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:
Incomplete DNR Forms for Two Residents: Two residents with DNR status had incomplete DNR paperwork. One resident with CKD and severe cognitive impairment had no resident signature on the DNR form, and the physician signed on the wrong line. Another resident with Alzheimer’s disease and severe cognitive impairment had the resident signature on the proxy line, but the physician signature, date, printed name, and license number were missing. The SW and ADM verified the forms were not completed correctly.
Incomplete DNR forms were found for two residents with DNR status. One resident with chronic respiratory failure, heart failure, and type 2 diabetes had a DNR form with the resident’s signature on the wrong line and an undated physician signature, and another resident with renal disease and type 2 diabetes had the resident’s signature on the wrong line with the Person’s Signature line left blank. The DON and SW both verified the missing information and stated the forms were not completed correctly.
Failure to Review Residents’ AD Decisions: The facility did not ensure that 3 residents were informed of and had their AD decisions reviewed. Each resident was able to make needs known and was their own responsible party, but the EHR did not show review of AD decisions on admission or at care conferences. The Social Services Director and Administrator both acknowledged the missing reviews.
A resident with CHF, pulmonary edema, and chronic respiratory failure had care plan and IDT documentation stating an Advance Directive was on file and up to date, but the document could not be found in the record. The ADON stated only a POST form was present, confirmed a POST is not an Advance Directive, and said there was no copy of the resident’s Advance Directive on file.
Failure to Assist Residents With Advance Directive Formulation: Multiple residents had no advance directive in the chart or documented follow-up after social services notes showed they either already had a POA/Living Will or wanted help completing one. Residents with conditions including fx, chronic resp failure, delirium, sepsis, HTN, CKD, AFib, UTI, discitis, and anemia had incomplete documentation, and one care plan had conflicting POA/Living Will information.
Incomplete OOH-DNR Documentation: A resident with severe cognitive impairment, dementia, HTN, CAD, and dysphagia had DNR status documented, but the OOH-DNR form was not fully completed. The form was signed by the qualified relative, yet the attending physician did not sign the required section and the document lacked the physician's dated signature, printed name, and license number; the DON stated the form was still valid based on the witness signature date.
Incomplete DNR Forms for Two Residents
Penalty
Summary
The facility failed to ensure that two residents with documented DNR status had properly completed DNR forms. One resident was a male admitted with chronic kidney disease and acute cystitis with hematuria; his face sheet and physician order summary both reflected DNR status, and his MDS showed severe cognitive impairment with a BIMS score of 6. His DNR form dated 8/06/24 did not contain the resident’s signature, and the physician signed on the line intended for the resident’s signature. The second resident was a female admitted with Alzheimer’s disease and chronic kidney disease; her face sheet and physician order summary also reflected DNR status, and her MDS showed severe cognitive impairment with a BIMS score of 3. Her DNR form dated 09/25/25 had the resident’s signature on the line for a legal guardian, agent, or proxy, but the physician’s signature, date, printed name, and license number were missing. The social worker and administrator both verified the missing information and stated the forms were not valid if not completed correctly.
Incomplete DNR Forms for Two Residents
Penalty
Summary
The facility failed to ensure that two residents with DNR status had completed DNR forms with all required information. Resident #9, a male with chronic respiratory failure, heart failure, and type 2 diabetes, had a DNR order on the physician order summary and a care plan for DNR, but the DNR form showed the resident’s signature on the line for Guardian/Agent/Proxy/Relative Signature, the Person’s Signature line was blank, and the physician’s signature was not dated. Resident #35, a male with renal disease and type 2 diabetes, also had a DNR order and a care plan for DNR, but the DNR form showed the resident’s signature on the line for Guardian/Agent/Proxy/Relative Signature and the Person’s Signature line was blank. During interviews, the DON stated the DNR was not valid if it was not filled out correctly and verified the missing information on the forms for Residents #9 and #35. He stated the SW was responsible for making sure the DNR was completed accurately and that quarterly audits of DNRs were completed for accuracy. The SW also verified the missing information on the DNR forms for both residents and stated she and the resource nurses were responsible for ensuring DNRs were completed correctly. The facility’s Social Services policy stated advance directives would be recognized and respected and that the facility would implement residents’ decisions and directives in compliance with state and federal law and facility policy.
