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 Immunization Documentation for Staff and Residents: The facility failed to maintain required COVID-19 vaccine documentation for three staff members and two residents. Staff interviews showed the selected employees reported prior vaccination, but the facility had no records showing vaccine dates or type. For two residents, consent forms indicated they were up to date, but the date fields were blank and the facility had no evidence that immunization status was verified with family or the physician; one resident’s record showed the last COVID-19 vaccine was given years earlier.
The facility failed to keep required documentation showing staff were educated on the risks and benefits of the COVID-19 vaccine and that the vaccine was offered to staff who declined it. The IP stated she tracked staff vaccination status, but the record for an CNA showed conflicting information, with a prior dose documented while the tracking log also listed the CNA as refused and left the vaccination date blank. The IP confirmed there was no documentation that the CNA was offered the vaccine or provided the required education.
A resident was not offered the COVID-19 vaccine and was documented as not eligible because the resident was admitted after flu season. The IP and MD stated the facility held COVID-19 vaccinations from July through September so residents would not have to wait for the updated fall formulation, despite the facility policy stating the vaccine will be offered when available unless medically contraindicated, already immunized, or refused.
Incomplete COVID-19 Vaccine Consent and Declination Documentation: The facility failed to document current COVID-19 booster consent, declination, or administration status for several residents. Records showed one resident with an outdated declination, another with a booster consent lacking a signature date and no proof of the current vaccine, a third with consent but no documentation of administration, and a fourth with a declination but no current booster offer documented. An ADON verified the missing documentation and stated the facility updates immunization status in October.
Failure to Provide Consented COVID-19 Vaccine: A resident signed a VIS acknowledgment and vaccination consent indicating they received education and wanted the COVID-19 vaccine, but the vaccine was not given. The IP confirmed the resident had not received the vaccine and was unsure why it had not occurred.
COVID-19 Vaccination Education and Documentation Deficiency: The facility failed to document staff COVID-19 immunization education and failed to show that two residents were educated and offered the COVID-19 vaccine. One resident had no chart evidence of immunization status, education, or vaccination, while another had a prior COVID-19 vaccine history and a booster refusal, but no further evidence of vaccine offers or education after that refusal.
Missing COVID-19 Immunization Documentation for Staff and Residents
Penalty
Summary
The facility failed to maintain required documentation of COVID-19 immunization status for three staff members reviewed for vaccination records and for two residents reviewed for immunization concerns. The report states that the facility was expected to educate residents and staff on COVID-19 vaccination, offer the vaccine to eligible individuals after education, and document vaccination status, refusals, and related information. Review of the facility policy showed that vaccination information was to be recorded in the resident medical record and that staff vaccination records were to be maintained in the employee medical file, including documentation of vaccine status as indicated by NHSN. For staff, the facility could not provide documentation showing the date or vaccine type of COVID-19 immunizations for Employees 6, 21, and 22. Employee 6 reported receiving COVID-19 immunizations around 2020 with no immunizations since, Employee 21 reported being initially fully vaccinated with no immunizations since 2021, and Employee 22 reported receiving initial COVID-19 immunizations plus one booster around 2022 with no immunizations since then. The facility’s records initially listed the COVID-19 vaccination status of 247 of 249 staff as unknown, and later information showed some staff as fully vaccinated, partially vaccinated, exempt, or not vaccinated, but the facility still had no data showing the date or vaccine type for the selected staff. For residents, Resident 175’s record contained no data showing when she last received a COVID-19 immunization, and her husband signed a consent form stating she was up to date, but the date received field was left blank. The facility had no evidence that immunization status was verified with her husband or physician. Resident 11’s record also had a blank date field on the consent form, even though she refused the vaccine because she had received the current recommended COVID-19 vaccine; however, her immunization record showed her most recent COVID-19 vaccine was given on March 12, 2021. The record contained no evidence that the facility attempted to verify that she had received COVID-19 immunizations per current CDC guidance.
Missing COVID-19 Vaccine Education and Tracking Documentation
Penalty
Summary
The facility failed to maintain staffing documentation of education regarding the risks and benefits of the COVID-19 vaccine and the offering of the vaccine. Review of the facility policy showed staff were to be provided education on the benefits, risks, and potential side effects before the vaccine was offered, and the infection preventionist was to maintain a tracking worksheet documenting staff vaccination status, including whether the vaccine was received or declined. The policy also required documentation that staff were offered the vaccine or information on obtaining it, were provided education, and had verification of vaccination or exemption/delay. During interviews and document review, the infection preventionist stated she tracked staff COVID-19 vaccination status on a log and that the log included staff who received or declined the vaccine. However, the facility’s untitled vaccination document showed CNA 1 had received a third COVID-19 dose on 10/27/21, while the same document also listed CNA 1 as refused with the vaccination date left blank. The infection preventionist verified the facility did not keep documentation showing the vaccine was offered to staff who declined it or that education on the risks and benefits was provided to those staff members, and specifically confirmed there was no documentation that CNA 1 was offered the vaccine or educated on its risks and benefits.
