CLIA Final Rule Changes: Effective Dec. 28, 2024
April 3, 2024
The CLIA final rule changes related to personnel and histocompatibility go into effect on December 28, 2024. The CAP is in the process of incorporating necessary changes into the 2024 checklist edition, which is expected to publish in late October or November. Laboratories must continue to follow their current checklist edition until that time.
2024 CAP Checklists to Publish in October or November Due to CLIA Regulatory Changes
April 1, 2024
On December 28, 2023, the CMS released the Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-F). This ruling includes changes to the CLIA regulations addressing personnel qualifications and histocompatibility testing, which will take effect on December 28, 2024.
The CAP is in the process of evaluating the recently announced changes to the CLIA regulations on personnel qualifications and histocompatibility testing to determine if checklist revisions are needed. As a condition of the CAP’s deeming authority under CLIA, the CAP is required to be at least as stringent as the CLIA regulations; however, the CAP may choose to be more stringent in some cases. Until a new Checklist Edition is published, CAP-accredited laboratories must continue to follow the CAP's published checklist requirements.
2024 Checklist Edition: October or November Publication
To ensure the necessary revisions to the CAP personnel and histocompatibility requirements are incorporated, the CAP expects the 2024 Checklist Edition to publish in October or November.
Learn about the Checklist changes at the November 20 Focus on Compliance webinar, "Staying in Sync: CAP Accreditation Checklist Changes for 2024.". Presenters Stephen Sarewitz, MD, FCAP, and Gregory A. Gagnon, MD, FCAP, will review the rationale for the 2024 requirement changes, identify laboratory/practice improvement opportunities to align with 2024 requirements, and explain how laboratories can use CAP resources to identify changes and compliance solutions.
FDA's Proposed Rule Regarding Laboratory-Developed Tests
January 15, 2024
Citing substantial undue regulatory burdens and costs on laboratories, the College of American Pathologists (CAP) called on the US Food and Drug Administration (FDA) to make significant changes to its proposed regulation of laboratory-developed tests (LDTs) in a letter to the FDA on December 4.
"As physician specialists in the diagnosis of disease, pathologists have a long history of delivering high-quality pathology and clinical laboratory services to patients," said CAP President Donald Karcher, MD, FCAP. "For more than a decade, the CAP has advocated for an LDT oversight framework that enhances patient safety, maintains quality laboratory testing, and promotes innovation without creating significant regulatory burdens on pathologists and laboratories. The FDA must strike the right balance of protecting the public without overburdening laboratories to the point where they can no longer offer highly accurate LDTs. The CAP and its members urge the FDA to ensure laboratories can meet any new requirements without interfering with patient care and stifling the innovation of future testing."
The proposed regulation would phase out the current enforcement discretion approach by the FDA for LDT oversight. The FDA would classify over the course of five years in vitro diagnostics (IVDs) offered as LDTs as Class I, II, or III medical devices depending on risk to patients.
In its comments to the FDA, the CAP recommended that the following categories of the proposed rulemaking should continue under the FDA’s enforcement discretion policies:
- Exempting tests offered prior to the rule’s enactment
- Forensic, Human Leukocyte Antigen (HLA), and manual tests
- LDTs developed and offered locally by a clinical laboratory
- Adverse events reporting
- Quality systems
- Corrective action and removal
- Labeling
First reported in the December 4, 2023 Advocacy Update.
Read the full comment letter.
Updated CLIA PT Regulations Set for January 1, 2025 Implementation
January 1, 2024
The final rule CMS–3355–F, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance, was published in the Federal Register on July 11, 2022. The revisions to PT requirements related to the addition and deletion of analytes or microbiology tests and updates to the criteria for acceptable performance and administrative processes for PT programs are effective on July 11, 2024, two years after the publication date of the final rule in the Federal Register.
While the final rule is effective July 11, 2024, per CMS directive, the implementation date for the laboratories and PT program providers for these revisions will be January 01, 2025, which is in alignment with its current process for PT program providers and PT enrollment.
As your partner in laboratory quality solutions, we wanted to reach out to you to make you aware of the implementation date of January 1, 2025, and will continue to provide guidance throughout 2024.