- HHS publishes a new Guidance document to aid with standardizing laboratory reporting of COVID-19 data elements for public health purposes
- Reporting of certain data elements are legally required, while reporting of other identifiable demographic data is encouraged but not mandatory
- HHS expressly supports health information exchanges (HIEs) being leveraged to facilitate required data reporting
Late last week, HHS published new Guidance that specifies what additional data must be reported by laboratories along with COVID-19 test results. In its Press Release, HHS says that the new Guidance would standardize reporting “to ensure that public health officials have access to comprehensive and nearly real-time data to inform decision-making in their response to COVID-19.” In addition, HHS specifically points out that health information exchanges (HIEs) can have “a valuable role in this process.”
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, requires all laboratories that perform or analyze a test that is intended to detect COVID-19 or to diagnose a possible case of COVID-19 to report the results from each such test to the Secretary of HHS. In addition, the CARES Act authorizes the Secretary of HHS to “prescribe the form and manner, and timing and frequency, of such reporting.” The new Guidance document offers that.
Who Reports?
The Guidance explains that “all laboratories” includes testing locations operating as temporary overflow or remote locations for a laboratory, and other facilities or locations performing testing at point of care or with at-home specimen. Otherwise, CLIA’s definition of laboratory applies, which includes only those facilities that perform “applicable testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.” A facility that is only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing is not considered a laboratory under CLIA. However, facilities collecting specimens may be directed by laboratories to provide the information required to be reported by the laboratories.
What Must be Reported?
HHS splits out data that must be reported from that which merely should be reported. The following data elements must be collected and reported to the CDC or Secretary HHS (or its designee) for COVID-19 laboratory tests:
- Test result
- Test result date
- Patient age, race, ethnicity, sex and zip code (but not the patient’s name)
- Ordering Provider’s Name, NPI, zip code
- Performing Facility Name, CLIO number, zip code
- Specimen source
- Date test ordered
- Date specimen collected
HHS notes that it could request additional required data elements at a future date. Reporting of required data elements by laboratories must be completed within 24 hours of a test result being known or determined to the appropriate state or local public health department based on the individual’s residence.
HHS states that the following additional demographic data elements should also be collected and reported to state or local public health authorities, however these will not be collected by the CDC or Secretary of HHS:
- Patient name (Last name, First name, Middle Initial)
- Patient street address
- Patient phone number with area code
- Patient data of birth
- Ordering provider address
- Ordering provider phone number
HHS also notes in its Guidance that the person or entity ordering or performing the diagnostic test should “make every reasonable effort” to collect complete demographic information about the patient, and include such data when reporting such information to local public health departments. Interestingly, HHS admits that the data elements being requested under its CARES Act authority go “over and beyond what has been historically requested.” Nevertheless, HHS is requesting that these data elements be made available in all reporting — including through using existing technical infrastructures such as HIEs – to state and local public health departments as soon as possible, but no later than August 1, 2020.
It is noteworthy that HHS made the effort to specifically point out in its Guidance that state and local privacy standards apply to the collection of these demographic data elements. Thus, laboratories, providers, HIEs/HINs, state and local public health authorities, and others must ensure that collecting and using such demographic data falls within the scope of identified legal authority granted to appropriate state or local health agencies to collect such identifiable information in accordance with applicable state law — and, if no such law exists or the collection and use of such identifiable information exceeds the legal authority granted under existing state law, then additional legislative or other executive action might be needed.
Leveraging HIEs and HINs
It is significant that HHS expressly supports HIEs and HINs being leveraged to facilitate required data reporting. For example, when the required data information is not readily available, HHS is encouraging ordering health care providers (or their designees), laboratories performing COVID-19 and associated tests, and State Public Health departments to leverage state or regional HIEs and National Health Information Networks (HIN) to obtain missing, required information. HHS specifically points out:
“These exchanges and networks have significant capacity to identify missing information as they typically work with a wide range of health care provider EHR generated data, as well as a broader array of ADT (admit, discharge, transfer) feeds from local or regional stakeholders.”
In addition, when possible and beneficial (i.e., more expedient), HHS is also encouraging laboratory testing data to be submitted through a state or regional HIE to the appropriate state or local public health department and to the CDC as directed by their applicable state.
