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
Resources
Below are regulatory guidelines relevant to this citation:
Advance Directive Not Maintained in Resident Record: A resident with dementia, muscle weakness, and protein-calorie malnutrition had documentation indicating an advance directive was in the chart, but record review did not locate a living will or DPOA for health care. The CNO confirmed the record did not include an advance directive and the facility did not have a living will on file.
Incomplete Advance Directive Documentation: The facility failed to keep complete and accurate advance directive records for two residents. One resident's chart contained a representative-signed acknowledgement that did not specify the type of advance directive, and another resident's record had no signed acknowledgement showing that advance directives were discussed. The SSD stated she was responsible for the documentation and that one form was filled out incorrectly while the other resident's paperwork could not be found.
The facility failed to timely respond to changes in condition for two residents, including one with severe cognitive impairment and another with dementia, CHF, diabetes, and a history of UTIs. Family members and DPOAs reported concerns about confusion, agitation, pain, SOB, and other worsening symptoms, but hospital evaluation was delayed while staff waited for physician input. Both residents were later admitted to the hospital with serious infections and other acute conditions, including sepsis, pneumonia, and respiratory failure.
A facility failed to ensure that active physician orders matched residents’ POLST code status for three residents. One resident with COPD, A-Fib, and anxiety had a POLST indicating DNR but no active code status order; another resident with dementia, hypothyroidism, and HTN had a POLST indicating DNR but a physician order for CPR; and a third resident with COPD, respiratory failure, and diabetes had a POLST indicating DNR but no active code status order. The DON confirmed the records were inconsistent and that physician orders and POLST should match.
A resident with dementia with agitation, stroke, and PE had an advanced directive noted in a care conference review, but the document could not be found in the medical record. Staff later confirmed the resident did not have an advance directive on file.
Failure to offer a resident the opportunity to create an advance directive. Record review showed the resident had no advance directive on file, and the SS Director stated there was no documentation that education was provided or that any attempts were made to obtain one. The resident had HTN, CKD, and mild cognitive impairment.
Advance Directive Not Maintained in Resident Record
Penalty
Summary
The facility failed to ensure that a copy of a resident's advance directive was maintained in the medical record for Resident #32, who was admitted with multiple diagnoses including dementia, muscle weakness, and protein-calorie malnutrition. The resident's care plan, revised 5/12/22, documented that the resident and appointed healthcare representative were to receive education regarding advance directives as needed, and a care conference evaluation dated 6/26/26 documented that the resident had an advance directive in the record. However, on 7/8/26, review of the medical record did not locate a living will or durable power of attorney for health care, and the CNO later confirmed that the record did not include an advance directive and the facility did not have a living will on file.
Incomplete Advance Directive Documentation
Penalty
Summary
The facility failed to ensure documentation regarding advance directives was complete and accurate for 2 of 7 residents reviewed. A policy titled "Advance Directives and Refusal of Treatment" stated that upon admission the Social Services Designee should obtain a copy of any existing Living Will, Health Care Proxy, Durable Power of Attorney for Health Care Decisions, or other recorded declaration and enter a progress note regarding the existence of an advance directive. Resident #7 was admitted with diagnoses including hemiplegia and hemiparesis following a nontraumatic intracerebral hemorrhage affecting the right dominant side. The record contained a "Resident Rights & Advance Directive Acknowledgement" signed by the resident's representative that indicated the resident had an advance directive, but the form did not identify the type of advance directive. Resident #81 was admitted with end stage renal disease, and the medical record contained no signed acknowledgement showing that advance directives were discussed with the resident or representative. The Social Services Director stated she was responsible for advance directive documentation, that the form for Resident #7 was filled out incorrectly and should have been corrected, and that the missing paperwork for Resident #81 meant the facility would not know whether the resident had an advance directive.
