New national requirements for COVID-19 laboratory test-data elements take effect Aug. 1 and ordering physicians will be called upon to help collect demographic information intended to allow public health agencies better track the spread of COVID-19 and identify areas highly impacted by the infection. This includes providing much needed data on the pandemic’s impact on marginalized and minoritized communities.
The new required data elements stem from a provision in the Coronavirus Aid, Relief, and Economic Security (CARES) Act that requires every lab that performs or analyzes a test to detect SARS-CoV-2 or diagnose a possible case of COVID-19 to report the results of each test to state or local public health departments using existing reporting channels to ensure rapid initiation of case investigations. Data is routed to the Centers for Disease Control and Prevention (CDC) after removal of personally identifiable information according to applicable rules and regulations.
The law also authorized the HHS secretary “to prescribe the form and manner, and timing and frequency, of such reporting,” according to an HHS guidance document on implementing the CARES Act.
HHS is requiring 18 data elements to be collected and reported including demographic data on each patient such as:
- Age or date of birth.
- ZIP code of residence.
- County of residence.
In addition, there is a set of questions considered “ask on order entry” that inquire whether a patient is a health care worker, has COVID-19 symptoms, is a resident of a congregate care setting, is pregnant or has been hospitalized.
HHS notes in the guidance that it recognizes these data elements “go above and beyond what has been historically requested.”
“These data contribute to understanding disease incidence and trends: initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and identifying supply-chain issues for reagents and other material,” the guidance states. “Laboratory testing data, in conjunction with case reports and other data, also provide vital guidance for mitigation and control activities.”
Also being requested are the addresses and phone numbers of the patient and ordering provider. HHS is calling on physicians and other ordering providers to contribute to an effort to improve collection of race and ethnicity data and contact information needed for health departments to conduct contact tracing.
“Any person or entity ordering a diagnostic or serologic test, collecting a specimen, or performing a test should make every reasonable effort to collect complete demographic information and should include such data when ordering a laboratory test to enable the entities performing the test to report these data to state and local public health departments,” the HHS guidance states.
When information is not available, HHS recommends leveraging resources such as state or regional health information exchanges or National Health Information Networks.
Labs that meet the definition of a “covered entity” under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) can disclose this protected health information, according to the HHS guidance. This applies to a lab’s business associates as well.
“Nothing in this guidance changes the existing requirements for HIPAA covered entities and business associates to comply with the applicable HIPAA privacy, security, and breach notification rules,” the guidance states.
The guidance also includes technical information on data reporting and transmission standards. Physicians are encouraged to reach out to their electronic health record vendor to make sure their technology supports these requirements.
Guidance is also available from the CDC on How to Report COVID-19 Laboratory Data.
COVID-19 is a reportable condition across the U.S., so it’s required that this information be reported to state and local health departments. Data elements, however, have varied across jurisdictions. The HHS guidance creates a national standard for the data elements to be reported to state and local health departments so they can plan and execute COVID-19 control and mitigation efforts.
“This data is central to understanding injustice and ensuring the optimal health of people, but it is gravely missing in this crisis—missing from health department websites, daily updates by political leaders and, until recently, news reports,” Aletha Maybank, MD, MPH, chief health equity officer and group vice president of the AMA Center for Health Equity, wrote in a New York Times op-ed column back in April.
Collection and reporting of demographic and health inequities data was one of seven recommendations made to Senate leaders by the AMA—along with the American Nurses Association and American Hospital Association—to address the ways in which COVID-19 has disproportionately affected racially and ethnically minorititized and marginalized communities.
More resources on COVID-19’s impact on these communities are available from the AMA Center for Health Equity, including information on using demographic data as a tool to fight inequity in the COVID-19 pandemic.