Failure to Obtain Proper Consent for COVID-19 and Influenza Vaccinations
Summary
The deficiency involves the facility’s failure to honor residents’ rights to refuse treatment and to obtain proper consent for immunizations, specifically COVID-19 and influenza vaccines, for two residents reviewed for immunizations. Facility policies for COVID-19 and influenza vaccination required that residents and/or resident representatives receive vaccine information sheets, be educated on risks and benefits, and that informed consent (written or verbal) be obtained prior to administration, with vaccination remaining voluntary. New York State regulations and federal resident rights documents cited in the report state that residents have the right to refuse medication and treatment after being fully informed, and that legal guardians or health care proxies have the right to make important decisions on the resident’s behalf when the resident lacks capacity. Resident #1 had diagnoses including Alzheimer’s disease, vascular dementia, and a prior stroke, with the MDS documenting moderate cognitive impairment. The resident’s care plan showed multiple advance directives, including a MOLST, Health Care Proxy, and Power of Attorney, with a goal that the resident’s wishes be honored. A Determination of Incapacity for Medical Decision-Making documented that the resident lacked capacity and that the Health Care Proxy/Agent had been informed of this determination by two medical providers. Despite this, a Vaccination Review: Consent/Declination form recorded that the Assistant Director of Nursing/Infection Preventionist obtained verbal consent directly from the resident for influenza and COVID-19 vaccines, and the vaccines were administered. The Immunization Audit Report also showed prior refusals of other immunizations by the family/resident, and the order summary confirmed active Health Care Proxy status and vaccine orders. The resident’s Agent/Surrogate later stated they were responsible for medical decisions, were not asked for consent, were only notified after the vaccines were given, and would have declined them. The previous Unit Manager stated that Resident #1 lacked capacity, had documentation of incapacity, and that the spouse should have been called; they further stated that the Assistant DON/Infection Preventionist went room to room obtaining verbal consents from residents without verifying capacity, resulting in vaccinations against the Health Care Proxy’s wishes. Resident #2 had diagnoses including dementia, encephalopathy, and COPD, with the MDS documenting severe cognitive impairment. The care plan described the resident as moderately impaired in decision making and referenced a cognitive level tool indicating Level 4 (moderately impaired). There was no initial documentation of capacity determination or advance directives in the care plan, but later orders showed that a Health Care Proxy was activated with an effective date prior to the vaccination clinic. The Vaccination Review: Consent/Declination form documented that the Assistant DON/Infection Preventionist obtained verbal consent from the resident for influenza and COVID-19 vaccines, and the vaccines were administered. The Immunization Audit Report and order summary confirmed the vaccines were given and that a Health Care Proxy order was in place. The Social Worker stated that a BIMS score under 12 indicated lack of capacity, that Resident #2 did not have the ability to make decisions, and that the Health Care Agent made decisions and should have been notified for vaccinations. The Assistant DON/Infection Preventionist stated they obtained consents verbally from residents and by phone from proxies, that it was not legal to vaccinate without proper consent, and acknowledged they did not document family consent for Resident #2 and should have done so. Resident #2’s Health Care Agent reported that vaccination consent was not discussed with them, they were unaware the vaccines were given, and that the resident would not have understood what they were consenting to. The DON, Administrator, and Medical Director all stated that capacity should be assessed (e.g., via BIMS and capacity forms), that if a resident lacks capacity the responsible party or Health Care Proxy must make decisions, and that residents who lack capacity should not receive vaccinations without proxy consent. These facts collectively demonstrate that the facility failed to ensure residents’ rights to refuse treatment and to obtain appropriate consent from authorized representatives before administering vaccines to two cognitively impaired residents.
Penalty
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Incomplete OOH-DNR forms were found for two residents whose records reflected DNR status. One resident’s form lacked the physician’s license number, date, and signature at the bottom, while another resident’s form had Section B left blank, including the checkboxes identifying the signer’s authority and basis for the order. Staff stated the forms were completed and reviewed by multiple departments, but the ADM had not yet reviewed these two forms.
A resident with intact cognition was admitted for rehab after hospitalization, and her EMR showed DNR status in the banner, care plan, and physician order. However, her signed advance directive stated she wanted CPR and full resuscitative measures, and the form was not in the EMR. The DON acknowledged the mismatch and that the facility’s advance directive policy was not specific about the documentation process.
Failure to Offer Advance Directive Option: The facility did not provide the option to formulate an advance directive for five sampled residents. Records showed several residents were informed of the right to develop an advance directive, but documentation did not show the option was actually offered to the resident or RP. One resident had capacity to understand and make decisions, yet the social services assessment documented that no advance directive was in place, the opportunity was not offered, and no educational materials or state form were provided. Interviews with residents and SSD staff confirmed the omission.
