Clinical Laboratory Improvement Amendments - Revision history

Shawndouglas: Updated URLs for 2022

2022-01-08T00:35:49Z

Updated URLs for 2022

← Older revision		Revision as of 00:35, 8 January 2022
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	[[File:CLIA_Logo.gif\|\|thumb\|400px\|right]]		[[File:CLIA_Logo.gif\|\|thumb\|400px\|right]]
	The '''Clinical Laboratory Improvement Amendments''' ('''CLIA''') of 1988 is a United States federal statute and regulatory standards program that applies to all [[clinical laboratory]] testing performed on humans in the United States, except clinical trials and basic research.<ref name="CMSAboutCLIA">{{cite web \|url=https://www.cms.gov/~~Regulations~~-and-~~Guidance~~/~~Legislation~~/~~CLIA/index~~ \|title=Clinical Laboratory Improvement Amendments (CLIA) \|publisher=Centers for Medicare and Medicaid Services \|date=26 March 2020 \|accessdate=~~15 April 2020~~}}</ref>		The '''Clinical Laboratory Improvement Amendments''' ('''CLIA''') of 1988 is a United States federal statute and regulatory standards program that applies to all [[clinical laboratory]] testing performed on humans in the United States, except clinical trials and basic research.<ref name="CMSAboutCLIA">{{cite web \|url=https://www.cms.gov/regulations-and-guidance/legislation/clia \|title=Clinical Laboratory Improvement Amendments (CLIA) \|publisher=Centers for Medicare and Medicaid Services \|date=26 March 2020 \|accessdate=07 January 2022}}</ref>


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	<blockquote>The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and (d) clinical laboratory regulations should be based upon objective data to the maximum extent possible.<ref name="KenneyQACLIA" /></blockquote>		<blockquote>The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and (d) clinical laboratory regulations should be based upon objective data to the maximum extent possible.<ref name="KenneyQACLIA" /></blockquote>

	On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as ''Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs''. The proposal aspired "to remove outdated, obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal credentialing requirements and detailed personnel standards in existing regulations."<ref name="SingerGLQA">{{cite book \|url=~~http~~://books.google.ca/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273 \|chapter=Appendix F: Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 - Department of Health and Human Services: Health Care Financing Administration \|title=Guidelines for Laboratory Quality Auditing \|author=Singer, Donald C.; Upton, Ronald P. \|publisher=CRC Press \|year=1993 \|pages=273–402 \|isbn=9780824787844}}</ref> This ultimately led to the proposal becoming law on October 31, 1988 under Public Law 100-578 as the ''Clinical Laboratory Improvement Amendments of 1988''.<ref name="CLIA88Doc">{{cite web \|url=https://www.govinfo.gov/content/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf \|format=PDF \|title=Public Law 100-578 \|work=United States Statutes at Large, Volume 102 \|date=1988 \|accessdate=15 April 2020}}</ref>		On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as ''Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs''. The proposal aspired "to remove outdated, obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal credentialing requirements and detailed personnel standards in existing regulations."<ref name="SingerGLQA">{{cite book \|url=https://books.google.ca/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273 \|chapter=Appendix F: Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 - Department of Health and Human Services: Health Care Financing Administration \|title=Guidelines for Laboratory Quality Auditing \|author=Singer, Donald C.; Upton, Ronald P. \|publisher=CRC Press \|year=1993 \|pages=273–402 \|isbn=9780824787844}}</ref> This ultimately led to the proposal becoming law on October 31, 1988 under Public Law 100-578 as the ''Clinical Laboratory Improvement Amendments of 1988''.<ref name="CLIA88Doc">{{cite web \|url=https://www.govinfo.gov/content/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf \|format=PDF \|title=Public Law 100-578 \|work=United States Statutes at Large, Volume 102 \|date=1988 \|accessdate=15 April 2020}}</ref>

