Failure to Obtain Valid Consent and Provide Education Before COVID-19 Vaccination
Summary
The deficiency involves the facility’s failure to obtain valid legal consent and provide required education prior to administering a COVID-19 vaccine to one resident. The resident’s immunization record showed that a COVID-19 vaccine was administered intramuscularly on 12/12/2024 by the Infection Preventionist (IP) A, with the EHR documenting the vaccine status as complete, consent confirmed by IP A, and education provided. However, record review showed that the resident had been deemed incapacitated on 08/06/2024 through a statement of capacity indicating an inability to make informed medical decisions. Despite this, a consent form for the COVID-19 vaccination was signed by the resident on 10/20/2024, and a separate consent form was signed by IP A acknowledging verbal consent from a family member identified as the resident’s legal guardian on the same date. Further review and interviews revealed that the family member did not become the resident’s legal guardian until 12/05/2024 and denied ever giving verbal consent for the COVID-19 vaccination, stating that consent would have been declined due to the resident’s medical history of Type 2 myocardial infarction and concerns about cardiovascular side effects associated with the vaccine. The family member also reported that no COVID-19 vaccine education was provided to either the resident or the family member. IP A stated in interview that verbal consent had been obtained from the family member and acknowledged that incapacitated residents cannot provide consent, and the Nursing Home Administrator confirmed that consent must come from the resident or legal guardian. The facility’s own COVID-19 Vaccination Policy required a signed consent from the resident or designated health care representative, or consent by two physicians for residents incapable of consenting without a representative, and required validation of consent and education prior to vaccine administration, which was not followed in this case.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
COVID-19 Vaccination Consent and Education Deficiencies: The facility failed to administer a COVID-19 vaccine to a resident who had already consented, and failed to document CDC vaccine education for two residents whose sons declined vaccination by phone. The RN responsible for infection prevention stated the facility did not currently have COVID-19 vaccine available and did not mail or document education for family review, while the DON stated residents and resident representatives needed full vaccination education and documentation of understanding.
Failure to Offer and Document COVID-19 Immunization: A resident with CAD, HTN, and non-Alzheimer's dementia had no documented review of immunization history, no COVID-19 vaccine status in the EMR, and no evidence that vaccine education, consent, or declination was completed. The IP stated the admission nurse should review immunizations within 24 hours and verify status through MIIC before offering needed vaccines, but the resident's record showed none of this had been done.
Failure to Educate and Document COVID-19 Vaccination Status: The facility did not document that a resident with a stroke diagnosis who could not make needs known, or the resident's representative, was educated on the risks and benefits of the COVID-19 vaccine or offered/administered the vaccine. Staff interviews also showed that employees were only asked for vaccine status on hire and were not educated on the vaccine, offered it, or directed where to obtain it, despite expectations from the HR Director, DNS, and Administrator.
The facility failed to document COVID-19 vaccine education, vaccination status, or refusal/contraindication information for two residents. One resident had acute kidney failure and the other had ESRD; both records lacked immunization data in the EMR and care plan. Interviews showed the ADON, DON, DCE, and Administrator described shared responsibility for admission paperwork and vaccine documentation, but the required documentation was not found in the records reviewed.
Failure to Offer COVID-19 Vaccine on Readmission: A resident with moderate cognition stated the facility did not offer the COVID-19 vaccine when he was readmitted, despite his request to receive it. The ID nurse said she did not re-offer the vaccine because he had refused it earlier in the same season, and the vaccine order and documentation were not in the EMR until later. The DON stated residents are to be offered the vaccine on admission, readmission, and upon request, with consent or refusal documented.
COVID-19 vaccination status was not assessed, discussed, offered, or documented for two residents reviewed for immunizations. One resident with diabetes and HTN had a last documented COVID-19 vaccine in 2021, but the record lacked evidence of admission assessment, CDC-based discussion, or an offer of the recommended vaccine. Another resident with CAD, HF, and thyroid disease also had no documentation of vaccination assessment, education, offer, or declination. Staff and the DON stated immunizations were expected to be reviewed and documented at admission.
