Incomplete informed consent for psychotropic medications
Summary
The facility failed to obtain informed consent for psychotropic medication use for two residents and failed to complete required consent documentation accurately. For one resident with diagnoses including dementia, major depressive disorder, and chronic kidney disease, the record showed an order for Mirtazapine 15 mg beginning on 6/27/2025 for depression manifested by poor PO intake, followed by discontinuation of that dose and a new order for Mirtazapine 30 mg beginning on 10/2/2025 for depression manifested by inability to sleep at night. Review of the resident’s MARs showed Mirtazapine 15 mg was administered from 6/27/2025 through 10/1/2025 and Mirtazapine 30 mg was administered from 10/2/2025 through 3/12/2026. The resident’s informed consent verification form dated 12/16/2026 listed Mirtazapine 30 mg PO, but did not include the frequency for administration. During interview and record review, RN 1 stated no informed consent was found for the initial administration of Mirtazapine 15 mg, and that consent was not obtained in a timely manner when the dose increased to 30 mg on 10/2/2025. RN 1 also stated the consent should have included the medication name, dosage, frequency, diagnosis, and associated behaviors or manifestations. The DON stated antidepressants are psychotropic medications and require informed consent before administration, and that consent forms should be completed accurately and thoroughly with at least the medication name, dosage, frequency, and indication. For the second resident, the record showed diagnoses including urinary tract infection and dementia with other behavioral disturbance, and the H&P stated the resident did not have the capacity to understand or make decisions. The resident had an order for divalproex sodium 250 mg twice daily for poor impulse control manifested by verbal aggression such as cursing. The psychotherapeutic drug informed consent form dated 3/10/2026 did not include the reason for use and benefits, probable side effects and significant risks, or reasonable alternative modes of treatment including possible nonpharmacological approaches; these sections were left blank. The DON stated the form was not filled out completely and that it was important for the form to be completed so the resident was informed of the specific medication and side effects involved in care.
Plan Of Correction
F552 CFR(s): 483.10(c)(1)(4)(5) Right to be Informed/Make Treatment Decisions Root Cause: The root cause of the deficient practice was failure of licensed nursing staff to consistently follow the established process for obtaining and documenting informed consent prior to medication administration, coupled with lack of consistent oversight to ensure compliance. How corrective action(s) will be accomplished for those residents found to have been affected by the deficient practice: On 3/12/2026, for residents #35 and #46, the facility contacted the Physician and Responsible Party and obtained complete informed consent for medication administration, including medication name, dose, frequency, risks, benefits, and alternatives particularly for psychotropic medication. Documentation was updated in both the electronic and physical medical records prior to continuation of medication administration. How the facility will identify other residents having the potential to be affected by the same deficient practice and what corrective action will be taken: On 3/15/2026, the Medical Records Director (MRD) conducted a 100% audit of all resident charts (electronic and physical) to verify that informed consent was obtained prior to medication administration. The audit confirmed that no other residents were affected. If any resident had been identified without proper informed consent, the facility would have immediately contacted the Physician and Responsible Party to obtain complete informed consent prior to further medication administration. What measures will be put into place or what systemic changes the facility will make to ensure that the deficient practice does not recur: On 3/30/2026, the Director of Nursing (DON) conducted mandatory in-service training for all licensed nurses on informed consent requirements. Education included that informed consent must be obtained prior to medication administration and must include, at minimum: medication name, dose, frequency, risks, benefits, and alternatives, with additional emphasis on psychotropic medications.Effective immediately:Licensed nurses are responsible for obtaining and documenting informed consent prior to initiation of any medication and upon any change in physician orders.The MRD will review informed consent documentation during quarterly care plan conferences and during routine chart reviews.Admission and new order workflows have been reinforced to include verification of informed consent prior to implementation.Completion Date: 4/1/2026 How the facility plans to monitor its performance to ensure that solutions are sustained:The facility will maintain a 100% compliance threshold for informed consent completion prior to medication