Failure to Obtain Informed Consent for Covid-19 Vaccine
Penalty
Summary
Moravian Hall Square Health and Wellness Center was found to be non-compliant with federal and state regulations regarding the right of residents to be informed and make treatment decisions. The facility failed to inform a resident or their responsible party in advance about a treatment option, specifically the administration of a Covid-19 vaccine. The facility's policy required that residents or their legal representatives receive information and education about the benefits and potential side effects of the vaccine and that consent be obtained prior to administration. However, this procedure was not followed for one of the sampled residents. The resident in question was admitted to the facility with diagnoses including dementia and muscle weakness, and required extensive assistance with activities of daily living. A physician had ordered the administration of a Covid-19 vaccine as needed in the event of an outbreak. On a specified date, the vaccine was administered without documented evidence that the resident or their representative was informed or consented to the treatment. The Director of Nursing confirmed that informed consent was not obtained prior to the vaccine administration.
Plan Of Correction
1. The Infection Prevention Nurse will provide education to residents and/or their designated representatives regarding vaccination options and their benefits and risks prior to obtaining informed consent. 2. If the resident representative and the resident are unable to recall IF they had received a recent vaccination, their community Primary Care Physician will be contacted. 3. The Infection Prevention Nurse will obtain informed consent for all vaccinations from residents and/or their designated representatives, utilizing the Document Manager in PCC or, where applicable, paper documentation. 4. A physician's order will be obtained. 5. The nurse will verify that informed consent has been obtained prior to administering any vaccinations. 6. Residents will be monitored for signs and symptoms for 24 to 48 hours following administration of the vaccine. 7. Vaccination administration will be documented by the nurse in EMAR on PCC and updated in the immunizations tab of the resident's EMR. 8. The COVID-19 Vaccine Policy has been reviewed, and staff have been educated on the associated policies and procedures. This includes training on how to effectively communicate with residents and their representatives regarding vaccination, ensuring they understand the informed consent process and their right to make an informed decision. 9. The Infection Preventionist will be responsible to ensure all vaccinations have physician orders and consent prior to administration. This will be completed by the Infection Preventionist, with the DON as her backup. This will be added to our QAPI reporting no less than quarterly for the next year.