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Chapter 57 : External Quality Assessment and Proficiency Testing in Diagnostic Molecular Microbiology

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Abstract:

Proficiency testing (PT) and external quality assurance/assessment (EQA) are considered interchangeable terms; the generally accepted international terminology is ‘‘proficiency testing,’’ which is used in this chapter. The requirement for PT, as discussed in the chapter, applies to the Centers for Medicare and Medicaid Services (CMS)-accredited laboratories and pertains to nonwaived testing. Laboratory-specific aspects of the protocols should include detailed information regarding specimen evaluation, methods and reagents used for sample reconstitution and testing, maximum interval between reconstitution and testing, storage of excess sample, documentation. In order for PT to be relevant to the quality of patient care testing, PT challenge specimens must be tested in the same manner as patient specimens, including the processing, method and extent of testing, and personnel assigned to perform the testing. Among the microbiology surveys, there are pathogen-specific surveys specifically challenging molecular diagnostic strategies, including qualitative detection and identification, quantification, and genotyping. Proficiency testing, along with other Clinical Laboratory Improvement Amendments (CLIA) quality requirements, provides laboratories and accreditation organizations the tools needed to assess and improve the quality of diagnostic testing. The collaborative efforts of external advocacy groups, professional organizations and societies, governmental and nongovernmental agencies, and commercial providers of quality assurance products should result in increasing improvements to the technical quality and clinical utility of molecular diagnostic testing for infectious diseases. These improvements should result in improvements in patient safety and clinical outcomes as well as the efficiency of diagnostic testing for laboratories and health care systems.

Citation: Mitchell M. 2011. External Quality Assessment and Proficiency Testing in Diagnostic Molecular Microbiology, p 891-898. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch57

Key Concept Ranking

West nile virus
0.57615155
Infectious Diseases
0.55932313
Analytical Methods
0.5230552
Molecular Techniques
0.5230552
Analytical Methods
0.5230552
Molecular Techniques
0.5230552
0.57615155
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References

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1. CLSI. 2008. Assessment of Laboratory Tests When Proficiency Testing Is Not Available; Approved Guideline, 2nd ed. CLSI Document GP29-A2. CLSI, Wayne, PA.
2. CLSI. 2005. Proficiency Testing (External Quality Assessment) for Molecular Methods; Approved Guideline. CLSI document MM14-A. CLSI, Wayne, PA.
3. CLSI. 2007. Using Proficiency Testing To Improve the Clinical Laboratory; Approved Guideline, 2nd ed. CLSI Document GP27-A2. CLSI, Wayne, PA.
4. Federal Register. 1992. Medicare, Medicaid, and CLIA programs: regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Fed. Regist. 57:71377186.
5. International Laboratory Accreditation Cooperation. 2007. Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes. ILAC G13:2007. International Laboratory Accreditation Cooperation, Sydney, Australia.
6. NCCLS. 2004. Application of a Quality Management System Model for Laboratory Services; Approved Guideline, 3rd ed. NCCLS document GP26-A3. NCCLS, Wayne, PA.
7. Association of Molecular Pathologists. AMP List of FDA Approved Molecular Diagnostic Tests. http://www.amp.org/FDATable/FDATable.doc.
8. Centers for Disease Control and Prevention. 24 January 2003. Subpart K—Quality Systems for Nonwaived Testing. http://wwwn.cdc.gov/clia/regs/subpart_k.aspx.
9. Centers for Disease Control and Prevention. 7 July 2004. Subpart H—Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing. http://wwwn.cdc.gov/clia/regs/subpart_h.aspx.
10. Centers for Disease Control and Prevention. 7 July 2004. Current CLIA Regulations. http://wwwn.cdc.gov/clia/regs/toc.aspx.
11. Centers for Medicare and Medicaid Services. 2006. CMS Initiatives to Improve Quality of Laboratory Testing under the CLIA Program. http://www.cms.gov/CLIA/downloads/060630._Backgrounder.rlEG.pdf.
12. Department of Health and Human Resources. 2009. CLIA Regulations and Federal Register Documents. http://www.cms.hhs.gov/CLIA/09_CLIA_Regulations_and_Federal_Register_Documents.asp#TopOfPage.
13. European Commission. 1998. European Proficiency Testing Information System, European Commission Project SMT-CT-8002. http://www.eptis.bam.de/en/index.htm.
14. International Organization for Standardization. 1997. ISO/ IEC Guide 43: 1997, Part 1. Development and Operation of Proficiency Testing Schemes, 2nd ed. International Organization for Standardization, Geneva, Switzerland.
15. International Organization for Standardization. 1997. ISO/ IEC Guide 43: 1997, Part 2. Selection and Use of Proficiency Testing Schemes by Laboratory, 2nd ed. International Organization for Standardization, Geneva, Switzerland.
16. Centers for Disease Control and Prevention. 31 August 1999. General Recommendations for Quality Assurance Programs for Laboratory Molecular Genetic Tests. http://wwwn.cdc.gov/dls/pdf/genetics/dyncor.pdf.
17. NCCLS. 1995. Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline. NCCLS Document MM3-A. NCCLS, Wayne, PA.
18. NCCLS. 2003. Quantitative Molecular Methods for Infectious Diseases; Approved Guideline. NCCLS Document MM6-A. NCCLS, Wayne, PA.

Tables

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TABLE 1

Systemic bias suggested in variability from peer group average

Citation: Mitchell M. 2011. External Quality Assessment and Proficiency Testing in Diagnostic Molecular Microbiology, p 891-898. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch57
Generic image for table
TABLE 2

Random appearing variability from peer group average

Citation: Mitchell M. 2011. External Quality Assessment and Proficiency Testing in Diagnostic Molecular Microbiology, p 891-898. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch57

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