Government Seeks Input on 1988 Lab Rules Upgrade
Published Date: 7/16/2026
Proposed Rule
Summary
The government wants your thoughts on updating lab testing rules from 1988 to keep up with new technology and safety needs. This affects labs doing medical tests, especially around breath tests, emergency plans, and cybersecurity. Share your ideas by September 14, 2026, so they can decide if and how to improve the rules—no money changes yet, just gathering info!
Analyzed Economic Effects
14 provisions identified: 2 benefits, 0 costs, 12 mixed.
Emergency Preparedness for Independent Labs
Following a 2025 OIG report, CMS and CDC are seeking comments on whether CLIA should require independent laboratories that participate in Medicare to have emergency preparedness plans so Medicare enrollees retain access to diagnostic testing during future public health emergencies. Comments due September 14, 2026.
Laboratory Cybersecurity Practices
CMS and CDC request information on cybersecurity policies labs use to protect patient data and lab operations, including identity/access verification, foreign access, IP/port restrictions, incident response plans, responsible job positions, and training. They seek challenges faced; comments due September 14, 2026.
Breath Testing Under CLIA
CMS and CDC are asking whether breath tests used in clinical care (for examples cited: COVID-19, cancer diagnosis, microbial ID, gastrointestinal disorders) fall under CLIA rules. They want examples of what breath tests, technologies, and facility types perform them and how specimens are collected, transported, and stored. Submit comments by September 14, 2026.
Pathology Block Retention (2-Year Rule)
Current CLIA rule (42 CFR 493.1105(a)(7)(ii)) requires pathology specimen blocks be kept for at least 2 years. CMS and CDC seek input on requests for additional testing on blocks older than 2 years and how often labs receive such requests. Comments are due by September 14, 2026.
Preanalytic Specimen Prep and Staff Qualifications
CMS and CDC request information on what activities count as specimen preparation (e.g., centrifuging, aliquoting, DNA/RNA extraction), and on the education, training, and competency verification of personnel who perform those tasks. They seek details on existing training and how labs ensure ongoing competence; comments due September 14, 2026.
Performance Specs for Non‑FDA Tests
CLIA (Sec. 493.1253) requires verification of FDA‑cleared tests and establishment of performance specs for non‑FDA‑cleared tests or modifications. CMS and CDC seek information on challenges labs face when establishing those specifications, including for methods like toxicology and next‑generation sequencing (NGS). Comments due September 14, 2026.
AI and Software in Test Interpretation
CMS and CDC request input on how laboratories use software algorithms and AI tools in postanalytic interpretation (e.g., NGS, histopathology, pharmacogenomics), how labs verify software performance, and whether CLIA should address cloud analytics, automation, or AI. Comments must be submitted by September 14, 2026.
Data‑Only Facilities and CLIA Coverage
CMS and CDC seek comments on whether facilities that only process analytical data or provide specialized data interpretation (including some medical device software manufacturers) qualify as ‘laboratories’ under CLIA and therefore require CLIA certification. They ask what activities these data‑only facilities perform. Deadline for comments: September 14, 2026.
Biosafety and Biosecurity Protocols
CMS and CDC seek public comments on biosafety and biosecurity protocols, risk assessments, and training for laboratory personnel handling infectious materials, drawing on CDC guidance used during the COVID-19 public health emergency. Respondents should describe challenges, best practices, and training approaches; comments due September 14, 2026.
Updating CLIA Specialties and Subspecialties
CMS and CDC are asking whether existing CLIA specialty and subspecialty categories (examples mentioned: Mohs testing, andrology, molecular testing) should be revised or expanded to reflect current testing practices. They request evidence-based rationale related to safety, complexity, and public health; comments due September 14, 2026.
Cytogenetics, Immunohematology, Microbiology Focus
CMS and CDC seek comments on technical advances and challenges in clinical cytogenetics, immunohematology (including electronic crossmatching and quality assurance), and microbiology (including blood culture contamination monitoring). CLIAC has recommended BCC monitoring be added to quality management considerations. Comments due September 14, 2026.
Handling Suboptimal Specimens
CMS and CDC ask how laboratories handle specimens that arrive in suboptimal condition, including when labs test them, how often, how results are documented and reported, and how labs communicate with ordering providers. They seek practices and challenges; comments due by September 14, 2026.
Calibration Verification for Factory‑Calibrated Devices
Sec. 493.1255 requires calibration verification for nonwaived testing, and CMS/CDC have received inquiries about factory‑calibrated, non‑adjustable instruments (closed systems/cartridge analyzers). They seek comments on technical and operational challenges laboratories face when performing calibration verification on such devices. Comments due September 14, 2026.
Remote Competency Assessment for Lab Staff
CMS and CDC request evidence and experience on using remote direct observation technology (smartphones, tablets, VR, dedicated video) to assess laboratory personnel competency. CLIAC recommended allowing remote assessment, especially to help rural facilities; comments due September 14, 2026.
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Key Dates
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