Chapter 5 Verification of Method Performance For Clinical Laboratories

Advances in Clinical Chemistry

Volumn 47, Issue , 2009, Pages 121-137

  Nichols, James H ^a  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; LABORATORY; LEGAL ASPECT; PRACTICE GUIDELINE; REVIEW; STANDARD;

ACCREDITATION; GUIDELINES AS TOPIC; LABORATORIES;

EID: 67849120993     PISSN: 00652423     EISSN: None     Source Type: Book Series    
DOI: 10.1016/S0065-2423(09)47005-7     Document Type: Review

References (20)

1. Clinical and Laboratory Standards Institute, Harmonized terminology database. (accessed on July 2008).
2. Health and Human Services, Health Care Financing Administration Public Health Service. Clinical laboratory improvement amendments of 1988; Final rule. Federal Register 57 40 (1992) 7001-7243 42 CFR Part 405, et al. Recent revisions available at (accessed on July 2008)
3. Clinical Pathology Accreditation (UK) Ltd. Standards for the Medical Laboratory (2007), CPA, Sheffield, UK 57 , (accessed on July 2008)
4. International Organization for Standardization. ISO 15189:2007 Medical Laboratories: Particular Requirements for Quality and Competence (2007), ISO, Geneva, Switzerland 40
5. International Organization for Standardization. ISO 9000:2005 Quality Management Systems: Fundamentals and Vocabulary (2005), ISO, Geneva, Switzerland 30
6. International Organization for Standardization. ISO 9001:2000 Quality Management Systems: Requirements (2000), ISO, Geneva, Switzerland 23
7. International Organization for Standardization. ISO 9004:2000 Quality Management Systems: Guidelines for Performance Improvement (2000), ISO, Geneva, Switzerland 56
8. International Organization for Standardization. ISO 22870:2006 Point-of-Care Testing: Requirements for Quality and Competence (2006), ISO, Geneva, Switzerland 11
9. Commission on Laboratory Accreditation. Laboratory General Checklist (2007), College of American Pathologists, Northfield, IL 130
10. Commission on Laboratory Accreditation. Chemistry and Toxicology Checklist (2007), College of American Pathologists, Northfield, IL 129
11. Joint Commission. 2009 Comprehensive Accreditation Manual for Laboratories and Point-of-Care Testing (2008), Joint Commission, Oakbrook Terrace, IL 440
12. CLSI. EP15-A2 User Verification of Performance for Precision and Trueness (2005), Clinical and Laboratory Standards Institute, Wayne, PA 49
13. CLSI. EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods (2004), Clinical and Laboratory Standards Institute, Wayne, PA 39
14. CLSI. EP9-A2 Method Comparison and Bias Estimation Using Patient Samples (2002), Clinical and Laboratory Standards Institute, Wayne, PA 56
15. CLSI. EP21-A Estimation of Total Analytical Error for Clinical Laboratory Methods (2003), Clinical and Laboratory Standards Institute, Wayne, PA 39
16. CLSI. EP6-A Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach (2003), Clinical and Laboratory Standards Institute, Wayne, PA 47
17. CLSI. C28-A2 How to Define and Determine Reference Intervals in the Clinical Laboratory (2000), Clinical and Laboratory Standards Institute, Wayne, PA 38
18. CLSI. EP7-A2 Interference Testing in Clinical Chemistry (2005), Clinical and Laboratory Standards Institute, Wayne, PA 107
19. CLSI. EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation (2004), Clinical and Laboratory Standards Institute, Wayne, PA 39
20. CLSI. HS1-A2 A Quality Management System Model for Health Care (2004), Clinical and Laboratory Standards Institute, Wayne, PA 79