Judy Stone, MT (ASCP), PhD, DABCC has worked with LC-MS in diagnostic laboratories since 1999. Her clinical practice involved small molecule method development, instrument to instrument and instrument to LIS interfacing, LC-MS automation, monitoring quality of LC-MS methods in production and staff training for clinical LC-MSMS. She served as faculty chair for the 2009 AACC online certificate program “Using Mass Spectrometry in the Clinical Laboratory”, as a scientific committee member for the MSACL Practical Training track, and was editor-in-chief for the AACC Clinical Laboratory News quarterly feature series on Clinical LC-MS. She enjoys documenting and presenting esoteric as well as absurdly common LC-MS problems in creative ways in order to help trainees learn troubleshooting (and avoid repeating her mistakes).

The U.S. FDA Final Rule (6 May 2024) on Laboratory Developed Tests (LDT) is a concern for all CLIA laboratories performing LC-MSMS testing for patient care. The ACLA and AMP lawsuits, and Supreme Court “Chevron” ruling, have added uncertainty to the future for the Final Rule. But the first compliance deadline of 6 May, 2025, required for all LDTs, is on the horizon. Expert overviews of the LDT Final Rule are now available (recorded webinars) and more are planned by the FDA, ADLM, CLSI, and CAP. After 6 May 2024, MSACL formed a Compliance and Accreditation Committee (CAC). A primary committee goal is to support clinical LC-MSMS users who are planning their compliance with the U.S. FDA LDT Final Rule.

MSACL Connect, with MSACL-CAC Co-chairs Jacqueline Hubbard and Judith Stone, will present a webinar focusing specifically on in depth review and translation of regulatory to clinical laboratory language for the Complaints, Medical Device Reporting (MDR), Corrections and Removals requirements of LDT Final Rule compliance. These are the sections of the FDA’s four-year enforcement discretion phaseout that are due by 6 May 2025. Recommendations for an action plan and templates of SOPs/Forms/Logs designed to help laboratories customize their compliance for these requirements will be discussed. The document templates will be available for download to webinar attendees.