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Chapter 52 : Proficiency Testing and External Quality Assessment for Molecular Microbiology

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Proficiency Testing and External Quality Assessment for Molecular Microbiology, Page 1 of 2

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Abstract:

The increased reliance on molecular test results for critical patient management decisions demands that those results be relevant, robust, and reliable from all laboratories that produce them. Commenting on the history of quality control (QC) and proficiency testing, F. William Sunderman, MD, a leading pioneer in clinical biochemistry laboratory standardization, stated, “There can be no more important task for the director of a clinical laboratory than to assess the precision and accuracy of the analytical procedures under his/her supervision. Maintenance of high standards of analysis not only serves as a scientific stimulus for the laboratory but is also of direct benefit to patients” (1).

Citation: Madej R. 2016. Proficiency Testing and External Quality Assessment for Molecular Microbiology, p 754-765. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch52
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Figures

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FIGURE 1

A Levey-Jennings chart representing a hypothetical 2 years of PT results for a given viral load PT program which has three events per year (A, B, C) and five challenges per event (1 to 5). For example, in the axis, Y1, B2 is year 1, testing event B, challenge (PT specimen) #2. The laboratory's result for each challenge is subtracted from the mean of the peer group, and the SD is calculated, allowing plotting of challenges with different values. A shift quantitation with regard to the peer group can be observed in year 1 for the B testing event. A random failure is observed in year 2, event B, PT sample #4 because the laboratory result was above 2 SD from the peer group mean.

Citation: Madej R. 2016. Proficiency Testing and External Quality Assessment for Molecular Microbiology, p 754-765. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch52
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References

