US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subparts B to F: certificates of waiver, registration, compliance and accreditation, deemed status, validation inspections and fees (sections 493.35 to 493.680) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 551-567: Deemed status through an approved accreditation organisation: obtain the certificate of accreditation, pay the fees, meet the proficiency testing subpart, authorise the PT program and the accreditation organisation to release results and adverse actions to CMS, and cooperate fully with any CMS validation inspection

What does 551-567 require?

A laboratory that meets CLIA through accreditation by a CMS-approved private nonprofit organisation must obtain a certificate of accreditation under Subpart D, pay the Subpart F fees, meet the Subpart H proficiency testing requirements, authorise its proficiency testing organisation to furnish its PT results and explanatory information to the accreditation organisation (for monitoring and for release to the public on request), and authorise the accreditation organisation to release to CMS any PT results that amount to unsuccessful participation and any action the organisation takes within 30 days of initiating it; refusal to authorise release ends deemed status and triggers a full CMS review. Where accreditation is withdrawn or revoked the certificate of accreditation survives for at most 45 days. A laboratory selected for a CMS validation inspection must authorise its accreditation organisation or State program to release its most recent full and any later partial inspection, authorise the validation inspection, give CMS or its agent access to all facilities, equipment, materials, records and information bearing on compliance and permit copying, and authorise CMS to monitor correction of deficiencies. Refusal to cooperate exposes an accredited laboratory to full CMS review and to suspension, revocation or limitation of its certificate; a CLIA-exempt laboratory's refusal is reported to its State.

Maintained by Gerard Blokdyk

Other controls in Subparts B to F: certificates of waiver, registration, compliance and accreditation, deemed status, validation inspections and fees (sections 493.35 to 493.680) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

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