Laboratory Quality Management

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CLIA

CFR (Code of Federal Regulations)› Title 42 (Public Health) › Chapter IV (Centers for the Medicare and Medicaid Services , Department of Health and Human Services) > Subchapter G (Standards and Certifications)› Part 493 (Laboratory Requirements (§§ 493.1 - 493.2001)

Subpart A - General Provisions (§§ 493.1 - 493.25)

Subpart B - Certificate of Waiver (§§ 493.35 - 493.39)

Subpart C - Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance (§§ 493.43 - 493.53)

Subpart D - Certificate of Accreditation (§§ 493.55 - 493.63)

Subpart E - Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program (§§ 493.551 - 493.575)

Subpart F - General Administration (§§ 493.602 - 493.649)

Subpart G [Reserved]

Subpart H - Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing (§§ 493.801 - 493.865)

Subpart I - Proficiency Testing Programs for Nonwaived Testing (§§ 493.901 - 493.959)

Subpart J - Facility Administration for Nonwaived Testing (§§ 493.1100 - 493.1105)

Subpart K - Quality System for Nonwaived Testing (§§ 493.1200 - 493.1299)

Subpart L [Reserved]

Subpart M - Personnel for Nonwaived Testing (§§ 493.1351 - 493.1495)

Subparts N-P [Reserved]

Subpart Q - Inspection (§§ 493.1771 - 493.1780)

Subpart R - Enforcement Procedures (§§ 493.1800 - 493.1850)

Subpart S [Reserved]

Subpart T - Consultations (§ 493.2001)

  1. [https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html Government Publishing Office

ISO

  1. ISO 15189ː2012
  2. ISO 15189ː2012 Abstract
  3. ISO 15189ː2012 Checklist for Medical Laboratories

Quality Management System

Quality Management System > Process Control > Quality Control

QC monitors processes related to examination phase of testing and is open to error detection in testing system. Errors could be caused by test system failure, adverse environmental conditions, operator performance.

̈Quality Control for Quantitative Tests

  1. Laboratory Quality Management System Training Toolkit
  2. COLA Laboratory Quality Assurance Insights
  3. UNC Laboratory Safety