2025 Changes to Point-of-Care Testing Regulatory Requirements

In January 2025, CLIA regulatory updates for point-of-care testing (POCT) went into full effect for labs and Proficiency Testing providers. These updates are intended to strengthen standards and improve the quality of testing services outside traditional laboratories. Key changes that have impact on Proficiency Testing (PT), Personnel Qualifications, and Technical Consultant (TC) Qualifications.

While there has been a long lead time to these changes, it’s certain that some POCT professionals will be under-prepared or unprepared entirely. Here’s are just a few key points we feel every POCT professional needs to know to make sure you’re ready. 

Sharper Focus on Accuracy: Proficiency Testing Gets a Boost

A big update in 2025 involves updates to proficiency testing for certain tests, most notably hemoglobin A1C, which is now considered a regulated analyte. Laboratories must meet newly defined performance criteria depending on the proficiency testing provider.  

• The US Centers for Medicare and Medicaid Services (CMS) has set a +/- 8% performance range.
• The College of American Pathologists (CAP) will use a +/- 6% accuracy threshold for evaluating results.

Evolving rules in personnel qualifications

The 2024 CLIA Final Rule has also revised qualification standards for POCT personnel. Two significant updates are:

• Nursing degrees reassessed: Nursing degrees no longer automatically qualify as an equivalent to biological science degrees for high-complexity testing. However, new equivalency pathways under 42 CFR 493.1489(b)(3)(ii) now allow nursing graduates to qualify through specific coursework and credit requirements.
• “Grandfathering in” – Provisions for previously qualified personnel: Personnel who met qualifications before December 28, 2024, and remain in their roles can continue testing under prior criteria.

These changes aim to align personnel standards with modern laboratory practices while ensuring continuity for experienced staff.

In contrast, moderate complexity testing qualifications remain largely unchanged. These roles still require a minimum of a high school diploma, along with documented training in key testing areas and ongoing competency assessments.

Raising the bar for Technical Consultant qualifications

Changes to Technical Consultant (TC) qualifications place greater emphasis on education and professional experience. Moving forward, new TCs must have a degree in a chemical, biological, or clinical laboratory science field. As part of the updates to qualifications, a person may now qualify as a TC with an associate’s degree in medical laboratory technology, medical laboratory science, or clinical laboratory science from an accredited institution with at least four years of training and experience.

Current TCs may continue their roles under the previous criteria, but new consultants must meet the updated criteria. TCs will be responsible for ensuring proper competency assessments, overseeing test performance, and guiding corrective actions when necessary. This strengthens oversight and ensures high-quality testing in point-of-care environments.

The bottom line – familiarize yourself with the new requirements

The 2025 CLIA regulatory changes for POCT aim to enhance accuracy, professionalism, and oversight. With improved Proficiency Testing standards and expanded qualifications for testing personnel and Technical Consultants, these updates ensure that POCT maintains its reliability and supports better patient care.

However, with change can come confusion. Now is the time to familiarize yourself with the new requirements if you haven’t already. Prepare yourself and your lab to make your next inspection as smooth as possible. 

The full final rule can is available on the Cod of the Federal Register at www.federalregister.gov.

Reference

1. Centers for Medicare & Medicaid Services. QSO-24-15-CLIA: Revised Final Rule—Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing—Analytes and Acceptable Performance Final Rule (CMS-3355-F). Centers for Medicare & Medicaid Services; July 8, 2024. Available at: https://www.cms.gov/files/document/qso-24-15-clia.pdf. Accessed April 15, 2025.
2. Department of Health and Human Services. Centers for Medicare & Medicaid Services. Medicare and Medicaid programs; clinical laboratory improvement amendments (CLIA) fee regulations and histocompatibility regulations. Final rule. Fed Regist. 2023;88(248):89976-90044. Codified at 42 CFR §493. Docket No. CMS-3326-F. Document No. 2023-28170. RIN 0938-AT47. Available at: https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and. Accessed April 15, 2025. Published December 28, 2023.