Common use of Vaccine Administration Clause in Contracts

Vaccine Administration. During an influenza pandemic, it is possible that persons of all ages will need multiple doses of pandemic vaccine separated by recommended time intervals in order to mount an appropriate level of immune response to be protected from pandemic virus infection. It may also be possible that adjuvant would be required in each pandemic vaccine dose, with the need to be mixed at the point of administration to patient. Furthermore, it may be possible that only certain types or brands of adjuvant will be approved for use with certain types or brands of pandemic vaccine antigen. Also, many patients will likely receive their first and second pandemic vaccine dose from different providers at different locations. These complexities will make the need for complete and accurate vaccine administration documentation extremely important for patient safety, so that all pandemic vaccine providers are able to access this documentation to correctly assess and therefore correctly match pandemic vaccines and adjuvants between doses in each patient. i. Assessing Pandemic Vaccination Dose Status at the Point of Vaccine Administration: Responsibility of Pharmacy: Pharmacy will ensure that all pharmacists, other vaccinating personnel, and designated personnel employed or contracted by Pharmacy have the resources, training, and equipment to assess the timing and type of prior pandemic vaccine and adjuvant, administered (if multiple vaccine doses are required) for each person presenting to a Pharmacy site or stores for pandemic vaccination. Assessment of prior pandemic vaccination by Pharmacy personnel should preferentially be made through the STATE or jurisdiction’s IIS at the point of administration and then by other means, such as through a patient’s individual shot card. ii. Submitting Doses Administered Data to STATE IIS: For both the vaccine antigen and the adjuvant (if required), Pharmacy must ensure administration data is recorded in the patient’s STATE’s IIS or in a permanent office log, if IIS submission is not feasible. The record needs to include the patient’s name, the date of administration, the site of administration, the vaccine and adjuvant manufacturer, the type and lot number of the vaccine and adjuvant dose, and the name and address of the immunization provider for each individual vaccinated. The record must be kept for a minimum of three years following vaccination (or longer if specified by state law). Medical records must be made available as requested by the state or local health department to the extent authorized by law. Further, data submitted to IIS must additionally include all core elements as required for IIS submission for seasonal influenza vaccine administration as designated by STATE and/or the Association of Immunization Registries of America’s (AIRA) core elements (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/vaccines/programs/iis/core-data-elements.html). All data submission will comply with the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and any applicable STATE law. It is expected that Pharmacy will submit all data on pandemic vaccine administered during the prior week by Pharmacy to STATE’s IIS by 8:00 AM each Monday. Consistency in requirements across jurisdictions within the STATE shall be facilitated by the STATE.

Vaccine Administration. During an influenza pandemic, it is possible that persons of all ages will need multiple doses of pandemic vaccine separated by recommended time intervals in order to mount an appropriate level of immune response to be protected from pandemic virus infection. It may also be possible that adjuvant would be required in each pandemic vaccine dose, with the need to be mixed at the point of administration to patient. Furthermore, it may be possible that only certain types or brands of adjuvant will be approved for use with certain types or brands of pandemic vaccine antigen. Also, many patients will likely receive their first and second pandemic vaccine dose from different providers at different locations. These complexities will make the need for complete and accurate vaccine administration documentation extremely important for patient safety, so that all pandemic vaccine providers are able to access this documentation to correctly assess and therefore correctly match pandemic vaccines and adjuvants between doses in each patient. i. Assessing Pandemic Vaccination Dose Status at the Point of Vaccine Administration: Responsibility of Pharmacy: Pharmacy will ensure that all pharmacists, other vaccinating personnel, and designated personnel employed or contracted by Pharmacy have the resources, training, and equipment to assess the timing and type of prior pandemic vaccine and adjuvant, administered (if multiple vaccine doses are required) for each person presenting to a Pharmacy site or stores for pandemic vaccination. Assessment of prior pandemic vaccination by Pharmacy personnel should preferentially be made through the STATE state or jurisdiction’s IIS at the point of administration and then by other means, such as through a patient’s individual shot card. ii. Submitting Doses Administered Data to STATE state IIS: For both the vaccine antigen and the adjuvant (if required), Pharmacy must ensure administration data is recorded in the patient’s STATEstate’s IIS or in a permanent office log, if IIS submission is not feasible. The record needs to include the patient’s name, the date of administration, the site of administration, the vaccine and adjuvant manufacturer, the type and lot number of the vaccine and adjuvant dose, and the name and address of the immunization provider for each individual vaccinated. The record must be kept for a minimum of three years following vaccination (or longer if specified by state law). Medical records must be made available as requested by the state or local health department to the extent authorized by law. Further, data submitted to IIS must additionally include all core elements as required for IIS submission for seasonal influenza vaccine administration as designated by STATE the Department and/or the Association of Immunization Registries of America’s (AIRA) core elements (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/vaccines/programs/iis/core-data-elements.html). All data submission will comply with the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and any applicable STATE state law. It is expected that Pharmacy will submit all data on pandemic vaccine administered during the prior week by Pharmacy to STATEstate’s IIS by 8:00 AM each Monday, unless a more frequent schedule is warranted by the course of the Pandemic. Pharmacy will be notified of changes in the submission schedule by the Department prior to the expected time and date of submission. Consistency in requirements across jurisdictions within the STATE state shall be facilitated by the STATEDepartment.