Failure to Document COVID-19 Vaccine Education
Summary
The facility failed to document education regarding the benefits and potential side effects of the COVID-19 immunization for three residents. Resident #10, who was cognitively intact, had no record of receiving this information in their medical file. Similarly, Resident #35, also cognitively intact, lacked documentation of such education. Resident #41, who was moderately cognitively impaired, also had no record of being informed about the benefits and potential side effects of the COVID-19 vaccine in their medical file. The Director of Nursing (DON) explained that the facility had recently reviewed and adjusted their immunization protocol. They discovered that the consent forms previously used did not include information on the risks and benefits of the COVID-19 vaccine. New consent forms with the required information were obtained from the pharmacy and implemented starting in December 2023 for new admissions. However, the lack of documentation for the three residents mentioned occurred before these changes were made. The Administrator confirmed that the facility had made changes to their immunization program after realizing the previous consent forms were inadequate. The new consent forms, which included the necessary risk and benefit information, were introduced in December 2023. Despite these updates, the deficiency was noted for the three residents whose records did not reflect the required education prior to the implementation of the new consent forms.
Penalty
Resources
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Surveyors determined that the facility did not document that several residents with conditions such as COPD, stroke, Parkinson’s disease, bipolar disorder, congestive heart failure, and diabetes were offered a COVID-19 vaccine or received required education on its benefits, risks, and potential side effects, despite a facility policy stating that residents would be educated and encouraged to stay up to date with COVID-19 vaccines. Review of consent/declination forms and immunization records showed no evidence that the vaccine was offered or declined, and the ICP confirmed the lack of documentation.
Surveyors determined that the facility did not follow its COVID-19 vaccination policy for two residents with multiple comorbidities, including muscle wasting, osteonecrosis, osteoarthritis, protein-calorie malnutrition, and dementia. Record review showed no documentation that these residents were educated on the risks, benefits, and potential side effects of the COVID-19 vaccine, nor that they were offered the opportunity to accept or decline vaccination, and the CRN confirmed there were no such records on file.
The facility did not follow its policy or CDC guidance requiring COVID-19 vaccination education, offers, and written consent for residents and staff. Two residents had no documentation that they were offered a 2025 COVID-19 vaccine or that they consented or refused, and another resident received a COVID-19 vaccine without any recorded informed consent. Additionally, five sampled employees had no evidence in their files that they were offered the COVID-19 vaccine for the 2025 season. The DON and Infection Preventionist confirmed that required consent and offer/refusal documentation for these residents and staff could not be produced.
A resident with cardiac conditions and moderate cognitive impairment had signed consents for a COVID-19 vaccine and booster through a representative, but review of records showed the resident never received a COVID-19 vaccination and lacked an updated consent or declination. The DON could not locate current vaccination forms, reported that vaccines were administered by an off-site company, and acknowledged that another vaccine clinic had not yet been scheduled, despite stating vaccines were to be offered yearly. The Infection Preventionist stated residents were offered COVID-19 vaccinations, while CDC guidance cited by surveyors recommended updated COVID-19 vaccines for adults, including those in LTC, with two doses for those 65 and older and consent required.
The facility failed to consistently offer COVID-19 vaccination and accurately document vaccination status for multiple residents. An Infection Preventionist/LPN reported that some residents had received prior COVID-19 vaccines and verbally declined further doses, but these refusals were not recorded in the immunization records. Cognitively intact residents stated that staff had not offered them the COVID-19 vaccine for an extended period and that they would have accepted it if offered. On the day of survey, the LPN produced COVID-19 vaccine consent forms dated the prior year, but residents reported signing them only that day and denied any earlier consents. The LPN admitted to completing the consents on the survey date, falsifying dates, and failing to document prior verbal refusals, contrary to the facility’s written policies on maintaining an updated COVID-19 vaccination program.
Surveyors found that a resident’s EMR lacked required documentation showing they had been educated about, offered, and either received or declined the COVID-19 vaccine. The EMR immunization report listed a historical COVID-19 vaccination date, but there was no supporting record of the immunization, consent, or declination. The Infection Preventionist could not provide the facility’s consent/declination form or any other documentation confirming that COVID-19 vaccination education and consent procedures, as required by facility policy, had been completed for this resident.
