References

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The page below is a sample from the LabCE course Hematology Instrument Validation/Calibration Verification Protocol. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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References

  1. "Calibration Verification." COLA Lab Guides/Lab Facts. https://www.colacentral.com/Content/LabGuides__LabFacts 8/10/2018.
  2. Code of Federal Regulations. https://www.ecfr.gov.
  3. College of American Pathologists. All Common Checklist. Northfield, IL; College of American Pathologists. 2019.
  4. College of American Pathologists. Chemistry and Toxicology Checklist. Northfield, IL; College of American Pathologists, 2019.
  5. College of American Pathologists. Hematology and Coagulation Checklist.Northfiels, IL; College of American Pathogists, 2019.
  6. College of American Pathologists. Laboratory General Checklist. Northfield, IL; College of American Pathologists. 2019.
  7. CLIA information: https://www.cdc.gov/clia/law-regulations.html
  8. CLIA regulations: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5
  9. CLSI. H26-A2. Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard -- Second Edition. Wayne, PA. June 2010.
  10. CMS Brochure #2 Verification of Performance Specifications https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/6064bk.pdf
  11. CMS Brochure #3 Clinical Laboratory Improvement Amendments (CLIA): Calibration and Calibration Verification https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/6065bk.pdf.
  12. COLA Laboratory Accreditation Manual. March 2019.
  13. "General Hematology Calibration Procedure Guideline." Streck. 5/2016.
  14. State Operations Manual, Appendix C - Interpretive Guidelines at §493.1253, available on the CMS website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf. p 175.
  15. Sun, Su-Chieh Pamela, MPH, MT(ASCP). "Validation of Hematology Analyzers." Medical Lab Management. October 2016. Volume 5, Number 8. Page 6.