Incomplete COVID-19 Vaccine Education, Offering, and Documentation
Summary
The facility failed to ensure that residents were offered the COVID-19 vaccine and that residents or their representatives received education about the benefits, potential risks, and side effects of the vaccine. The facility also failed to ensure the medical record contained documentation of vaccine education, administration of each dose, or a resident’s refusal or medical contraindication for 5 of 5 sampled residents: R16, R22, R35, R37, and R41. CMS guidance reviewed by surveyors stated that LTC facilities must offer residents COVID-19 vaccination when vaccine supplies are available and must screen residents for prior immunization, precautions, and contraindications before offering vaccination. R16 was admitted with acute and chronic respiratory failure, COPD, and CHF, and had a BIMS score of 12, indicating moderate cognitive impairment. Her immunization report showed no documented COVID-19 vaccinations or declinations during the vaccination period. A consent form was signed on the same day the surveyor requested the information and showed the resident declined the vaccine, but the EMR contained no documentation that education about the vaccine’s benefits and potential risks had been provided. During interview, R16 stated she did not remember being offered the vaccine or signing a consent form and said she did not receive a vaccine information sheet. R22, R35, and R41 were cognitively intact with BIMS scores of 15, and R37 had severe cognitive impairment with a BIMS score of 5. Their immunization reports also showed no documented COVID-19 vaccinations or declinations during the vaccination period. For R22 and R35, consent forms were signed on the same day the surveyor requested the information; R22’s form indicated she consented but was not administered the vaccine, while R35’s form contained only initials and did not document acknowledgement of receiving vaccine information, understanding risks and benefits, or having the opportunity to ask questions. For R37 and R41, verbal informed consent was obtained from representatives by telephone, and both representatives declined vaccination. In each of these cases, the EMR lacked documentation that education regarding the benefits and potential risks of the COVID-19 vaccine had been provided. During interviews, the Infection Preventionist stated she had multiple roles, including staff nurse and ADON, and said competing responsibilities interfered with infection prevention oversight. She explained that state-supplied vaccines had previously been available, but once they were no longer available she sought direction about ordering vaccines and was told the facility would not cover the cost, so no further action was taken. She also stated she contacted pharmacies to arrange on-site clinics, but no formal determination had been made about when a clinic would occur or who would conduct it. The IP acknowledged that consent documentation was initiated during the survey, that documentation was incomplete, and that the breakdown was related to staffing changes, role confusion, and lack of clear responsibility. The DON, Administrator, and Medical Director each stated that residents should receive vaccine education, that consent or declination should be documented, and that immunizations should be managed in accordance with CDC guidance.
Penalty
Resources
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