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Chapter 3 : Regulatory Compliance

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Regulatory Compliance, Page 1 of 2

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Abstract:

Clinical laboratories have come a long way since the 1900s when concerns were raised that they were too expensive and testing was too time consuming to be of practical use (1). In spite of those objections, laboratories have become the cornerstone of medical decision making. The beginning of laboratory regulation can be traced to the 1940s when Sunderman and Belk published findings from a voluntary survey of proficiency testing of regional laboratories that showed significant variation in laboratory performance (2). At around the same time, the College of American Pathology (CAP) was established, and one of its first functions was the initiation of national proficiency surveys in 1947 and 1948. The results further confirmed the need for standardization and regulation of clinical laboratories (3). In subsequent years, participation in proficiency surveys became standard practice among large hospital and reference laboratories (4). In 1967, Congress passed the Clinical Laboratory Improvement Amendment of 1967 (CLIA 67), which mandated certain minimum performance standards for reference laboratories involved in interstate commerce (4, 5). Similar regulation for hospital laboratories that were funded by Medicare followed in 1968 (6). The CLIA 67 regulations mandated that laboratories participate in “state approved or state operated proficiency testing programs” (5).

Citation: Samuel L. 2016. Regulatory Compliance, p 35-39. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch3
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References

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1. Camac C. 1900. Hospital and clinical ward laboratories. J Am Med Assoc XXXV:219227.
2. Belk WP, Sunderman FW. 1947. A survey of the accuracy of chemical analyses in clinical laboratories. Am J Clin Pathol 17:853861.[PubMed]
3. Sunderman FW Sr. 1992. The history of proficiency testing/quality control. Clin Chem 38:12051209, discussion 1218–1225.[PubMed]
4. Laessig RH, Ehrmeyer SS, Lanphear BJ, Burmeister BJ, Hassemer DJ. 1992. Limitations of proficiency testing under CLIA '67. Clin Chem 38:12371244, discussion 1245–1250.[PubMed]
5. Department of Health, Education, and Welfare, Public Health Service, Centers for Disease Control. 1967. Clinical Laboratory Improvement Act of 1967. Part F, Title ifi, Public Health Service Act, sect. 353.
6. 1968. Federal health insurance for the aged: regulations for coverage of service of independent laboratories, Public Health Rep-13. Department of Health, Education, and Welfare, Washington, DC.
7. Bogdanich W. 1987. Lax laboratories: the Pap test misses much cervical cancer through labs’ errors. Wall Street Journal 210(88):1,20.
8. Public Law No. 100-578—100th Congress, Oct. 31, 1988. 2903, Clinical Laboratory Improvement Amendments of 1988.
9. Garcia LS, Bachner P. 2014. Clinical laboratory management, 2nd ed. ASM Press, Washington, DC.
10. International Organization for Standardization (ISO) (ed.). 2012. Medical laboratories—requirements for quality and competence. In ISO 15189:2012, 3rd ed.

Tables

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TABLE 1

Categories for determination of test complexity

Citation: Samuel L. 2016. Regulatory Compliance, p 35-39. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch3
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TABLE 2

List of accrediting agencies with deemed status under CLIA

Citation: Samuel L. 2016. Regulatory Compliance, p 35-39. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch3
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TABLE 3

Scope of ISO 15189 management review

Citation: Samuel L. 2016. Regulatory Compliance, p 35-39. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch3
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TABLE 4

Technical components of ISO 15189:2012

Citation: Samuel L. 2016. Regulatory Compliance, p 35-39. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch3
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TABLE 5

Steps in the ISO 15189 accreditation pathway

Citation: Samuel L. 2016. Regulatory Compliance, p 35-39. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch3

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