Failure to Document Offering and Education of COVID-19 Vaccination for Multiple Residents
Penalty
Summary
Surveyors found that the facility failed to document that certain residents were offered a COVID-19 vaccine and received required education on its benefits, risks, and potential side effects, as required by 42 CFR 483.80(d)(3). The facility’s policy titled “Covid Protocols Post PHE,” dated 1/5/26, stated that vaccines are administered in accordance with CDC recommendations, that all residents are encouraged to remain up to date with recommended COVID-19 vaccine doses, and that staff and residents will be educated on the risks and benefits of the COVID-19 vaccination and will be offered the vaccination. However, for four of five residents reviewed for immunizations, the clinical records and consent/declination forms did not contain evidence that the COVID-19 vaccine was offered or that education was provided. Resident records showed that one resident admitted with COPD, one with a history of stroke, one with Parkinson’s disease and bipolar disorder, and one with congestive heart failure and diabetes each had a “Resident Influenza/Pneumococcal/Covid-19 Consent Declination” form completed in October 2025 that lacked documentation that the COVID-19 vaccine was offered. Additionally, the “Immunizations” sections of their clinical records, reviewed on 4/10/26 at 11:00 a.m., did not include information that COVID-19 vaccines were offered or declined. During an interview at the same time, the Infection Control Preventionist confirmed that the facility failed to document that these residents were offered a COVID-19 vaccine and that they or their representatives were provided education regarding the benefits and potential side effects of the immunization.
Plan Of Correction
The facility will document that each resident was offered a Covid 19 immunization and the resident or resident's representative was provided education regarding the benefits and potential side effects of immunizations. Resident R 20 is no longer in the facility. Resident R24, R31, R98 will be offered the Covid 19 immunization, and the resident or resident's representative will be provided education regarding the benefits and potential side effects of immunizations. On Admission and annually residents will be offered a Covid 19 immunization, and the resident or resident's representative was provided with education regarding the benefits and potential side effects of immunizations. Education will be provided to the licensed Nursing Staff that resident on admission and annually need to be offered the COVID-19 Immunization provided education regarding the benefits and potential side effects of immunizations.Audits will be completed by the DON/Designee on 10% of facility admission for being offered and educated on side effects of the COVID-19 weekly times four and monthly times twoResults of these audits will be reviewed at the QAPI committee meeting for further recommendations.
Failure to Document COVID-19 Vaccine Education and Offer for Residents
Penalty
Summary
Surveyors found that the facility failed to follow its COVID-19 Vaccination policy requiring documentation in the medical record of education on risks, benefits, and potential side effects of the COVID-19 vaccine, as well as documentation of each dose administered or the reason for non-receipt (medical contraindication or refusal). Record review for two residents showed no documentation that they were offered the opportunity to accept or decline the COVID-19 vaccine, nor that any vaccine-related education was provided. One resident was readmitted with multiple diagnoses including muscle wasting and osteonecrosis, and another was admitted with multiple diagnoses including osteoarthritis, protein-calorie malnutrition, and dementia, yet neither record contained any entries regarding COVID-19 vaccine education or offer. In staff interview, the Clinical Resource Nurse confirmed there were no records on file related to educating or offering the COVID-19 vaccine for these residents. This deficient practice created the potential for harm when residents were not offered education related to the risks and benefits of receiving the COVID-19 vaccination.
Failure to Educate, Offer, and Document COVID-19 Vaccination for Residents and Staff
Penalty
Summary
The facility failed to follow its Coronavirus Prevention and Control policy requiring that all residents and staff be educated about COVID-19 vaccination, be offered the vaccine unless contraindicated or already fully immunized, and that written informed consent be obtained and documented prior to administration. Record review showed that two residents’ immunization records contained no evidence that they were offered a COVID-19 vaccination for 2025, and there was no documentation of either consent or refusal in their medical records. Another resident received a COVID-19 vaccination in 2025 with no evidence in the record that the resident or resident representative had provided informed consent for that vaccination. Review of employee files revealed that five sampled staff members had no documentation that they were offered the COVID-19 vaccine for the 2025 season. The DON confirmed that consent forms should be present in the medical record for all vaccinations, including COVID-19, and was unable to provide evidence of COVID-19 consents or offer/refusal documentation for the three sampled residents for 2025. In a joint interview, the DON and the Infection Preventionist also confirmed they could not provide evidence that COVID-19 vaccinations had been offered to the five sampled employees, despite current CDC guidance emphasizing the importance of updated COVID-19 vaccination, particularly for individuals aged 65 and older and those living in LTC settings.