administration.Monitoring Plan:The MRD or designee will conduct weekly audits of 5 randomly selected residents for 4 weeks, followed by monthly audits for 2 months.Audits will verify that informed consent is complete, accurate, and includes all required elements. Any identified noncompliance will result in immediate correction, notification to the DON, and re-education of the responsible licensed nurse prior to the next shift worked. Repeated noncompliance will be addressed through progressive discipline per facility policy. Reporting & Oversight: The MRD will report audit findings to the DON weekly during the monitoring period. The DON is responsible for oversight and ensuring corrective actions are implemented. Results will be presented at the Monthly QA Committee Meeting, and ongoing monitoring will continue until sustained 100% compliance is achieved. Responsible Parties: Licensed Nurses: Obtain and document informed consent prior to medication administration and with any change in orders Medical Records Director (MRD): Conduct audits and report findings Director of Nursing (DON): Provide education, ensure compliance, and oversee monitoring process
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
Failure to obtain informed consent for ordered psychotropic and PRN meds. A resident with COPD, anxiety, and PTSD had orders for Seroquel ER, Seroquel, and lorazepam, but the record had no documentation that the resident or representative was informed of the risks and benefits or signed consent for either medication. The CRN and CNO confirmed the missing consents.
Failure to document informed consent for psychotropic meds: a resident with mildly impaired cognition, dementia, TBI, anxiety, and depression was receiving escitalopram and quetiapine, but the ADON could not find documentation that consent was obtained or that the risks, benefits, and alternative tx options were explained to the resident or resident representative. The facility policy required physician documentation of consent before starting a new psychotropic medication.
A resident with bipolar disorder and autistic disorder was prescribed risperiDONE 2 mg BID and received it for several days, but the record did not contain a signed consent for the antipsychotic. Staff interviews confirmed that antipsychotic medications required RP signature consent, and the DON stated there was verbal consent, though no documentation of it was found in the EMR.
A facility failed to obtain and document complete informed consent before giving psychotropic medications to four residents. Records showed incomplete consent forms for antipsychotic, antidepressant, anxiolytic, and dementia-related medications, with missing physician signatures, representative signatures or dates, and in some cases missing ordered dose details or no consent form in the chart for the medication actually given. The DON stated the forms were not filled out entirely even though the facility policy required the prescriber to explain the medication’s risks, benefits, frequency, duration, and alternatives before consent was documented.
A resident with capacity, osteoarthritis, muscle wasting, and a history of refusing care was transferred from bed to the shower room with a Hoyer lift even though he repeatedly said no, yelled for staff to stop, and complained of back pain and discomfort. CNAs and an LVN acknowledged the resident refused the shower and transfer, but staff continued anyway. The record did not show the resident agreed to the shower or was offered a choice to refuse. Afterward, the resident had severe low back pain, was sent to the hospital, and was found to have acute compression fractures.
Failure to inform a resident's representative about psychotropic medication orders. A resident with dementia with psychotic disturbances became increasingly agitated and combative, leading to Haldol being ordered and administered, then ordered PRN. The record did not show that the RN notified the representative or provided education about the new Haldol orders, despite facility policy requiring discussion of alternatives, rationale, risks and benefits, and the right to accept or decline treatment.
Failure to Obtain Informed Consent for Psychotropic and PRN Medication
Penalty
Summary
The facility failed to ensure that residents were informed in advance of the care and treatment to be furnished, including the risks and benefits of treatment, for 1 of 5 residents reviewed for informed consent. Resident #23 was admitted with multiple diagnoses including COPD, anxiety, and PTSD, and the record showed physician orders for Seroquel ER 200 mg at bedtime for schizoaffective disorder and bipolar disorder, Seroquel 100 mg daily for bipolar disorder, and lorazepam 0.5 mL by mouth every 4 hours as needed for palliative care related to COPD. A review of the record found no documentation that Resident #23 or the resident's representative were informed of the risks and benefits or provided consent for the initiation of Seroquel and lorazepam. On 7/10/26 at 10:42 AM, the CRN and CNO confirmed that Resident #23 did not have signed consents for Seroquel or lorazepam.
