Failure to Obtain Informed Consent for Influenza Vaccine
Summary
The facility failed to obtain informed consent for the administration of the influenza vaccine to a resident, identified as Resident 38, during the 2024-2025 influenza season. Resident 38 was administered the influenza vaccine on September 20, 2024, without obtaining written consent from the resident's responsible party, as required by the facility's policy and procedure. The policy, revised in January 2024, mandates that written, informed consent be obtained from the resident or their decision maker prior to vaccine administration. A review of Resident 38's medical records revealed that the resident was unable to make medical decisions, necessitating consent from a responsible party. However, no such consent was documented. The Director of Staff Development (DSD) confirmed the oversight during an interview and acknowledged the failure to secure informed consent before administering the vaccine. The Administrator and Director of Nursing (DON) also acknowledged these findings, confirming the deficiency in the facility's adherence to its vaccination policy.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
Failure to offer due pneumococcal vaccinations: Two residents with significant chronic conditions were found without documentation that they were offered or declined indicated pneumococcal vaccines. One resident had COPD and asthma and had previously received PPSV23, while another resident had CHF, DM, and severe cognitive impairment and had previously received PCV13. The IP stated she identified residents who were past due but had not offered the vaccines because she was pulled to other nursing and staffing coordination tasks.
A resident admitted with CAD, HTN, and non-Alzheimer's dementia did not have current flu or pneumococcal immunization status reviewed in the EMR, and the record lacked vaccine history, consent, or declination documentation. The IP stated the admission nurse was to review immunizations within 24 hours, verify status through MIIC, and offer needed vaccines, but this had not been done for the resident.
Failure to Document Pneumococcal Vaccine Education Before Consent: A resident with mild cognitive impairment and multiple chronic conditions had a pneumococcal vaccine decision declined by the son, but the record did not show that the resident or representative received education on the benefits, side effects, or booster guidance before the refusal was obtained. RN-B stated the family declined by phone and no education was mailed or documented, while the DON stated residents and representatives need full vaccination education and documentation of their understanding.
Missing Immunization Documentation for Two Residents: The facility failed to document flu and pneumococcal vaccine education, receipt, refusal, or contraindication for two residents. One resident had acute kidney failure with tubular necrosis and the other had ESRD; both charts lacked immunization data in the EMR and care plan. Staff interviews showed the ADON, DON, DCE, and Administrator each described admission paperwork and EMR entry responsibilities, but the required vaccine documentation was not present.
Failure to Offer Flu and Pneumococcal Vaccinations: The facility did not document offering influenza vaccination to two residents or their representatives, and the DON confirmed the pneumococcal status for those residents was not up to date after reviewing CDC guidance. Records showed prior PPSV23/PCV13 and prior annual flu vaccines, but no evidence that the residents were offered, consented to, or declined the current flu vaccine.
A resident admitted with aphasia, hemiplegia, and hemiparesis after a stroke had documentation that he refused the pneumococcal vaccine, but the record did not show that he or his representative was offered the vaccine or educated on its risks and benefits. The MDS Nurse stated pneumococcal vaccines were offered on admission, but she could not find documentation that this resident received the required offer or education.
Failure to Offer Due Pneumococcal Vaccinations
Penalty
Summary
The facility failed to offer pneumococcal immunizations for 2 of 5 sampled residents reviewed for immunizations. The facility’s Pneumococcal Vaccine policy, dated 6/19/25, directed staff to follow the CDC Pneumococcal Vaccine Timing for Adults guide. The CDC guidance reviewed by surveyors described the available pneumococcal vaccines and the recommended timing for adults 65 years or older based on prior vaccination history. Resident 56 was admitted in 11/2021 with diagnoses including COPD and asthma. Records showed the resident last received PPSV23 on 2/27/23, with no documentation of pneumococcal consent after 2/23/24 and no documented evidence that the resident was offered or declined PCV15, PCV20, or PCV21. Resident 56 stated on 6/5/26 that she would have wanted to have been offered the pneumococcal vaccination. Resident 7 was admitted in 4/2024 with diagnoses including chronic heart failure and diabetes. Records showed the resident last received PCV13 on 7/17/17, with no pneumococcal vaccination consent after that date and no documented evidence that the resident was offered or declined PCV20 or PCV21. Resident 7’s 4/30/26 Quarterly MDS indicated severe cognitive impairment. Staff 15, the Infection Preventionist, stated she had developed a tracking system and found residents were past due for vaccinations, knew Resident 7 and Resident 56 were due for pneumococcal vaccinations, but had not offered them. Staff 15 stated she struggled completing past due vaccinations because she was pulled to other nursing and staffing coordination tasks. Staff 2, the DNS, confirmed knowing Staff 15 was working on past due vaccinations but did not confirm knowing specific residents.
