Ready. Set. CLIA 2024!

The 2024 CLIA proposed acceptance limits for proficiency testing will be implemented January 2025.* Are you ready?
Ready. Set. CLIA 2024!

In his recent webinar,1 Sten Westgard, Director of Client Services and Technology at Westgard QC, an independent consulting and training company specializing in clinical laboratory quality control (QC), gave insights into how laboratories can evaluate their performance ahead of the pending CLIA changes. He also presented results of benchmarking performance of the “big five” diagnostic manufacturers: Abbott, Beckman Coulter, Roche, Siemens, and Sysmex.

What’s CLIA?

The United States Congress first passed CLIA, the Clinical Laboratory Improvement Amendments, in 1988, “to establish quality standards, strengthen Federal oversight of clinical laboratories, and ensure the accuracy and reliability of patient test results.”2

CLIA are federal standards applicable to any laboratory in the United States that performs in-vitro diagnostic tests on human specimens for assessing health or diagnosing, preventing, or treating disease3 to ensure that patients receive accurate, reliable, and timely results, no matter where their test is performed.2 And CLIA rules, while not required outside the US, international laboratories may also apply for CLIA certification.4

In 2024, CLIA requirements for proficiency testing will be implemented. The 2024 guidelines incorporate 23 new tests and update the criteria for dozens more across chemistry, immunoassay, and hematology,5 marking the biggest changes in United States regulations since 1992. Some updates additions of previously unregulated tests (e.g., hemoglobin A1c testing), and some updates are due to improvements in accuracy and precision of many tests.6

What’s changing?

CLIA 2024 introduces new quality requirements for proficiency testing, with hard numbers and tighter goals for many analytes. The changes will affect the QC practices and efficiency of laboratories and will vary depending on how the analyte goal was previously measured and what instruments the laboratory is using.

Some of the newly regulated analytes were never regulated, some have shrinking ranges (up to 40%), and still others were previously relative numbers. For example, hemoglobin A1c (HbA1C) was previously not regulated, but now has a target value ± 8%. Human chorionic gonadotropin (β-hCG) testing previously required the target value ± 3 standard deviations (SD),7 but these SD-based goals rely on individual laboratory performance, making them non-transferrable between labs. The new goal will require the target value ± 18%—a hard number. And for cortisol, the target range is shrinking from 25% to 20%—a 40% reduction.1,8

Similarly, the 2024 CLIA guideline changes for hematology analyzers include significant tightening of goals. One Westgard survey of almost 60 labs in the United Kingdom showed that >70% of labs set their target ranges to 3 standard deviations or more, >40% were over 4 standard deviations, and it was not unusual to have values over 5 standard deviations! For 2024, the total allowable error goals for hematocrit (HCT), red blood cell (RBC), and total white blood cell (WBC) counts are all dropping by 33.3%, while that for hemoglobin (Hgb) is dropping 42.8%.1

Good Company

For CLIA, a test system usually includes both the analyzer and the assay, labs must verify the performance of each assay on each of their instruments. Tighter CLIA goals mean that QC efforts will need to increase for some tests and for some instruments.1

The analytical sigma metric is a way to measure the performance of an assay against a quality requirement. Using sigma metrics, current assays and analyzers can be benchmarked and compared with the 2024 CLIA requirements to understand what changes labs may need to be incorporated to be in compliance come July. The higher the sigma value, the better the chance for compliance.

Analyzers, of course, are not created equally. Different instruments and assays vary in their sigma performances. Of the immunoassay analyzers evaluated by Westgard, the DxI 9000 Immunoassay Analyzer† showed the highest number of six sigma assays and the lowest number of assays below three sigma.

"The DxI 9000 analyzer “has the highest number of performance expected to be at six sigma when benchmarked against these CLIA 2024 assays. And it has the least percentage of the performance that is below three sigma and in danger of not passing proficiency testing on January 1st.”
Sten Westgard

Like the DxI 9000 analyzer, preliminary analysis of the Beckman Coulter DxH 900 hematology analyzer showed that it had higher numbers of measurements at 4, 5, and 6 sigma and lower numbers of measurements below 4 sigma than Sysmex hematology analyzers.1

Benefits

Labs not meeting the high-quality sigma levels for the tighter 2024 CLIA targets may need to implement more QC goals to avoid repeating controls, recalibrating more frequently, and losing hours to troubleshooting. Overall, higher sigma performance leads to fewer errors in reportables and more confidence in results, minimizing reruns and reflex tests, which allows staff to focus on samples and tasks that truly need their attention, saving time, reducing costs, and optimizing instrument use.

“When we find the four-, five-, and six-sigma assays … that’s the opportunity to reduce how much QC effort you’re making. … The analytical sigma metric helps you identify where you can cut out waste and get hours back for your precious resource staff.”
Sten Westgard

*Revisions to proficiency testing requirements are effective on July 11, 2024, two years after the publication date of the final rule in the Federal Register. The implementation date for laboratories for these revisions is January 01, 2025.

Full name: DxI 9000 Access Immunoassay Analyzer

References:

1. Westgard S. Game Change | The Impact of New CLIA PT Goals on Immunoassays and Hematology. Presented at the: Webinar; May 23, 2024; Madison, WI.

2. Centers for Medicare and Medicaid Services. CLIA Program and Medicare Laboratory Services. May 2020.

3. CDC. Clinical Laboratory Improvement Amendments (CLIA). Centers for Disease Control and Prevention, Division of Laboratory Systems (DLS). April 29, 2024. Accessed May 23, 2024. https://www.cdc.gov/clia/index.html

4. Division of Clinical Laboratory Improvement and Quality Centers for Medicare & Medicaid Services. Enrollment Number of Labs Number of POLs. March 2024.

5. Westgard JO. 2024 CLIA Proposed Acceptance Limits for Proficiency Testing. Quality Requirements. 2023. Accessed April 15, 2024. https://www.westgard.com/clia-a-quality/quality-requirements/1002-2024-clia-requirements.html

6. Analytes P, -F A. Center for Clinical Standards and Quality/Quality, Safety & Oversight Group Ref: QSO-22-21-CLIA. July 11, 2022.

7. Westgard J. CLIA Requirements for Analytical Quality. 2023. Accessed May 28, 2024. https://westgard.com/clia-a-quality/quality-requirements/125-clia.html

8. Westgard JO. 2024 CLIA Proposed Acceptance Limits for Proficiency Testing. Westgard Quality Requirements. 2023. Accessed May 29, 2024. https://westgard.com/clia-a-quality/quality-requirements/1002-2024-clia-requirements.html

Editorial Team
Editorial Team
The Beckman Coulter editorial team brings you timely news and resources focused on elevating clinical laboratory performance and advancing patient care.

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