Some side effects of COVID-19 Immunization Data Submission

Now that COVID-19 doses administered data are flowing to Immunization Information Systems (IIS), we are noticing some unintended side effects from the data management component of the vaccination program. Here are a few that have bubbled up from the jurisdictions we support:

• We have seen providers get immunizations at a hospital, then record the immunization again in their local Electronic Health Record (EHR). Of course, both doses are sent up to the IIS for submission to CDC. Duplicate doses are not normally a problem for IIS, but when the date of administration is recorded incorrectly, it can be difficult for IIS to distinguish between mistakes and real second doses. This is especially challenging with COVID-19, since patients who receive doses too close together are still considered to be finished with the series, according to the Advisory Committee on Immunization Practices (ACIP). So in one such case early in the vaccination program, a misreported dose was one week off and showed up on the state dashboard as the first person with two doses.  COVID-19 dashboards, fed by IIS, are heavily scrutinized.
• In a similar case in another jurisdiction, a duplicate dose showed up as being administered in a private practice setting (remember, the provider entered their own dose in their own ambulatory EHR) when no such vaccine shipments had been authorized or made to this type of site. Management at the agency was caught off guard and had to answer, once again, to the many stakeholders scrutinizing the COVID-19 data coming out of the IIS.
• Pharmacies that participate in the Federal Pharmacy Partnership receive vaccine shipments directly from the Federal government and do not order it through the IIS or their jurisdictions. As pharmacies report doses to IIS from inventory that the IIS does not know about, it changes the way the data should be understood. Jurisdictions can no longer reconcile doses administered with orders unless some additional calculations are done and jurisdictions may not have the necessary order information to adjust their statistics accordingly.
• IIS often have algorithms that track the ratio between doses ordered and shipped to a provider and doses reported as administered by the provider to track the effectiveness of the program. There have been reports that vaccinators have been able to get more usable doses out of a vial of COVID-19 vaccine than was originally planned by the manufacturers. These discrepancies affect the accuracy of the accountability data used by IIS.

What this is surfacing is that data submitted to an IIS, and the processes that support it, were never designed to be scrutinized closely without review and quality assurance by IIS staff. Yet the urgency has forced jurisdictions to both use valuable labor to very carefully review each and every dose submitted, and try to identify and resolve any suspected data anomaly instantly. HL7 data submission and processing are very much dependent on trusting the provider sites to submit data that is appropriate. Given what providers are dealing with it is difficult to perform quality assurance in real time – often over the telephone – but IIS staff are forced to do this.

And to make matters worse, we know that every action, activity, and consequence is now politically charged and there is very little room or tolerance for error.