COVID-19 Vaccination Consent and Education Deficiencies
Penalty
Summary
The facility failed to ensure an eligible resident received the COVID-19 vaccination after consent had been obtained. R30’s admission MDS identified multiple diagnoses including multiple sclerosis, CHF, rheumatoid arthritis, and Parkinson’s disease, and the resident was not up to date for COVID-19 vaccination. An Immunization Consent form dated 2/17/26 showed R30 consented to receive the COVID-19 vaccine, but the medical record did not show that the vaccine was administered or explain why it was not given. During interview, the RN responsible for infection prevention and resident vaccinations stated she was unsure why R30 had not received the vaccine and said the facility did not currently have any COVID-19 vaccine available, noting vaccines were usually ordered once per year in the fall. The facility also failed to provide current CDC COVID-19 vaccine education regarding the potential benefits and risks of vaccination before obtaining refusals for two residents. R16 and R42 were both not up to date for COVID-19 vaccination, and their Immunization Consent forms documented that their sons declined the vaccine by phone. However, the forms did not identify what education had been provided to the resident representatives. The RN stated that family members often did not want to read the education, so she did not mail education to anyone for review and did not document that it was provided. The DON stated the resident and resident representative needed to be provided all vaccination education so they could understand what they were refusing or consenting to, and that documentation should reflect their understanding of that education.
Failure to Offer and Document COVID-19 Immunization
Penalty
Summary
The facility failed to ensure COVID-19 immunization was offered and/or administered in accordance with current standard of practice for 1 of 5 residents reviewed for immunizations. Resident R29 was admitted on 4/29/26 and had diagnoses including coronary artery disease, hypertension, and non-Alzheimer's dementia. The resident's electronic medical record lacked a review of current immunizations, including any prior vaccination history, and did not show the current status of COVID-19 vaccinations. The record also lacked any consent for vaccination reviewed with R29 or the responsible party, including no documentation that vaccines were offered or refused. During interview, the infection preventionist stated the admission nurse was responsible for reviewing immunization status within the first 24 hours and that the status was then verified through MIIC before needed immunizations were offered. Upon review of R29's immunization tab, the infection preventionist stated the resident's immunization status had not been reviewed and the record lacked vaccination history or evidence that vaccinations were offered. The facility policy required residents to be screened for eligibility, educated on vaccine risks and benefits, and have consent or declination documented before vaccination orders and administration.
Failure to Educate and Document COVID-19 Vaccination Status
Penalty
Summary
The facility failed to implement policies and procedures to ensure each resident and staff member was offered and received education about the COVID-19 vaccine, and that vaccination status was properly documented. Review of the electronic health record for Resident 75 showed the resident was admitted with a diagnosis of stroke and was not able to make needs known. The record contained no documentation that Resident 75 or the resident's representative was educated on the risks and benefits of the COVID-19 vaccine, or that the vaccine was offered or administered. During interviews, the LPN/Infection Preventionist stated the facility should have offered and educated the resident or representative on the COVID-19 vaccine but found no records showing this was done for Resident 75. The DNS stated it was the expectation that Resident 75 or the representative received education on the risks and benefits and was offered the vaccine. For staff vaccination practices, the Human Resources Director stated staff COVID-19 vaccine status was requested on hire, but staff were not educated on the risks and benefits, offered the vaccine, or directed where to obtain it. The Administrator stated it was the expectation that residents receive education and be offered the vaccine, and that staff be provided education and offered or directed where to obtain the vaccine on hire, with this documented and tracked.
