Failure to Ensure Informed Consent for Influenza Vaccination
Summary
The facility failed to ensure that a resident received the influenza vaccine and did not adequately document the refusal process. Specifically, the facility did not provide the resident's representative with the necessary information about the risks and benefits of the influenza vaccination when the vaccine was refused. The facility's policy requires that individuals or their legal representatives sign a consent or declination form, which should be filed in the individual's medical record. However, for the resident in question, the documentation was incomplete, lacking the signature of the resident's representative, the time of contact, and confirmation that the risks and benefits were discussed. The medical record review revealed that the resident's representative was contacted multiple times regarding the flu vaccine, but there was no evidence that the representative was informed about the risks and benefits of the vaccination. The facility's Infection Preventionist (IP) confirmed these findings and acknowledged the lack of follow-up with the resident's representative. Additionally, the Director of Nursing (DON) was informed and acknowledged the deficiency, which highlights a failure in the facility's process to ensure informed decision-making regarding vaccinations.
Penalty
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The facility failed to ensure pneumococcal vaccinations were properly assessed and tracked in the EHR for two residents. One resident with diabetes, stroke, and a seizure disorder had an immunization record showing a pneumococcal vaccine due on a specific date, but there was no documentation that the vaccine status was assessed on that date. Another resident with stroke, hemiplegia, and Parkinson’s disease also had a pneumococcal vaccine due on a specified date, with no corresponding assessment documented. The IP and regional risk staff confirmed that pneumococcal vaccinations were not being tracked in the EHR as required by facility policy.
Surveyors found that the facility did not follow its own immunization policy requiring education and documentation regarding influenza and pneumococcal vaccines. Three residents with significant medical conditions, including muscle wasting, osteonecrosis, cancer, CAD, osteoarthritis, protein-calorie malnutrition, and dementia, had no documentation that they or their representatives received CDC Vaccine Information Statements, supplemental explanations, or an opportunity to accept or decline the vaccines based on education about risks and benefits. A CRN confirmed that there were no records of vaccine education or consent for these residents in their medical charts.
Surveyors found that two residents did not have required documentation showing they were offered or declined influenza and pneumococcal (PCV20) vaccines, nor any record of prior vaccination or MD-documented contraindications. EMR immunization sections were incomplete, and staff could not locate consent or declination forms, while also indicating uncertainty or shifting responsibility regarding who tracks and documents immunizations, despite facility policies requiring that all eligible residents be offered these vaccines and be given information on their risks and benefits.
Two residents were not appropriately offered or administered pneumococcal vaccinations per CDC guidance and facility policy. One resident with a history of tonsillar cancer, traumatic brain injury, and diabetes had only a historical PPSV23 documented prior to admission, with no consent/declination form and no record of being offered current PCV15, PCV20, or PCV21 vaccines. Another resident with cardiac conditions and muscle weakness had a signed pneumococcal vaccine consent on file but no documentation of any pneumococcal vaccine being offered or given, and no updated consent or declination. The DON reported difficulty locating current vaccination forms and noted that an off-site company provides vaccinations, but no clinic had yet been scheduled, resulting in missing documentation and incomplete pneumococcal vaccination offerings for these residents.
A resident’s record lacked required documentation showing they were educated about, offered, and either received or declined influenza and pneumococcal vaccines. The EMR listed the flu status only as historical without supporting details and did not show any pneumococcal vaccination information. The Infection Preventionist could not produce a consent/declination form and confirmed that documentation of vaccine education, offer, and acceptance or refusal was not available, contrary to facility policies requiring such records.
A resident’s APOA signed a consent form requesting an influenza vaccination in accordance with facility policy, which requires consent prior to vaccine administration and placement of the consent in the medical record. However, review of the resident’s electronic health record showed no documentation that the flu vaccine was administered, refused, or that education was provided. During interviews, the DON confirmed that only the consent could be found and acknowledged that the expectation would be that the vaccine was administered when a signed consent is present.
