F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
E

Failure to Document and Administer Required Influenza and Pneumococcal Vaccinations

Gardens Of Mayfield VillageMayfield Heights, Ohio Survey Completed on 05-29-2025

Summary

The facility failed to ensure that residents were offered, screened, educated, and received influenza and pneumococcal vaccinations as required by both facility policy and CDC guidance. This deficiency was identified through record reviews, policy reviews, and staff interviews, affecting five residents who were reviewed for vaccinations, with the potential to impact all 59 residents in the facility. For each of the five residents, there was no documentation in the medical records regarding the administration of influenza or pneumococcal vaccines, nor any record of consent, declination, or education provided about these vaccines. Specifically, the medical records for residents with various diagnoses, including dementia, schizophrenia, muscle weakness, congestive heart failure, asthma, morbid obesity, diabetes, respiratory failure, and COPD, lacked any evidence of vaccination status or related documentation. Interviews with the President of Operations and the Regional Registered Nurse confirmed that they were unable to locate any vaccination records, refusals, or educational materials for these residents in the electronic medical records. This absence of documentation was consistent across all five residents reviewed. Facility policies required that for residents who received vaccines, the date, lot number, expiration date, person administering, and site of vaccination be documented in the medical record, and that refusals also be documented. Additionally, policies stated that residents should be assessed for vaccine eligibility upon or prior to admission and offered the vaccine series within thirty days unless contraindicated. The CDC guidance reviewed also emphasized the importance of following recommended immunization schedules for at-risk populations, but there was no evidence that these requirements were met for the residents in question.

Penalty

Fine: $173,90029 days payment denial
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

Resources

Below are regulatory guidelines relevant to this citation:

See other F0883 citations in Ohio
Failure to Administer Pneumococcal Vaccines per CDC Recommendations
D
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

Two residents with severe cognitive impairment and multiple chronic conditions did not receive pneumococcal vaccinations in accordance with CDC guidelines. One resident had no record of receiving any pneumococcal vaccine, while another was not offered an additional dose as recommended. An LPN confirmed the lack of proper vaccination documentation, despite facility policy requiring immunizations for all residents unless contraindicated or refused.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Offer and Document Pneumococcal Vaccinations
E
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

Several residents with complex medical conditions were not offered, screened, educated, or documented for pneumococcal vaccination, as required. Immunization records lacked evidence of vaccination, consent, or education, and interviews with the DON and a regional nurse consultant confirmed that the facility prioritized influenza and COVID-19 vaccines instead of pneumococcal vaccines.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Provide and Document Immunization Education and Consent
E
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

The facility did not ensure that education on the risks and benefits of flu and pneumonia vaccines was provided or documented, and failed to obtain written consent for these immunizations. Several residents with complex medical conditions were affected, with consent forms either missing, incomplete, or only indicating verbal consent or declination without specifying who made the decision or providing a signature. Staff confirmed that forms were not properly completed, following instructions from the previous DON.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Obtain Consent and Provide Education Prior to Influenza Vaccination
D
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

Three residents with complex medical conditions received influenza vaccinations without documented consent or evidence of receiving required vaccine education. Review of records and staff interviews confirmed that the facility did not follow its policy to provide CDC vaccine information statements and obtain signed consent forms prior to administering the vaccine.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Offer and Document Pneumococcal Vaccine and Education
D
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

Two residents were not offered the pneumococcal vaccine nor provided education about its benefits and side effects, as required by facility policy. Medical records lacked documentation of vaccine offering or education, and interviews with the DON and a resident confirmed these omissions. The facility's policy mandates education and documentation for all residents, but these steps were not completed for the affected individuals.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Lack of Documentation and Education for Influenza Vaccine Refusal
D
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

A resident with multiple chronic conditions and severe cognitive impairment refused the influenza vaccine, but there was no documentation of vaccine consent or declination, nor evidence that education on the vaccine's benefits and risks was provided, as required by facility policy. The DON confirmed the absence of this documentation.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

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