Editor: Frederick L. Kiechle, MD, PhD
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May 2024—“Q&A” this month is devoted to the updated CLIA proficiency testing regulations set for Jan. 1, 2025 implementation.
Q.I know that CLIA is changing and more tests/analytes will become CMS regulated, along with other changes. Can you provide some background and an overview of the changes and when they will become effective?
A. May 2024—The Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) regulations were published in the Federal Register on Feb. 28, 1992. Since the regulations first became effective, the testing has evolved and the technology has improved. As part of the process for developing the proposed rule, the U.S. Department of Health and Human Services solicited input from the Clinical Laboratory Improvement Advisory Committee (CLIAC), the official federal advisory committee responsible for advising HHS on regulatory standards for ensuring the accuracy and reliability of laboratory testing. In addressing CLIAC’s recommendations, the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention collaborated in revising the required analytes listed in subpart I (Proficiency Testing Programs for Nonwaived Testing) of the Federal Register and published a proposed rule on Feb. 4, 2019. In response to the proposed rule, the CMS received 107 public comments representing individuals, providers of proficiency testing programs, accreditation organizations, laboratory professional organizations, and business, including in vitro diagnostic manufacturers.
Generally, a final rule is issued within three years of the publication of a proposed rule. However, due to the COVID-19 pandemic, the final rule (CMS-3355-F) was published in the Federal Register on July 11, 2022 (https://bit.ly/CMS-3355-F). It is the first significant update to the CLIA regulations since 1992. While the final rule is effective July 11, 2024, per the CMS’ directive to proficiency testing program providers, the implementation date for these revisions for laboratories and PT program providers is Jan. 1, 2025, which is in alignment with its current process for PT program providers and PT enrollment. For the 2024 calendar year, existing CLIA ’88 grading criteria will continue to be applied. All the changes, whether new or deleted analytes and new acceptance limits, will go into effect on Jan. 1, 2025.
Since the CAP offers comprehensive proficiency testing programs, the impact to CAP PT customers from a participation standpoint will be minimal. Some programs will require reconfigurations to meet the minimum five-specimens-three-times-per-year requirement, except for mycobacteriology, where there are, and will remain, two events per year. As in the past, laboratories must get four of the five challenges correct (80 percent) or the event will be considered unsatisfactory, except for immunohematology. (More on that later.) The CAP 2025 proficiency testing catalog/order renewal will include all CLIA changes, at the CLIA-required configurations. Your laboratory will continue to be in full compliance with new CLIA changes for CMS proficiency testing participation requirements.
Effective in the 2024 A mailings, the CAP has been providing detailed information on the newly regulated analytes, current and new acceptance limits, and all other critical changes in the participant summary of each CMS regulated proficiency testing program. This information will be included throughout the year so our customers will be aware of the changes and can prepare accordingly. Reviewing the participant summary of each CMS regulated PT program for program-specific changes is strongly encouraged. Examples of the chemistry and hematology participant summary inserts are at https://bit.ly/CMS-CAP_criteria.
Some of the high-level changes are listed below. For detailed information, including new acceptance limits, review each participant summary for program-specific changes.
- There are 53 analytes (existing or new) for which percentage-based acceptance limits are published, eliminating the standard deviations except for white blood cell differential, as there were no biological variability data available. Laboratories performing both a manual cell identification and an automated WBC differential must enroll in proficiency testing for both. The CAP will submit both scores to the CMS.
- The CMS updated (tightened) the acceptance limits to reflect advancements in technology and analytical accuracy since 1992. Your individual CAP proficiency testing evaluation report lists your results, the statistics for your peer group, and your normalized results as the standard deviation index (SDI). Review of the graphical presentation of three consecutive mailings of each analyte listed in your evaluation report can help identify bias, shifts, or trends. It can be helpful to troubleshoot and evaluate whether your results will be within or outside the limits of acceptability when the new (tighter) grading criteria are applied.
- The final rule added 29 (non-microbiology) new analytes to subpart I of the Federal Register (Table).
- The CMS deleted five analytes from subpart I: lactate dehydrogenase (LDH) isoenzymes at §493.931 and ethosuximide, primidone, quinidine, and procainamide (and its metabolite N-acetyl procainamide) at §493.937. Although the deleted analytes will not be CLIA required in 2025, the CAP will continue to offer these tests to meet the alternative performance assessment requirements for its customers.
- If any CAP-offered program had no CLIA changes of any kind, a note to that effect is included in the participant summary.
- Only the conventional cardiac troponin test will be CMS regulated in 2025. Additionally, CAP-accredited laboratories that perform high-sensitivity cardiac troponin I or T testing will be required to enroll in proficiency testing to meet the accreditation requirements in 2025.
- The microbiology subspecialties (bacteriology, mycobacteriology, mycology, parasitology, virology) provide detailed changes, where applicable, in each CAP proficiency testing subspecialty participant summary. Types of services listed for each microbiology subspecialty were removed, and a list with broader categories of organism was added to allow flexibility for the inclusion of new technologies. Laboratories must detect and identify organisms for proficiency testing to the highest level that the laboratory reports results on patient specimens.
- For the bacteriology subspecialty, the number of graded antimicrobial susceptibility testing challenges increased from one to two per mailing. The mycobacteriology subspecialty is unique in that only two proficiency testing events per year are required; for that and other reasons, the susceptibility challenge in the mycobacteriology subspecialty is removed. If a laboratory performs susceptibility on patient specimens in any other subspecialties, verifying the accuracy of those procedures at least twice per year, as described at §493.1236(c)(1), is required. The CAP will continue to offer the susceptibility challenges in mycobacteriology (E) and the antifungal susceptibility challenges in its mycology and aerobic actinomycetes (F) and yeast (F1) PT programs to help laboratories meet regulatory requirements.
- A bacterial toxin detection category will be added for CMS reporting. Gram stain result reporting to the CMS will now include both reaction and morphology.
- Fungal and parasite antigen detection categories will be added for CMS reporting.
- The criterion for units of reporting of prothrombin time is either seconds or the international normalized ratio (INR). Laboratories must report proficiency testing the same way they report patient results.
- In immunohematology, unexpected antibody detection will no longer use 80 percent for satisfactory performance. Like ABO, Rh, and compatibility testing, 100 percent accuracy will be needed for unexpected antibody detection. Antibody identification will remain at 80-percent-plus accuracy.
Saeed Ahmad, MLS(ASCP)
Technical Director, Proficiency Testing
College of American Pathologists
Northfield, Ill.