Regulatory

Regulatory

Updates to the Condition of Participation (CoP) requirements for hospitals and critical access hospitals (CAHs) to report acute respiratory illnesses

LABline

Oct. 28, 2024

Memo from CMS.

Regulatory

Issue of CLIA SAPR FY 2024

LABline

Oct. 1, 2024

Regulatory

Reorganization of the Office of Laboratory Science and Safety

LABline

Sept. 20, 2024

Regulatory

Meeting of the Clinical Laboratory Improvement Advisory Committee

LABline

Sept. 13, 2024

Regulatory

ADLM survey finds that FDA’s final laboratory developed tests rule will hinder patient care for underserved communities

LABline

Sept. 6, 2024

Regulatory

A2LA announces first clinical laboratory in U.S. accredited to new version of ISO 15189 as part of platinum choice program

LABline

Aug. 28, 2024

Regulatory

Association for Molecular Pathology files lawsuit against FDA to challenge final rule on regulation for laboratory developed testing procedures

LABline

Aug. 20, 2024

Drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures...

Regulatory

Updated Model Signage for the Emergency Medical Treatment and Labor Act

LABline

Aug. 15, 2024

CMS memo.

Regulatory

Medicare Program; Transitional Coverage for Emerging Technologies

LABline

Aug. 12, 2024

Final notice.

Regulatory

REVISED: Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing - Analytes and Acceptable Performance Final Rule (CMS-3355-F)

LABline

July 10, 2024

Revisions to QSO-22-21-CLIA originally released on July 11, 2022.

Regulatory

CDRH announces partnership to develop new methods to accelerate diagnostic device development for underserved populations

LABline

June 28, 2024

These new methods are intended to help developers create a more efficient and affordable option that could be more easily deployed across populations living in rural and remote...

Regulatory

Association for Diagnostics & Laboratory Medicine (formerly AACC) survey finds that FDA’s final laboratory developed tests rule will impede the fight against the U.S.’s drug epidemic

LABline

June 27, 2024

A laboratory developed test is a new or significantly modified test that is developed, validated, and used within a single clinical laboratory in response to a specific patient...