Failure to Obtain Informed Consent for Covid-19 Vaccine
Summary
Moravian Hall Square Health and Wellness Center was found to be non-compliant with federal and state regulations regarding the right of residents to be informed and make treatment decisions. The facility failed to inform a resident or their responsible party in advance about a treatment option, specifically the administration of a Covid-19 vaccine. The facility's policy required that residents or their legal representatives receive information and education about the benefits and potential side effects of the vaccine and that consent be obtained prior to administration. However, this procedure was not followed for one of the sampled residents. The resident in question was admitted to the facility with diagnoses including dementia and muscle weakness, and required extensive assistance with activities of daily living. A physician had ordered the administration of a Covid-19 vaccine as needed in the event of an outbreak. On a specified date, the vaccine was administered without documented evidence that the resident or their representative was informed or consented to the treatment. The Director of Nursing confirmed that informed consent was not obtained prior to the vaccine administration.
Plan Of Correction
1. The Infection Prevention Nurse will provide education to residents and/or their designated representatives regarding vaccination options and their benefits and risks prior to obtaining informed consent. 2. If the resident representative and the resident are unable to recall IF they had received a recent vaccination, their community Primary Care Physician will be contacted. 3. The Infection Prevention Nurse will obtain informed consent for all vaccinations from residents and/or their designated representatives, utilizing the Document Manager in PCC or, where applicable, paper documentation. 4. A physician's order will be obtained. 5. The nurse will verify that informed consent has been obtained prior to administering any vaccinations. 6. Residents will be monitored for signs and symptoms for 24 to 48 hours following administration of the vaccine. 7. Vaccination administration will be documented by the nurse in EMAR on PCC and updated in the immunizations tab of the resident's EMR. 8. The COVID-19 Vaccine Policy has been reviewed, and staff have been educated on the associated policies and procedures. This includes training on how to effectively communicate with residents and their representatives regarding vaccination, ensuring they understand the informed consent process and their right to make an informed decision. 9. The Infection Preventionist will be responsible to ensure all vaccinations have physician orders and consent prior to administration. This will be completed by the Infection Preventionist, with the DON as her backup. This will be added to our QAPI reporting no less than quarterly for the next year.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
A resident with severe cognitive impairment and diagnoses including Alzheimer's disease, stroke, and non-Alzheimer's dementia was started on risperidone without documented informed consent from the resident or representative before administration. The EMR did not show consent prior to initiation, and the RN CM later obtained verbal consent from the family after the medication had already been started. The DON stated consent should have been obtained and signed before the psychotropic was given, consistent with the facility's psychotropic medication policy.
Failure to obtain informed consent for psychotropic medications. A resident with severe cognitive impairment and diagnoses including Alzheimer’s disease, non-Alzheimer’s dementia, anxiety, and schizophrenia was prescribed Clozaril, Lexapro, lorazepam, and Olanzapine, but the record lacked evidence of consent with risk/benefit discussion for any of the medications. The DON stated the resident was not asked to sign because of cognitive concerns, despite the resident being their own decision maker and having windows of lucidity, and the decision was made without input from the resident or other IDT members.
Failure to use effective communication methods for a deaf resident: A resident with diagnoses including paraplegia, DM2, traumatic brain injury, schizoaffective disorder, depression, deaf non speaking, and HTN was documented as having highly impaired hearing and no speech. His care plan noted he wanted sign language and could use video interpreter services, iPad typing, and pointing, but staff often relied on writing, lip reading, or speaking slowly. Interviews showed multiple staff were unaware of his limited English and did not consistently use the ASL app or interpreter services, while the DON stated staff had been in-serviced on the ASL application.
Failure to Obtain Informed Consent for Psychotropic Medications: The facility did not obtain documented informed consent before giving psychotropic meds to two residents. One resident with moderately impaired cognition received buspirone for anxiety without a consent form in the record, and another resident with decision-making capacity received Clozaril and Depakote for behavioral symptoms without documented consent. An RN verified the missing consents, and the DON acknowledged the omissions.
A resident with severely impaired cognition, dementia, and high fall risk had 1:1 observation discontinued and was later moved to another room, but the DON confirmed there was no written evidence that the RP was notified of either change. The record showed the resident’s daughter was the RP, and facility policy required informing the resident or representative about health status, treatment options, and advance notice of room changes when possible.