Failure to Track Pneumococcal Vaccinations in the EHR
Penalty
Summary
The facility failed to ensure pneumococcal vaccinations were properly assessed and tracked in the electronic health record for two residents, as required by its Infection Prevention and Control Plan. The policy dated 8/15/25 states that the Infection Preventionist (IP) is responsible for oversight of infection prevention strategies, including vaccinations. For one resident with diagnoses of diabetes, stroke, and seizure disorder, the face sheet showed admission to the facility and the MDS dated 2/9/26 documented these conditions. The resident’s immunization record indicated that a pneumococcal vaccine was not due until 3/26/25, but the facility could not provide documentation in the medical record that the immunization was assessed on that due date. For another resident admitted to the facility with diagnoses of stroke, hemiplegia, and Parkinson’s disease, the MDS documented these conditions, and the immunization record indicated that a pneumococcal vaccine was not due until 4/28/25. As with the first resident, the facility could not provide documentation in the medical record that the pneumococcal immunization was assessed on the identified due date. During interviews, the IP confirmed that there was no documentation of assessment for either resident on their respective due dates, and the Regional Risk staff member confirmed that the facility failed to ensure pneumococcal vaccinations were tracked in the electronic health record for these residents.
Failure to Educate Residents on Risks and Benefits of Flu and Pneumonia Vaccines
Penalty
Summary
Surveyors identified a deficiency related to the facility’s failure to educate residents on the risks and benefits of pneumococcal and influenza immunizations as required by facility policy and SOM Appendix PP. The facility’s written policy, last reviewed on 12/22/25, stated that prior to administration of influenza or pneumococcal vaccines, the resident or legal representative would be provided the current CDC Vaccine Information Statement, supplemented with visual or oral explanations, and that a signed consent form and documentation of education and acceptance/refusal would be maintained in the medical record. Record review and staff interview showed that this process was not followed for several residents. For one resident with muscle wasting and osteonecrosis who was readmitted to the facility, the medical record did not contain documentation that he was offered the opportunity to accept or decline the pneumococcal vaccine based on education about risks and benefits, and the Clinical RN confirmed there were no records of such education. For another resident with cancer and coronary artery disease, the record likewise lacked documentation of education or an opportunity to accept or decline the pneumococcal vaccine, which the Clinical RN also confirmed. A third resident with osteoarthritis, protein-calorie malnutrition, and dementia, and/or her representative, had no documented evidence in the record that she was offered the opportunity to accept or decline influenza and pneumococcal vaccines based on staff education regarding risks and benefits, and the Clinical RN again stated there were no records of this education. This lack of documented education and consent occurred for 3 of 5 residents reviewed for current immunizations.
Failure to Offer and Document Influenza and Pneumococcal Vaccinations
Penalty
Summary
The facility failed to follow its policies for offering and documenting influenza and pneumococcal vaccinations for two residents. For one resident, admitted on an unspecified date, review of the EMR under the Immunization tab on 03/30/26 showed no documentation that the influenza vaccine had been offered or declined, and there was no record of prior influenza vaccination or a physician-documented contraindication. The facility was unable to provide any declination form for this resident’s annual influenza vaccination. For another resident, also admitted on an unspecified date, the EMR Immunization tab on 03/30/26 lacked documentation that either the influenza vaccine or the PCV20 pneumococcal vaccine had been offered or declined, and there was no record of historical administration or physician-documented contraindications for either vaccine. The facility could not produce declination forms for this resident’s annual influenza or PCV20 vaccinations. During interviews, a licensed nurse stated she was not responsible for tracking resident immunization history or vaccine administration, and an administrative nurse reported she could not locate the consent or declination forms and indicated the infection preventionist was responsible for tracking and documenting immunizations. The facility’s written policies stated that all residents without medical contraindications would be offered influenza and pneumococcal vaccines and that pertinent information about vaccine risks and benefits would be provided to residents or their legal representatives.