Delayed Provider Signature on POLST: A resident with heart failure, dementia, diabetes, hyperlipidemia, and heart disease signed a POLST, but the provider did not sign it until later after the issue was identified. The DON stated the admission coordinator completed the form with the resident or decision maker and then it went into the chart as an order, but could not explain why the POLST was not signed by the provider on admission.
A resident with multiple serious diagnoses, including COPD, CHF, CKD on dialysis, and an implanted cardiac defibrillator, had a signed Florida DNR and physician DNR order in the chart. After returning from HD, the resident became unresponsive in bed, staff called a code blue, and CPR was started based on an initial report that the resident was full code. Staff later found the DNR paperwork and told others the resident was DNR, but compressions continued until EMS arrived.
Failure to Provide Written Advance Directive Information and Accurate Code Status: The facility did not provide written information to residents or RP about the right to accept or refuse tx and to formulate an advance directive. Records for multiple residents showed DNR or Full Code orders, but documentation of written advance directive information was absent. One resident had a DNR order in the chart, yet an NP note listed the resident as Full Code without a new order or documentation of the change. Staff interviews showed reliance on hospital paperwork and uncertainty about who was responsible for discussing advance directives.
Incomplete OOH-DNR Forms for Two Residents
Penalty
Summary
The facility failed to ensure that two residents had complete Out-of-Hospital Do Not Resuscitate (OOH-DNR) forms as part of their advance directive records. Resident #74 was admitted with diagnoses including sepsis, atherosclerotic heart disease, and muscle weakness, and the admission record, physician order summary, and care plan all reflected DNR status. However, the OOH-DNR form for this resident did not include the physician’s license number, did not include the date with the physician’s signature, and was not signed at the bottom by the physician. Resident #84 was admitted with diagnoses including acute kidney failure, atrial fibrillation, and heart failure, and the admission record and physician order summary also reflected DNR status. The OOH-DNR form for this resident had Section B left blank, including the checkmark areas identifying the legal basis for the order and the basis for the signer’s authority or knowledge of the patient’s wishes. During interviews, the DON, BOM, RN A, and ADM stated staff were responsible for completing and reviewing the forms, and the ADM stated she had not yet reviewed the OOH-DNRs for these residents. The facility policy stated residents’ choices regarding advance directives should be honored and that residents should have a complete advance directive with all known wishes clearly outlined.
Advance Directive and Code Status Not Matched
Penalty
Summary
The facility failed to ensure that a resident’s advance directive and code status were accurately documented to reflect her chosen wishes. Resident 16 was admitted for rehabilitation after a hospitalization, had a BIMS score of 15 indicating intact cognition, and stated she hoped to regain strength and return home with her husband. Her EMR contained a banner indicating she did not want CPR, her baseline care plan listed her code status as DNR, and there was a physician’s order for DNR. However, review of the resident’s signed advance directive showed that she wanted CPR and full resuscitative measures. The EMR did not contain the advance directive form, and staff acknowledged that without the form scanned into the EMR they could not verify whether the code status matched the resident’s advance directive. The DON also acknowledged that the facility’s policy regarding advance directives was not specific about the process for obtaining and documenting residents’ advance directives.
Failure to Offer Advance Directive Option
Penalty
Summary
The facility failed to provide the option to formulate an advance directive for five sampled residents: Residents 10, 158, 163, 169, and 213. The facility’s policy stated that residents would be given information about advance directives upon admission and, if no advance directive existed, would be provided an opportunity to complete one upon resident request. Survey review found that this opportunity was not provided or documented for the five residents reviewed. Resident 213’s record showed the resident was informed of the right to develop an advance directive, but the record did not show the facility provided the resident or responsible party the opportunity to formulate one. Resident 213 had a full LPS conservatorship status, was cognitively intact on the MDS, and had a diagnosis of schizoaffective disorder. Similar findings were identified for Resident 169, whose record showed full LPS conservatorship status, cognitive intactness on the MDS, and a diagnosis of schizoaffective disorder, but no documentation that the resident or responsible party was offered the opportunity to formulate an advance directive. Resident 158’s record showed the resident was informed of the right to develop an advance directive, but the resident refused to sign the acknowledgement and the record did not show the facility provided the resident or responsible party the opportunity to formulate one. Resident 158 stated during interview that the facility did not provide information or the option to form an advance directive. Resident 163’s record also showed the resident was informed of the right to develop an advance directive, but no documentation showed the resident or responsible party was offered the opportunity to formulate one; the resident stated the facility did not provide information or the option to form an advance directive. Resident 10’s record showed the resident had capacity to understand and make decisions, yet the social services assessment documented that an advance directive was not in place, the opportunity to complete one was not offered, and no educational materials, including the state form, were provided. The SSD and SSD-STP acknowledged that the residents were not offered the option to formulate advance directives.
