Prior to the CAP’s engagement on this issue, laboratories had faced burdensome data requirements—some of which were impossible for laboratories to meet—and stiff penalties for failure to comply to the new rules. The CAP had called the original reporting rules unworkable and strongly opposed penalties the HHS sought to impose on those that do not meet the COVID-19 data reporting requirements.
The HHS responded to the CAP’s requests for clarification and stated that its policy “provides extensive guidance regarding other information, such as data transmission and reporting language via Logical Observation Identifiers Names and Codes and Systemized Nomenclature of Medicine that, at this time, is not regulatory.” Laboratories are still strongly encouraged to implement those elements. However, the HHS will only enforce whether laboratories are reporting COVID-19 positive or negative results to their respective public health departments.
The beginning of the three-week grace period is retroactive to September 2. The CAP remains engaged with HHS on implementation of the reporting requirements.
You can read an FAQ document developed by the CAP to answer additional questions about what’s required for laboratories.