§483.80(d) Influenza and pneumococcal immunizations §483.80(d)(1) Influenza. The facility must develop policies and procedures to ensure that- (i) Before offering the influenza immunization, each resident or the resident's representative receives education regarding the benefits and potential side effects of the immunization; (ii) Each resident is offered an influenza immunization October 1 through March 31 annually, unless the immunization is medically contraindicated or the resident has already been immunized during this time period; (iii) The resident or the resident's representative has the opportunity to refuse immunization; and (iv)The resident's medical record includes documentation that indicates, at a minimum, the following: (A) That the resident or resident's representative was provided education regarding the benefits and potential side effects of influenza immunization; and (B) That the resident either received the influenza immunization or did not receive the influenza immunization due to medical contraindications or refusal.
§483.80(d)(2) Pneumococcal disease. The facility must develop policies and procedures to ensure that- (i) Before offering the pneumococcal immunization, each resident or the resident's representative receives education regarding the benefits and potential side effects of the immunization; (ii) Each resident is offered a pneumococcal immunization, unless the immunization is medically contraindicated or the resident has already been immunized; (iii) The resident or the resident's representative has the opportunity to refuse immunization; and (iv)The resident's medical record includes documentation that indicates, at a minimum, the following: (A) That the resident or resident's representative was provided education regarding the benefits and potential side effects of pneumococcal immunization; and (B) That the resident either received the pneumococcal immunization or did not receive the pneumococcal immunization due to medical contraindication or refusal.
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Observations:
Based on review of facility policy, review of clinical records, interview with residents and staff, it was determined that the facility failed to offer and educate all residents on the prevention of pneumococcal disease and failed to offer the pneumococcal vaccine to residents for five of five residents reviewed for immunizations. (Residents R12, R13, R14, R15, and R16) Findings include: Review of the facility policy titled " Pneumococcal Vaccination of Residents " revealed that according to the Centers for Disease Control and Prevention (CDC), pneumococcal vaccination is recommended for adults 65 years of age and older and for younger adults with certain underlying health conditions. The policy states that: -All residents aged 65 and older, or younger residents with qualifying medical conditions, should receive the pneumococcal vaccine. -Revaccination may be necessary as indicated. -Vaccines are to be administered by appropriately qualified personnel following facility procedures, with a physician's order required. -Immunization status is to be determined by reviewing available medical records. -Residents with undocumented or unknown pneumococcal vaccination status are to be offered the vaccine after informed consent and education regarding risks and benefits. -Vaccine administration is to be documented in the clinical record. A review of the CDC ' s Pneumococcal Vaccine Recommendations for Adults (updated October 26, 2024) indicated that adults aged 65 years and older have the option to receive PCV20 or PCV21, or to forego additional pneumococcal vaccines if previously immunized. Pneumococcal disease is caused by bacteria that commonly reside in the nose and throat and can lead to illnesses ranging from mild ear infections to serious infections such as pneumonia. The disease is spread through direct contact with respiratory secretions. Adults aged 65 years and older are at increased risk for pneumococcal disease. Review of Residents R12, R13, R14, R15, and R16 reviewed revealed no documentation of pneumococcal vaccination or evidence that the vaccine had been offered or discussed with the residents. Interview with Employee E11, Infection Preventionist, on November 7, 2025 at 10:00 am confirmed that pneumococcal vaccines have not yet been offered to any residents in the facility. Employee E11 stated she began her position in infection prevention and control in March 2025 and has not yet addressed the pneumococcal vaccination program for residents.
28 Pa. Code 211.2 (d)(3)(5) Medical Director
28 Pa. Code 211.12(d)(3)(5) Nursing Services
| | Plan of Correction - To be completed: 01/02/2026
The facility will offer and educate all residents on the prevention of pneumococcal disease. The IP or designee will review the immunization records of the five residents and all current residents for their pneumococcal vaccine. All residents who are not up to date will be educated on the prevention of pneumococcal disease and will be offered the vaccine. The IP or designee will review the immunization records of all new admissions and will educate and offer the pneumococcal vaccine to the residents who are not up to date. The DON or designee will complete an audit all current residents to ensure their pneumococcal vaccine status is up to date and all residents have been educated and offered the pneumococcal vaccine. The DON or designee will complete audits on all new admissions pneumococcal vaccine status including education and offering of the pneumococcal vaccine weekly x 4 weeks then monthly x 3 months, and random checks quarterly. Results will be reported to QAPI.
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