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Chapter 14.2 : Quality Control

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Abstract:

QC programs ensure that information generated by a laboratory is accurate, reliable, and reproducible. This is accomplished by assessing the quality of the specimens; monitoring the performance of test procedures, reagents, media, instruments, and personnel; reviewing test results; and documenting the validity of the test methods.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
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Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
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Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
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Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
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References

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1. August, M. J.,, J. A. Hindler,, T. W. Huber,, and D. L. Sewell,. 1990. Cumitech 3A, Quality Control and Quality Assurance Practices in Clinical Microbiology. Coordinating ed., A. S. Weissfeld. American Society for Microbiology, Washington, DC.
2.Becton Dickinson Microbiology Systems. 1991. Quality Control and Product Information Manual for Prepared (Plated) and Tubed Media. Becton Dickinson Microbiology Systems, Cockeyville, MD.
3. Blazevic, D. J.,, C. T. Hall,, and M. E. Williams,. 1976. Cumitech 3, Practical Quality Control Procedures for the Clinical Microbiology Laboratory. Coordinating ed., A. Balows. American Society for Microbiology, Washington, DC.
4.Commission on Laboratory Accreditation. 1990. Inspection Checklist. Diagnostic Immunology and Syphilis Serology. CAP, Northfield, IL.
5.Department of Health and Human Services. 2003. Medicare, Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications; final rule. Fed. Regist. 68:36403714.
6.Health Care Financing Administration. 1988. Medicare, Medicaid, and CLIA programs; revision of the clinical laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs. Fed. Regist. 53:2959029632.
7. Kirsop, B. E.,, and J. S. Snell. 1984. Maintenance of Microorganisms. Academic Press, Inc., San Diego, CA.
8. Kost, G. J. 1990. Critical limits for urgent clinician notification at US medical center. JAMA 263:704707.
9. McFaddin, J. F. 1985. Media for Isolation, Cultivation, Identification, and Maintenance of Medical Bacteria, vol. 1. Williams & Wilkins Co., Baltimore, MD.
10. Miller, J. M. 1987. Quality Control in Microbiology. Centers for Disease Control, Atlanta, GA.
11. Miller, J. M., 1991. Quality control of media, reagents, and stains, p. 12031225. In A. Balows,, W. J. Hausler, Jr.,, K. L. Herrmann,, H. D. Isenberg,, and H. J. Shadomy (ed.), Manual of Clinical Microbiology, 5th ed. American Society for Microbiology, Washington, DC.
12. Miller, J. M.,, and B. B. Wentworth (ed.). 1985. Methods for Quality Control in Diagnostic Microbiology. American Public Health Association, Washington, DC.
13.NCCLS. 2002. Clinical Laboratory Technical Procedure Manuals. Approved Guideline-4th ed. NCCLS document GP2-A4. NCCLS, Wayne, PA.
14.NCCLS. 1996. Quality Assurance for Commercially Prepared Microbiological Culture Media, 2nd ed. Approved standard. NCCLS Document M22-A2. NCCLS, Wayne, PA.
15.Remel. 1990. Remel Technical Manual. Remel, Lenexa, KS.
16. Weissfeld, A. S.,, and R. C. Bartlett,. 1987. Quality Control, p. 35. In B. J. Howard,, J. Klaas,, S. J. Rubin,, A. S. Weissfeld,, and R. C. Tilton (ed.), Clinical and Pathogenic Microbiology. C. V. Mosby Co., St. Louis, MO.
17. Wicklund, G. D.,, and B. K. Horton. 1990. Manual of Product Technical Data Sheets. PML Microbiologicals, Tualatin, OR.
1.Federal Register. 1968. Clinical Laboratories Improvement Act of 1967. Fed. Regist. 33:1529715303.
2.Federal Care Financing Administration. 1988. Medicare, Medicaid, and CLIA programs; revision of the clinical laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs. Fed. Regist. 53:2959029632.
3.Health Care Financing Administration. 1990. Medicare, Medicaid, and CLIA programs; revision of laboratory regulations; final rule with request for comments. Fed. Regist. 55:1953819610.
1. McPherson, B. S.,, and C. A. Needham,. 1987. Method evaluation and test selection, p. 2733. In B. B. Wentworth (ed.), Diagnostic Procedures for Bacterial Infections, 7th ed. American Public Health Association, Washington, DC.
1. Galen, R. S.,, and S. R. Gambino. 1975. Beyond Normality: the Predictive Value and Efficiency of Medical Diagnosis. John Wiley & Sons, Inc., New York, NY.
2. Gardner, M. J.,, and D. G. Altmann. 1989. Statistics with Confidence: Confidence Intervals and Statistical Guidelines. British Medical Journal Publishers, London, United Kingdom.
3.Health Care Financing Administration. 1988. Medicare, Medicaid, and CLIA programs; revision of the clinical laboratory regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 programs. Fed. Regist. 53:2959029632.
4. Ilstrup, D. M. 1990. Statistical methods in microbiology. Clin. Microbiol. Rev. 3:219226.
5. McPherson, B. S.,, and C. A. Needham,. 1987. Method evaluation and test selection, p. 2733. In B. B. Wentworth (ed.), Diagnostic Procedures for Bacterial Infections, 7th ed. American Public Health Association, Washington, DC.
6. Washington, J. A. 1990. Confidence intervals. Clin. Microbiol. Newsl. 12:109110.

