According to the guidance, which HHS issued on June 4, “complete and comprehensive laboratory testing data, including standardized test results, relevant demographic details and additional information” plays a key role in furthering understanding of COVID-19 incidence and trends thereby enabling public health officials to:
- Determine when to initiate epidemiologic case investigations;
- Assist with contact tracing;
- Assess the availability and use of testing resources;
- Identify supply chain issues for reagents and other materials; and
- Provide vital guidance for COVID-19 and SARS-CoV-2 mitigation and control activities.
Of course, the value of lab data in responding to COVID-19 is beyond dispute. That’s why Vice President Pence sent a letter on March 29 requesting that hospitals with in-house labs submit daily COVID-19 testing data reports to HHS to help the U.S. Centers for Disease Control and Prevention (CDC) “support states and localities in addressing and responding to the virus.”
The New HHS Data Reporting Guidance
However, the original Pence request was limited to data about test results. The new HHS guidance is far broader not only in terms of the labs it covers but especially the kind of data it asks for. Here’s a rundown of the crucial details.
Which Labs Must Report
The new lab data reporting requirements cover all labs—including commercial and hospital labs, testing locations operating as temporary overflow or remote locations for a lab and other facilities or locations performing testing at point of care or with at-home specimen collection related to SARS-CoV-2.
When Labs Must Report
Labs must complete daily reports for all testing they complete and for each individual they test within 24 hours of knowing or determining the results. All data must be made available by August 1.
To Whom Labs Must Report
Labs must report the data on a daily basis to the appropriate state or local public health department based on the individual’s residence.
How Labs Must Report
The guidance lists three methods labs can use to submit lab testing data to state or local public health departments:
- Direct submission, as required by state and/or local law or policy. These entities will then submit deidentified data to the CDC on a daily basis using either Health Level 7 (HL7) messaging;
- Submission through a centralized platform (such as the Association of Public Health Laboratories’ AIMS platform) which will then route the data to the appropriate state and local authorities and, eventually to the CDC after the data is properly de-identified; or
- Submission through a state or regional Health Information Exchange (HIE) to the appropriate state or local public health department and thence to the CDC as directed by the state.
What Labs Must Report
The real headline of the new guidance is the unprecedented scope of the data that labs must collect and report to state and local public health officials for subsequent transmission to the CDC, including personal demographic information about patients’ age, ethnicity, race and sex, as well as:
- Test ordered (using harmonized LOINC codes provided by the CDC);
- Device Identifier
- Test result (using appropriate LOINC and SNOMED codes, as defined by the Laboratory)
- In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by the CDC);
- Test Result date (date format);
- Accession #/Specimen ID;
- Patient residence zip code and county;
- Ordering provider’s name and NPI (as applicable) and zip code;
- Performing facility’s name and/or CLIA number (if known), and zip code;
- Specimen Source (using appropriate LOINC, SNOMED-CT or SPM4, or equivalently detailed alternative codes);
- Date test ordered (date format); and
- Date specimen collected (date format).
In addition to the above information, the guidance says labs should collect and report even more detailed personal demographic information that public health officials will not pass along to the CDC, including the ordering provider’s address and phone number as well as the patient’s:
- Name (Last name, First name, Middle Initial);
- Street address;
- Phone number with area code; and
- Date of birth.
How Labs Are Supposed to Get the Data
As the guidance acknowledges, the data elements required “go above and beyond what has been historically requested” of labs. And there’s a good reason for this, namely, that clinical labs don’t usually interact directly with patients. Consequently, labs will have to gather the information from the test order.
The good news is that the guidance attempts to address this bottleneck by saying that persons or entities that order a diagnostic or serologic test, collect a specimen or perform a test “should make every reasonable effort to collect complete demographic information and include the data” when ordering a lab test to enable the test provider to collect and report the data to state and local public health departments (emphasis added). If information isn’t available, the guidance says that ordering providers or their designees, labs and State Public Health departments “should consider leveraging resources like state or regional HIEs and National Health Information Networks (HIN) to obtain missing, required information” (once again, our emphasis).
Takeaway
Labs can look to downstream ordering physicians and even upstream public health departments for help gathering the necessary data in time for the August 1 deadline. Ultimately, though, while the collection and reporting obligations of the latter are all “should,” the core reporting obligations of labs, i.e., the obligation to report the data elements to be passed along to the CDC, are a “must.”
Moreover, HHS officials, including Admiral Brett Giroir, M.D., assistant secretary for health and lead for COVID-19 testing efforts, have reported that labs would be the ones targeted for penalties if the data aren’t reported. Specifically, those penalties would be dished out by the FDA in the form of fines, warning letters or even imprisonment, in extreme cases.
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