CLIA on Path to Recognize Lab Data As a Specimen

New recommendations also portend a new CLIA certification and approval of remote testing

CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to CLIA, whose language has remained largely untouched since its inception in 1988.

SWEEPING RECOMMENDATIONS ARE BEFORE FEDERAL CLINICAL LABORATORY OFFICIALS about the need to permanently allow remote testing arrangements and recognize that digital data is a vital component of diagnostic specimens. 

Those recommendations will eventually create a foundation for much needed updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). “The CLIA regulations have not been updated substantially since 1988, when they were published,” said Heather Stang, MS, MT(AMT), Deputy Chief of the Quality and Safety Systems Branch at the federal Centers for Disease Control and Prevention (CDC) Division of Laboratory Services.

Stang also serves as Executive Secretary for the Clinical Laboratory Improvement Advisory Committee (CLIAC), a group managed by the CDC that provides scientific and technical advice about improvements in clinical laboratory quality and laboratory medicine. (See TDR, “Director of CDC’s Division of Laboratory Systems Talks COVID-19, CLIA, and More,” Oct. 31, 2022.)

A regulatory assessment workgroup under CLIAC has delved into data and lab personnel topics and it recently prepared a report with agreements that CLIAC discussed during a November 2022 meeting. 

“The workgroup’s charge is to look at the CLIA regulations and see how they may need to be updated to accommodate new and emerging technologies,” Stang explained during an exclusive interview with The Dark Report.

Three Recommendations

The recommendations involve three areas of particular interest to clinical laboratory managers and pathologists:

  • The need for CLIA to define data as specimen.
  • A new CLIA certificate for entities that work with lab data.
  • Changes to CLIA that will allow remote testing activities for clinical laboratory staff and pathologists.

Owing to technology developments, clinical laboratory data is a key part of lab operations, yet CLIA’s wording does not recognize digital information.

“Data has never really been addressed in the CLIA regulations,” Stang noted. “There have been very lively workgroup conversations on how to address data. One agreement that came from the workgroup is that there needs to be a definition for data in the CLIA regulations.”

New Definitions for CLIA 

The workgroup is aiming to include data as part of a bigger new definition for “materials” in the statute.

Heather Stang, MS, MT(AMT), CDC
Heather Stang, MS, MT(AMT)

“The term ‘materials’ is used in the definition of a laboratory in the CLIA regulations,” Stang said. “We all know that ‘materials’ references blood and body fluids derived from the human body that undergo diagnostic testing. But the term ‘materials’ itself is not defined in the CLIA regulations.

“So, CLIAC agreed that we need to put a definition for the term ‘materials’ into the regulations that notes it is the patient specimen, including the data derived from a human specimen,” she added. “Such data could include images, genetic and protein sequences, -omics data, and other data that is used for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of the health of human beings.”

Lab Data as ‘Specimen’

Taking that approach creates a larger sphere of information to consider with specimens, as well as technology that relies on this data, such as next generation sequencing (NGS), whole genome analysis, and digital pathology.

“It opens the conversation up to the idea that data is considered a specimen,” Stang said. “It’s not only data as a specimen, but also the emergence of all of these new technologies.”

Tied into the above discussion is the need to properly qualify people who analyze or interpret diagnostic data received from a clinical laboratory and then return that data to the lab for inclusion in a patient’s record.

CLIAC has recommended that federal agencies create a new type of CLIA certificate for such work beyond the traditional Certificate of Compliance or Certificate of Accreditation. 

“CLIAC agreed that entities that manipulate the data need some form of CLIA certificate,” Stang said. “CLIAC recommended that this would be a new certificate type under CLIA.”

Under this new designation, entities may be subject to some of the same regulatory requirements as the referring clinical laboratory.

Evolving Job Roles in Labs

Clinical laboratory data and associated technology has led to new job positions that deal with this work—roles that CLIA does not clearly cover yet. These jobs include: 

  • Bioinformaticists and variant scientists who analyze data.
  • Image technicians, cytotechnologists, and histotechnologists who use digital pathology tools.
  • Analysts who work with NGS.

