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Centers for Medicare and Medicaid Services. Individualized quality control plan (IQCP): a new Quality Control (QC) Option. 2013. Memorandum S&C: 13-54-CLIA. Available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-54.pdf. Accessed March 13, 2016.
Code of Federal Regulations. Title 42, Part 493, §493.551. 2010.
- Quality management for unit-use testing; approved guideline.CLSI, Wayne (PA)2002 (CLSI document EP18-A)
- Risk management techniques to identify and control laboratory error sources; approved guideline—second edition.CLSI, Wayne (PA)2009 (CLSI document EP18–A2)
- Laboratory quality control based on risk management; approved guideline.CLSI, Wayne (PA)2011 (CLSI document EP23-A)
Centers for Medicare and Medicaid Services. CLIA Brochure #12, “Considerations when deciding to develop an IQCP” and brochure #13, “What is an IQCP?” Available at: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures.html. Accessed March 13, 2016.
- Standards for laboratory accreditation.College of American Pathologists, Northfield (IL)2013
- Medicare, Medicaid and CLIA programs: laboratory requirements relating to quality systems and certain personnel qualifications. Final rule.Fed Regist. 2003; 68: 3640-3714
Centers for Medicare and Medicaid Services. Effect on microbiology laboratories due to the removal of references to the Clinical Laboratory Standards Institute (CLSI) and to CLSI Documents. 2015. Memorandum S&C: 15-07-CLIA. Available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-07.pdf. Accessed March 13, 2016.
- Performance standards for antimicrobial disk susceptibility tests; approved standard—twelfth edition.CLSI, Wayne (PA)2015 (CLSI document M02–A12)
- Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; approved standard—tenth edition.CLSI, Wayne (PA)2015 (CLSI document M07–A10)
- Quality control for commercially prepared microbiological culture media; approved standard—third edition.NCCLS, Wayne (PA)2004 (NCCLS document M22–A3)
- Quality control for commercial microbial identification systems; approved guideline.CLSI, Wayne (PA)2008 (CLSI document M50-A)
- Verification of commercial microbial identification and antimicrobial susceptibility testing systems.1st edition. CLSI, Wayne (PA)2015 (CLSI guideline M52)
- Performance standards for antimicrobial susceptibility testing.25th edition. CLSI, Wayne (PA)2015 (CLSI supplement M100S)
Centers for Medicare and Medicaid Services. Interpretive guidelines for laboratories; Appendix C. Available at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html. Accessed March 13, 2016.
2015 IQCP Requirements. CAP Web site. 2015. Available at: http://www.cap.org/ShowProperty?nodePath=/UCMCon/Contribution%20Folders/WebContent/pdf/iqcp-requirements.pdf. Accessed April 13, 2016.
American Society for Microbiology. IQCP. Available at: http://clinmicro.asm.org/index.php/lab-management/laboratory-management/445-iqcp-iqcp. Accessed March 14, 2016.
- Risk management steps up labs’ QC game under IQCP.College of American Pathologists: CAP TODAY Web site, 2014 (Available at:)Accessed April 13, 2016)
- In lab QC, how much room for improvement?.College of American Pathologists: CAP TODAY Web site, 2014 (Available at)Accessed April 13, 2016)
- IQCP worries? Help with what ends and begins.College of American Pathologists: CAP TODAY Web site, 2015 (Available at)Accessed April 13, 2016)
- Full-court collaboration in transition to IQCP.College of American Pathologists: CAP TODAY Web site, 2015 (Available at)Accessed April 13, 2016)
Centers for Medicare and Medicaid Services (CMS). Individual Quality Control Plan (IQPC) for Clinical Laboratory Improvement Amendments (CLIA) laboratory nonwaived testing. Available at: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-announcement-letter-for-CLIA-CoC-and-PPM-labs.pdf. Accessed October 31, 2016.
Department of Health and Human Services, Centers for Medicare & Medicaid Services. Brochure #13. CLIA Individualized Quality Control Plan, What is an IQCP?. 2014. Available at: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure13.pdf. Accessed October 31, 2016.
- Laboratory quality control based on risk management.Ann Saudi Med. 2011; 31: 223-228
- Validating the performance of QC procedures.Clin Lab Med. 2013; 33: 75-88
Disclosure: The author has nothing to disclose.