Failure to Review and Document Immunizations
Penalty
Summary
The facility failed to ensure all residents were offered and up to date on immunizations for 1 of 5 residents reviewed, R29. R29 was admitted on 4/29/26 and had diagnoses including coronary artery disease, hypertension, and non-Alzheimer's dementia. The resident's electronic medical record lacked a review of current immunizations, including vaccines received prior to admission, and did not show the current status of pneumococcal immunizations or influenza vaccinations. The record also lacked documentation that vaccination consent had been reviewed with R29 or the responsible party, including no consent marked refused. During interview, the infection preventionist stated the admission nurse was to review each resident's immunization status within the first 24 hours and then verify it through MIIC before offering needed vaccines. Upon review of R29's immunization tab, the infection preventionist confirmed the immunization status had not been reviewed and the record lacked a vaccination history or evidence that vaccines had been offered. The facility policy required screening for eligibility, providing vaccine education, obtaining consent or declination, and documenting these steps in the medical record.
Failure to Document Pneumococcal Vaccine Education Before Consent
Penalty
Summary
The facility failed to provide education regarding the benefits and potential side effects of pneumococcal vaccination and failed to document that education was provided before obtaining a vaccination decision from the resident representative for one resident. The resident’s MDS identified the resident as an older adult with mild cognitive impairment and diagnoses including heart failure, peripheral vascular disease, diabetes, and dementia. The resident had been offered the pneumococcal vaccination but declined, and the immunization record showed prior receipt of PPSV23 and pneumococcal conjugate vaccine doses in the past. The resident’s medical record did not include evidence that the resident or the resident’s representative received education regarding pneumococcal vaccine booster guidance, and there was no indication the resident was offered the pneumococcal vaccine per CDC guidance. The immunization consent form documented that the resident’s son declined the pneumococcal vaccination by phone, but it did not show that education about the pneumococcal vaccine booster had been provided. During interview, RN-B stated the family declined by phone and that education was not mailed because most family members did not want to read it, and this was not documented. The DON stated the resident and representative need to receive all vaccination education so they understand what they are refusing or consenting to, and documentation should reflect that education.
Missing Immunization Documentation for Two Residents
Penalty
Summary
The facility failed to ensure that the medical records for two residents included documentation of education about the benefits and potential side effects of influenza and pneumococcal immunizations, or documentation that the residents received the vaccines, declined them, or had a medical contraindication. For one resident, the record showed the resident was not in the facility during the influenza vaccination season and that the pneumococcal vaccine was not up to date and was offered and declined, but the chart did not contain immunization documentation in the electronic record or care plan. For the other resident, the electronic medical record also showed no immunization data, and the admission and care plan records did not include immunization information. Resident #2 was admitted with acute kidney failure with tubular necrosis and had a BIMS that could not be completed because the resident was rarely or never understood. Resident #115 was admitted with end stage renal disease, and the record review did not reveal cognition or immunization status information in the entry MDS. For both residents, the immunization tab in the electronic medical record showed no data available, and the care plans did not include immunization information. During interviews, the ADON, who said she was the facility’s Infection Preventionist, stated residents were asked on admission about flu, pneumonia, and COVID vaccines and that refusals should be documented. She said immunization information should have been entered in the electronic medical record or admission packet and that she was responsible for entering vaccine information. The DON stated obtaining immunization information fell to the infection control nurse, though nursing management and admitting staff could also assist. The DCE and Administrator stated the admission packet contained vaccine information and consents and that admissions paperwork was the responsibility of the DCE or Admissions, but the DCE was new to the facility and the prior DCE had left before the current one started.
Failure to Offer Influenza and Pneumococcal Vaccinations
Penalty
Summary
The facility failed to offer two residents, R73 and R76, and/or their representatives the opportunity to receive influenza vaccination in accordance with nationally recognized standards. Review of R73’s record showed admission on 07/29/25, prior PPSV23 on 04/29/11, PCV13 on 10/05/16, and an annual influenza vaccine on 10/04/24, but there was no evidence that the resident was offered, consented to, or declined the 2025 influenza vaccine. Review of R76’s record showed admission on 08/05/21, PCV13 on 04/05/17, influenza vaccine on 10/02/24, and no evidence that the resident was offered, consented to, or declined the 2025 influenza vaccine. Record review and facility documents showed both residents had personal immunization histories indicating prior pneumococcal vaccination, with the facility documenting them as up to date on pneumococcal vaccines. During interview on 05/29/26, the DON confirmed that R73’s and R76’s pneumococcal vaccines were not up to date after reviewing CDC guidelines, and stated there was no documented evidence that either resident was offered an influenza vaccine and accepted or declined it. The facility policies titled Pneumococcal Vaccination (Series) and Influenza Vaccination stated that residents are to be offered immunization in accordance with current CDC guidelines and annual influenza vaccination guidance.
Failure to Document Pneumococcal Vaccine Offer and Education
Penalty
Summary
Develop and implement policies and procedures for flu and pneumonia vaccinations was identified as deficient because the facility did not ensure immunizations were offered and/or provided as indicated. Record review showed that Resident #4, who was admitted with multiple diagnoses including aphasia, hemiplegia, and hemiparesis affecting the right dominant side following a stroke, had documentation that he refused the pneumococcal vaccine on 10/21/24. However, there was no documentation in the resident's record that he and/or his representatives were offered the vaccine or educated about the risks and benefits of pneumococcal vaccination. During interview, the MDS Nurse, who was the previous IP, stated pneumococcal vaccine was being offered to residents upon admission, but she was unable to find documentation that Resident #4 was offered or educated regarding the risks and benefits of the pneumococcal vaccination.
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