. The other ADON, however, stated she did not notify the family by phone, that all communication with the responsible party was in person, and that she discussed the BuSpar order with the responsible party at the next in-person visit and believed the resident did not receive any doses. There was no documentation in the medical record of timely notification to the responsible party about the initiation of BuSpar, contrary to facility policy.
Failure to Honor Resident's Right to Hospital Transfer
Penalty
Summary
The facility failed to honor a resident's right to self-determination regarding treatment options, specifically the right to request transfer to a hospital. The resident, who had a history of type II diabetes, hypertension, heart disease, schizophrenia, and other mental health conditions, was cognitively intact as evidenced by a BIMS score of 15. Multiple progress notes documented that the resident experienced various acute symptoms, including pallor, clamminess, twitching, incontinence, difficulty breathing, sweating, shaking, diarrhea, nausea, and chest pain radiating to the left arm. On several occasions, the resident explicitly requested to be transferred to the hospital due to these symptoms. Despite these requests, the nursing staff contacted the primary care provider (PCP), who typically ordered laboratory tests and monitoring rather than approving a hospital transfer. In some instances, the PCP did not return calls, and when contacted, often instructed staff to treat the resident in the facility, stating that hospital care would not differ from what could be provided on-site. The resident's care plan did not document repeated requests for hospital transfer, and staff interviews confirmed that the resident's wishes were not honored, with the PCP's refusal cited as the reason. The Social Services Director and the Interim Director of Nursing both acknowledged that the resident had the right to seek care elsewhere, and the Administrator stated that the resident should have been allowed to go to the hospital if requested. The facility's policy on resident rights, which includes self-determination and participation in care decisions, was not followed in these instances. Interviews with staff and the resident confirmed that the resident's repeated requests to be transferred to the hospital were not granted, and the staff deferred to the PCP's decision rather than honoring the resident's right to choose their treatment options. This resulted in a failure to comply with federal and state regulations regarding resident rights.
Failure to Notify Resident Representative of Incident and Change in Condition
Penalty
Summary
The facility failed to notify a resident's representative of an incident involving the resident, specifically a skin tear sustained during a mechanical lift transfer. The resident, who had diagnoses including hemiplegia, hemiparesis following cerebral infarction, and cognitive communication deficit, was assessed as severely cognitively impaired. Documentation showed that the resident's son was listed as the responsible party and emergency contact. Despite this, there was no record that the son was informed of the skin tear or the subsequent new wound care orders. The son only learned of the injury days later during a visit, after inquiring about his father's comments regarding his foot. Staff interviews revealed confusion and inconsistency regarding notification responsibilities. The ADON stated she did not notify the family because she believed the resident was sometimes alert and oriented, and typically notified the resident directly. The DON admitted to not checking the responsible party information and assumed the resident was his own responsible party. Other staff confirmed the resident's cognitive status fluctuated, with orientation primarily to self and inconsistent recognition of others. Facility policy required notification of the resident's representative within 24 hours of any incident or change in condition, unless otherwise instructed by the resident, but this was not followed in this case.
Failure to Notify Guardian and Obtain Informed Consent for Therapy and Dental Services
Penalty
Summary
The facility failed to notify a resident's court-appointed guardian about the initiation and potential charges for therapy services, as well as failed to obtain informed consent prior to starting dental services. Record review showed that the resident, who had multiple diagnoses including Parkinson's disease, dementia, and malnutrition, was rarely or never understood and had a guardian appointed. Despite multiple therapy orders and treatments, there was no documentation that the guardian was informed of the therapy evaluations, treatments, or the associated charges. Billing statements confirmed that charges were incurred for occupational, speech, and physical therapy, but the guardian was not notified. Additionally, after the resident switched from Medicaid to private pay, there was no evidence that updated consent was obtained for dental services or that the guardian was notified of a dental visit. The previous ancillary consent form had been signed by the resident's wife for other services while the resident was on Medicaid, but no updated consent was documented after the change in payor status. The administrator confirmed that no updated informed consent was obtained and that billing for ancillary services was handled by the service providers, not the facility.
Failure to Support Resident's Self-Determination in Medical Care
Penalty
Summary
The facility failed to ensure that a resident, who was cognitively intact, was fully informed and able to direct his own medical care. The resident, who had a history of pneumonia, acute respiratory failure, and other serious health conditions, expressed concerns about his respiratory status and requested a chest x-ray to confirm his condition. Despite his requests and the presence of symptoms such as a cough and fluctuating oxygen saturation levels, the facility did not facilitate a chest x-ray due to the resident's body habitus and did not send him to the hospital for further evaluation. The resident's progress notes indicated that he repeatedly expressed concerns about having pneumonia and requested medical interventions similar to those he received in a hospital setting. However, the facility's physician did not examine or communicate with the resident from the time of his admission until he was eventually sent to the hospital. The Director of Nursing confirmed that the physician did not order a chest x-ray and instructed the nurses not to send the resident to the hospital, despite the resident's persistent requests and concerns. Interviews with the resident and a family member revealed dissatisfaction with the facility's handling of the situation, particularly regarding the lack of a chest x-ray and the perceived lack of responsiveness to the resident's health concerns. The facility's policy on resident rights emphasizes the importance of supporting resident self-determination and choice in their healthcare, which was not upheld in this case. This deficiency was investigated under a specific complaint number, indicating non-compliance with resident rights.
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