Influenza Vaccine Consent and Documentation Deficiencies
Summary
The facility failed to ensure influenza vaccinations were completed properly for three residents reviewed for vaccines. For one resident with acute and chronic respiratory failure, obstructive sleep apnea, morbid obesity with alveolar hypoventilation, and intact cognition, the record showed the resident refused the influenza vaccine, but the immunization record marked education as not provided. The signed consent form contained only the word declined, with no resident signature, no documentation that risks and benefits were explained, and no progress notes showing education or the resident’s informed decision to decline the vaccine. For a second resident with severe dementia, hemiplegia and hemiparesis following cerebral infarction, respiratory failure, heart failure, emphysema, dysphagia, depression, mood disorder, convulsions, obesity, and a BIMS score of 2, the record showed the influenza vaccine was administered with verbal consent documented and education marked as not provided. There was no documentation that the resident understood the risks and benefits, no physician review or determination that the vaccine was in the resident’s best interest, no documentation of attempts to contact family or a legally authorized representative, and no progress note supporting how consent was obtained or why verbal consent was appropriate for a resident with severe cognitive impairment. For a third resident with multiple sclerosis, polyneuropathy, anxiety disorder, and intact cognition, the influenza vaccine was documented as administered with consent confirmed, but education was again marked as not provided. The consent form stated verbal consent was obtained, but no date was documented next to that statement, and the medical record contained no progress notes showing when verbal consent was obtained or that risks and benefits were explained before the vaccine was given. An additional vaccine consent form signed later included influenza, COVID-19, and pneumococcal vaccines, but it was dated after the influenza vaccine had already been administered.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
A resident with diabetes, chronic kidney disease, and a history of breast cancer had previously received PPSV23 and PCV13 at the appropriate age, but review of the EMR and vaccine consent form showed the pneumococcal section was marked as "not needed" and no additional pneumococcal vaccine was offered. The ADON/IP acknowledged that, according to CDC guidelines, the resident was not fully vaccinated and should have been offered PCV20, and the DON stated her expectation that vaccine status be reviewed on admission and tracked to ensure residents are fully vaccinated.
A facility failed to ensure pneumococcal immunization status was assessed for 5 of 5 sampled residents. Medical record review showed no evidence that PCV had been assessed or offered, and the IP confirmed there was no documentation of pneumococcal vaccination status. The facility reported its immunization process tracked vaccines on admission and documented annual COVID and influenza vaccines, but the pneumococcal audit had been delayed because records could not be accessed.
A resident with multiple medical conditions, including a fracture, stroke, unsteadiness, need for assistance with personal care, and generalized muscle weakness, consented to receive a pneumococcal vaccine in accordance with CDC guidance. Despite a facility policy requiring that influenza, pneumococcal, and COVID-19 vaccines be offered and administered to eligible residents after consent, the resident’s record contained no documentation that the pneumococcal vaccine was given. The IP later stated she had misunderstood the information and incorrectly believed the resident was already up to date on pneumococcal vaccination, resulting in the vaccine not being administered and creating a potential for increased risk of pneumococcal pneumonia and severe illness or death.
A resident with heart failure and pleural effusion, who was alert and cognitively intact, consented twice to receive influenza and PNA vaccines and had active MD orders for both. Facility records and CAIR showed the last flu and PNA vaccines were given years earlier, and there was no documentation that the ordered vaccines were administered or that the resident refused them in accordance with facility P&P requiring annual flu vaccination and routine PNA vaccination. The IPN reported the resident refused when re-offered and that vaccines were readily available from the pharmacy, while the DON acknowledged the vaccines should have been given promptly after consent.
Failure to timely review and offer recommended immunizations affected two residents. One resident with ESRD, dialysis dependence, and cardiac disease had incomplete pneumococcal documentation in the EMR, and the DON had not identified the full vaccine history before interview. Another resident with HTN, DM, cognitive impairment, and wheelchair use had a prior PPSV23 documented, but the record lacked evidence that the next pneumococcal vaccine was reviewed, offered, or communicated to the responsible party; the DON stated no vaccines had been offered.
