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Centers for Medicare & Medicaid Services proposed amendments to Clinical Laboratory Improvement Amendments regulations regarding virtual access, proficiency testing, and personnel qualifications.
Centers for Medicare & Medicaid Services proposed amendments to Clinical Laboratory Improvement Amendments regulations regarding virtual access, proficiency testing, and personnel qualifications. — via Downstream, https://downstream.sh/daily/agency/centers-for-medicare-and-medicaid-services/#s-2026-10-08
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Proposed RuleHealth and Human Services DepartmentCenters for Medicare & Medicaid Services
This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow for virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the subspecialty of cytology, and the use of digital images for gynecologic cytology proficiency testing. This proposed rule also includes proposed changes to personnel qualification requirements and other proposed changes pertaining to SARS-CoV-2 reporting requirements, certificate requirements, test reporting requirements, enforcement requirements, public consultation requirements, and editorial and technical updates. These proposed updates aim to strengthen the Federal oversight of clinical laboratories and ensure accurate and reliable patient test results while adapting to modern technological capabilities and industry needs, including workforce shortages.
- ○Comments close in 49 days
91 FR 64480FR Doc. 2026-20613official PDF↗federalregister.gov↗