F0552 F552: Ensure that residents are fully informed and understand their health status, care and treatments.
E

Failure to Inform Residents of Risks and Benefits Before Psychotropic Medication Use

New Castle Health And Rehabilitation CenterNew Castle, Delaware Survey Completed on 12-13-2025

Summary

The deficiency involves the facility’s failure to ensure residents or their representatives were informed of the risks and benefits of psychotropic medications prior to their use, as required by resident rights. For one resident with traumatic brain injury and dementia with agitation, records showed ongoing administration of trazodone, risperidone, and buspirone per physician orders, with the MDS indicating significant cognitive impairment and use of antidepressant, antianxiety, and antipsychotic medications. However, there was no documentation that risks and benefits were discussed before these psychotropic medications were administered. Another resident with severe cognitive impairment, emotional lability, and dementia had an order for trazodone 50 mg twice daily with medication monitoring, but the EMR contained no record of any risk-versus-benefit discussion with the resident or representative prior to starting the medication. A third resident, cognitively intact with a diagnosis of depression, was started on sertraline 25 mg daily, yet the EMR lacked documentation that risks and benefits were reviewed before initiation. A fourth resident with severe cognitive impairment, multiple neurological and psychiatric diagnoses, and existing use of antipsychotic and antianxiety medications had a care plan noting risk for adverse reactions related to psychotropic use and a physician order for risperidone 0.5 mg twice daily for dementia with severe agitation. Despite this, there was no documentation that the risks and benefits of this psychotropic medication were reviewed with the responsible party prior to initiation. During an interview, the Administrator, DON, and Regional President of Operations confirmed that risk-versus-benefit discussions for psychotropic medications had not been conducted for at least one of the residents, despite the facility’s resident rights document stating that residents have the right to be fully informed of the risks and benefits of proposed treatments.

Penalty

Inspection fine: $28,776
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

Resources

Below are regulatory guidelines relevant to this citation:

See other F0552 citations
Failure to Obtain Informed Consent for Psychotropic and PRN Medication
D
F0552 F552: Ensure that residents are fully informed and understand their health status, care and treatments.
Short Summary

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.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Document Informed Consent for Psychotropic Medications
D
F0552 F552: Ensure that residents are fully informed and understand their health status, care and treatments.
Short Summary

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.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Antipsychotic Given Without Signed Consent
D
F0552 F552: Ensure that residents are fully informed and understand their health status, care and treatments.
Short Summary

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.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Incomplete informed consent for psychotropic medications
D
F0552 F552: Ensure that residents are fully informed and understand their health status, care and treatments.
Short Summary

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.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Resident’s refusal of shower care was ignored
D
F0552 F552: Ensure that residents are fully informed and understand their health status, care and treatments.
Short Summary

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.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Inform Representative About Psychotropic Medication Orders
D
F0552 F552: Ensure that residents are fully informed and understand their health status, care and treatments.
Short Summary

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.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
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