Failure to offer and educate on flu and pneumococcal vaccines for two residents. EHR review showed no documentation that one resident received influenza vaccine education for the season and no documentation that another resident received education on influenza or pneumococcal vaccination after admission. The RDQA stated residents were expected to be offered pneumococcal vaccines on admission and influenza vaccine annually, with risks and benefits explained and consent or declination completed, but this was not done for the two residents.
Failure to Offer Pneumococcal Vaccination per CDC Guidelines
Penalty
Summary
Surveyors identified a deficiency in the facility’s implementation of its pneumococcal vaccination policy for one resident. The resident was admitted with diagnoses including diabetes mellitus, chronic kidney disease, and a history of malignant neoplasm of the breast, and was over the age threshold referenced in CDC guidance. Record review showed the resident had previously received PPSV23 on 06/07/04 and PCV13 (Prevnar 13) on 11/04/14, both administered when the resident was older than the specified age. The resident’s Informed Consent Form for vaccines, dated 09/17/25, had the pneumococcal section marked as “not needed,” despite documentation of prior PPSV23 and PCV13 doses. During interviews, the ADON/Infection Preventionist stated she tracks resident vaccine records on a spreadsheet and confirmed that, based on CDC recommendations, the resident was not fully vaccinated and should have been offered PCV20. She also stated she did not know why “not needed” was written on the consent form. The DON stated her expectation was that residents’ vaccine status would be reviewed on admission, tracked when due, and that the IP nurse would review pneumonia vaccine status to determine if residents were fully vaccinated and offer the vaccine if not. Review of the facility’s pneumococcal vaccination policy and the CDC Adult Immunization Schedule showed that, for adults who previously received both PCV13 and PPSV23 with PPSV23 given at age 65 or older, one dose of PCV20 or PCV21 should be considered at least five years after the last pneumococcal vaccine dose, indicating the resident met criteria to be offered an additional pneumococcal vaccine dose.
Failure to Assess and Offer Pneumococcal Vaccination
Penalty
Summary
The facility failed to ensure residents were immunized for pneumococcal disease for 5 of 5 sampled residents (#66, #69, #1, #33, and #4) reviewed for current vaccination status. Medical record review showed no pneumococcal conjugate vaccine had been assessed or offered for these residents. The infection preventionist confirmed there was no evidence of pneumococcal vaccination status, and also stated the facility’s immunization process assessed and tracked vaccines on admission, with annual COVID and influenza vaccines offered and documented, but that the pneumococcal vaccine audit had been delayed because records could not be accessed. CDC guidance reviewed by surveyors indicated that adults age 19 years or older with unknown or no prior PCV history should receive PCV15, PCV20, or PCV21.
Failure to Administer Requested Pneumococcal Vaccine After Consent
Penalty
Summary
The facility failed to ensure a resident who requested pneumococcal vaccination actually received it, as required by its immunization policy. The written policy dated 1/26 stated that the facility would offer and administer influenza, pneumococcal, and COVID-19 immunizations to eligible residents after providing education and obtaining consent. Record review for Resident #6, who had multiple diagnoses including left tibia fracture, stroke, unsteadiness on feet, need for assistance with personal care, and generalized muscle weakness, showed that on 9/27/25 she consented to receive the pneumococcal vaccine per CDC guidance. However, there was no documentation in her medical record that the pneumococcal vaccine was ever administered. During interview, the IP reported she had misunderstood the information, believed the resident was up to date on pneumococcal vaccination, and was mistaken, resulting in the resident not receiving the requested vaccine. This failure created the potential for the resident to have an increased risk of pneumococcal pneumonia, a serious bacterial lung infection, and the potential for severe illness or death.
