§483.80 Infection control
§483.80(d)(3) COVID-19 immunizations. The LTC facility must develop and implement policies and procedures to ensure all the following:
(i) When COVID-19 vaccine is available to the facility, each resident and staff member is offered the COVID-19 vaccine unless the immunization is medically contraindicated or the resident or staff member has already been immunized;
(ii) Before offering COVID-19 vaccine, all staff members are provided with education regarding the benefits and risks and potential side effects associated with the vaccine;
(iii) Before offering COVID-19 vaccine, each resident or the resident representative receives education regarding the benefits and risks and potential side effects associated with the COVID-19 vaccine;
(iv) In situations where COVID-19 vaccination requires multiple doses, the resident, resident representative, or staff member is provided with current information regarding those additional doses, including any changes in the benefits or risks and potential side effects, associated with the COVID-19 vaccine, before requesting consent for administration of any additional doses.
(v) The resident or resident representative, has the opportunity to accept or refuse a COVID-19 vaccine, and change their decision; and
(vi) The resident's medical record includes documentation that indicates, at a minimum, the following:
(A) That the resident or resident representative was provided education regarding the benefits and potential risks associated with COVID-19 vaccine; and
(B) Each dose of COVID-19 vaccine administered to the resident, or
(C) If the resident did not receive the COVID-19 vaccine due to medical contraindications or refusal.
(vii) The facility maintains documentation related to staff COVID-19 vaccination that includes at a minimum, the following:
(A) That staff were provided education regarding the benefits and potential risks associated with COVID-19 vaccine;
(B) Staff were offered the COVID-19 vaccine or information on obtaining COVID-19 vaccine; and
(C) The COVID-19 vaccine status of staff and related information as indicated by the Centers for Disease Control and Prevention's National Healthcare Safety Network (NHSN).
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Observations:
Based on review of facility policies and clinical records, as well as staff interviews, it was determined that the facility failed to provide accurate and timely documentation related to offering the COVID-19 vaccination for five of 22 residents reviewed (Residents 7, 11, 23, 32, 50).
Findings include:
A comprehensive Minimum Data Set (MDS) assessment (a mandated assessment of a resident's abilities and care needs) for Resident 7, dated June 9, 2026, revealed that the resident was cognitively impaired and that his COVID vaccination was not up to date.
Review of Resident 7's clinical record revealed no immunization or declination information documented related to the COVID-19 vaccine.
A comprehensive MDS assessment for Resident 11, dated June 29, 2026, revealed that the resident was cognitively intact, was admitted to the facility on June 23, 2026, and that her COVID-19 vaccination was not up to date.
Review of Resident 11's clinical record revealed no immunization or declination information documented related to the COVID-19 vaccine.
A comprehensive MDS assessment for Resident 23, dated May 26, 2026, revealed that the resident was cognitively intact and that his COVID vaccination was not up to date.
Review of Resident 23's clinical record revealed no immunization or declination information documented related to the COVID-19 vaccination.
A comprehensive MDS assessment for Resident 32, dated May 21, 2026, revealed that the resident was cognitively intact, was admitted to the facility on May 15, 2026, and that her COVID-19 vaccination was not up to date.
Review of Resident 32's clinical record revealed no immunization or declination information documented related to the COVID-19 vaccine.
Resident 50's clinical record indicated that he was admitted on June 26, 2026. There was no documented evidence that he was offered the COVID-19 vaccination.
Review of Resident 50's clinical record revealed no immunization or declination information documented related to the COVID-19 vaccine.
Interview with the Infection Control Nurse on July 8, 2026, at 1:39 p.m. revealed that Residents 7, 11, 23, 32, and 50 were not offered the COVID-19 vaccination. She stated that the pharmacist advised her not to offer the COVID vaccination outside of the "COVID season" because the new formula is released in October and a person must wait three months after receiving a COVID-19 vaccination prior to receiving another one.
Interview with the Nursing Home Administrator on July 8, 2026, at 9:32 a.m. revealed that they do not offer the COVID-19 vaccination at this time because their pharmacist advised them not to do so.
28 Pa. Code 201.14(a) Responsibility of licensee.
28 Pa. Code 201.18(b)(1)(e)(1) Management.
| | Plan of Correction - To be completed: 07/31/2026
1. No harm occurred to guests 7, 11, 23, 32, and 50 due to not being offered the Covid-19 vaccination. Guests 7, 11, and 32 no longer reside in the facility. COVID vaccines were offered to guests 23 and 50.
2. The Infection Preventionist will be re-educated on the requirements of providing accurate and timely documentation related to offering the COVID vaccination to guests.
3. The Infection Preventionist and/or designee will review the COVID vaccination status of all new admissions daily Monday-Friday at Clinical Stand Up Meeting. The COVID vaccine will be offered to those who are eligible and documented timely in the guest's medical record.
4. Identified issues will be brought to the Quality Assurance and Improvement Committee for further review and discussion until substantial compliance is achieved.
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