1887

Chapter 121 : Clinical Immunology Laboratory Accreditation, Licensure, and Credentials

MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Ebook: Choose a downloadable PDF or ePub file. Chapter is a downloadable PDF file. File must be downloaded within 48 hours of purchase

Buy this Chapter
Digital (?) $30.00

Preview this chapter:
Zoom in
Zoomout

Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555818722/9781555818715_CH121-1.gif /docserver/preview/fulltext/10.1128/9781555818722/9781555818715_CH121-2.gif

Abstract:

Today's clinical immunology laboratories have emerged from research laboratories as new assays became available to researchers and clinician-scientists. However, in today's hospital and reference laboratory environment, many governmental regulations and professional guidelines mandate defined education levels of individuals who oversee and perform patient testing, recommend test procedures, and define acceptable ordering, result reporting, and billing practices. Among these organizations is the Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA). CMS is a federal agency within the U.S. Department of Health and Human Services (DHHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid. CMS also regulates billing practices and has a significant impact on the manner in which laboratories must be structured and managed. Today's successful clinical immunology laboratory practitioners must be knowledgeable about current guidelines and regulations and keep abreast of the constant changes in order to ensure compliance and professionalism in all areas of the laboratory. This chapter provides a broad overview of the major governmental agencies and regulations that impact on clinical laboratory practices. Various agencies and regulations are discussed in this chapter. To assist the reader, a list of their abbreviations is provided. In addition, an extensive list of websites is given in Table 1 to enable the reader to obtain further information regarding specific agencies, regulations, and programs.

Citation: Cook L, Harbeck R. 2016. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1169-1179. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch121
Highlighted Text: Show | Hide
Loading full text...

Full text loading...

References

/content/book/10.1128/9781555818722.ch121
1. Bogdanich W. 2 February 1987. Medical labs, trusted as largely error-free, are far from infallible, p 1. Wall Street Journal, New York, NY.
2. Bogdanich W. 2 November 1987. The Pap test misses much cervical cancer through labs’ errors, p 1. Wall Street Journal, New York, NY.
3. U.S. Department of Health and Human Services. 1988. The Clinical Laboratory Improvement Amendments of 1988. Public law no. 100-578. U.S. Department of Health and Human Services, Washington, DC.
4. U.S. Department of Health and Human Services, Office of Inspector General. 1998. Publication of the OIG compliance program guidance for hospitals—OIG. Notice. Fed Regist 63:89878998.[PubMed]
5. Wanamaker V. 1999. Health Care Financing Administration/clinical laboratory improvement amendments of 1988. Arch Pathol Lab Med 123:478481.[CrossRef].[PubMed]
6. 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, and Rockville, MD.
7. Federal Register. 1997. Medical devices; classification/reclassification; restricted devices; analyte specific reagents. 21 CFR 809. Final rule. 1997. Fed Regist 62:6224362260.[PubMed]
8. U.S. Department of Health and Human Services. 1992. Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)—HCFA. Final rule with comment period. Fed Regist 57:70027186.[PubMed]
9. McQueen MJ. 1997. Laboratory quality assurance at the international level: the role of nongovernmental organizations. J Int Fed Clin Chem 9:144146, 148, 150.[PubMed]
10. Jansen RT, Blaton V, Burnett D, Huisman W, Queraltó JM, Zérah S, Allman B. 1997. Essential criteria for quality systems in medical laboratories. Eur J Clin Chem Clin Biochem 35:121122.[PubMed]
11. Sanders GT, Jansen RT, Beastall G, Gurr E, Kenny D, Kohse KP, Zérah S. 1999. Recent activities of EC4 in the harmonization of clinical chemistry in the European Union. Clin Chem Lab Med 37:477480.[CrossRef].[PubMed]
12. Burnett D, Blair C, Haeney MR, Jeffcoate SL, Scott KWM, Williams DL. 2002. Clinical pathology accreditation: standards for the medical laboratory. J Clin Pathol 55:729733.[PubMed].[CrossRef]

Tables

Generic image for table
TABLE 1

Website addresses of governmental and private agencies that establish regulations and guidelines for clinical laboratories

Citation: Cook L, Harbeck R. 2016. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1169-1179. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch121
Generic image for table
TABLE 2

Immunology standardization documents available from CLSI

Citation: Cook L, Harbeck R. 2016. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1169-1179. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch121
Generic image for table
TABLE 3

Credentialing agencies and programs

Citation: Cook L, Harbeck R. 2016. Clinical Immunology Laboratory Accreditation, Licensure, and Credentials, p 1169-1179. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch121

This is a required field
Please enter a valid email address
Please check the format of the address you have entered.
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error