Failure to Check COVID-19 Vaccine Allergy and Delay in Post-Vaccination Assessment
Summary
The deficiency involves the facility’s failure to verify a resident’s documented COVID-19 vaccine allergies prior to administering a COVID-19 vaccine and the failure to provide timely assessment and medical intervention afterward. The resident had an extensive medical history including end stage renal disease with dependence on dialysis, type 2 diabetes, heart disease, COPD, heart failure, reduced mobility, and need for assistance with personal care. Her allergy list in the medical record documented allergies to the Pfizer mRNA BNT 162b2 COVID-19 vaccine with reactions of altered mental status and anaphylaxis, and to the Moderna mRNA-1273 COVID-19 vaccine with altered mental status, both dated 04/12/24. Guardianship papers showed she had a court-appointed guardian due to being assessed as incompetent to make her own decisions, although a recent MDS assessment documented her as cognitively intact, requiring assistance with ADLs, dialysis, and having a legal guardian. On the day of the incident, the resident returned from dialysis with stable vital signs documented on the dialysis communication form. A physician order dated that same day directed administration of a single dose of Mnexspike 2025–2026 COVID vaccine intramuscularly. The COVID-19 vaccine administration report showed that consent and education were provided to the guardian by an RN, and that the resident received the Moderna mNEXSPIKE COVID-19 vaccine in the left deltoid at 12:10 P.M. The report also indicated that the RN administered the vaccine before assessing or screening the resident for contraindications related to allergies. The facility’s EMR later alerted to the allergy when the ADON entered the vaccine order, but by that time the infection prevention RN had already given the vaccine. Facility policy on General Dose Preparation and Medication Administration required staff to check for allergies prior to administration, but this was not done in this case. Following administration of the contraindicated vaccine, there was no documented immediate assessment, monitoring, or vital sign checks for the resident. Review of progress notes, evaluation screens, and vital sign flow sheets from the date of vaccination through several days afterward revealed no documentation that the resident was assessed after receiving the vaccine or that staff recognized she had been given a vaccine listed as an allergy. The physician was not notified at the time of vaccine administration. The first documented assessment occurred later that night when the resident told a CNA she was not feeling well, and an LPN found her panicked, short of breath, sweating heavily, with a heart rate of 140 bpm, oxygen saturation of 84% on 2 L O2, respirations of 25, and an unobtainable blood pressure. EMS was called and she was transported to the ED, where she was treated for anaphylaxis and admitted with diagnoses including altered mental status, encephalopathy, and acute hypoxic respiratory failure. Interviews with the DON and regional clinical staff confirmed there was no documentation of an assessment after the vaccine administration and that the facility lacked a policy for verbal consent for vaccines, while the Resident Change in Condition policy required recognition, assessment (including vital signs), and provider notification for incidents or reactions to medications or treatments, which did not occur in a timely manner for this resident.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
A resident with dementia and other chronic conditions, who was severely cognitively impaired per MDS, received a COVID-19 vaccine dose based on a consent form signed by a former guardian. After guardianship was transferred to the resident's nephew, no new consent was obtained before a subsequent COVID-19 vaccination was administered by a contracted vaccination company, which relied on the outdated consent and did not verify current guardianship status with facility staff. The current guardian reported he had not been informed about the vaccination and would not have consented due to the resident's prior reaction to a shingles vaccine.
A resident with intact cognition and multiple medical diagnoses requested a COVID-19 vaccine, for which a provider order was obtained and entered. On the scheduled administration date, an LPN documented the vaccine as not available on the MAR, and the vaccine was never given. The resident reported being told the vaccine was on back order and was only offered the option to obtain it at a local pharmacy, which she declined. The ADON stated nurses are expected to confirm vaccine orders with the pharmacy, while pharmacy staff reported the vaccine was in stock but could not be released because the facility failed to submit the required vaccine request form, resulting in noncompliance with the facility’s vaccination policy.
The facility did not offer or provide the COVID-19 vaccine to staff members, even though the vaccine was available on site. Documentation and staff interviews confirmed that the updated vaccine was not administered to team members, potentially impacting all residents.
The facility did not screen, educate, or offer the COVID-19 vaccine to several residents with complex medical conditions, and failed to document vaccination status, consent, or education in their medical records, as confirmed by facility leadership and record review.