Failure to Offer COVID-19 Vaccine to Eligible Resident
Penalty
Summary
The facility failed to offer a COVID-19 vaccination to one resident, R113, out of five residents reviewed for COVID-19 immunizations. R113’s EMR documented the resident as not eligible for the COVID-19 vaccine, with the reason listed as admitted after flu season. The resident was admitted to the facility on 7/7/2026 with diagnoses of chronic obstructive pulmonary disease, generalized muscle weakness, and hypertension. The most recent MDS showed a BIMS score of 10, indicating impaired cognition. During interviews, the Infection Preventionist stated R113 was not offered the COVID-19 vaccine because the Medical Director had implemented a policy of not offering the current vaccine from July until September so residents would not have a delay in receiving the updated version in September. The Medical Director stated COVID-19 vaccinations were held starting in July so residents would not have to wait to get a booster when the updated formulation for new COVID-19 strains became available in the fall. A facility policy titled COVID-19 Vaccination stated COVID-19 vaccinations will be offered to residents when supplies are available, per CDC and/or FDA guidelines, unless medically contraindicated, the individual has already been immunized during that time period, or refuses the vaccine.
Incomplete COVID-19 Vaccine Consent and Declination Documentation
Penalty
Summary
The facility failed to follow the latest CDC guidance for COVID-19 vaccination by not properly documenting written consent, informed declination, or administration status for four residents. Resident 2 had a declination for a COVID-19 booster documented on 06/14/2024, but the record lacked a current declination for the latest booster. Resident 1 had documentation of a COVID booster received on 06/14/2023 and a consent form for a booster, but the consent lacked a signature date and there was no record that the most current vaccine had been given. Resident 8 had a consent for a COVID-19 booster dated 07/20/2026, but the record did not show that the current booster had been administered. Resident 23 had a documented declination of a COVID-19 booster on 12/18/2024, but the facility did not document a current offer of the booster vaccine. On 07/29/2026, Administrative Nurse D verified the missing documentation and stated the facility uses the month of October to update residents' immunization status. The facility's policy stated that residents would be offered the COVID-19 vaccination when available through the community or a third-party partner, that residents or their representatives would receive education on the benefits and risks, and that refusals would be documented in the medical record.
Failure to Provide Consented COVID-19 Vaccine
Penalty
Summary
The facility failed to provide a COVID-19 immunization to a resident who had consented to receive it. A facility policy titled, COVID-19 Vaccination, stated that all residents would be offered the vaccine, educated about it, and that the DON would follow up with the physician's office when questions arose about prior vaccination history. The policy also stated that residents would be questioned during admission about their COVID-19 vaccine status and offered the vaccine if they had never received it. Resident 4 was admitted to the facility and later signed an Acknowledgement of Vaccine Information Statement (VIS) and Vaccination Consent form indicating they received education and wanted the COVID-19 vaccine. A review of the resident's record showed that no COVID-19 vaccine was provided after the consent was signed. During interview, the Infection Preventionist confirmed that Resident 4 had not received the vaccine and was unsure why it had not occurred.
COVID-19 Vaccination Education and Documentation Deficiencies
Penalty
Summary
The facility failed to ensure residents were educated and offered the COVID-19 immunization unless contraindicated for two residents reviewed for immunizations, and failed to maintain documentation related to staff COVID-19 vaccination education. Review of Resident 3’s clinical record showed the resident was admitted on July 4, 2026, but there was no information in the chart indicating COVID-19 immunization status or whether the resident had been offered COVID-19 immunization education, and there was no evidence the resident received a COVID-19 vaccine. Review of Resident 59’s record showed admission on March 21, 2024, historical documentation of a COVID-19 immunization in 2021, and a COVID-19 booster refusal dated February 2, 2024, but no further evidence that the resident or resident representative had been offered any COVID-19 vaccinations or education since that time. In interview, the Nursing Home Administrator and an RN stated the facility had no evidence of documentation regarding staff COVID-19 immunization education and no practice documenting that education.
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