Regulatory Information

We have developed several tools and resources to keep laboratories informed regarding the latest regulatory requirements from the Centers for Medicaid and Medicare Services (CMS).

CMS Releases Final Rule to Update CLIA PT Regulations

The CMS recently released a final rule to update CLIA proficiency testing (PT) regulations. This is the first update to the CLIA 1988 PT regulations since its inception in 1992.

Based on initial review of the final rule, there are two effective dates that may impact some laboratories:

  • July 11, 2024: this is the effective date for revisions to PT requirements primarily related to the addition of new regulated analytes, removal of regulated analytes and changes in grading and reporting criteria (§§ 493.2 and 493.801 through 493.959). This delayed effective date reflects the timeframe PT programs will need to produce or acquire PT samples to meet the revised regulations and incorporate any updates to PT reporting requirements. In addition, laboratories will need time to prepare and enroll in PT to meet the new requirements once the samples are available from the PT programs.
  • 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).

The CAP continues to review the proposed regulation. Based on that review, the CAP will provide further guidance to PT and Accreditation customers as soon as possible about the impact of any changes and when these changes might be initiated.

CMS Analyte Reporting

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 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:

Monitoring Performance of Glucose Meters

Beginning in 2017, proficiency testing for waived whole blood glucose on glucose meters will no longer be required for laboratories accredited by the CAP. Take a moment to review the resources below to learn about this requirement.