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CAC
CAC Workgroups
The MSACL Compliance and Accreditation Committee (CAC) was established in 2024 during a period of significant regulatory shifts surrounding the U.S. FDA’s Final Rule on Laboratory Developed Tests (LDTs). Following the vacating of that rule in April 2025, the CAC pivoted its focus to address compliance and accreditation for clinical mass spectrometry.
To achieve this, the CAC has organized its efforts into four strategic Workgroups, detailed in the below “Summary of CAC Workgroups and Objectives”:
- MSACL Guidance Document Advisory Group
- CLIA Modernization Workgroup (U.S. Focus)
- QMS and ISO Workgroup (U.S. and International Focus)
- Training Workgroup
Learn more about each workgroup by watching this 24 minute Introduction to the CAC Workgroups Presentation.
Why Your Expertise Matters
We believe that the most effective regulatory recommendations and training materials come directly from the clinical mass spectrometry community. By volunteering, you contribute to the development of rational, practical, and accessible standards that directly benefit patients, students, and laboratory operations worldwide.
This is an opportunity to collaborate with your peers, expand your professional knowledge base, and distill complex clinical experience into high-impact guidance. In short, the CAC Workgroups need YOU.
Interested in a CAC Workgroup?
Attend this Discussion Group at MSACL 2026: CAC Working Groups – What are they, why they matter, and how to get
involved, Thursday Oct 8, 7:45am, Westmount 2
Summary of CAC Workgroups and Objectives
CLIA Modernization Workgroup (US Focus)
Advocate for appropriate regulation for Clinical Mass Spectrometry Testing.
Purpose
Develop and publish recommendations for CLIA LDT regulations that optimize patient outcomes while minimizing laboratory burden. These recommendations will address regulatory gaps and reference existing standards (CLSI, CAP, ISO 15189) and modernization proposals (e.g., AMP), rather than duplicating them.
Objectives
- Identify gaps in current regulation of CLIA MS LDTs.
- Review existing regulatory proposals and consensus standards.
- Engage the MSACL community for feedback and best practices.
- Draft suggested compliance language to maximize clarity for end users.
- Collaborate with other workgroups as appropriate.
QMS and ISO Workgroup (US and International Focus)
Provide guidance for adopting best practices related to Clinical Mass Spectrometry to enable high-quality laboratory testing.
Purpose
Develop practical recommendations for clinical mass spectrometry laboratories for implementing Quality Management Systems (QMS), ISO standards, and CLSI standards to improve quality of patient care.
Objectives
- Identify gaps in best practices in clinical mass spectrometry laboratories, particularly as they pertain to QMS, ISO, and CLSI standards.
- Engage the community for feedback on guidance needed and potential barriers to implementation of international quality standards in their laboratories.
- Produce, present, or publish educational materials related to the availability, evaluation, selection, and deployment of QMS and ISO standards in clinical mass spectrometry laboratories.
- Collaborate with other workgroups as appropriate.
Training Workgroup
Teach the laboratory medicine community the basics of clinical mass spectrometry and requirements to direct a clinical mass spectrometry laboratory.
Purpose
Create and share free, web-based training resources for clinical MS, targeting medical laboratory scientists (MLSs), bench-level staff, and other stakeholders.
Objectives
- Establish training needs.
- Review existing training resources for gaps.
- Develop modular content accessible to bench-level staff.
- Promote adoption of training materials via MSACL platforms.
Guidance Document Advisory Group
Formalize a process for creating and publishing clinical mass spectrometry guidance documents that are reviewed and supported by the MSACL community. Serve as a liaison among CAC working groups, JMSACL, and the MSACL community in developing guidance documents.
Purpose
Provide oversight and structure for the development of formal guidance documents for clinical mass spectrometry testing.
Objectives
- Identify priority topics.
- Recruit expert groups to draft documents.
- Ensure timely completion of guidance documents.
- Facilitate review and ensure appropriate revision of documents prior to publication.
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