Delayed Response to Changes in Condition and Family Requests for Hospital Evaluation
Penalty
Summary
The facility failed to timely provide requested medical evaluation and treatment for two residents with changes in condition. The deficiency was identified during review of Complaint #3035494 and involved delayed responses to worsening symptoms, resulting in delayed medical treatment, worsening of condition, and dissatisfaction with care. For one resident with diagnoses including Alzheimer's disease and other medically complex conditions, the record showed severely impaired cognition and inability to make decisions. A family member reported that the resident had a decline in health about a week before hospitalization, with severe UTI and stool impaction. The hospital record documented that the resident arrived from the nursing home via EMS with confusion and altered mental status that had worsened since several days earlier, and the ED physician suspected sepsis. The resident was febrile, tachycardic, had elevated white blood cell count and creatinine, and was diagnosed with proctitis, cystitis, sepsis, NSTEMI, and acute kidney injury. The urine culture was positive for gram-negative rods/Pseudomonas aeruginosa. For another resident with diagnoses including diabetes mellitus, a history of UTIs, CHF, Alzheimer's disease, and dementia, the progress notes showed family concerns about abnormal behavior, confusion, agitation, shortness of breath, congestion, lethargy, and shallow breathing. The resident's DPOA reported repeatedly expressing concern that something was wrong and requesting hospital evaluation, but the facility did not immediately send the resident out and instead contacted the physician first. The change-in-condition documentation noted altered mental status and respiratory symptoms, and the physician initially recommended a nebulizer treatment before later directing transfer to the ED. The resident was admitted to the hospital with bilateral pneumonia, acute hypoxic respiratory failure, likely demand ischemia, chronic diastolic CHF, fluid overload, severe anemia, and human metapneumovirus infection.
Physician Orders Did Not Match POLST Code Status
Penalty
Summary
The facility failed to ensure that active physician orders reflected residents’ end-of-life wishes as documented on their Pennsylvania POLST forms for three residents. Facility policy stated that residents are presumed to consent to CPR unless there is documentation in the medical record showing a DNR order, and that all DNR orders must be rewritten by the attending physician for each admission or readmission. Review of the clinical records showed that Resident R14 had diagnoses including COPD, A-Fib, and anxiety, and had a POLST indicating DNR, but the current physician orders lacked evidence of code status. Resident R38 had diagnoses including dementia, hypothyroidism, and high blood pressure, and had a POLST indicating DNR; however, a physician order dated in the record indicated CPR, creating inconsistency between the POLST and the physician orders. Resident R50 had diagnoses including COPD, respiratory failure, and diabetes, and had a POLST indicating DNR, but current physician orders also lacked evidence of code status. During interviews, the DON confirmed that Resident R14’s record lacked active physician orders reflecting code status and that Resident R38’s physician orders and POLST were not consistent, and further confirmed that resident physician orders and POLST should match regardless of the POLST.
Advance Directive Not Available in Resident Record
Penalty
Summary
The facility failed to ensure a resident exercised the right to formulate an Advance Directive. Review of the State Operations Manual, record review, and staff interview showed that Resident #5 had an advanced directive documented on a Care Conference Review Comprehensive dated 4/3/26, but the document could not be located in the medical record. Resident #5 was admitted and later readmitted to the facility with diagnoses including dementia with agitation, stroke, and pulmonary embolism. On 6/26/26 at 9:48 AM, a request was made for a copy of Resident #5's advanced directive. Later that day at 11:19 AM, the CEO confirmed that Resident #5 did not have an advanced directive on file. The report states that this deficiency involved 1 of 5 residents whose records were reviewed.
Failure to Offer Advance Directive Opportunity
Penalty
Summary
The facility failed to ensure residents were offered the opportunity to create an advance directive for Resident #13, who was re-admitted with multiple diagnoses including hypertension, chronic kidney disease, and mild cognitive impairment. Record review on 6/24/26 showed that Resident #13 did not have an advance directive on file. On 6/25/26 at 2:43 PM, the Social Service Director stated there was no documentation that education was provided to Resident #13 and no attempts were made to obtain an advance directive.
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