OIG Work Plan: Agency to Focus on Vaccine Adverse Event Reporting

The five new items the OIG added to its Work Plan in December 2019 have no direct impact on labs or lab services, although three of them might have an indirect effect on some labs. Here’s the rundown.

1. CDC Cybersecurity Controls Over the Vaccine Adverse Event Reporting System (VAERS)

Issue: Run by the CDC and FDA, VAERS is a national vaccine safety surveillance program that serves as an early warning system to detect possible safety issues with U.S. vaccines by collecting information about adverse events (possible side effects or health problems) that occur after vaccination.

OIG Action: The OIG will do an audit of VAERS to determine whether federally required cybersecurity controls are in place.  

2. Use of Technology for Emergency Response

 Issue: During the 2017 and 2018 California wildfires, some responders used technology-driven tools such as data analytics to locate vulnerable Medicare beneficiaries in a disaster zone and a network of health information exchanges to access patients’ electronic medical records and deliver care away from their typical care setting.

OIG Action: The OIG will do a case study addressing two uses of technology during the California wildfires for emergency response, to identify ways that entities can incorporate technology into their own emergency preparedness and response strategies.

3. National Background Check Program for Long-Term-Care Providers: Assessment of State Programs

Issue: The Affordable Care Act (ACA) authorizes CMS to provide grants to states via the National Background Check Program to implement background check programs for prospective employees and providers of long-term-care services. The ACA also requires OIG to evaluate the grant program after its completion.

OIG Action: The OIG will audit the implementation of select Program requirements for conducting background checks completed by states in 2019 to determine the outcomes of the states’ programs and whether the checks led to any unintended consequences.