Failure to Implement Flu and Pneumococcal Vaccination Practices
Penalty
Summary
Surveyors identified a deficiency in the facility’s infection prevention and control program related to influenza and pneumococcal immunizations for one resident. The resident was admitted with diagnoses including a left radius fracture, heart failure, and pleural effusion, and was documented as alert and oriented with intact cognition for daily decision-making. On two separate vaccine consent forms, the resident consented to receive both influenza and pneumococcal (PNA) vaccines. The resident’s Order Summary Reports contained physician orders for a yearly Fluzone influenza vaccine and a Pneumococcal 13 vaccine, both to be given intramuscularly as needed for vaccination. The facility’s policies, reviewed on 12/18/2025, required that influenza vaccines be offered annually between October 1 and March 31 and that all residents be offered pneumococcal vaccines. Record review and interviews showed that, despite the resident’s consent and existing physician orders, there was no documentation that the influenza or pneumococcal vaccines were administered or refused in accordance with facility policy and current standards of practice. The California Immunization Registry (CAIR) indicated the resident’s last influenza vaccine was received in 2024 and the last pneumococcal vaccine in 2014, with recommendations for additional doses of both vaccines. The Infection Preventionist Nurse stated that the facility could obtain flu and PNA vaccines from the pharmacy without issues and reported that the resident refused the vaccines on one date when they were re-offered, but this refusal was not supported by documentation of administration or refusal consistent with the policies. The DON acknowledged that the resident should have received the flu and PNA vaccines as soon as consent was obtained and that the resident was at risk for flu and PNA infections.
Failure to Timely Review and Offer Immunizations
Penalty
Summary
The facility failed to ensure recommended influenza, pneumococcal, and Covid-19 vaccinations were offered and/or provided in a timely manner for 2 of 5 residents reviewed for immunizations, R16 and R19. The deficiency was identified during interview and document review, which showed that the facility’s admission immunization review process was intended to verify resident vaccination status through MIIC and determine whether additional vaccines were recommended, with the resident or responsible party consulted as appropriate. R16’s admission MDS showed he was cognitively intact, independent with ADLs, and used a walker/wheelchair. His diagnoses included ESRD with dialysis dependence and multiple cardiac conditions. On review, his immunization record initially showed pneumococcal vaccines on 7/2/15 and 12/22/22, but the documentation did not identify which vaccine types had been given, and there was no indication that additional pneumococcal vaccination had been offered or that the record had been reviewed to determine whether more vaccination was needed. Later review of the EMR added historical pneumococcal information, including PPSV23 on 8/25/11, PCV13 on 7/2/15, and PCV20 on 12/22/22; however, this information had not been identified before the DON interview, and the third dose had not been listed initially. R19’s admission MDS showed some cognitive impairment, need for ADL assistance, and wheelchair use. Her diagnoses included hypertension, diabetes, and Klebsiella pneumoniae. Her EMR showed a Pneumovax 23 vaccine on 6/4/07, but there was no documentation showing review of what vaccine was indicated next, no documentation that PCV13 had been received, and no documentation that the vaccine information had been provided to the resident’s responsible party. PneumoRecs indicated a dose of PCV15 or PCV20 was recommended at least one year after the last PPSV23 dose, but the record lacked evidence that any vaccine had been offered. The DON stated there was no indication any vaccines had been offered, and an email later noted a consent was to be sent regarding the Pneumovax vaccine, which had not been completed before the interview.
Failure to Offer and Educate on Flu and Pneumonia Vaccinations
Penalty
Summary
The facility failed to offer and provide education on influenza and pneumococcal vaccinations for 2 of 5 sampled residents, Residents 21 and 10, as documented by interview and record review. Resident 21 was admitted on 07/02/2022, and the electronic health record contained no documentation that the facility provided education on the risks and benefits of the influenza vaccine for the 2025/2026 season. Resident 10 was admitted on 01/10/2026, and the electronic health record contained no documentation that the facility provided education on the risks and benefits of the influenza vaccine or the pneumovax vaccine in 2026. During interview, Staff C, Regional Director of Quality Assurance, stated the expectation was that all residents be offered pneumococcal vaccines on admission and influenza vaccine annually, with education on risks and benefits and a consent or declination form completed, and stated this was not done for Residents 21 and 10.
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