We value your partnership as a CAP Laboratory Quality Solutions program participant. This page is dedicated to keeping you informed and clarifying the regulatory changes impacting our Accreditation and Proficiency Testing/EQA programs.
Prepare your laboratory for the upcoming changes in CLIA proficiency testing regulations.
Accreditation Updates
CLIA Final Rule: Resources for Accreditation Customers
May 17, 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 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.
CLIA Final Rule: Resources for Accreditation and PT Customers
Webinar: 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.
Laboratory-Developed Tests Updates
FDA LDT Oversight Stage One
June 20, 2024
Pathologists and laboratories will consider several factors to determine if a test must meet Food and Drug Administration (FDA) regulatory requirements for laboratory-developed tests (LDTs). See the FDA Oversight of LDTs Phase 1 Requirements table for the first stage or phase of requirements beginning May 6, 2025.
Phase 1 Requirements Starting May 6, 2025
Medical device reporting: Laboratories must report certain device-related adverse events and product problems to the FDA.
- FDA Resource: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities
Correction and Removal: Required to make a report to the FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health.
- FDA Resource: Recalls, Corrections and Removals (Devices)
Quality system for complaints requirements:
- Maintain complaint files.
- Designate a formal complaint handling unit.
- Establish and maintain procedures for receiving, reviewing, and evaluating complaints.
PT/EQA Updates
We have developed the following resources to keep laboratories informed regarding the latest regulatory requirements from the Centers for Medicare and Medicaid Services (CMS).
Updated CLIA PT Regulations
June 26, 2024
Register for the "Get Ready for the PT CLIA Changes: Stay Ahead, Stay Compliant" Webinar
Join us on Thursday, June 27, 2024, from 12:00 PM–1:00 PM CDT for the "Get Ready for the PT CLIA Changes: Stay Ahead, Stay Compliant" webinar. Led by experts representing our Clinical Chemistry and Microbiology committees, this webinar will provide a thorough review of the revisions to the PT requirements, including the addition and deletion of analytes and microbiology tests.
- Refer to the table linked here to review the new 2025 regulated analytes, their acceptance limits, and corresponding program codes and revised scoring criteria established by the Centers for Medicare & Medicaid Services (CMS) that meet all updated CLIA requirements.
May 22, 2024
The CMS released a final rule, CMS–3355–F, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance, published in the Federal Register on July 11, 2022. This is the first significant update to the CLIA regulations since 1992.
Based on the final rule, there are two dates that may impact some laboratories:
- January 1, 2025: Proficiency Testing Final Rule (CMS–3355–F) requirements related to PT program providers and laboratories, including PT enrollment, while effective July 11, 2024, will be implemented on January 1, 2025.
- August 10, 2022: CMS clarified that effective on this date, if a laboratory chooses to perform PT for waived testing, they will be subject to the same regulations and sanctions related to PT referral as laboratories that perform non-waived testing (§§ 493.20 and 493.25).
Access the following for the latest CAP guidance:
- The May 2024 issue of CAP Today, Q&A section
- Your laboratory's 2024 PT program participant summary (PS), accessible via e-LAB Solutions Suite
- Participant summaries include detailed program-specific information on grading criteria changes
- Participant summaries with detailed information are indicated by a note on the cover page
CMS Analyte Reporting Selections
Proficiency testing is required for regulated analytes. To determine which results are submitted to CMS, the CAP follows a predefined precedence, unless otherwise specified by the laboratory. Our CMS Analyte Reporting Selections (PDF) reference guide helps you navigate your way through the process. Log in to e-LAB Solutions Suite to access your current analyte reporting selections.
CMS Directive Regarding Proficiency Testing on Multiple Instruments
In response to the CMS directive, the CAP created resources to help laboratories stay in compliance:
Learn More
Review additional upcoming CAP evidence-based guidelines by the Center.