The facility did not provide documented education on COVID-19 vaccine risks and benefits or obtain written consent for immunization for five residents with complex medical conditions. Consent forms were incomplete, often only noting a verbal declination without specifying who made the decision, and lacked signatures. Staff interviews confirmed that written consent and proper documentation were not obtained, contrary to facility policy.
A resident with multiple chronic conditions and severe cognitive impairment was not offered the COVID-19 vaccine as required, and there was no documentation of vaccine consent or declination in the medical record. The DON confirmed the lack of documentation regarding the vaccine offer or administration.
COVID-19 Vaccine Given Without Consent From Current Guardian
Penalty
Summary
Surveyors identified a deficiency related to COVID-19 immunization consent when a resident received a COVID-19 vaccine dose without consent from the current legal guardian. The resident, who had diagnoses including late-onset Alzheimer's disease, dementia, atherosclerotic heart disease, hypertensive heart disease without heart failure, and a history of falls, was admitted in March 2021 and re-entered in November 2025. The medical record showed a COVID-19 vaccine consent form signed by the resident's former guardian in April 2025, and the resident received a COVID-19 vaccination on that same date. Guardianship paperwork indicated that the resident's nephew became the legal guardian in July 2025. The resident's quarterly MDS from April 2026 documented a Brief Interview for Mental Status (BIMS) score of three, indicating severe cognitive impairment, although the resident was independent with ADLs, always continent, and had no pain or skin issues during the review period. Record review further showed that the resident received another COVID-19 vaccination in November 2025, but there was no consent form signed by the current guardian for that dose. In an interview, the current guardian stated he had not been informed that the resident was eligible for a COVID-19 vaccine prior to administration and reported he would not have consented due to the resident's prior reaction to a shingles vaccine. The DON confirmed that the resident's guardian had changed in July 2025 and that no consent from the current guardian was obtained before the November 2025 vaccination. The DON also stated that a contracted vaccination company administered the vaccine and used the prior consent from April 2025 without checking with the facility before giving the later dose.
Plan Of Correction
F 0887 1. Resident #44 was assessed by Director of Nursing on 4/29/26 and suffered no ill effects from receiving the covid vaccine. 2. Like Residents are identified as residents who received the covid vaccine within the facility. An audit will be completed by the Director of Nursing or designee for like residents utilizing the Immunization Documentation Audit Tool which was created on 4/20/26 by the Director of Nursing for the purpose of this POC to ensure consents are accurate, including guardian signatures, as applicable. This audit along with identified corrections will be completed on or before 5/13/26. 3. The Director of Nursing or designee will re-educate licensed nurses on the Resident Covid – 19 Vaccination Policy to include obtaining consent prior from the resident or designated healthcare representative to administering the covid 19 vaccine. This education will be completed on or before 5/13/26. 4. Utilizing the Immunization Documentation Audit Tool which was created on 4/20/26 by the Director of Nursing for the purpose of this POC, the Director of Nursing or designee will complete an audit of residents who receive the covid 19 vaccine during the last 7 days weekly for four weeks, beginning 5/14/26 to ensure consent is obtained from the resident or the residents designated healthcare representative prior to administering the covid 19 vaccine. Noncompliance noted during the audits will be corrected with consents obtained prior to administering the covid 19 vaccine. Negative findings to be addressed immediately and negative trends or system wide issues will be reported to the QAPI committee, and the action plan will be adjusted as needed.
Failure to Provide Requested COVID-19 Vaccination Due to Breakdown in Ordering Process
Penalty
Summary
The deficiency involves the facility’s failure to administer a requested SARS-CoV-2 (COVID-19) vaccination to a cognitively intact resident after a provider order was obtained. The resident, admitted with diagnoses including asthma, malnutrition, and vertigo, had previously received four COVID-19 vaccinations, the last in late October 2024. On 12/30/25, the resident requested another COVID-19 vaccination, and the nurse practitioner issued an order on 12/31/25 for a Comirnaty 30 mcg/0.3 mL intramuscular dose. The order was entered with an end date of 01/08/26. On 01/07/26, an LPN documented the vaccine on the MAR as “Med Not Available” and did not administer it. Review of the January and February 2026 MARs showed no evidence that the vaccine was ever given. The resident later developed a cough and was transferred to the hospital after independently calling EMS; she reported being hospitalized for eight days with COVID-19 and double pneumonia. During interview, the resident stated she had been told she would receive the vaccine on 01/07/26 but did not, and was informed it was on back order, with the only alternative offered being to go to a local pharmacy, which she declined due to cold weather. The LPN unit manager did not recall the request but confirmed placing and revising the vaccine order. The LPN who signed the MAR as “Med Not Available” stated the pharmacy required paperwork before sending the vaccine and that she notified someone at the facility, though she could not recall whom. The ADON stated nurses should call the pharmacy to confirm vaccine orders and provide needed information. Pharmacy staff reported the COVID-19 vaccine was not on back order and had been available throughout the relevant months, but the facility had not submitted the required vaccine request form, so the pharmacy could not release the vaccine. Facility policy required that residents be offered influenza, pneumonia, and COVID vaccines unless contraindicated or already vaccinated.