Failure to Ensure Appropriate COVID-19 Vaccination and Documentation
Penalty
Summary
The facility failed to administer appropriate COVID-19 vaccinations in accordance with CDC guidance for one resident. Resident 45 had diagnoses including aortic valve insufficiency, heart disease, and muscle weakness, and a quarterly MDS dated 3/9/26 documented moderately impaired cognition. A COVID-19 vaccine consent and a COVID-19 booster consent were signed by the resident’s representative on 12/6/24. However, a review of the vaccination record showed the resident had not received any COVID-19 vaccination, and the record also indicated that the family representative had refused the vaccination in December 2024. The clinical record lacked an updated or yearly COVID-19 vaccination consent or declination. During interviews, the DON stated she was unable to locate current COVID-19 vaccination forms for this resident and confirmed that the facility did not administer vaccinations directly, instead using an off-site company to provide vaccines. She acknowledged that another vaccine clinic needed to be scheduled but had not yet done so, and also stated that COVID-19 vaccinations were to be offered yearly. The Infection Preventionist reported that residents were offered COVID-19 vaccinations. CDC guidance reviewed by surveyors indicated that adults, including those in LTC settings, should receive an updated COVID-19 vaccine, and that individuals aged 65 and older should receive two doses of an updated vaccine six months apart, with consent required from LTC residents. The deficiency was cited under 410 IAC 16.2-3.1-18(b)(5).
Failure to Offer and Accurately Document COVID-19 Vaccination and Falsification of Consent Records
Penalty
Summary
The deficiency involves the facility’s failure to offer COVID-19 vaccinations and to accurately document COVID-19 vaccination status for four of five residents reviewed for immunizations. During an interview, the Infection Preventionist/LPN (V25) stated that infection control policies are reviewed annually and that the first positive COVID-19 case in the facility’s current outbreak occurred on February 26, 2026. While reviewing immunization records, V25 reported that certain residents had previously received COVID-19 vaccines in 2024 and that some had refused subsequent doses, but acknowledged that these refusals were not documented in the residents’ immunization records as required. Resident interviews conflicted with the documentation and staff statements. One cognitively intact resident (R25), with diagnoses including hypertensive heart disease without heart failure, lymphedema, multiple sclerosis, and reduced mobility, stated that staff had not offered a COVID-19 vaccine since 2024 and that the resident would have accepted it if offered, including an upcoming dose that had just been mentioned. Another cognitively intact resident (R103), with diagnoses including idiopathic gout, type 2 diabetes mellitus, hypertension, heart failure, osteoarthritis, and stage 3 chronic kidney disease, stated that the vaccine was only offered on the day of the survey and denied that staff had offered the COVID-19 vaccine during the previous year or during the recent outbreak. Further review revealed issues with documentation and consent forms. Shortly after the resident interviews, V25 provided four COVID-19 vaccine consent forms for residents reviewed for immunizations, all bearing dates in 2025. When questioned, V25 admitted not having spoken with these residents that day about vaccines and that only hallway rounds had been done. The residents reported signing the consent forms that day, not in 2025, and denied signing any prior COVID-19 vaccine consents. V25 then admitted to completing the consent documents on the day of the survey, falsifying and tampering with them by adding 2025 dates, and acknowledged that refusals had been verbal only and not documented in the charts. These actions were inconsistent with the facility’s written policies requiring an updated vaccination program for COVID-19 and encouraging staff and residents to remain up to date with recommended COVID-19 vaccine doses.
Failure to Document COVID-19 Vaccination Education and Status for a Resident
Penalty
Summary
Surveyors identified a deficiency in the facility’s process for COVID-19 vaccination education, offering, and documentation for one of six sampled residents. Record review on 03/25/2026 showed that Resident #124, admitted on an unspecified date, had no documentation in the EMR indicating that the resident or representative had been educated about, offered, received, or declined the COVID-19 vaccine. An Immunizations Report from the EMR listed the resident’s COVID-19 vaccination status as “historical” with a date of 12/5/24, but there was no supporting documentation of the immunization itself. During interviews on 03/25/2026, the Infection Preventionist was unable to produce the facility’s Vaccination Review: Consent/Declination SNF Resident Form for this resident and confirmed that documentation of offering education and obtaining consent or declination for COVID-19 vaccination was not available, despite the facility’s written policy requiring written affirmation for declinations, provision of vaccination fact sheets, and informed consent (written or verbal) for all individuals being vaccinated. This lack of documentation for Resident #124’s COVID-19 vaccination education, offer, consent/declination, and administration status constituted the cited deficiency.
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