Finding Text
Finding No. 2021-008 - Special Tests and Provisions - Control, Accountability and Safeguarding of Vaccine Identification of the federal program: Federal Agency: Department of Health and Human Services AL Program: 93.268 Immunization Cooperative Agreement Award Number: 5 NH23IP922587-03, 6 NH23IP922587-03, 6 NH23IP922587-02 Criteria or specific requirement (including statutory, regulatory or other citation): In accordance with 2 CFR 200.303(a), the recipient and subrecipient must establish, document, and maintain effective internal control over the Federal award that provides reasonable assurance that the recipient or subrecipient is managing the Federal award in compliance with Federal statutes, regulations, and the terms and conditions of the Federal award. Vaccine for Children Program (VFC) Policies and Procedures at the State/Local Immunization Program section 5.2.7 states that 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, VFC Policies and Procedures at the State/Local Immunization Program section 4.1 states that 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. CHCC did not provide all sampled monthly inventory reconciliations. 2. CHCC did not provide all sampled annual site visit reports. Cause: CHCC’s current document maintenance and retention control and procedure is not designed effectively. Effect or potential effect: CHCC is in noncompliance with the applicable Special Tests and Provisions - Control, Accountability and Safeguarding of Vaccine. Questioned Costs: There are no questioned costs as the finding is non-monetary. Context: 1. For ten (or 71%) of fourteen monthly provider inventory reconciliations selected for testing, CHCC did not provide the supporting documentation. 2. For six (or 86%) of seven providers selected for testing, CHCC did not provide the annual site visit reports and the related supporting documentation that evidences that CHCC is monitoring the provider’s proper storage of vaccines and reviewing provider medical records for eligibility screening. Identification as a repeat finding, if applicable: Finding No. 2020-010. Recommendation: CHCC should improve its records management and document retention controls to ensure that documentation is available for oversight and audit purposes. Management may consider implementing centralized electronic storage and system-based retention procedures (such as the database functionality of its new financial management system). Views of Responsible Officials: CHCC concurs with the finding. 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. A summary report of FY2021 vaccine transactions on the CNMI Immunization Registry, WebIZ was submitted via spreadsheet format under, “Vaccine Inventory Reports” Views of Responsible Officials, continued: Additionally, the CHCC has conducted the following steps to strengthen 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 VFC Operations Guide, 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 Site visits were suspended per the CDC Project Officer during that time period due to the COVID-19 response. E-mail communication from the CDC Project Officer is attached. The Program continued to continuously monitor VFC Providers were maintaining proper storage of vaccines and reviewing medical records for eligibility screening despite not conducting a formal site visit.