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1. Sunderman FW Sr. 1992. The history of proficiency testing/quality control. Clin Chem 38:12051209, discussion 1218–1225.[PubMed]
2. International Organization for Standardization. 2010. ISO/IEC 17043 Conformity Assessment—General Requirements for Proficiency Testing. ISO, Geneva, Switzerland.
3. CLSI. 2013. Design of Molecular Proficiency Testing/External Quality Assessment: Approved Guideline 2nd ed. CLSI document MM14-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
4. Miller WG, Jones GRD, Horowitz GL, Weykamp C. 2011. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 57:16701680[CrossRef].[PubMed]
5. Best SJ, Gust AP, Johnson EIM, McGavin CH, Dax EM. 2000. Quality of human immunodeficiency virus viral load testing in Australia. J Clin Microbiol 38:40154020.[PubMed]
6. Schirm J, van Loon AM, Valentine-Thon E, Klapper PE, Reid J, Cleator GM. 2002. External quality assessment program for qualitative and quantitative detection of hepatitis C virus RNA in diagnostic virology. J Clin Microbiol 40:29732980[CrossRef].[PubMed]
7. Zaaijer HL, Cuypers HTM, Reesink HW, Winkel IN, Gerken G, Lelie PN. 1993. Reliability of polymerase chain reaction for detection of hepatitis C virus. Lancet 341:722724[CrossRef].[PubMed]
8. Gretch DR. 1997. Diagnostic tests for hepatitis C. Hepatology 26(Suppl 1):43S47S[CrossRef].[PubMed]
9. Laperche S, Bouchardeau F, Thibault V, Pozzetto B, Vallet S, Rosenberg AR, Roque-Afonso AM, Gassin M, Stoll-Keller F, Trimoulet P, Gault E, Chanzy B, Mercier B, Branger M, Pawlotsky JM, Henquell C, Lunel F, Gaudy-Graffin C, Alain S, Chaix ML, Duverlie G, Izopet J, Lefrère JJ. 2007. Multicenter trials need to use the same assay for hepatitis C virus viral load determination. J Clin Microbiol 45:37883790[CrossRef].[PubMed]
10. Ieven M, Finch R, van Belkum A. 2013. European quality clearance of new microbiological diagnostics. Clin Microbiol Infect 19:2938[CrossRef].[PubMed]
11. Centers for Medicare and Medicaid Services, US Department of Health and Human Services. Part 493—Laboratory Requirements: General Provisions; Definitions (codified at 42CFR §493.2). http://www.ecfr.gov/cgi-bin/text-idx?SID=a716447f72ce767510508308dc9039dd&mc=true&node=se42.5.493_12&rgn=div8
12. Centers for Medicare and Medicaid Services, US Department of Health and Human Services. Part 493 Subpart I—Proficiency Testing Programs for Nonwaived Testing (codified at 42CFR §§493.901–903). http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=a716447f72ce767510508308dc9039dd&mc=true&n=pt42.5.493&r=PART&ty=HTML#sp42.5.493.i
13. Centers for Medicare and Medicaid Services, US Department of Health and Human Services. Part 493 Subpart H—Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing (codified at 42CFR §493.801). http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=a716447f72ce767510508308dc9039dd&mc=true&n=pt42.5.493&r=PART&ty=HTML#sp42.5.493.h
14. CLSI. 2007. Using Proficiency Testing to Improve the Clinical Laboratory: Approved Guideline, 2nd ed. CLSI document GP27-A2. Clinical and Laboratory Standards Institute., Wayne, PA.
15. International Organization for Standardization. 2012. ISO 15189 Medical Laboratories—Requirements for Quality and Competence. ISO, Geneva, Switzerland.
16. CLSI. 2010. Quantitative Molecular Methods for Infectious Diseases—Approved Guideline, 2nd ed. CLSI document MM6-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
17. CLSI. 2008. Assessment of Laboratory Tests When Proficiency Testing Is Not Available—Approved Guideline, 2nd ed. CLSI document GP29-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
18. Orlando C, Verderio P, Maatman R, Danneberg J, Ramsden S, Neumaier M, Taruscio D, Falbo V, Jansen R, Casini-Raggi C, Malentacchi F, Marubini E, Pizzamiglio S, Vernelen K, Libeer JC, Palicka V, Pazzagli M. 2007. EQUAL-qual: a European program for external quality assessment of genomic DNA extraction and PCR amplification. Clin Chem 53:13491357[CrossRef].[PubMed]
19. Ramsden SC, Daly S, Geilenkeuser WJ, Duncan G, Hermitte F, Marubini E, Neumaier M, Orlando C, Palicka V, Paradiso A, Pazzagli M, Pizzamiglio S, Verderio P. 2006. EQUAL-quant: an international external quality assessment scheme for real-time PCR. Clin Chem 52:15841591[CrossRef].[PubMed]
20. Dorn-Beineke A, Ahmad-Nejad P, Pfeiffer U, Ramsden S, Pazzagli M, Neumaier M. 2006. Improvement of technical and analytical performance in DNA sequencing by external quality assessment-based molecular training. Clin Chem 52:20722078[CrossRef].[PubMed]
21. Günther K, Malentacchi F, Verderio P, Pizzamiglio S, Ciniselli CM, Tichopad A, Kubista M, Wyrich R, Pazzagli M, Gelmini S. 2012. Implementation of a proficiency testing for the assessment of the preanalytical phase of blood samples used for RNA based analysis. Clin Chim Acta 413:779786[CrossRef].[PubMed]
22. Pazzagli M, Malentacchi F, Simi L, Orlando C, Wyrich R, Günther K, Hartmann CC, Verderio P, Pizzamiglio S, Ciniselli CM, Tichopad A, Kubista M, Gelmini S. 2013. SPIDIA-RNA: first external quality assessment for the pre-analytical phase of blood samples used for RNA based analyses. Methods 59:2031[CrossRef].[PubMed]

Tables

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TABLE 1

Terms used in this chapter

Citation: Madej R. 2016. Proficiency Testing and External Quality Assessment for Molecular Microbiology, p 754-765. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch52
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TABLE 2

Regulatory and guidance documents for PT

Citation: Madej R. 2016. Proficiency Testing and External Quality Assessment for Molecular Microbiology, p 754-765. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch52
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TABLE 3

Considerations in choosing commercial PT programs

Citation: Madej R. 2016. Proficiency Testing and External Quality Assessment for Molecular Microbiology, p 754-765. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch52
Generic image for table
TABLE 4

Strategies when commercial PT programs are unavailable

Citation: Madej R. 2016. Proficiency Testing and External Quality Assessment for Molecular Microbiology, p 754-765. In Persing D, Tenover F, Hayden R, Ieven M, Miller M, Nolte F, Tang Y, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555819071.ch52

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