Relating to required reports of certain vaccine-related or drug-related adverse events.

Contracts

• Physician Employment Agreements: Amend contracts to explicitly require compliance with Texas Health and Safety Code reporting mandates. Non-compliance puts the practice at risk of TMB scrutiny.
• EHR/EMR Vendor Agreements: Request immediate updates to clinical decision support systems. You need a flag that cross-references a diagnosis of a Serious Adverse Event (SAE) with a medication history containing EUA or investigational codes.
• Locum Tenens & Staffing: Update service agreements to ensure temporary physicians are trained on this Texas-specific reporting requirement, as out-of-state providers may be unfamiliar with this state mandate.

Hiring/Training

• Clinical Training: Physicians and mid-level providers must be trained on the specific definitions of "Serious Adverse Event" (Death, Life-Threatening, Hospitalization, Incapacity, Birth Defect, Medically Important Intervention).
• Portal Proficiency: Staff must be trained on the actual mechanics of submitting data to the Federal Vaccine Adverse Event Reporting System (VAERS) and the FDA MedWatch program. This is a manual, time-consuming process.
• Intake Staff: Front-desk and nursing staff must be trained to ask the "One-Year Lookback" question regarding EUA medications during patient history intake.

Reporting & Record-Keeping

• Mandatory Documentation: If a physician diagnoses an SAE but determines it is *not* related to the EUA drug/vaccine, this medical judgment must be explicitly documented in the patient chart to defend against future TMB complaints.
• Proof of Submission: When a report is filed, the federal system generates a confirmation number. You must establish a protocol to retain this confirmation indefinitely. It is your primary defense in a TMB investigation.
• Lookback Protocol: The reporting requirement applies if the adverse event occurs within one year of administration. Your systems must flag administration dates going back 12 months from the current visit.

Fees & Costs

• No State Fees: There are no filing fees associated with this bill.
• Operational Costs: Anticipate unbillable administrative time for physicians or clinical staff to complete the federal reporting forms (estimated 30-45 minutes per incident).