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:
The facility did not provide required education on the benefits and risks of the COVID-19 vaccine or offer the vaccine to its staff, despite having a policy stating that such education and vaccination would be provided unless medically contraindicated or already immunized. An MDS nurse and a nurse consultant both reported that neither COVID-19 education nor vaccination had been offered to them or other staff. Administration reported that approximately 99 staff members, including therapy staff, were employed at the time, and this failure had the potential to affect all residents in the facility.
Failure to Offer COVID-19 Vaccination: A resident with HTN, HLD, and malnutrition was documented as overdue for a COVID-19 vaccine, but the medical record had no evidence the vaccine was offered or given. The IP and DON both confirmed the resident had not been offered or received the vaccine, despite expectations that it would have been completed shortly after admission.
Facility staff did not maintain required documentation of staff COVID-19 vaccination education, offers, or vaccination status. When surveyors requested Infection Control information for staff, the IP reported she had not been directed to track staff COVID-19 vaccination status and had no records showing that staff were educated on COVID-19 vaccine benefits and risks, offered the vaccine, or given information on how to obtain it. In a subsequent interview, facility leadership, including the Administrator and DON, did not provide any additional information regarding staff COVID-19 vaccination data.
Failure to Offer COVID-19 Vaccine to Residents: The facility did not offer the COVID-19 vaccine to residents because staff believed repeated refusals meant it no longer needed to be offered. The ICPN, DON, MD, and administrator each stated they were unaware residents should still be offered the vaccine and allowed to accept or refuse it. The facility policy required residents and staff to be offered the vaccine, screened for contraindications, and educated before it was offered.
The facility failed to document COVID-19 vaccine education for two residents reviewed for vaccination status. EHR review showed no evidence that either resident received education on the risks and benefits of the vaccine, and there was no documented consent or declination form. A QA leader stated residents were expected to be offered the vaccine on admission with education and a completed consent/declination form, but this was not done for the two residents.
Failure to Document COVID-19 Vaccine Refusal: A resident with dementia, diabetes, and HTN had severely impaired decision-making and lacked capacity to make decisions. The IPN stated she offered the COVID-19 vaccine to the resident’s RP, who refused, but the refusal was not documented in the health record. The DON stated the declination should have been signed and the refusal documented with the risks and benefits explained and a timeline for reoffering the vaccine.
Failure to Educate and Offer COVID-19 Vaccination to Facility Staff
Penalty
Summary
The facility failed to provide education on the benefits and risks of the COVID-19 vaccine and failed to offer the COVID-19 vaccine to its employees, contrary to its own COVID-19 policy dated 11/25/25, which required education and vaccine offering unless medically contraindicated or already immunized. During an interview on 4/30/26, the MDS nurse reported that COVID-19 education and vaccination had not been offered to her. In a separate interview on 5/1/26, the Nurse Consultant also stated that COVID-19 education and the vaccine had not been offered to the staff. On 5/6/26, Administration indicated there were 99 staff members, including therapy staff, employed by the facility. The surveyors determined that the failure to provide COVID-19 vaccine education and to offer vaccination to staff had the potential to affect all residents residing in the facility.
Failure to Offer COVID-19 Vaccination
Penalty
Summary
The facility failed to ensure COVID-19 vaccinations were offered to 1 of 5 residents reviewed for COVID-19 vaccination status. Resident R6’s quarterly MDS showed the resident was admitted to the facility and had diagnoses of high blood pressure, hyperlipidemia, and malnutrition. R6’s undated client information vaccination record indicated the resident was overdue for a COVID-19 vaccination, but the medical record contained no evidence that the vaccine was offered or provided. The Infection Preventionist stated R6 had been on a list from the previous IP to be completed, but no supportive documentation could be found showing the vaccine was ever offered or completed, and stated it should have been completed within a few days of admission. The DON also confirmed R6 had not been offered or received the COVID-19 vaccination and stated the expectation was that it would have been completed within a week of admission.