Failure to Offer and Administer Pneumococcal Vaccines per CDC Guidance
Penalty
Summary
The facility failed to offer and administer pneumococcal vaccinations in accordance with CDC guidance and its own policy for two residents. Resident 27, who had diagnoses including tonsillar cancer, traumatic brain injury, and diabetes, had a historical PPSV23 (Pneumovax 23) documented from 12/19/11 prior to admission. The clinical record did not contain a Pneumococcal Vaccine Consent or Declination Form and lacked any documentation that the resident had been offered or received the currently recommended pneumococcal conjugate vaccines (PCV15, PCV20, or PCV21) as outlined by CDC recommendations for adults 50 years and older. This was inconsistent with the facility’s written policy requiring assessment of pneumococcal vaccination status upon or shortly after admission and administration of vaccines per current CDC recommendations. Resident 45, with diagnoses including aortic valve insufficiency, heart disease, and muscle weakness, had no record of receiving any pneumococcal vaccination. The record contained a Pneumococcal Vaccine Consent signed on 12/6/24, but there was no updated consent or declination and no documentation that any pneumococcal vaccine had been offered or administered. During interviews, the DON stated she could not locate current pneumococcal vaccination forms for these residents, explained that vaccinations were administered by an off-site company, and acknowledged that another vaccine clinic needed to be scheduled but had not yet been arranged. The DON and Infection Preventionist both stated that pneumonia vaccinations were offered per guidelines, but the clinical records for these two residents did not support that pneumococcal vaccines had been appropriately offered or administered in accordance with CDC guidance and the facility’s policy.
Failure to Document Influenza and Pneumococcal Vaccination Status for a Resident
Penalty
Summary
Surveyors identified a deficiency in the facility’s documentation of influenza and pneumococcal vaccinations for one resident. Record review on 03/25/2026 showed that Resident #124 was admitted on an unspecified date, and the EMR contained no documentation that the resident or their representative had been educated about, offered, and had either received or declined influenza and pneumococcal vaccines. An Immunizations Report from the EMR listed the resident’s influenza status as historical but did not include supporting documentation of the immunization, nor did it indicate whether the resident had received a pneumococcal vaccination. During interviews on 03/25/2026, the Infection Preventionist was unable to provide a Vaccination Review: Consent/Declination SNF Resident Form for this resident and confirmed that documentation of offering, educating, and either receiving or declining the influenza and pneumococcal vaccinations was not available. This lack of documentation was inconsistent with the facility’s written policies, which require education, completion of consent/declination forms, and placement of immunization documentation or reasons for non-immunization in the resident’s record.
Lack of Documentation and Administration of Influenza Vaccination After Consent
Penalty
Summary
The deficiency involves the facility’s failure to ensure that a resident was offered and received an influenza vaccination, and that the resident’s medical record contained documentation of administration, refusal, or education regarding the vaccine. The facility had a written Influenza Vaccination policy dated 7/1/25 stating that individuals receiving the influenza vaccine, or their legal representative, must provide consent prior to administration and that the consent would be located in the resident’s medical record. For one resident (R4), the Activated Power of Attorney (APOA) signed the facility’s Influenza Vaccination Information and Release Form on 10/2/25, indicating that they had read information about influenza and the flu vaccine, understood the benefits and risks, and requested that the influenza vaccine be given to the resident named on the form. Despite the signed consent, surveyor review of R4’s electronic health record revealed no documentation that the influenza vaccination was administered, nor any record of refusal or education. During an interview on 3/23/26, the DON stated that they had located the consent but were still looking for documentation that the vaccine had been given. On 3/24/26, the DON reported they were unable to find any documentation indicating that R4 had received the influenza vaccination. When asked if the expectation would be that the vaccine was administered when a signed consent was present, the DON confirmed that this was the expectation.
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