MEDICAL LABORATORIES HAVE LIVED WITH THE REGULATIONS FOR THE CLINICAL LABORATORY IMPROVEMENTS AMENDMENTS (CLIA) since they were first implemented in 1992. Over the past 30 years there has been no major revision or updating of CLIA regulations. Nor has there been much change in the long-standing status quo associated with how labs choose which deeming authority they use to earn accreditation to CLIA.
That appears to be no longer the case, at least in the world of CLIA regulation and inspections. This issue of The Dark Report presents intelligence briefings on both topics.
As to CLIA lab inspections, the past year has seen major developments without precedent. Early in 2021, it became public knowledge that two large national health systems—Ascension Health and the Veterans Administration—had signed agreements to switch their preferred CLIA accrediting organization. (See TDR, “Why Are Health Systems Changing CLIA Accreditors?” January 19, 2021.) Similarly, in the past 60 days, one CLIA deeming organization has decided to not recognize the accreditations of another deeming organization. In this story, you’ll read about the decision of The Joint Commission (TJC) to no longer recognize the CLIA accreditations issued by COLA for labs located within TJC-accredited facilities, effective January 1.
The second aspect of CLIA compliance is an effort underway in recent years to review the current state of diagnostic technologies and how they are utilized by clinical labs and pathology groups. The goal is to do a major revamp of the current CLIA regulations. These regulations have not had a significant overhaul or revision since their implementation in 1992—30 years ago.
The Dark Report presents its exclusive interview with one of the principles involved in coordinating the different committees tasked with identifying specific aspects of daily lab testing operations that did not exist in 1992. (See this story.) Genetic tests, whole genome sequencing, and use of machine learning algorithms to analyze large volumes of lab test data are examples of diagnostic technologies in wide use today that did not common in 1992.
There is a significant message here for every lab manager and pathologist tasked with keeping their labs compliant with CLIA: changes are happening and the consequences of these changes are unknown. However, you can depend on The Dark Report to keep you informed as things develop.