Failure to Document Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to ensure informed consent was obtained and documented for a resident receiving psychotropic medications, including an explanation of the risks and benefits and alternative treatment options. The resident had a mildly impaired cognition, was dependent on staff for ADLs, and had diagnoses of dementia, traumatic brain injury, anxiety, and depression. The resident’s MDS also indicated feeling down, depressed, or hopeless several days during the look-back period. The MAR showed the resident was receiving escitalopram 5 mg daily for generalized anxiety and quetiapine 100 mg at bedtime for unspecified dementia with agitation. During interview and record review, the ADON was unable to locate documentation in the resident’s medical record showing that consent had been obtained or that risks, benefits, or alternative treatment options had been discussed with the resident or resident representative. The facility’s Antipsychotic Medication Use policy stated that prior to starting a new psychotropic medication, the physician was to document resident or resident representative consent in the progress notes, and that monitoring for side effects and use of standardized tools was required after initiation or dose changes.
Antipsychotic Given Without Signed Consent
Penalty
Summary
Resident #3, a [AGE]-year-old male admitted on 06/25/2026 with diagnoses including bipolar disorder and autistic disorder, was prescribed risperiDONE 2 mg by mouth twice daily for bipolar disorder starting 06/26/2026. The record showed the medication was administered from 06/26/2026 through 07/02/2026, but the medical record did not contain a signed consent for the antipsychotic risperidone. The Entry MDS was not completed, and the care plan was also not completed. During interviews, LVN C stated antipsychotics required RP signature consent and could not be administered before consent was given. LVN D stated she would not give an antipsychotic before the consent was signed and said she had never given one without signed consent. The DON stated antipsychotics needed signature consent and acknowledged there was no RP signature on Resident #3’s consent, stating she had verbal consent from the RP, but there was no documentation in the electronic medical record that verbal consent had been given.
Incomplete informed consent for psychotropic medications
Penalty
Summary
The facility failed to ensure informed consent for psychotropic medications was obtained and properly documented before administration for four sampled residents. Across the records reviewed, psychotropic medication consent forms were repeatedly incomplete, with missing physician signatures, missing representative signatures or dates, missing staff signatures, and in some cases missing medication frequency, dose details, or the correct ordered medication information. The Director of Nursing stated the forms were not filled out entirely but should have been, and that the physician was expected to explain the medication risks and benefits and obtain consent before administration. Resident 1 had diagnoses including dementia, diabetes mellitus, and atherosclerotic heart disease, and the H&P stated the resident did not have the capacity to understand and make decisions. The resident received quetiapine fumarate 12.5 mg daily and PRN and 25 mg at bedtime, and later Trileptal 300 mg twice daily. The psychotherapeutic drug informed consent forms for these medications included staff signatures but did not include physician signatures or dates, and did not include the representative’s name, signature, or date. The DON stated the physician did not sign the form and without the physician’s signature the medications were not allowed to be given, but the forms were not completed as required. Resident 2 had diagnoses including dementia, mood affective disorder, and depression, and the H&P stated the resident did not have capacity to understand and make decisions. The resident received risperidone 0.25 mg twice daily, donepezil 10 mg at bedtime, and memantine 10 mg twice daily. The consent forms for risperidone, donepezil, and memantine were incomplete, with missing physician signatures and dates, and the chart did not contain consent forms for the ordered doses of donepezil 10 mg and memantine 10 mg. Resident 3 had diagnoses including depression, anxiety disorder, and insomnia, and the H&P stated the resident had capacity to understand and make decisions. The resident received trazodone 150 mg at bedtime and mirtazapine, but the consent forms lacked physician signatures, dates, and representative signatures or dates, and the chart did not include a consent form for the ordered mirtazapine 7.5 mg dose. Resident 4 had diagnoses including anxiety, unspecified psychosis, and alcohol abuse, and the H&P stated the resident had capacity to understand and make decisions. The resident received quetiapine, Ativan, and mirtazapine, but the consent forms were incomplete or undated, lacked required signatures, and the chart did not include a consent form for the ordered Ativan and later mirtazapine via g-tube. The facility’s P&P required residents and/or representatives to be fully informed of benefits, risks, frequency, duration, and alternatives before psychotropic medications were initiated, and required the prescriber to sign the informed consent form after explaining the information.
