Finding Text
Federal Agency: Department of Health and Human Services CFDA Program: 93.268 Immunization Cooperative Agreement Award Number: 1NH23IP922587-01-00, 6NH23IP922587-01-01, 6NH23IP922587-01-02, 5NH23IP922587-02-00, 6 NH23IP922587-02-01 and 6NH23IP000736 Area: Special Tests and Provision – Control, Accountability and Safeguarding of Vaccine Questioned Costs: $ -0- Criteria: In accordance with the Vaccine for Children Program (VFC) Policies and Procedures at the State/Local Immunization Program section 5.2.7, CHCC is required to conduct monthly reconciliation of the vaccination records which includes the vaccine inventory, patient screening forms, vaccine administered log sheet and the temperature log sheet. Additionally, in accordance with the VFC Policies and Procedures at the State/Local Immunization Program section 4.1, visits must be conducted on an annual or as per need basis which evaluates the program’s adherence to VFC program requirements, including appropriate vaccine handling, storage, and ordering procedures. CHCC is required to perform sampling of patient records to verify eligibility screening and the administration of VFC vaccine only to eligible children. Condition: 1. For 12 (or 100%) of 12 monthly provider inventory reconciliations selected for testing, no supporting documentation was provided to evidence that reviews and approvals were conducted by CHCC over the reconciliations. Condition, continued: 2. For five (or 83%) of six providers selected for testing, CHCC was unable to provide the annual Site Visit Reports. Cause: CHCC was unable to provide the supporting documents as it was lost during the transition to the new management and their current control and procedures are not suitably designed to properly maintain and retain all the documents. Effect: The CHCC is in noncompliance with the applicable Special Tests and Provisions – Control, Accountability and Safeguarding of Vaccine. Recommendation: CHCC should improve their record-keeping policies and controls, such as duplication of documents into a soft copy, to ensure that a seamless transition is achieved whenever changes to management take into effect. Views of Responsible Officials: CHCC concurs with the findings. To address this finding, the Immunization Program conducts the following reconciliation of vaccination records as follows: Vaccination records: daily entries of vaccination records are captured through the patient encounter form for all providers administering vaccinations. Data Entry Assistants and Program Assistants are responsible for entering the vaccinations based on the form. The Immunization Information Systems (IIS) team are responsible for ensuring data quality elements are complete on the form and reflected on the WebIZ system. Patient screening forms: also known as the patient encounter form is the paper-based document in which patient demographics and vaccination data elements are recorded upon visit for all providers. Data Entry Assistant and Program Assistant capture demographic and input vaccines an individual is to receive for the visit. The vaccinator then inputs vaccination data elements (lot number, manufacturer, site, route, etc.) to be inputted into the registry, WebIZ. Temperature log: utilized to document the vaccine storage unit temperature based on the thermometer reading and logged at the start and end of each workday, as well as after hours and weekends/holidays. The VFC Coordinator and Security team logs the temperatures on a daily, routine basis. Vaccine inventory: monitored weekly by the Logistics Technician via spreadsheet and tracked using the registry WebIZ for overall vaccine inventory management. Inventory is reported to CDC by the Program Manager every 14 days. Vaccine wastage from all providers is submitted to the program at the first week of each month for the previous month reporting period. Overall wastage reporting is done monthly to CDC. In addition, since 2020, CHCC has conducted the following steps to ensure that annual site visits for VFC providers are completed and documented appropriately to evaluate adherence to the VFC program requirements: - Provided training to the staff member assigned/responsible (VFC Coordinator) for conducting site visits - Worked with CDC Subject Matter Experts to ensure that data systems for site visit findings/reporting were accessible to the VFC Coordinator. Training on the system was also provided to the VFC Coordinator. This system is cloud based and accessible to anyone provided access. Therefore, should staff turnover occur, access to prior reports and the system for submitting new site visit reports will continue to be accessible to the organization and to team members who will take on the responsibility. - Ensure that Position Description for the VFC Coordinator clearly specify responsibilities for implementing the VFC Program in accordance with the Immunization Program Operating Manual (IPOM), which outlines the requirements for annual provider compliance site visits, including the sampling of patient records to verify eligibility screening and administration of VFC vaccine only to eligible children. - Entries of vaccine reconciliation documentation such as vaccine inventory (orders, transfers, and wastages) are accessible on the registry, CNMI WebIZ, as well as routine reporting to CDC VtrckS