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Chapter 14.2 : Quality Control

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Quality Control, Page 1 of 2

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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: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
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Figures

Image of FIGURE 14.2–A1
FIGURE 14.2–A1

Fishbone diagram for identification of potential failure modes. Redrawn from CLSI EP23-A ( ) with permission of the publisher.

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
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Image of FIGURE 14.2–A2
FIGURE 14.2–A2

Process to develop and continually improve a QCP. The terms corrective and preventive action and continual improvement are referred to as CAPA and CI, respectively, in risk management literature.

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
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References

/content/book/10.1128/9781555818814.chap14.2
1. CLSI. 2006. Clinical Laboratory Technical Procedure Manuals. Approved guideline, 5th ed. CLSI document GP2-A5. CLSI, Wayne, PA.
2. 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.
3. CLSI. 2004. Quality Assurance for Commercially Prepared Microbiological Culture Media, 3rd ed. Approved standard. CLSI document M22-A3. CLSI, Wayne, PA.
4. Blazevic DJ, Hall CT, Williams ME. 1976. Cumitech 3, Practical Quality Control Procedures for the Clinical Microbiology Laboratory. Coordinating ed, Balows A. American Society for Microbiology, Washington, DC.
5. Weissfeld AS, Bartlett RC. 1987. Quality control, p 35. In Howard BJ, Klaas J, Rubin SJ, Weissfeld AS, Tilton RC (ed), Clinical and Pathogenic Microbiology. CV Mosby Co, St. Louis, MO.
6. Becton Dickinson Microbiology Systems. 1991. Quality Control and Product Information Manual for Prepared (Plated) and Tubed Media. Becton Dickinson Microbiology Systems, Cockeyville, MD.
7. August MJ, Hindler JA, Huber TW, Sewell DL. 1990. Cumitech 3A, Quality Control and Quality Assurance Practices in Clinical Microbiology. Coordinating ed, Weissfeld AS. American Society for Microbiology, Washington, DC.
8. Commission on Laboratory Accreditation. 1990. Inspection Checklist. Diagnostic Immunology and Syphilis Serology. CAP, North-field, IL.
9. Miller JM. 1991. Quality control of media, reagents, and stains, p 12031225. In Balows A, Hausler WJJr, Herrmann KL, Isenberg HD, Shadomy HJ (ed), Manual of Clinical Microbiology, 5th ed. American Society for Microbiology, Washington, DC.
10. Miller JM. 1987. Quality Control in Microbiology. Centers for Disease Control, Atlanta, GA.
11. Miller JM, Wentworth BB (ed). 1985. Methods for Quality Control in Diagnostic Microbiology. American Public Health Association, Washington, DC.
12. Remel. 1990. Remel Technical Manual. Remel, Lenexa, KS.
13. Wicklund GD, Horton BK. 1990. Manual of Product Technical Data Sheets. PML Microbiologicals, Tualatin, OR.
14. 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.
15. Kirsop BE, Snell JS. 1984. Maintenance of Microorganisms. Academic Press, Inc, San Diego, CA.
16. McFaddin J F. 1985. Media for Isolation, Cultivation, Identification, and Maintenance of Medical Bacteria, vol 1. Williams & Wilkins Co, Baltimore, MD.
17. Kost GJ. 1990. Critical limits for urgent clinician notification at US medical center. JAMA 263:704707.
1. Federal Register. 1968. Clinical Laboratories Improvement Act of 1967. Fed Regist 33:1529715303.
2. 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.
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 BS, Needham CA. 1987. Method evaluation and test selection, p 2733. In Wentworth BB (ed), Diagnostic Procedures for Bacterial Infections, 7th ed. American Public Health Association, Washington, DC.
1. 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.
2. Galen RS, Gambino SR. 1975. Beyond Normality: the Predictive Value and Efficiency of Medical Diagnosis. John Wiley & Sons, Inc, New York, NY.
3. Ilstrup DM. 1990. Statistical methods in microbiology. Clin Microbiol Rev 3:219226.
4. Gardner MJ, Altmann DG. 1989. Statistics with Confidence: Confidence Intervals and Statistical Guidelines. British Medical Journal Publishers, London, United Kingdom.
5. Washington JA. 1990. Confidence intervals. Clin Microbiol Newsl 12:109110.
6. McPherson B S, Needham CA. 1987. Method evaluation and test selection, p 2733. In Wentworth BB (ed), Diagnostic Procedures for Bacterial Infections, 7th ed. American Public Health Association, Washington, DC.
1. CLSI. 2011. Laboratory Quality Control Based on Risk Management. Approved guideline. CLSI document EP23-A. CLSI, Wayne, PA.
2. Centers for Medicare & Medicaid Services (CMS), Office of Clinical Standards and Quality/Survey & Certification Group. 2011. Memorandum. Ref: S&C: 12-03-CLIA. Subject: Initial Plans and Policy Implementation for Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol-23 (EP), ‘Laboratory Quality Control Based on Risk Management’, as Clinical Laboratory Improvement Amendment (CLIA) Quality Control (QC) Policy. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_03.pdf.
3. Centers for Medicare & Medicaid Services (CMS), Office of Clinical Standards and Quality/Survey & Certification Group. 2012. Memorandum. Ref: S&C-12-20-CLIA. Subject: Implementing the Individualized Quality Control Plan (IQCP) for Clinical Laboratory Improvement Amendments (CLIA). http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/Survey-CertificationGenInfo/Downloads/SCLetter12_20-.pdf.
4. ISO. 2007. Medical Devices—Application of Risk Management to Medical Devices. ISO 14971. ISO, Geneva, Switzerland.
5. ISO/IEC. 1999. Safety Aspects—Guidelines for Their Inclusion in Standards. ISO/IEC Guide 51. ISO, Geneva, Switzerland.
6. ISO. 2004. Clinical Laboratory Medicine—In Vitro Diagnostic Medical Devices – Validation of User Quality Control Procedures by the Manufacturer. ISO 15198. ISO, Geneva, Switzerland.

Tables

Generic image for table
Table 14.2–1

QC parameters

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
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Table 14.2–2

Performance standards for bacteriological media

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
Generic image for table
Table 14.2–3

Performance standards for mycobacterial media and tests

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
Generic image for table
Table 14.2–4

Performance standards for mycologic media

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
Generic image for table
Table 14.2–5

Performance standards for stains

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
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Table 14.2–6

Performance standards for reagents used for bacteria

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
Generic image for table
Table 14.2-A1

Format for a positive-negative diagnostic test

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
Generic image for table
Table 14.2-A2

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

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2
Generic image for table
Table 14.2-A3

Determination of CI

Citation: Leber A. 2016. Quality Control, p 14.2.1-14.2.41. In Clinical Microbiology Procedures Handbook, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818814.ch14.2

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