Failure to Review Residents’ Advance Directive Decisions
Penalty
Summary
The facility failed to ensure that residents were informed of their right to establish an advance directive for 3 of 3 sampled residents reviewed for advance directives. Resident 6 was admitted with diagnoses including COPD and diabetes, was able to make needs known, and was their own responsible party, but the electronic health record did not show that the facility reviewed the resident’s advance directive decisions. Resident 11 was admitted with diagnoses including metabolic encephalopathy and diabetes, was able to make needs known, and was their own responsible party, but the record also did not show review of advance directive decisions. Resident 141 was admitted with diagnoses including acute kidney failure and diabetes, was able to make needs known, and was their own responsible party, but the record did not show review of advance directive decisions. During interviews, the Social Services Director stated that residents’ advance directive decisions should be reviewed on admission, at quarterly care conferences, and at the resident’s request. The Social Services Director later stated that Resident 6’s most recent care conference on 02/24/2026 did not include review of the advance directive decision, Resident 11’s initial care conference on 04/07/2026 did not include review, and Resident 141’s most recent care conference on 11/17/2025 did not include review. The Administrator also stated that social services would review advance directive decisions with residents on admission and at quarterly care conferences, and acknowledged that the lack of review for Residents 6, 11, and 141 did not meet expectations.
Advance Directive Not Located in Resident Record
Penalty
Summary
The facility failed to ensure residents exercised their right to formulate an Advance Directive for Resident #33. The State Operations Manual defines an Advance Directive as a written instruction such as a living will or durable power of attorney for health care, and distinguishes a POLST form from an Advance Directive. Resident #33 was readmitted with multiple diagnoses including congestive heart failure, pulmonary edema, and chronic respiratory failure. Resident #33’s care plan, initiated on 5/4/26 and revised on 5/18/26, documented that the resident had an Advance Directive on file and that it was up to date. An IDT Conference Note dated 5/12/26 also documented that the resident’s Advance Directives were reviewed, accurate, and up to date. However, the resident’s Advance Directive could not be located in the record. On 5/28/26, the ADON stated she only saw the resident’s POST form, acknowledged that a POST form is different from an Advance Directive, and stated she did not believe Resident #33 ever gave the facility an Advance Directive; she confirmed there was no copy on file.
Failure to Assist Residents With Advance Directive Formulation
Penalty
Summary
The facility failed to ensure residents and their representatives received assistance to exercise their right to formulate an Advance Directive. Based on policy review, record review, and staff interview, 9 of 12 reviewed residents did not have an advance directive in the medical record or documentation that advance directive information was provided, discussed, or followed up on with the resident or representative. The facility policy stated that on admission the facility would determine whether the patient had executed an advance directive and, if not, determine whether the patient would like to formulate one. Several resident records showed social services notes documenting that the resident either already had a POA/Living Will or wanted assistance obtaining one, but the records did not contain the actual advance directive or documented follow-up. Resident #2, admitted with a nondisplaced left femur fracture and chronic respiratory failure, stated he had a POA/Living Will and that the facility could obtain a copy, but the record did not show an advance directive or follow-up. Resident #37, admitted with a displaced intertrochanteric fracture and delirium, stated she did not have one and wanted assistance making one, yet the record did not document the completed directive at the time of review. Resident #60, with diabetes and anxiety, and Resident #66, with acute embolism/thrombosis and anemia, both stated they had advance directives and would have family provide copies, but no copies or follow-up documentation were present. Additional records also lacked required documentation. Resident #61, with multiple rib fractures and atrial fibrillation, had no advance directive documented and no social services note showing the resident was asked about one or offered assistance. Resident #3, with UTI and discitis, had a social services note indicating she had a POA/Living Will and would let family know, but no advance directive or follow-up was documented. Resident #17, with sepsis and hypertension, had conflicting documentation in social services and care planning records regarding POA/Living Will status, while the baseline care plan did not address advance directive status. Resident #29, with a fractured pubis and chronic kidney disease, and Resident #52, with a fractured hip and hypertension, also lacked advance directive documentation in the medical record.
Incomplete OOH-DNR Documentation
Penalty
Summary
The facility failed to ensure a resident had a properly completed advance directive for Resident #5, whose electronic face sheet listed Advance Directives: DNR. Resident #5 had diagnoses including unspecified dementia with behavioral disturbance, hypertension, atherosclerotic heart disease with angina, and dysphagia. The quarterly MDS reflected a BIMS score of 0, indicating severe cognitive impairment, and the quarterly care plan noted that the resident's family/representative completed documentation for DNR status and that the code status would be reviewed quarterly and as needed. Record review of the resident's OOH-DNR form dated 12/08/22 showed the form was signed by the qualified relative in section C, but the attending physician did not sign section E, and the form did not include the physician's dated signature, printed name, or license number. Section F, which required all persons who signed above to acknowledge the document was properly completed, was also not signed by the physician. During interview, Social Services stated DNR forms must be filled out completely and said forms may not be valid if the physician's dated signature and license number were missing. The DON stated the form was valid and said they went with the date of the witness signature when the physician's signature was not dated.
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