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Chapter 142 : Clinical Immunology Laboratory Accreditation, Licensure, and Credentials

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Abstract:

This chapter provides a broad overview of the major agencies and regulations which have had an impact on laboratory practices. Laboratory personnel must be kept constantly updated by reading appropriate professional articles and reviewing the appropriate Web pages of the responsible agencies and organizations for the latest information. Various governmental agencies, regulations, organizations, etc., are referred to in this chapter. In addition, an extensive list of websites is provided to help the reader obtain further information regarding specific agencies, regulations, and programs. Clinical laboratory improvement amendments (CLIA) has established four categories of testing,: waived, moderate complexity, provider-performed microscopy, and high complexity. The CLIA regulations issued by the federal government have mandated that all laboratories performing clinical testing must undergo regular inspections by an agency or organization with deemed status, e.g., the CAP, JCAHO, or New York State. The process to become accredited by the College of American Pathologists (CAP) begins with the submission of an application. Generally a medical technologist surveyor is assigned to review the laboratory’s activities and policies. A significant ongoing requirement of all accrediting agencies is the regular performance of testing on blinded samples. A number of organizations are involved in issuing credentials or licenses for individuals who demonstrate technical and management skills in clinical immunology. Several professional and voluntary organizations have developed standards for the testing of clinical specimens and provide reagents for the standardization of assays.

Citation: Cook L, Harbeck R. 2006. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1279-1290. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch142

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Clinical Immunology
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References

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1. Bogdanich, W. 1987. Medical labs, trusted as largely error-free, are far from infallible. Wall Street Journal, 2 February 1987, p. 1.
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4. Centers for Disease Control and Prevention. 1997. 1997 revised guidelines for performing CD4+ T-cell determinations in persons infected with human immunodeficiency virus (HIV). Morb. Mortal. Wkly. Rep. 10:129.
5. College of American Pathologists. 1998. “Statline.” 14 (20):23. 14 October 1998.
6. Federal Register. 1997. Medical devices; classification/ reclassification; restricted devices; analyte specific reagents. 21 CFR 809. Final rule. Fed. Regist. 62:6224362260.
7. Jansen, R. T.,, V. Blaton,, D. Burnett,, W. Huisman,, J. M. Querealto,, S. Zerah, and , B. Allman. 1997. Essential criteria for quality systems in medical laboratories. Eur. J. Clin. Chem. Clin. Biochem. 35:121122.
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9. Nakamura, R. M. 1998. National and international reference preparations for the clinical diagnostic immunology laboratory, p. 5463. In R. M. Nakamura,, C. L. Burek,, L. Cook,, J. D. Folds, and , J. L. Sever (ed.), Clinical Diagnostic Immunology, Protocols in Quality Assurance and Standardization. Blackwell Science, Inc., Malden, Mass.
10. Sanders, G. T.,, R. T. Jansen,, G. Beastall,, E. Gurr,, D. Kenny,, K. P. Kohse, and , S. Zerah. 1999. Recent activities of EC4 in the harmonization of clinical chemistry in the European Union. Clin. Chem. Lab. Med. 37:477480.
11. Smolen, J. S.,, B. Butcher,, M. J. Fritzler,, T. Gordon,, J. Hardin,, J. R. Kalden,, R. Lahita,, R. N. Maini,, W. Reeves,, M. Reichlin,, N. Rothfield,, Y. Takasaki,, W. J. van Venrooij, and , E. M. Tan. 1997. Reference sera for antinu-clear antibodies. II. Further definition of antibody specificities in international antinuclear antibody reference sera by immunofluorescence and western blotting. Arthritis Rheum. 40:413418.
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14. U.S. Department of Health and Human Services. 1980. Survey Procedures and Interpretative Guidelines for Laboratories and Laboratory Services. HCFA State Operations Manual. Health Care Financing Administration and Food and Drug Administration, Baltimore, Md.
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Tables

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TABLE 1

Websites of governmental and private agencies setting regulations and guidelines for clinical laboratories

Citation: Cook L, Harbeck R. 2006. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1279-1290. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch142
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TABLE 2

New York State Department of Health technical categories and subcategories

Citation: Cook L, Harbeck R. 2006. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1279-1290. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch142
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TABLE 3

Credentialing agencies and programs

Citation: Cook L, Harbeck R. 2006. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1279-1290. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch142
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TABLE 4

Immunology standardization documents available from the CLSI

Citation: Cook L, Harbeck R. 2006. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1279-1290. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch142
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TABLE 5

Available standards and reference materials

Citation: Cook L, Harbeck R. 2006. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1279-1290. In Detrick B, Hamilton R, Folds J (ed), Manual of Molecular and Clinical Laboratory Immunology, 7th Edition. ASM Press, Washington, DC. doi: 10.1128/9781555815905.ch142

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