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Chapter 1 : Quality Assurance in Clinical Virology

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Quality Assurance in Clinical Virology, Page 1 of 2

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Abstract:

Today, medical practitioners rely on the ability of the clinical laboratory to provide key scientific data used for the diagnosis, treatment, and monitoring of persons with viral diseases. Therefore, the accuracy of test results is critical, and ongoing quality assurance (QA) and quality improvement programs are key factors in maintaining service excellence. QA programs must be comprehensive so that all aspects of the laboratory testing are monitored, including the preanalytical, analytical, and postanalytical phases. Another key component of QA is maintaining staff proficiency and competency. Monitoring of equipment and environmental conditions is required at least each day of use for all sections of clinical virology. The main quality standards of the regulatory and accrediting organizations can be categorized as (i) personnel qualifications, responsibilities, and competency assessment; (ii) proficiency testing for all analytes and staff; (iii) written and approved procedures; (iv) method verification and validation; (v) test reagent and equipment quality control (QC) and preventive maintenance; and (vi) patient test management. Written policies defining the process for proficiency testing (PT) must be clearly defined and understood by all personnel. The policies should include (i) requirements for assessment of the preanalytical, analytical, and postanalytical phases of testing; (ii) ongoing verification requirements for proficiency testing; (iii) safety; (iv) technical training; and (v) ongoing competency assessment. QC is an integral part of daily laboratory testing and is intended to ensure the performance of test systems and the accuracy of patient results.

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
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Tables

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TABLE 1

Top CMS inspection CLIA-88 deficiencies cited, 1996 to 1998

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
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TABLE 2

Staff training verification and competency assessment documentation a

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
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TABLE 3

Mandatory components of procedure manuals a

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
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TABLE 4

CLIA-approved PT programs as of August 2007

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
Generic image for table
TABLE 5

Troubleshooting unacceptable patient or PT results a

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
Generic image for table
TABLE 6

Examples of specimen rejection criteria a

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
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TABLE 7

CLIA requirements for QC: types and frequency a

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
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TABLE 8

Cell culture-specific QC documentation a

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
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TABLE 9

Molecular testing: specific QC documentation a

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
Generic image for table
TABLE 10

Mandated QA documentation a

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1
Generic image for table
TABLE 11

GAO-identified weakness in oversight programs

Citation: Ginocchio C. 2009. Quality Assurance in Clinical Virology, p 3-17. In Specter S, Hodinka R, Young S, Wiedbrauk D (ed), Clinical Virology Manual, Fourth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815974.ch1

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