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:
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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