The facility failed to ensure two residents were informed and involved in psychotropic medication treatment. One resident received multiple psychoactive meds, including an antipsychotic, antianxiety, antidepressant, anticonvulsant, and dementia medication, but the chart lacked current active consents and did not show matching anxiety or depression diagnoses. Another resident had orders for Trazodone for insomnia and Quetiapine for depression without corresponding diagnoses, and the MD stated the Quetiapine order was entered incorrectly.
Failure to Obtain Informed Consent for Psychotropic Medication
Penalty
Summary
The facility failed to ensure a resident and/or resident representative was informed of and participated in treatment decisions regarding psychotropic medication use, including failure to obtain informed consent before initiating risperidone for one resident. The resident had severe cognitive impairment and required assistance with ADLs, with diagnoses including non-traumatic brain dysfunction, Alzheimer's disease, stroke, and non-Alzheimer's dementia. The resident's MDS also indicated two or more falls since admission. Physician orders showed risperidone was initiated when the resident was admitted to the facility, but the EMR did not contain documentation that informed consent had been obtained before the medication was started. During interview, the RN Case Manager stated psychotropic medication consents were obtained upon admission and reviewed with the resident and/or family member, but she could not locate the consent in the EMR and later contacted the family to obtain verbal consent over the phone. The DON stated consent should have been obtained when the medication order was received, either upon admission if the resident was already on the medication or when a new psychotropic medication was initiated, and that the consent should have been signed by the resident or family member prior to administration. The facility's psychotropic medication policy required residents and/or their family or legal representative to be notified when psychotropic medications were initiated or when residents were admitted on psychotropic medications, and required the Permission for Use of Psychotropic Medications consent form to be completed and signed.
Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to obtain informed consents, including risk and benefit information, for psychotropic medications for one resident who was reviewed. The resident’s quarterly MDS indicated severe cognitive impairment and diagnoses of hyperlipidemia, Alzheimer’s disease, non-Alzheimer’s dementia, anxiety, and schizophrenia. The resident’s order summary showed prescriptions for Clozaril, Lexapro, lorazepam, and Olanzapine, but the medical record lacked evidence of informed consents for any of these medications. The DON stated they were responsible for completing psychotropic consents and did not have the resident sign because they believed the resident was unable to do so cognitively, even though the resident had windows of lucidity and confusion and was their own decision maker. The DON also stated they had been trying to obtain guardianship but had not been successful, and confirmed they made the decision not to have the resident sign without speaking to the resident or involving other interdisciplinary team members.
Failure to Use Effective Communication Methods for a Deaf Resident
Penalty
Summary
The facility failed to ensure that Resident #3, who was deaf and mute, was fully informed of and able to participate in his care and treatment using a communication method he could understand. Resident #3’s record showed diagnoses including paraplegia, type 2 diabetes mellitus, focal traumatic brain injury, chronic ulcer of the right lower leg, dysphagia, schizoaffective disorder, major depressive disorder, deaf non speaking, and hypertension. His Quarterly MDS indicated a BIMS score of 15, highly impaired hearing, no speech, and need for limited to extensive assistance with activities of daily living, with frequent bladder and bowel incontinence. The care plan identified impaired communication due to being deaf and mute and stated that he refused a communication board, wanted someone who could use sign language, used interpreter services by video, could communicate via iPad, and could type and point to communicate needs. It also noted that staff members in the facility knew basic needs for him and that VRI was available as needed. During interviews, the Ombudsman stated the facility believed the resident could read, write, spell, and read lips, but she learned he had poor reading, writing, and spelling skills and could not read lips, and that the facility had failed to assist him with VRS and VRI services. Observations and interviews showed inconsistent use of the ASL application and interpreter services. During wound care, an ADON scanned a QR code and used an ASL translation service with an interpreter on the screen to communicate with the resident. However, the resident stated most staff did not use the ASL service and did not know how to use it, and he wanted them to use the ASL interpreter so he could understand them. Multiple staff members stated they wrote notes, talked slowly, faced him to read lips, or used his tablet, and several said they were unaware he understood very little English or that the ASL application should be used. The DON stated she had in-serviced staff about the ASL application and did not understand why they were not using it to communicate with him. The facility policy stated it was the policy to accommodate communication needs for residents who are deaf, hard of hearing, or speak a language other than English so information is provided in a form and manner the resident can access and understand.
Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to fully inform residents or their responsible parties and obtain completed informed consent before administering psychotropic medications to two sampled residents. Review of facility policy and state guidance showed informed consent was required before treatment, and the state notice indicated a psychotherapeutic drug informed consent form was to be used for new residents, new psychotherapeutic drugs, and dosage changes. The facility’s own policy also stated that, when possible, consent should be obtained in advance and that the licensed nurse should contact the healthcare practitioner if informed consent could not be verified. For one resident, the medical record showed a physician’s order for buspirone hydrochloride 10 mg three times daily for anxiety, along with nonpharmacological interventions. The resident’s assessment showed moderately impaired cognition. Review of the record did not show documented informed consent for the buspirone. During interview and record review, an RN verified there was no informed consent for the medication and stated the licensed nurse should have informed the resident of the need for consent and informed the physician. The RN also stated the resident should have been informed of the risks and benefits of the psychotherapeutic medication. For another resident, the record showed the resident had mental capacity to make decisions and had physician’s orders for Clozaril 200 mg at bedtime, Clozaril 25 mg daily, and Depakote 750 mg twice daily for behaviors described as angry outbursts and sudden irritability, with nonpharmacological interventions also listed. The medical record did not show documented informed consent for the Clozaril or Depakote. During interview and record review, an RN verified there was no informed consent for those medications and stated the licensed nurse should have checked the files to ensure the updated informed consent was present. The DON acknowledged the findings and stated the facility had decided to renew psychotropic informed consents every six months, but the informed consents for these two residents were missed.
Failure to Notify Responsible Party of Care Changes
Penalty
Summary
The facility failed to inform Resident 1’s responsible party when 1:1 observation was discontinued and when the resident was moved to another room. Resident 1 had diagnoses including encephalopathy, dementia, depression, anxiety, difficulty walking, and generalized muscle weakness. His MDS dated 3/11/26 showed a BIMS score of 5, indicating severely impaired cognition, and physician orders dated 2/26/26 stated he was incapable of understanding rights, responsibilities, and informed consent. He was also identified as very high risk for falls, and his daughter was the responsible party for his care. Records and interviews showed that a sitter was assigned to Resident 1 from 4/25/26 through 4/30/26, then discontinued on 5/1/26 because his overall condition had improved and he was placed on regular safety checks. The DON confirmed there was no written evidence that the responsible party was notified before the sitter was discontinued. In addition, the medical record showed Resident 1 was offered and agreed to a room change on 12/4/25, but the DON confirmed there was no written evidence that the responsible party was informed of the room change. The facility policy stated that residents or their representatives should be given advance notice of room changes when possible, and that residents and representatives are to be informed of health status, medical condition, and treatment options.
Failure to Obtain Current Medication Consents and Match Diagnoses for Psychotropic Orders
Penalty
Summary
The facility failed to ensure that two residents were fully informed and able to participate in their treatment related to psychoactive medications, including obtaining current active consents and matching diagnoses for the medications ordered. For one resident, the record showed active orders for Quetiapine Fumarate, Buspirone, Depakote ER, Paroxetine, and Donepezil, with medication administration continuing from November 2025 through May 2026. The chart contained only limited or expired consents for some of these medications, and there was no consent at all for Donepezil. The resident’s MDS reflected severe cognitive impairment and active use of an antipsychotic, antianxiety, antidepressant, and anticonvulsant, but psychiatric or mood disorders such as anxiety and depression were not listed as active diagnoses. The same resident’s care plan did not include a focus for the use of antipsychotic, antidepressant, or antianxiety medications. During interview, the DON stated she could not find the needed consents in the chart or consent binder and did not know why the existing Seroquel consent stated the resident did not have the psychiatric condition required for the medication while the medication continued to be given. The ADM stated he expected consents to be on file so the family or RP would be aware of what was being used and could ask questions or refuse the medication. The NP stated psychotropic medications required consents and that if a consent was only obtained for a limited period, it should have been revisited if the medication was still needed. For the second resident, the physician orders included Trazodone for insomnia and Quetiapine Fumarate for depression, but the resident’s diagnoses did not include insomnia or depression. The MD stated he would not treat depression with Seroquel and said that if the Quetiapine order stated it was for depression, then the order was entered incorrectly. He also stated he may have missed the error when reviewing the verbal orders before signing them. The facility’s Resident Rights policy stated residents have the right to be free from chemical restraints not required to treat symptoms and to be informed of and participate in care planning and treatment.
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