Clin Chem Lab Med. 2026 Feb 3. doi: 10.1515/cclm-2025-1322. Online ahead of print.

ABSTRACT

OBJECTIVES: Despite growing interest in artificial intelligence (AI) and machine learning (ML), many laboratory professionals lack experience with developing in-house AI systems or implementing those supplied by external providers. The IFCC Committee on AI in Laboratory Medicine (C-AILM) conducted a survey to collect the status of AI/ML applications, challenges, and expert perspectives on key technical considerations.

METHODS: An 20-item survey was distributed to laboratory professionals experienced in AI. It covered application status (in-house or provider-supplied, with or without regulatory approval); essential information to request from AI system providers; validation or verification practices; monitoring strategies; and perceived implementation challenges.

RESULTS: Fifty complete responses from global experts were received. AI implementation in clinical laboratories was limited and heterogeneous. Most respondents agreed that AI systems provided externally, regardless of regulatory approval status, require local verification. Key information needed from providers included performance metrics from original and external datasets, and demographics of the training/test populations. For both approved and non-approved models, high-priority verification studies were local performance analysis, confirmation of intended-use alignment, and verification of privacy and security safeguards. Top monitoring strategies were regular accuracy checks and comparison against human decision-making. Leading challenges were insufficient IT infrastructure and lack of practical implementation guidelines.

CONCLUSIONS: Although many challenges remain, clinical laboratories demonstrate strong enthusiasm for AI, particularly with the growing prevalence of commercial AI products. The timely expert insights from our survey and C-AILM recommendations for both AI system providers and clinical laboratories on essential information, verification requirements, and monitoring strategies will inform standardized guideline development.

PMID:41630421 | DOI:10.1515/cclm-2025-1322