Compliance Briefing

How to Comply with the New HHS COVID-19 Test Data Reporting Rules

The U.S. Department of Health and Human Services (HHS) has ordered labs that perform COVID-19 testing to report test data to state and local public health agencies by August 1, 2020. What makes the task so challenging isn’t just the immediacy of the deadline but the data labs are being asked to report, including not just testing results but also extensive personal and demographic data about the patients being tested. Because labs generally don’t have direct contact with patients—particularly in the COVID-19 context—they’re simply not set up to collect and process this data. Here’s a look at the new reporting rules and what your lab must do to comply with them.

Why Labs Are Being Asked to Report Data

It’s kinda’ flattering that the U.S. government has come to understand the crucial role lab test data plays in the direction of public health. This is particularly so during a global pandemic. According to the guidance HHS issued on June 4, “complete and comprehensive laboratory testing data, including standardized test results, relevant demographic details and additional information” is essential to 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.

This isn’t the first time the administration has called on labs to report test data. On March 29, Vice President Mike Pence sent a letter 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 difference is that the new request is so much broader, not only in terms of the labs it covers but especially the scope of data that must be reported.

HOW TO COMPLY: 8 FAQs

Here are some FAQs breaking down the key details lab managers need to understand to ensure compliance by the August 1 deadline.

Q1. Is Your Lab Required to Report?

A: The new HHS 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.

Q2. When Must Your Lab Report?

A: 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.

Q3. To Whom Must Your Lab Report?

A: Labs must report the data on a daily basis to the appropriate state or local public health department based on the individual’s residence.

Q4. How Must Labs Report the Data?

A: The guidance lists three methods labs can use to submit lab testing data to state or local public health departments for subsequent transmission to the CDC:

  • 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 via 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.

Q5. What Data Must Your Lab Report?

A: The trickiest aspect of the new guidance is the unprecedented scope of the data it requires labs to collect and report, including:

  • Personal demographic information about patients’ age, ethnicity, race and sex;
  • 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).

As if this weren’t challenging enough, the guidance also 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.

Q6. How Will Your Lab Get the Data?

A: The first task, of course, will be figuring out how to get personal and demographic data from patients with whom your lab doesn’t directly interact. As the guidance acknowledges, the data elements required “go above and beyond what has been historically requested” of labs. Consequently, labs will have to gather the information from the test orderer.

Of course, the difficulty of relying on ordering providers for reportable data is something labs understand all too well. Can you say “medically necessary.” The good news, sort of, is that HHS 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).

Q7. How Will Your Lab Get the Data When Patients Collect Samples at Home?

A: According to the guidance, the sample collection process should address submission to the testing lab of not only the specimen but also the required data elements. For point of care testing, the lab (including a facility or setting with a certificate of waiver) must ensure the test is set up and operational to deliver timely and complete electronic results (with identifiers) in accordance with the methods of submission.

Q8. How Will Your Lab Get the Data When Testing Is Done at Home?

A: What about the COVID-19 tests where not only sample collection but also actual testing is done at home via a testing device that displays test results? Although the FDA has yet to issue Emergency Use Authorization (EUA) for one, COVID-19 home test products are in the pipeline and likely to reach the market soon. HHS “encourages” developers of such tests “to consider ways in which” the data elements and information required by the guidance “could be collected and reported, such as “through applications on a personal smartphone or tablet, a patient portal, direct transmission from the test platform itself or other innovative technologies.”

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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