Tables

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Table 14.2-1a

QC parameters

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-1b

QC parameters

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2a

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2b

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2c

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2d

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2e

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2f

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2g

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2h

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-2i

Performance standards for bacteriological media

Abbreviations are as follows. A, for testing nutritive properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:100 (0.1 ml of suspension plus 9.9 ml of saline). Inoculate each medium with 10 µl of dilution. If isolated colonies are not obtained, use 10-fold-lighter inoculum. B, for testing selective properties. Dilute standardized cell suspension (0.5 McFarland standard) 1:10 (0.1 ml of suspension plus 0.9 ml of saline). Inoculate each medium with 10 µl of dilution. C, for testing tubed media. Inoculate medium with 10 µl of the standardized suspension (0.5 McFarland standard). Adjust the inoculum if heavier or lighter growth is required. D, for testing biochemical media. Inoculate each medium according to the procedure for the routine use of the medium. E, for testing transport media. Place a sterile swab in the standardized suspension (0.5 McFarland standard), squeeze out excess fluid on the wall of the tube, and submerge the swab in the transport medium. Hold at room temperature, and plate on the appropriate medium.

Organisms recommended for QC testing of media ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

MR, methyl red; VP, Voges-Proskauer; Mot, motility; Ind, indole; Lys, lysine; Orn, ornithine; +, positive; −, negative; oxidation, color change in open tube; fermentation, color change in overlaid tube.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-3

Performance standards for mycobacterial media and tests

Inoculate primary plating media according to method A or B (detailed in Table 14.2-2 , footnote ). Inoculate biochemical test media according to the procedure for each test.

Organisms recommended for QC testing of media and tests ( ). Although American Type Culture Collection strains are listed, any organism that will yield an identical result is acceptable.

ATCC, American Type Culture Collection.

Exempt from QC by user ( ). Applies only to commercially prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-4a

Performance standards for mycologic media

Media can be inoculated directly from working slants. The inoculum is not standardized.

Organisms recommended for QC of media and test ( ). Although American Type Culture Collection strains are listed, any fungus that yields identical results is acceptable.

ATCC, American Type Culture Collection.

Exempt from QC by user ( ). Applies only to commercial prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-4b

Performance standards for mycologic media

Media can be inoculated directly from working slants. The inoculum is not standardized.

Organisms recommended for QC of media and test ( ). Although American Type Culture Collection strains are listed, any fungus that yields identical results is acceptable.

ATCC, American Type Culture Collection.

Exempt from QC by user ( ). Applies only to commercial prepared media.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-5

Performance standards for stains

Organisms recommended for QC testing of stains ( ). Although American Type Culture Collection strains are listed, any organism that yields identical results is acceptable.

ATCC, American Type Culture Collection.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-6a

Performance standards for reagents used for bacteria

Organisms recommended for QC testing of reagent ( ). Although American Type Culture Collection strains are listed, any organism that yields identical results is acceptable.

ATCC, American Type Culture Collection.

ONPG, -nitrophenyl-β-d-galactopyranoside.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-6b

Performance standards for reagents used for bacteria

Organisms recommended for QC testing of reagent ( ). Although American Type Culture Collection strains are listed, any organism that yields identical results is acceptable.

ATCC, American Type Culture Collection.

ONPG, -nitrophenyl-β-d-galactopyranoside.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-A1

Format for a positive-negative diagnostic test

True positive, number of diseased patients correctly identified by test; false positive, number of nondiseased patients incorrectly identified by test; true negative, number of nondiseased patients correctly identified by test; false negative, number of diseased patients incorrectly identified by test.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-A2

Effects of sensitivity, specificity, and disease prevalence on test parameters

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2
Generic image for table
Table 14.2-A3

Determination of CI

Standard error (SE) = [(1 − )]/, where is the proportion of subjects with a parameter (e.g., sensitivity) in a sample size SE = [0.8 × (1 − 0.8)]/50; SE = 0.06.

Calculation of CI with 95% confidence level. 95% CI = − (1.96 × SE) to + (1.96 × SE); 95% CI = 0.8 − (1.96 × 0.06) = 68; 95% CI = 0.8 + (1.96 × 0.06) = 92. Normal distribution values for confidence levels are 1.65 for 90%, 1.96 for 95%, and 2.58 for 99%.

Citation: Garcia L. 2010. Quality Control, p 583-616. In Clinical Microbiology Procedures Handbook, 3rd Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817435.ch14_2

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