Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program

  1. Law
  2. CFR 42
  3. Public Health
  4. Centers for Medicare & Medicaid Services, Department of Health and Human Services
  5. Standards and Certification
  6. Laboratory Requirements
  7. Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program

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Section
493.551

General requirements for laboratories.

Section
493.553

Approval process (application and reapplication) for accreditation organizations and State licensure programs.

Section
493.555

Federal review of laboratory requirements.

Section
493.557

Additional submission requirements.

Section
493.559

Publication of approval of deeming authority or CLIA exemption.

Section
493.561

Denial of application or reapplication.

Section
493.563

Validation inspections - Basis and focus.

Section
493.565

Selection for validation inspection - laboratory responsibilities.

Section
493.567

Refusal to cooperate with validation inspection.

Section
493.569

Consequences of a finding of noncompliance as a result of a validation inspection.

Section
493.571

Disclosure of accreditation, State and CMS validation inspection results.

Section
493.573

Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs.

Section
493.575

Removal of deeming authority or CLIA exemption and final determination review.