Missing COVID-19 Immunization Documentation for Two Residents
Penalty
Summary
The facility failed to document COVID-19 vaccination education, vaccination status, or refusal/medical contraindication information for 2 of 9 residents reviewed for immunizations. The deficiency involved Resident #2, a female admitted with acute kidney failure with tubular necrosis, and Resident #115, a female admitted with end stage renal disease who was later discharged. For both residents, the electronic medical record showed no data available in the immunization tab, and the care plans did not include immunization information. For Resident #2, the admission MDS showed she was rarely or never understood and could not complete a BIMS. Her MDS also showed she did not receive the influenza vaccine in the facility and was not present during the influenza vaccination season, and that her pneumococcal vaccination was not up to date and had been offered and declined. However, the record did not show documentation that she or her responsible party received education on the benefits, risks, or potential side effects of COVID-19 immunization, or documentation of receipt, refusal, or medical contraindication for the COVID-19 vaccine. For Resident #115, the entry MDS contained no information related to cognition or immunization status, and the Medicare 5 Day and Death in Facility MDS assessments were still in progress. The ADON, who said she was the Infection Preventionist, stated residents were asked during admission about influenza, pneumonia, and COVID vaccines and that refusals should be documented, but she could not find Resident #115's admission packet and was unsure whether the admission paperwork had been completed within the 72-hour timeframe. Interviews with the ADON, DON, DCE, and Administrator showed that responsibility for admission paperwork and immunization documentation was shared among multiple staff, but the required documentation was not present in the records reviewed.
Failure to Offer COVID-19 Vaccine on Readmission
Penalty
Summary
The facility failed to follow its policy to provide COVID-19 vaccination upon readmission for one resident in a sample of 20 residents reviewed. The resident’s MDS dated May 6, 2026 documented a BIMS score of 13, indicating moderate cognition. On May 26, 2026, the resident was observed in a wheelchair, alert and oriented to person, place, and time, calm, and free from pain. The resident stated he had been in the facility since March 2026 and reported that when he first arrived about 6 months earlier, the facility did not offer the COVID-19 vaccine. He stated he requested the vaccine and was told by the DON that it had to be requested from the lab, and he had still not received it but remained interested in receiving it. The Infectious Disease Nurse stated she was responsible for offering vaccinations and providing education, and that residents are to be offered vaccinations upon admission, readmission, every 6 months after the initial COVID-19 vaccination, or per request. She stated the resident had been readmitted in early March and that she had offered the COVID-19 vaccine before discharge, but did not offer it again upon readmission because he had refused in February and she would not ask again within the same season. She also stated the resident requested the vaccine, but there were no vaccines available at that time. Review of the provider order sheet showed a new order for the COVID-19 vaccination entered on May 27, 2026. The DON stated residents are to be offered the vaccine during admission, readmission, and if they inquire about receiving it, and that consent or refusal is to be documented in the electronic medical record.
COVID-19 Vaccination Status Not Assessed or Documented for Two Residents
Penalty
Summary
The facility failed to assess COVID-19 vaccination status and ensure current CDC-recommended COVID-19 vaccination was offered and documented for 2 of 5 residents reviewed for immunizations, including R20 and R27. R20 was admitted with diagnoses of diabetes and hypertension, was cognitively intact, and able to make her needs known. Her record showed the last documented COVID-19 vaccination was given on 11/23/21, but there was no evidence that her vaccination status was assessed on admission, that current CDC recommendations were discussed, or that she was offered the recommended COVID-19 vaccination after admission. R27 was admitted to the facility and had diagnoses of coronary heart disease, heart failure, and thyroid disease. Her medical record also lacked evidence that staff assessed her COVID-19 vaccination status upon admission, provided education regarding current CDC recommendations, offered vaccination, or obtained a documented declination. The infection preventionist stated immunizations were offered upon admission and seasonally, and the DON stated she expected immunizations to be discussed with the resident and/or resident representative upon admission and per CDC guidance, with documentation in the medical record. The facility's standard work process stated staff reviewed vaccination history at admission, assessed whether vaccinations including COVID-19 were needed, discussed the most current VIS, and documented administration or declination.
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