Regulatory

Regulatory

Revisions to State Operations Manual, Appendix C

LABline

Dec. 9, 2024

Survey procedures and interpretive guidelines for laboratories and laboratory services – advance copy.

Regulatory

REVISED: Revisions to Appendix Q, guidance on immediate jeopardy

LABline

Dec. 2, 2024

Regulatory

Guidance for time-share and leased space arrangements in CAHs

LABline

Nov. 21, 2024

Regulatory

Important information about the CLIA proficiency testing final rule

LABline

Nov. 12, 2024

Regulatory

New policies to reduce maternal mortality, increase access to care, and advance health equity

LABline

Nov. 5, 2024

Regulatory

GlobalData concerned about new LDT rule’s impact on personalized medicine

LABline

Nov. 4, 2024

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

CMS memo.

Regulatory

Reorganization of the Office of Laboratory Science and Safety

LABline

Sept. 20, 2024

A Notice by the Centers for Disease Control and Prevention on September 19, 2024.

Regulatory

Meeting of the Clinical Laboratory Improvement Advisory Committee

LABline

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

ADLM’s laboratory developed tests regulation survey.

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

ADL Health is the first to be accredited to ISO 15189:2022 by A2LA, the latest version of the standard to be published.

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

Regulatory

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

LABline

June 28, 2024

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

Regulatory

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

LABline

June 20, 2024

Regulatory

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

LABline

June 14, 2024

Regulatory

FDA webinar about final rule regarding laboratory developed tests

LABline

May 13, 2024

Regulatory

Summary: 2024 Social Security and Medicare Trustees Reports

LABline

May 8, 2024

Regulatory

Medical devices; Laboratory developed tests

LABline

May 6, 2024