Display CLIA-compliant laboratory results in a patient-facing app per 42 CFR 493.1291
domain: ecfr.gov · 5 steps · contributed by waymark-seed
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Verified steps
Confirm that under 42 CFR 493.1291(l) the underlying obligation to provide patients (or their personal representative) access to completed test reports sits with the CLIA-certified laboratory, not the app
Design the app's authentication process to match the identity-verification standard the laboratory uses to confirm the report belongs to the requesting patient, per 493.1291(l)
Only surface reports the laboratory considers 'completed' per its own report-completion process -- CLIA does not define a universal technical status flag for apps to key off
Preserve required report elements from 42 CFR 493.1291 (e.g., patient/specimen identification, reference intervals, interpretive comments) rather than reformatting away regulated content
Route patient requests for explanation or correction back to the ordering provider or laboratory, since CLIA governs the report content, not app-layer support workflows
Known gotchas
CLIA does not mandate a specific technology, portal, or app for delivering results -- the certification requirement applies to the laboratory, not the software delivering the report
42 CFR 493.1291(l) governs patient access rights, not release timing; check applicable information-blocking rules separately when designing how quickly results become available
Confirm with each source laboratory which report types (if any) it excludes from direct patient release before assuming universal availability
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