055748
04/15/2025
Sunset Park Healthcare
2250 29th Street Santa Monica, CA 90405
F 0758
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Few
Implement gradual dose reductions(GDR) and non-pharmacological interventions, unless contraindicated, prior to initiating or instead of continuing psychotropic medication; and PRN orders for psychotropic medications are only used when the medication is necessary and PRN use is limited. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review and interview, the facility failed to follow their own Policy and Procedure (P&P) by failing to ensure one of three sampled residents (Resident 1), physician had educated Resident 1 or her Responsible Party (RP) about the risks and benefits of taking mirtazapine (an antidepressant used to treat major depressive disorder). This deficient practice had the potential to result in Resident 1 in receiving a medication that she (Resident 1) was not well informed about.
Findings: During a review of the admission record for Resident 1 indicated Resident 1 was initially admitted to the facility on [DATE] and was readmitted on [DATE] with major depressive disorder (a mood disorder that causes a persistent feeling of sadness and loss of interest), hypertension (HTN-high blood pressure) , and dysphagia (difficulty swallowing). During a review of the facility document titled INFORMED CONSENT- INFORMED CONSENT FOR USE OF PSYCHOTROPIC MEDICATION, for Resident 1 indicated, mirtazapine 7.5 milligram (mg, unit of measurement) PO (by mouth) qhs (at bedtime), an antidepressant used to treat depression. The same informed consent indicated Resident 1 ' s RP was provided information on 2/23/2025, the name of the physician with no physician signature, and the name and signature of staff who was the witness with no date indicating when they witnessed the education provided. During a review of Resident 1 ' s physician order dated 2/23/2025, indicated, mirtazapine 7.5 mg tablets (tabs), give 1-tab po at bedtime for depression m/b (manifested by) poor po intake behavior. During a review of the Minimum Data Set (MDS – a resident assessment tool) dated 3/4/2025, indicated Resident 1 had severe cognitive impairment (a significant decline in thinking, learning, remembering, and reasoning abilities, impacting daily functioning and potentially leading to the inability to live independently). The same MDS indicated, Resident 1 required between partial/moderate assistance and dependence on staff for most Activities of Daily Living such as: (ADLs- routine tasks/activities such as eating, oral hygiene, toileting hygiene, personal hygiene, lower/upper body dressing, putting on/taking off footwear). During a concurrent interview and record review of Resident 1 ' s informed consent for mirtazapine with Licensed Vocational Nurse (LVN) 1 on 4/15/2025 at 1:39 pm stated that for a consent to be
Page 1 of 2
055748
055748
04/15/2025
Sunset Park Healthcare
2250 29th Street Santa Monica, CA 90405
F 0758
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Few
complete and accurate, education is provided and residents sign to indicate that they understand. She stated that residents who have capacity to understand and make decisions give consent and RPs are identified for residents who do not have capacity. LVN 1 stated that the physician needs to sign consents to indicate that they had provided education, with risks and benefits to the resident. LVN 1 stated that if signatures are not there, then the consents are not complete and therefore not valid. LVN 1 confirmed that Resident 1 ' s consent for mirtazapine did not have a physician ' s signature and did not indicate a date of when the facility staff witnessed the physician provide education to Resident 1. During a concurrent interview and record review of Resident 1 ' s informed consent for mirtazapine with Social Services Director (SSD) on 4/15/2025 at 2:04 pm, the SSD acknowledged that Resident 1 did not include a physician signature and the date on when the facility staff witnessed the education regarding the mirtazapine educating about the risks and benefits. The SSD stated that it was very important to get a complete consent because antidepressants have a lot of side effects so residents must be well educated about the medication before the medication are administered. During a concurrent interview and record review of Resident 1 ' s informed consent for mirtazapine with Director of Nursing (DON) on 4/15/2025 at 2:23 pm, the DON stated that that the physician must sign an informed consent at least within 72 hours if that consent was obtained over the phone and immediately if obtained in person. If a physician does not sign, then the consent is not effective. The DON confirmed that Resident 1 ' s consent was not signed by the physician nor was it dated by the witness. During a review of the facility P&P titled Verification of Informed Consent for Psychotherapeutic Medications, revised 5/2024 indicated, Each resident has the right t be free from psychotherapeutic drugs and, to provide informed consent before treatment with psychotherapeutic drugs. Informational materials concerning psychotherapeutic drugs. The facility will obtain a written informed consent for treatment using psychotherapeutic drugs and consent renewal every six months. the same P&P indicated, the if a resident/RP cannot sign the consent, then a licensed nurse can sign, indicated the name of the person giving consent along with a date. The physician signature may be signed using remote technology.
055748
Page 2 of 2