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Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change

By Oscelle Boye, MBiomed | Apr 30, 2025 | 1 min read

CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight

With a judge having vacated the LDT final rule, CAP and AMP officials promote future advocacy as a next step.

LDT Oversight Remains Under CLIA, for Now

By Scott Wallask | Apr 4, 2025 | 1 min read

Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests

In the latest twist on LDT oversight, a judge vacated the FDA’s LDT rule

Further Details to Note about Updated Clinical Lab Director Qualifications

By Ron Shinkman | Mar 20, 2025 | 1 min read

Put into place late last year, the new rules place more emphasis on formal and continuing education requirements

Clinical lab director qualifications have changed under CLIA

Updates to CLIA Personnel Requirements May Lengthen Hiring Times

By Tara Cepull, MA | Feb 28, 2025 | 1 min read

Changes ‘have had a significant impact on the recruitment process for laboratory directors and technical supervisors,’ recruiter says

Clinical lab hiring managers may feel the pinch from newly updated CLIA personnel requirements.

CMS Provides New Guidance on When International Labs Must Seek CLIA Certification

By Glenn S. Demby | Jul 31, 2023 | 1 min read

Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.

Staffing Special Report: CMS Proposes Changes to CLIA Laboratory Personnel Requirements

By Glenn S. Demby | May 17, 2023 | 1 min read

An overview and analysis of the recently proposed changes and how they could affect your medical laboratory.

CMS Proposes CLIA Fee Increases and Nurses Doing High-Complexity Testing

By Glenn S. Demby | Aug 11, 2022 | 1 min read

In addition to increasing and imposing new user fees, the proposed rule would allow nurses to perform high and moderate complexity testing, essentially placing nursing degrees on the same level as degrees in clinical laboratory science, biology, and chemistry. Here's what lab managers need to know about the proposed rule.