References

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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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References

AABB Accreditation Program. Standards for Blood Bank and Transfusion Services, 29th edition. Bethesda, MD: American Association of Blood Banks; April 1, 2016.
CAP Commission on Laboratory Accreditation- Laboratory Accreditation Program. Laboratory General Checklist. Northfield, IL: College of American Pathologists; October 24, 2022.
Clinical Laboratory Standards Institute, Management of Nonconforming Laboratory Events; Approved Guideline. CLSI Document QMS11, 2nd ed. Wayne, PA. 2015.
Clinical Laboratory Standards Institute, Quality Management System: A Model for Laboratory Services; Approved Guideline - Fourth Edition. CLSI Document QMS01-A4, Wayne, PA. 2011.
COLA Accreditation Program. COLA Laboratory Accreditation Manual. Columbia, MD: Commission on Office Laboratory Accreditation; March 2022.
Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing. The Joint Commission, January 2021.
Det Norske Veritas Germanischer Lloyd web site. International Healthcare Accreditation. Available at: https://www.dnvgl.com/services/international-healthcare-accreditation-7516. Accessed January 18, 2023.
Electronic Code of Federal Regulations. CLIA Laboratory Requirements (42 CFR 493). Available at: http://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5. Accessed January 18, 2023.
ISO International Standard 15189:2012; Medical Laboratories-Requirements for quality and competence.
Tartal J. US Food and Drug Administration. Corrective and Preventive Action Basics [presentation]. November 4, 2014. Available at: https://www.fda.gov/downloads/Training/CDRHLearn/UCM421767.pdf. Accessed January 18, 2023.
US Food and Drug Administration, Code of Federal Regulations Title 21, Volume 8, Revised as of April 1, 2016.