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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.
Learn more about Hematology Instrument Validation/Calibration Verification Protocol (online CE course)
References
"Calibration Verification."
COLA Lab Guides/Lab Facts
.
https://www.colacentral.com/Content/LabGuides__LabFacts
8/10/2018. Accessed 4/28/2020.
Code of Federal Regulations.
https://www.ecfr.gov
. Accessed 4/20/2020.
College of American Pathologists.
All Common Checklist.
Northfield, IL; College of American Pathologists. 2019.
College of American Pathologists.
Chemistry and Toxicology Checklist
. Northfield, IL; College of American Pathologists, 2019.
College of American Pathologists.
Hematology and Coagulation Checklist.
Northfiels, IL; College of American Pathogists, 2019.
College of American Pathologists.
Laboratory General Checklist.
Northfield, IL; College of American Pathologists. 2019.
CLIA information:
https://www.cdc.gov/clia/law-regulations.html
; Accessed 4/20/2020.
CLIA regulations:
https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5
; Accessed 4/20/2020.
CLSI. H26-A2.
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Approved Standard -- Second Edition
. Wayne, PA. June 2010.
CMS Brochure #2 Verification of Performance Specifications
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/6064bk.pdf
; Accessed 4/20/2020.
CMS Brochure #3 Clinical Laboratory Improvement Amendments (CLIA): Calibration and Calibration Verification
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/6065bk.pdf
. Accessed 4/20/2020.
COLA Laboratory Accreditation Manual. March 2019.
"General Hematology Calibration Procedure Guideline." Streck. 5/2016.
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. Accessed 4/10/2020 and 4/23/2020.
Sun, Su-Chieh Pamela, MPH, MT(ASCP). "Validation of Hematology Analyzers."
Medical Lab Management
. October 2016. Volume 5, Number 8. Page 6.
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