Resident’s refusal of shower care was ignored
Penalty
Summary
The facility failed to protect and promote a resident’s right to self-determination and freedom from interference when staff transferred the resident from bed to the shower room using a Hoyer lift despite repeated verbal objections. The resident had diagnoses including muscle wasting, osteoarthritis of both knees, and a history of psychological trauma, and the record indicated he had the capacity to understand and make decisions. His care plans documented multiple refusals of care, including refusal to get out of bed, refusal of restorative nursing activities, refusal to be cleaned, and refusal of weight monitoring, with interventions directing staff to listen to the resident, be slow and gentle, respect his decisions, and address pain before care. On the day of the event, staff moved the resident from his bed to the shower room during a shift change even though he repeatedly said no, yelled for staff to stop, and stated he did not want to be moved because of back pain and discomfort. CNA 1, CNA 2, and LVN 1 all acknowledged in interviews that the resident refused the transfer and shower, and they described continuing the shower anyway. The resident’s family member stated that he screamed and pleaded not to be moved, and the roommate stated he heard the resident shouting at staff to stop moving him and to put him back in bed. The record did not include documented evidence that the resident agreed to be showered or was given an option to refuse the shower and transfer. After the shower event, the resident reported severe low back pain, and later requested transfer to the hospital because the pain medication was not effective. The medical record showed hydrocodone-acetaminophen was given for severe pain, a change-in-condition evaluation documented uncontrolled lower back pain, and the resident was transferred to the hospital with an order for severe low back pain. Hospital records later showed acute L1, L3, and L4 compression fractures and discharge diagnoses of acute lower back fractures, with kyphoplasty performed. Interviews with nursing staff confirmed that if a resident complains of pain or discomfort during care, the procedure should stop, and the DON stated staff should step away and re-approach when a resident refuses care. The facility’s Resident Rights and Refusal of Treatment policies stated residents have freedom of choice, may refuse treatment, and are not to be forced to accept care.
Failure to Inform Representative About Psychotropic Medication Orders
Penalty
Summary
The facility failed to fully inform a resident and the resident's representative of the risks, benefits, and alternate treatment options for psychotropic medication use. Resident #4 had diagnoses including dementia with psychotic disturbances and was admitted to the facility before being discharged on 2/16/26. His physician's orders included Memantine 5 mg, Mirtazapine 7.5 mg, and Rivastigmine 9.5 mg patch, and on 2/12/26 he became combative and aggressive, prompting a one-time order for Haldol 5 mg that was administered at about 8:00 PM. A new order for Haldol 5 mg every 12 hours as needed for agitation and combativeness was written on 2/12/26 and discontinued on 2/14/26. A progress note by Staff A, RN stated the resident had become increasingly aggressive, agitated, and combative and that new orders were obtained, but the documentation did not show that the representative was made aware of the new medication orders. The DON reviewed the record and confirmed there was no evidence that Staff A communicated with the resident's representative about the Haldol orders or provided education regarding the use of and new orders for Haldol. The facility policy required review with the resident or representative of non-pharmacological alternatives, indications and rationale, potential risks and benefits, and the right to accept or decline treatment before initiating or changing a psychotropic medication.
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