Delayed Provider Signature on POLST
Penalty
Summary
The facility failed to ensure that 1 of 1 resident's Provider Orders for Life Sustaining Treatment (POLST) was completed timely. The resident had diagnoses including heart failure, dementia, diabetes mellitus, hyperlipidemia, and heart disease, and the admission MDS identified the resident as moderately cognitively intact and requiring partial to moderate assistance with activities of daily living. The resident signed the POLST on 5/6/26, but the provider did not sign it until 7/30/26, after the issue was brought to the facility's attention. During interview, the DON stated the admission coordinator would complete the form with the resident or decision maker and then it would go into the chart as an order, but could not explain why the POLST had not been signed by the provider on admission. The facility's Advance Care Planning policy stated that on admission the resident and/or legal representative would be notified of the need for an order for cardiopulmonary resuscitation and that the POLST would become a medical order.
Failure to Honor Resident DNR During Code Event
Penalty
Summary
The facility failed to act in accordance with a resident’s advance directive and did not honor the resident’s Do Not Resuscitate (DNR) status when the resident was found unresponsive and absent of life. Resident #6 had multiple diagnoses including COPD, type 2 diabetes mellitus, morbid obesity, hemiplegia and hemiparesis following cerebral infarction, generalized muscle weakness, dyspnea, atrial fibrillation, congestive heart failure, chronic kidney disease with dependence on renal dialysis, and an implantable cardiac defibrillator. The resident had a Florida DNR order signed by the resident and an APRN, and the physician order set also listed the resident as DNR. On the day of the incident, the resident returned from hemodialysis and was described as awake, alert, and conversing with staff during transport back to the room. Multiple staff statements described that after the resident was lowered into bed, the resident became unresponsive. Staff then assessed the resident and asked about code status. One nurse stated the resident was full code, and a code blue was called. CPR was started, the AED was applied, and EMS was called. Several staff later stated that the resident’s DNR paperwork was in the chart or red book and that they informed others that the resident was DNR after CPR had already begun. Witness statements and interviews showed conflicting accounts about when the DNR was discovered and whether CPR should have been stopped. Some staff stated they were told to continue compressions until EMS arrived even after the DNR was identified. Other staff stated they checked the record, confirmed the resident was DNR, and communicated that information to the team. The DON later stated that once the DNR was discovered, staff should have stopped CPR, and the Medical Director stated there was a process for checking code status using the code book and computer. The facility policy stated that CPR would be provided unless the resident had a fully executed Florida DNR order, and that two licensed nurses were to verify the resident identification and DNR order in the medical record.
Failure to Provide Written Advance Directive Information and Maintain Accurate Code Status
Penalty
Summary
The facility failed to inform residents and their representatives, in writing, of their right to accept or refuse medical or surgical treatment and to formulate an advance directive. Record review and resident interviews showed that multiple residents had code status orders documented in the chart, including DNR and Full Code orders, but there was no indication in the electronic medical record that written information about advance directives had been provided. Residents identified in the report included cognitively intact residents, residents with moderate cognitive impairment, and residents with severe cognitive impairment. For Resident #16, the record showed a DNR order dated 7/14/26, but a Nurse Practitioner progress note dated 7/15/26 listed the resident as Full Code without documentation of a change from DNR back to Full Code and without a new Full Code order. During interview, Resident #16 stated that advanced directives had not been discussed with her, that she had not received written information about her rights, and that she believed she was supposed to be DNR. She also stated she found out accidentally that she had been listed as Full Code when she saw paperwork sent to the doctor. Other residents reviewed included Resident #8, #47, #12, #9, #13, #75, #80, #71, #102, #103, #104, #105, #107, and #11. Their records showed code status orders such as DNR or Full Code, and the MDS assessments reflected varying cognitive status, including cognitively intact, moderately impaired, and severely cognitively impaired. Interviews with the Social Worker Assistant, Admission Coordinator, Social Worker, DON, NP, and Administrator showed that staff relied on hospital paperwork or the Golden Rod form to determine code status, that written information was not being provided to residents or responsible parties regarding advance directives, and that staff were not clear on who was responsible for addressing advance directives during admission.
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