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:
Missing COVID-19 Vaccine Offer and Documentation: The facility failed to document that several residents were offered the COVID-19 vaccine or had informed declinations on file. EMR review showed no vaccine-offer documentation for multiple residents over several years, and staff could not confirm current consents or declinations. For staff, the COVID education materials reviewed during orientation covered COVID symptoms and masking, but did not include vaccine education or how to obtain the vaccine, despite verbal education being reported.
The facility failed to maintain documentation for 4 staff members regarding COVID-19 vaccination. Record review showed no evidence that the staff were educated on the vaccine’s benefits and risks, offered the vaccine or information on how to obtain it, or had their vaccination status documented for CDC NHSN reporting. The DON stated the COVID-19 immunization was offered to all staff during flu season, but it was not documented.
Missing COVID-19 Immunization Documentation for Two Residents: The facility failed to document COVID-19 vaccine education, consent, receipt, refusal, or medical contraindication for two residents. One resident had moderate cognitive impairment and the other had severe cognitive impairment; both had no immunization information in the EMR, and staff interviews confirmed the admitting nurse was responsible for screening and documenting vaccine status, but the records were incomplete.
Missing Staff COVID-19 Vaccination Documentation: The facility did not maintain required documentation of staff screening, education, offering, and current COVID-19 vaccination status. RN G stated vaccination information was shared at staff meetings and offered yearly, but the facility did not keep records of the education provided or which staff received it. A CNA reported being offered the COVID vaccine through a staff chat platform and had a signed declination in the employee record, while the NHA and DON acknowledged the documentation requirement.
Staff COVID-19 Vaccine Education and Offer Not Documented: The facility failed to document education on the benefits and risks of the COVID-19 vaccine and failed to document that the vaccine was offered to three sampled staff members. Record review showed the employee files lacked evidence of vaccine education or an offer of vaccination, and interviews with the IP, DSD, CNA, and DNS confirmed the facility had not continued offering the vaccine or ongoing COVID-19 education after orientation, despite the facility policy requiring staff education and offering the vaccine.
Failure to document staff COVID-19 vaccine education and vaccination status. The facility's policy stated employee vaccination status would be assessed before or upon duty assignment and that declined vaccines would be documented, but the Infection Preventionist said the facility did not keep records of SARS or COVID-19 vaccine education or whether employees received or declined the vaccine. A Nurse Consultant confirmed there was no documentation for the sampled staff.
Missing COVID-19 Vaccine Offer and Documentation
Penalty
Summary
The facility failed to offer and provide, or obtain an informed declination for, the COVID-19 vaccine for five residents: R5, R44, R8, R48, and R49. Record review showed that R5’s EMR lacked documentation of a COVID-19 vaccine being offered since 2021, R8’s EMR lacked documentation since 2023, and R44, R48, and R49 each lacked documentation of a COVID-19 vaccine being offered since 2024. Administrative Staff A stated she did not have current consents or declinations for the residents. For staff vaccination education, Administrative Staff A reported she was unsure whether the facility offered COVID-19 vaccine education to staff. Consultant Staff HH stated that new hires received COVID education during orientation and were offered the vaccine through their own provider or through the facility if they could not receive it elsewhere. However, the PowerPoint used for COVID education only covered what COVID was, symptoms, and masking or staying home, and it did not include education about the COVID-19 vaccine or how to obtain one. Consultant Staff HH stated that vaccine education was completed verbally during the education.
Missing Documentation for Staff COVID-19 Vaccination
Penalty
Summary
The facility failed to maintain documentation related to staff COVID-19 vaccination for 4 staff members identified as Staff 1, 2, 3, and 4. Record review showed there was no documentation that these staff members were provided education regarding the benefits and potential risks associated with the COVID-19 vaccine, offered the vaccine or information on how to obtain it, or had their COVID-19 vaccination status documented as required by CDC NHSN reporting. During the record review, the employee files for these staff members did not show that immunizations had been offered or administered. In interview, the DON stated that the COVID-19 immunization was offered to all staff during flu season but was not documented.