“We started looking a little bit closer into the bioinformatician and how those particular types of individuals may not qualify under CLIA right now as testing personnel,” Stang noted. “We have a new work group that we’ll be forming. It will be focused on the education, training, experience, and competencies that should be required by CLIA to qualify personnel performing NGS bioinformatic data analysis and interpretation. 

“The workgroup will discuss whether CLIA should be updated to include these personnel or whether they are already defined in CLIA, and the CLIA interpretive guidelines just need to be updated,” she added.

Remote Testing Activities

The SARS-CoV-2 pandemic brought remote work arrangements across many industries to the forefront, including at clinical laboratories and anatomic pathology practices.

Besides mitigating potential COVID-19 infections, remote testing also proved valuable in terms of serving rural or underserved communities that lacked easy access to pathologists.

The federal Centers for Medicare and Medicaid Services (CMS) issued a memorandum in 2020 that allowed remote pathology work as long as the COVID-19 public health emergency remains in effect.

“CMS did put out a notice that allowed remote pathology activities, but it was very specific to pathology,” Stang noted. “During the CLIAC work group discussions, they wanted to open up the ability for remote testing to other diagnostic fields—for example, if a lab scientist looks at a Gram stain via their home.” 

Expect recommendations from CLIAC regarding permanently allowing remote testing arrangements for bench staff and pathologists. “The workgroup agreed that CLIA needs to be updated to modify and allow remote testing,” Stang said. “CLIA needs more specificity to what is meant by remote testing.” 

Among the provisions that could be defined include that a remote workspace would be covered as an extension of a lab’s CLIA certificate, and that the certificate would also cover staff using technology such as virtual private networks to view cases.

What’s Next for CLIA? 

Any changes to CLIA will require formal rulemaking through CMS, a process that can take months or years. Don’t expect CLIA revisions on data as a specimen or remote testing in 2023, Stang said.

“We have to put any type of rulemaking activity on a unified agenda that is announced to the public,” she explained. “The CLIA updates are not something that’s on the 2023 CMS unified agenda. 

“Behind the scenes, agencies could potentially discuss CLIA changes, but there’s no CLIA rulemaking related to the recommendations made by CLIAC during the November meeting that will go out in 2023, or that would impact any clinical laboratory in 2023.”

Note that the November discussions do not affect CLIA rulemaking that was released last summer. That proposed rule included potential increases in CLIA fees and possible changes to qualifications for personnel who handle high and moderate complexity testing. A final rule on those proposals could be published in 2023, Stang said. (See TDR, “Clinical Laboratories Face 20% Increase in CLIA Fees,” Aug. 29, 2022.)

Pathologists and clinical laboratory managers with ideas and suggestions on ways to revise and update CLIA requirements to address new diagnostic practices that emerged since CLIA’s 1992 implementation may want to send comments to the CLIAC workgroups. 

CLIAC Will Not Address Lab Staffing Shortages

AS IT EXAMINES POTENTIAL UPDATES OF PERSONNEL REQUIREMENTS, lab staffing shortages are not part of the discussion within the regulatory assessment workgroup under the Clinical Laboratory Improvement Advisory Committee (CLIAC). 

“The workgroup itself did not focus on staffing shortages,” Heather Stang, MS, MT(AMT), Deputy Chief of the Quality and Safety Systems Branch at the federal Centers for Disease Control and Prevention (CDC) Division of Laboratory Services.

“The workgroup was looking primarily at the CLIA regulations and what needs to be updated to reflect the current environment of clinical laboratory testing,” Stang added.

She noted that the CDC’s OneLab Rapid Education and Capacity-building Hub—or OneLab REACH—offers training resources for clinical laboratories facing staffing shortages. Go to reach.cdc.gov for more information.

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