Failure to Document Staff COVID-19 Vaccination Education, Offers, and Status
Penalty
Summary
Facility staff failed to document COVID-19 vaccination information for staff members, including education, offers of vaccination, and vaccination status. During the Infection Control task on 4/23/26 at approximately 1:05 PM, surveyors requested the facility’s Infection Control information for staff. At 3:38 PM, the Infection Preventionist (IP) reported that she had not been directed to maintain staff COVID-19 vaccination status and therefore had no records of staff vaccination information. The IP further stated she had no documentation that any staff had been provided education on the benefits and potential risks of the COVID-19 vaccine, nor that staff had been offered the vaccine or given information on how to obtain it, because she had not been instructed to perform these activities. On 4/28/26 at 3:30 PM, during a final interview with the Administrator, Assistant Administrator, DON, Regional Nurse Consultant, and Regional MDS Consultant, the facility’s leadership team did not provide comments or additional information regarding staff COVID-19 data. No specific residents or their medical histories were mentioned in relation to this deficiency, and the report focuses solely on the lack of staff COVID-19 vaccination documentation and associated education and offering processes.
Failure to Offer COVID-19 Vaccine to Residents
Penalty
Summary
The facility failed to ensure each resident was offered the COVID-19 vaccine unless the immunization was medically contraindicated or the resident had already been immunized. During interviews, the ICPN stated the facility did not offer COVID vaccines to residents because residents and their representatives always declined the vaccination, so the facility stopped offering it. She stated she was unaware the facility should have continued to offer the vaccine and allow residents to accept or refuse it, and she did not recall when the facility stopped offering it. The DON, MD, and administrator each stated they were unaware the facility should have offered the COVID vaccine to residents and allow them to accept or refuse it, and each did not recall when the facility stopped offering the vaccine. Record review of the facility’s Infection Control Policy dated 05/13/2023 showed residents and staff were to be offered the COVID-19 vaccine when supplies were available, screened for prior immunization and contraindications, and given education about the vaccine before it was offered. CDC ACIP recommendations dated October 2024 stated adults aged 65 years and older should receive 2 doses of the 2024-2025 COVID-19 vaccine, and CDC COVID recommendations dated 11/19/2025 stated the vaccine helps protect against severe illness, hospitalization, and death and is especially important for persons ages 65 and older.
Failure to Document COVID-19 Vaccine Education and Consent
Penalty
Summary
The facility failed to ensure COVID-19 vaccination education was documented in the medical record for 2 of 5 sampled residents, Residents 10 and 7, who were reviewed for COVID-19 vaccinations. Review of Resident 10's electronic health record showed an admission date of 01/10/2026, but there was no documentation that the facility provided education on the risks and benefits of the COVID-19 vaccine. Review of Resident 7's electronic health record showed an admission date of 02/11/2026, and there was also no documentation that the resident was provided education on the risks and benefits of the COVID-19 vaccine. During an interview on 04/24/2026 at 11:39 AM, Staff C, Regional Director of Quality Assurance, stated it was the facility's expectation that all residents be offered the COVID-19 vaccine on admission with education on risks and benefits and a consent/declination form completed, and stated this was not done for Residents 7 and 10.
Failure to Document COVID-19 Vaccine Refusal
Penalty
Summary
The facility failed to document the responsible party’s refusal of the COVID-19 vaccine for one sampled resident. Resident 52 was admitted and later readmitted to the facility and had diagnoses including type 2 diabetes mellitus, dementia, and hypertension. The resident’s MDS showed severely impaired cognitive skills for daily decision making, and the H&P stated the resident did not have the capacity to understand and make decisions. RP 3 was the assigned responsible party for vaccine decisions. The Infection Preventionist Nurse stated she reviewed residents’ vaccines on admission and offered vaccines to the resident or responsible party within five days of admission. She reported that she spoke with RP 3 and offered the COVID-19 vaccine, and RP 3 refused, but this refusal was not documented in the resident’s health record. The DON stated the licensed nurse was responsible for asking about vaccines on admission and that the refusal should have been documented with the risks and benefits explained and a timeline for reoffering the vaccine. The resident’s immunization report showed the last COVID-19 vaccine was received on 12/22/2023, and the MDS was not updated on the resident’s COVID-19 vaccine status.
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