Missing COVID-19 Immunization Education and Documentation
Penalty
Summary
The facility failed to implement its policy to ensure residents or their responsible parties received education on the benefits, risks, and potential side effects of COVID-19 immunization, and to document whether the vaccine was received, refused, or not given due to medical contraindication for 2 of 5 residents reviewed. The deficiency involved Resident #3 and Resident #65, and the report states that the lack of documentation could place residents at risk of not being informed of complications and potential adverse health outcomes. Resident #3 was a male admitted with vascular dementia, and his quarterly MDS showed a BIMS score of 10, indicating moderate cognitive impairment. His admission and quarterly MDSs did not include COVID-19 vaccination information, his care plan did not address immunizations, and his electronic medical record had no information in the immunization tab. Resident #65 was a male admitted with cellulitis of the right lower limb, and his admission MDS showed a BIMS score of 3, indicating severe cognitive impairment. His MDS indicated that pneumonia and COVID-19 vaccinations were not up to date, but his care plan did not address immunizations and his electronic medical record also lacked immunization documentation. During interview, the ADON stated the facility did not have consent forms for Resident #65 and that the medical record did not contain vaccine information. She said the resident was combative and not agreeable at times, and that the facility would call the family to obtain consent or ask whether he had received the vaccines. The DON stated immunization history should be completed as soon as records are received and that if vaccine data was not available, it should be documented in the nurse's note. The Unit Manager for Resident #3 stated the admitting nurse was responsible for screening for vaccinations and that if the resident refused immunizations, it should have been documented. The Infection Control Nurse and Education Coordinator stated the admitting nurse was responsible for screening residents for immunizations and offering the vaccine.
Missing Staff COVID-19 Vaccination Documentation
Penalty
Summary
The facility did not maintain documentation of screening, education, offering, and current COVID-19 vaccination status for staff. The facility policy titled, Employee Infection and Vaccination Status, revised January 2024, states employees are to be offered or provided vaccinations per state or local policies, given educational materials for non-mandated vaccinations, and have declinations documented in the employee health record. During interview, RN G stated staff vaccination information was provided at staff meetings and offered yearly, but the facility did not maintain documentation of the education provided or which staff received it, although current vaccination status was kept. During interview and record review, CNA P reported being offered the COVID vaccine and influenza vaccine through a staff chat platform and stated they did not receive the COVID vaccine. CNA P’s employee record showed vaccinations received at hire on 10/12/22 and a signed declination for the COVID vaccine on that date. On 06/24/26, the NHA and DON acknowledged the regulation requiring documentation of screening, education, offering, and current COVID vaccination status for staff. The DON stated they were unaware this was not being done and said the facility used to maintain this information, with the expectation that the Infection Preventionist would maintain the required documentation for all staff.
Staff COVID-19 Vaccine Education and Offer Not Documented
Penalty
Summary
The facility failed to educate and offer COVID-19 vaccination to three of three sampled employees, CNA 5, CNA 7, and LVN 5, and their employee files did not contain documentation that they were provided education about the benefits and potential risks associated with the COVID-19 vaccine or that the vaccine was offered. During record review with the DSD, the employee files for these three staff members were reviewed and found to lack the required documentation. The DSD stated the facility had not offered the COVID-19 vaccine to staff since 2023 because it was no longer required. During interviews, the IP stated the facility did not offer COVID-19 vaccinations for staff because it was no longer mandated for staff to be vaccinated. CNA 8 stated she could not remember the last time she received information or was offered a COVID-19 vaccination at the facility and said COVID-19 had not been brought up in recent years. The DNS reviewed the facility policy titled, Coronavirus Disease (COVID-19)-Vaccination of Staff, dated May 2024, and stated the facility provided COVID-19 education and vaccination only at orientation upon hire and did not continue ongoing education or offer the vaccine after the initial orientation period. The DNS also stated the facility's policy was not being followed.
Failure to Document Staff COVID-19 Vaccine Education and Status
Penalty
Summary
The facility failed to document whether it educated staff about severe acute respiratory syndrome (SARS) or the COVID-19 vaccine, and failed to document whether staff received or declined the COVID-19 vaccine. Review of the facility policies for COVID-19 Vaccine and Employee Infection and Vaccination Status, last reviewed in 2026, stated that prior to or upon an employee's duty assignment, the facility would assess the employee's vaccination status against infectious conditions and that employees would be current with mandated vaccinations prior to performing resident care. The policy also stated that vaccinations declined by an employee would be documented on the applicable form. During interview, the Infection Preventionist stated the facility did not think it documented employees' education or vaccination status. When asked for documentation for one sampled employee and then four additional sampled staff members, the Infection Preventionist said the facility did not keep employee records of SARS or COVID-19 vaccine education, or records showing whether employees had received the SARS or COVID-19 vaccine. Nurse Consultant #1 also stated the facility had not documented whether the five sampled staff had declined or been administered the COVID-19 vaccine.
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