Amending Utah's Communicable Disease Rule to Require Reporting of Negative Laboratory Test Results

BACKGROUND:  There are compelling reasons to require reporting of negative laboratory test results to improve surveillance including: quantifying denominator data to confirm trends; determining when a patient is no longer infectious; identifying the seroconversion period; and finalizing cases when the positive screening test is not confirmed, all of which may reduce workload for local health departments.  However, there are equally compelling reasons not to mandate reporting of negative results, e.g., data security and privacy concerns.  Utah has recently approved a Communicable Disease Rule change that mandates reporting of all negative test results from electronic reporters for nine infectious disease conditions.  This talk will examine the steps the Utah Department of Health (UDOH) took to address the concerns of stakeholders during the approval process on a variety of issues including:  data security, database integrity, and communication with stakeholders.  

METHODS: UDOH first determined the situations for which negative data would be useful and then identified the specific infectious diseases where these situations were applicable; the negative test requirement was limited to these diseases.  Epidemiologists met with administrators and State legal counsel to determine potential legal roadblocks.  Local health departments, infection control practitioners, and others were briefed on the rationale and process for reporting negative tests (e.g., limiting negative test reporting to labs participating in electronic laboratory reporting [ELR]). Programmers rewrote the rules structure for the ELR system so that privacy and security concerns could be addressed and sufficient infrastructure was in place to handle all of the negative test data.

RESULTS:  : After approximately one year of preparation, Utah submitted amendments to Utah's Communicable Disease Rule for the required 30-day public comment period on October 15, 2014.  The rule specifies that negative test results for the following conditions are mandatory for ELR reporters: chlamydia, gonorrhea, hepatitis A, hepatitis B, hepatitis C (including viral loads), human immunodeficiency virus (including viral loads and confirmatory tests), salmonellosis, STEC, and tuberculosis.  No significant public comments were made regarding the proposed amendment.  The rule changes were enacted on December 15, 2014.

CONCLUSIONS: Significant up-front preparation is essential to passing legislation to require the reporting of negative laboratory test results. The identification of problems in the current surveillance system combined with proactive education of individuals likely to be impacted by the new rule were key elements in the successful outcome of this endeavor.