Regulatory

Sept. 13, 2024

A notice by the Centers for Disease Control and Prevention.

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

Regulatory

Updated Model Signage for the Emergency Medical Treatment and Labor Act

LABline

Aug. 15, 2024

Regulatory

Medicare Program; Transitional Coverage for Emerging Technologies

LABline

Aug. 12, 2024

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...

Regulatory

CMS preparing to close program that addressed Medicare funding issues resulting from Change Healthcare cyber-attack

LABline

June 20, 2024

Change Healthcare/Optum Payment Disruption (CHOPD) program provided funding lifeline to Medicare providers and suppliers.

Regulatory

Revisions to the Review and Approval of Plans of Correction (POCs) and CLIA Allegations of Compliance (AOCs)

LABline

June 14, 2024

Center for Clinical Standards and Quality memo.

Regulatory

FDA webinar about final rule regarding laboratory developed tests

LABline

May 13, 2024

Laboratory update.

Regulatory

Summary: 2024 Social Security and Medicare Trustees Reports

LABline

May 8, 2024

Fact sheet summary.

Regulatory

Medical devices; Laboratory developed tests

LABline

May 6, 2024

A Rule by the Food and Drug Administration on 05/06/2024.

Regulatory

FDA takes action aimed at helping to ensure the safety and effectiveness of laboratory developed tests

LABline

May 2, 2024

On May 14, 2024, the FDA will host a webinar to provide an overview of the final rule and phaseout policy.

Regulatory

Dear API Abby

Danielle Casey, MBA, MLS(ASCP)CM

April 22, 2024

It’s back! Dear API Abby is here to answer a series of commonly asked questions about laboratory quality. This time, the American Proficiency Institute (API) is offering...