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

Missing vaccine consent and administration documentation

Warren Nursing & RehabWarren, Ohio Survey Completed on 12-31-2025

Summary

The facility failed to ensure that consent or declination forms were obtained for influenza and pneumococcal vaccinations for multiple residents, and it also failed to document required vaccine administration details when vaccines were given. Resident #5, who had diagnoses including major depressive disorder, bipolar disorder, hypertension, congestive heart failure, and chronic kidney disease stage III, had documentation showing consent for both vaccines, and the MAR showed influenza and pneumococcal vaccines were administered, but the record did not include the site of administration, lot number, or expiration date. Resident #25 had diagnoses including chronic respiratory failure with hypoxia, hypertension, tracheostomy status, gastrostomy status, and traumatic subdural hemorrhage; the record showed consent for pneumococcal vaccination and documentation that the vaccine was given, but there was no influenza consent or declination and no documentation of the pneumococcal administration site, lot number, or expiration date. Resident #20, with diagnoses including acute on chronic respiratory failure, end stage renal disease, acute on chronic congestive heart failure, history of sepsis, and COVID-19, had no consent or declination documented for either influenza or pneumococcal vaccination. Resident #29, who had dependence on renal dialysis, end stage renal disease, COPD, and pulmonary hypertension, had documentation of pneumococcal vaccination but no influenza consent or declination. Resident #38, with type II diabetes, major depressive disorder, hypertension, tracheostomy status, ventilator dependency, acute pulmonary edema, and acute on chronic respiratory failure with hypoxia, also had no consent or declination documented for either vaccine. The Infection Preventionist RN confirmed that vaccinations were not to be given without signed consent and that administration site, lot number, and expiration date were required documentation, and the facility policy required signed consent or declination and documentation of vaccine details in the medical record.

Penalty

Inspection fine: $214,42523 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
Incomplete Pneumococcal Vaccine Documentation
E
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

Incomplete pneumococcal vaccine documentation was identified for three residents. The facility policy required admission review of prior immunizations and documentation in the EHR, but records for residents with DM, HTN, CAD, MS, and COPD showed pneumococcal status coded as not up to date and not offered, while the immunization entries listed consent not obtained or status to be determined, with education not checked for two residents and no documented evidence that vaccine status was discussed with the attending physician for one resident. The DON acknowledged the facility failed to provide accurate and timely documentation related to the pneumonia 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 Consistently Manage Flu and Pneumococcal Immunizations
E
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

The facility failed to consistently educate, offer, or administer influenza and pneumococcal vaccines for multiple residents. Records for one resident did not clearly show prior vaccine history or eligibility, another resident had no evidence of shared decision making or additional pneumococcal vaccination, and a third resident’s consent was incomplete and lacked documentation of vaccination. The IP nurse stated she handled MIIC review and PCC entry herself and that vaccine review was behind during a period when she was also serving as 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.
Pneumococcal Immunization Education and Offer Process Deficient
E
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

Pneumococcal immunization education and offer process deficient: The facility did not provide accurate education about current CDC guidance for PCV20/PCV21 and did not ensure that eligible residents were reoffered pneumococcal vaccine during ongoing stay. One resident’s declination form incorrectly stated no further vaccine was needed after PCV13 and PPSV23, another resident’s son declined based on outdated information, and two other residents had no evidence of a later vaccine offer after becoming eligible.

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 Recommended Pneumococcal Vaccinations
E
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

Failure to Offer Recommended Pneumococcal Vaccinations: The facility did not document offering the recommended pneumococcal vaccine to three residents who had prior pneumococcal immunizations. EMR review showed one resident had received PCV13, another had received PCV13, and a third had received PPV23, but there was no record that any of them were offered, received, or declined the additional recommended vaccine. The RN unit manager/IP acknowledged the residents were not offered the vaccines and had not refused them.

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 Document and Provide Pneumococcal and Influenza Vaccinations
D
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

A facility failed to ensure one resident received a pneumococcal vaccine after consent was obtained, with no documentation that it was administered or contraindicated. The facility also failed to document that another resident was offered the influenza vaccine and refused it, despite the MDS indicating the vaccine was not received in the facility. The DON confirmed the missing documentation for both residents.

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 Document Vaccine Education and Refusals
D
F0883 F883: Develop and implement policies and procedures for flu and pneumonia vaccinations.
Short Summary

Failure to document vaccine education and refusals for two residents. One resident with type 2 DM and another resident with respiratory failure both had BIMS scores of 15/15, but their records showed refusal of PCV 20 and refusal of influenza and pneumococcal vaccines without documentation that education on benefits and risks was provided. The IP stated education was provided regardless of refusal, while the DON confirmed the records lacked documentation of vaccine education.

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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