Failure to Offer COVID-19 Vaccine to Facility Staff
Penalty
Summary
The facility failed to ensure that the COVID-19 vaccine was offered or provided to staff members, despite the vaccine being available on site. Review of facility documentation showed that the updated COVID-19 vaccine would not be administered to team members at the facility. This was confirmed during an interview with a corporate registered nurse, who verified that the vaccine was not offered or provided to staff. This deficiency had the potential to affect all 70 residents in the facility, as staff vaccination is a key component in preventing the spread of COVID-19 within the facility. No information was provided regarding the vaccination status of individual residents or staff, nor were any specific medical histories or conditions mentioned in relation to the deficiency.
Failure to Screen, Educate, and Document COVID-19 Vaccination for Residents
Penalty
Summary
The facility failed to ensure that residents were screened for COVID-19 immunization, educated on the risks and benefits of the COVID-19 vaccine, or offered and received the vaccine as required. Record reviews for five residents with various diagnoses, including dementia, schizophrenia, muscle weakness, congestive heart failure, asthma, morbid obesity, diabetes, respiratory failure, and COPD, revealed no documentation of COVID-19 vaccination status, consent or declination, or education provided regarding the vaccine. These findings were confirmed during interviews with the President of Operations and a Regional Registered Nurse, who stated they were unable to locate any vaccination records, refusals, or education documentation for the affected residents in the electronic medical records. CDC guidance reviewed during the survey indicated that everyone over six months of age should receive the 2024-2025 COVID-19 vaccination to protect against circulating strains and prevent severe health outcomes. Despite these recommendations, there was no evidence in the medical records that the five residents had been screened, educated, or offered the COVID-19 vaccine, nor was there documentation of their vaccination status or any refusals.
Failure to Provide COVID-19 Vaccine Education and Obtain Written Consent
Penalty
Summary
The facility failed to provide education on the risks and benefits of COVID-19 immunization and did not obtain written consent for COVID-19 vaccinations for five residents. Medical record reviews for these residents, who had complex medical histories including hypertension, dementia, cerebrovascular disease, dysphagia, chronic kidney disease, Alzheimer's disease, Parkinson's disease, and end stage renal disease, revealed that COVID-19 vaccination consent forms were either not dated, not signed, or only indicated a verbal declination without specifying whether the decision was made by the resident or a representative. There was also no documentation confirming that education on immunization risks and benefits had been provided. Interviews with facility staff confirmed that the consent forms lacked signatures and did not indicate who provided the consent or declination. An LPN stated that the previous DON had instructed staff to simply write "verbal" or "verbally" on the forms, which was considered sufficient at the time. Review of the facility's policy indicated that resources and counseling on the importance of COVID-19 vaccination were to be offered, but this was not reflected in the documentation for the affected residents.
Failure to Offer and Document COVID-19 Vaccination for Resident
Penalty
Summary
The facility failed to ensure that a resident was offered the COVID-19 vaccine in accordance with its policy and CDC guidance. Medical record review showed that the resident, who had diagnoses including type two diabetes mellitus, schizoaffective disorder, and chronic kidney disease, was admitted to the facility after having received a COVID-19 booster prior to admission. Despite being severely cognitively impaired and requiring staff assistance with activities of daily living, there was no documentation in the resident's medical record from the time of admission through the review period indicating that the COVID-19 vaccine was offered, declined, or administered. Additionally, there was no consent or declination form present in the chart, and the DON confirmed the absence of such documentation.
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