References

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References

American Academy of Family Physicians. "CLIA Inspections: Information for Your Lab on CLIA Inspections." AAFP.gov, 2021, https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/clia/inspections.html. Accessed April 22, 2023.
Bachman, M Ann. “How to make your laboratory inspection-ready.” MLO: medical laboratory observer vol. 44,1 (2012): 30, 32.
Byrne, Karen M et al. “They're Here! How to Prepare Your Blood Bank for Inspection.” Laboratory medicine vol. 46,1 (2015): e2-6. doi:10.1309/LMIGNO604GBVAMGM
Centers for Disease Control and Prevention. "Standards and Certification: Laboratory requirements (42 CFR 493)." CDC.gov, 6 Aug 2018, http://wwwn.cdc.gov/clia/Regulatory/default.aspx. Accessed April 22, 2023.
Centers for Medicare and Medicaid Services. "How to Obtain a CLIA Certificate." CMS.gov, 2021, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCLIACertificate.pdf Accessed April 22, 2023.
Centers for Medicare and Medicaid Services. "How to Obtain a CLIA Certificate of Waiver." CMS.gov, 2021, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf. Accessed April 22, 2023.
Centers for Medicare and Medicaid Services. "Individualized Quality Control Plan (IQCP)." CMS.gov, 2021, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html. Accessed April 22, 2023.
Centers for Medicare and Medicaid Services. "List of Approved Accreditation Organizations Clinical Laboratory Improvement Amendments(CLIA)." CMS.gov, 2021, https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/aolist.pdf. Accessed April 22, 2023.
Centers for Medicare and Medicaid Services. "List of Exempt States Under the Clinical Laboratory Improvement Amendments (CLIA)." CMS.gov, 5/30/2022, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ExemptStatesList.pdf. Accessed April 22, 2023.
Centers for Medicare and Medicaid Services. "Principles of Documentation." CMS.gov, Oct 2018, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/Principles-of-Documentation-Oct-2018.pdf. Accessed April 22, 2023.
Centers for Medicare and Medicaid Services. "What do I Need to Do to Assess Personnel Competency." CMS.gov, 2012, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf. Accessed April 22, 2023.
Chittiprol, Seetharam, et al. "Top Laboratory Deficiencies Across Accreditation Agencies." AACC.org, 2021, https://www.aacc.org/cln/articles/2018/july/top-laboratory-deficiencies-across-accreditation-agencies. Accessed April 22, 2023.
Clinical and Laboratory Standards Institute (CLSI). Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline. 3rd ed. CLSI document EP05­A3. Wayne, PA: Clinical and Laboratory Standards Institute; 2014.
College of American Pathologists. All Common Checklist. Northfield, IL: College of American Pathologists: 202.2
College of American Pathologists. Laboratory General Checklist. Northfield, IL: College of American Pathologists: 2022.
COLA. "Laboratory Accreditation Manual." COLA.org, February 2023. Accessed April 22, 2023.
Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical Laboratory Improvement Amendments of 1988; Final Rule. Fed Register. 2003(Oct 1) [42CFR493].
Eden, Lt Colonel Paul R. "Getting Ready for Your Laboratory Inspection." Medical Laboratory Observer, 22 June 2016, https://www.mlo-online.com/diagnostics/poct/article/13008694/getting-ready-for-your-laboratory-inspection. Accessed April 22, 2023.
State Agency and CLIA Operations Branch Contacts. STATE SURVEY AGENCIES (CLIA CONTACT LIST) (cms.gov). Accessed April 23, 2023.
The Joint Commission. "The Joint Commission’s Tracer Methodology Toolkit for the Lab Program." TJC.org, 2021, https://www.whitehatcom.com/POCWebMtgs/Slides/Lab_Tracer_Toolkit.pdf. Accessed April 22, 2023.
The Joint Commission. "Tracer Methodology 101: The Laboratory Tracer." The Joint Commission on Accreditation Organizations, September 2010. Volume 8, Issue 9.
Wager EA, Cohen MB, Karcher DS, Siegal GP. Laboratory Administration for Pathologists. 2nd ed. Northfield, IL: College of American Pathologists; 2019.