	Regulations for implementing CLIA continued to be developed afterwards, with the [[United States Department of Health and Human Services\|Department of Health and Human Services]] considering thousands of comments to the proposed regulations. The final regulations were published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA '88 put into place regulations concerning test complexity, certification, proficiency testing, patient test management, personnel requirements, quality assurance, and other processes in the clinical laboratory.<ref name="MMERFeb2892">{{cite journal \|url=https://www.cdc.gov/mmwr/preview/mmwrhtml/00016177.htm \|title=Regulations for Implementing the Clinical Laboratory Improvement Amendments of 1988: A Summary \|journal=Morbidity and Mortality Weekly Report \|volume=41 \|issue=RR-2 \|page=1–17 \|year=28 February 1992 \|pmid=1538689 \|accessdate=15 April 2020}}</ref> However, phase-in effective dates were extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May 12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and December 29, 2000 in the Federal Register (65 FR 82941).<ref name="68FR3639">{{cite journal \|url=https://www.govinfo.gov/content/pkg/FR-2003-01-24/html/03-1230.htm \|journal=Federal Register \|title=Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule \|volume=68 \|issue=16 \|date=24 January 2003 \|pages=3639–3714 \|pmid=12545998 \|accessdate=15 April 2020}}</ref>		Regulations for implementing CLIA continued to be developed afterwards, with the [[United States Department of Health and Human Services\|Department of Health and Human Services]] considering thousands of comments to the proposed regulations. The final regulations were published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA '88 put into place regulations concerning test complexity, certification, proficiency testing, patient test management, personnel requirements, quality assurance, and other processes in the clinical laboratory.<ref name="MMERFeb2892">{{cite journal \|url=https://www.cdc.gov/mmwr/preview/mmwrhtml/00016177.htm \|title=Regulations for Implementing the Clinical Laboratory Improvement Amendments of 1988: A Summary \|journal=Morbidity and Mortality Weekly Report \|volume=41 \|issue=RR-2 \|page=1–17 \|year=28 February 1992 \|pmid=1538689 \|accessdate=15 April 2020}}</ref> However, phase-in effective dates were extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May 12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and December 29, 2000 in the Federal Register (65 FR 82941).<ref name="68FR3639">{{cite journal \|url=https://www.govinfo.gov/content/pkg/FR-2003-01-24/html/03-1230.htm \|journal=Federal Register \|title=Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule \|volume=68 \|issue=16 \|date=24 January 2003 \|pages=3639–3714 \|pmid=12545998 \|accessdate=15 April 2020}}</ref>
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	On January 24, 2003, the [[Centers for Medicare and Medicaid Services]] submitted their final rule (68 FR 3639), effective April 24, 2003, affecting QC requirements for laboratories and qualification requirements for lab directors. The final rule also made revisions to 42 CFR 493, including the renaming, reorganizing, and consolidation of similar requirements into one section, the deletion of duplicate requirements, and the rewording of the requirements to better clarify their original intent. It also addressed requirements regarding the entire testing process, making those requirement better correlate with the workflow of a lab specimen in the laboratory, from acquisition to reporting of results, including the subdivision of testing into pre-analytic, analytic, and post-analytic phases.<ref name="68FR3639" /><ref name="NewMexH">{{cite web \|url=http://dhi.health.state.nm.us/CLIA/clia_history.php \|archiveurl=https://web.archive.org/web/20140309070758/http://dhi.health.state.nm.us/CLIA/clia_history.php \|title=Clinical Laboratory Improvement Act (CLIA) - Legislative History \|publisher=New Mexico Department of Health \|archivedate=09 March 2014 \|accessdate=15 April 2020}}</ref>		On January 24, 2003, the [[Centers for Medicare and Medicaid Services]] submitted their final rule (68 FR 3639), effective April 24, 2003, affecting QC requirements for laboratories and qualification requirements for lab directors. The final rule also made revisions to 42 CFR 493, including the renaming, reorganizing, and consolidation of similar requirements into one section, the deletion of duplicate requirements, and the rewording of the requirements to better clarify their original intent. It also addressed requirements regarding the entire testing process, making those requirement better correlate with the workflow of a lab specimen in the laboratory, from acquisition to reporting of results, including the subdivision of testing into pre-analytic, analytic, and post-analytic phases.<ref name="68FR3639" /><ref name="NewMexH">{{cite web \|url=http://dhi.health.state.nm.us/CLIA/clia_history.php \|archiveurl=https://web.archive.org/web/20140309070758/http://dhi.health.state.nm.us/CLIA/clia_history.php \|title=Clinical Laboratory Improvement Act (CLIA) - Legislative History \|publisher=New Mexico Department of Health \|archivedate=09 March 2014 \|accessdate=15 April 2020}}</ref>

	In the fall of 2019, the [[Centers for Disease Control and Prevention]]'s Director of Laboratory Systems Reynolds Salerno requested comments from its Clinical Laboratory Improvement Advisory Committee (CLIAC), as well as from the public, in regards to how CLIA regulations should be revised. “It’s a dramatic step for the government to ask the laboratory community how to revise the CLIA regulations,” Salerno told Dark Daily.<ref name="BurnsFederal19">{{cite web \|url=https://www.darkdaily.com/federal-advisory-committee-seeks-public-comments-on-revising-clia-regulations-says-keynote-speaker-at-13th-annual-lab-quality-confab-in-atlanta/ \|title=Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta \|author=Burns, J. \|work=Dark Daily \|date=16 October 2019 \|accessdate=~~15 April 2020~~}}</ref> During the November CLIAC meeting, attendees reviewed CLIAC's 23 recommendations it had made prior (April 2019) in regards to updates to CLIA, grouped into CLIA personnel requirement changes, nontraditional test workflow (big data- and machine learning-driven) changes, and changes related to next-generation sequencing testing, workflows, and best practices.<ref name="CLIACSumm19">{{cite web \|url=https://www.cdc.gov/cliac/docs/summary/cliac0919_summary.pdf \|format=PDF \|title=CLIAC Summary Report November 6–7, 2019, Atlanta, Georgia \|author=Clinical Laboratory Improvement Advisory Committee \|publisher=Centers for Disease Control and Prevention \|date=07 November 2019 \|accessdate=15 April 2020}}</ref><ref name="CLIACClinical19">{{cite web \|url=https://www.cdc.gov/cliac/docs/CLIAC_RecommendationsTable_10012019.pdf \|format=PDF \|title=Clinical Laboratory Improvement Advisory Committee (CLIAC) Recommendations Table \|author=Clinical Laboratory Improvement Advisory Committee \|publisher=Centers for Disease Control and Prevention \|date=01 October 2019 \|accessdate=15 April 2020}}</ref>		In the fall of 2019, the [[Centers for Disease Control and Prevention]]'s Director of Laboratory Systems Reynolds Salerno requested comments from its Clinical Laboratory Improvement Advisory Committee (CLIAC), as well as from the public, in regards to how CLIA regulations should be revised. “It’s a dramatic step for the government to ask the laboratory community how to revise the CLIA regulations,” Salerno told Dark Daily.<ref name="BurnsFederal19">{{cite web \|url=https://www.darkdaily.com/2019/10/16/federal-advisory-committee-seeks-public-comments-on-revising-clia-regulations-says-keynote-speaker-at-13th-annual-lab-quality-confab-in-atlanta/ \|title=Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta \|author=Burns, J. \|work=Dark Daily \|date=16 October 2019 \|accessdate=07 January 2022}}</ref> During the November CLIAC meeting, attendees reviewed CLIAC's 23 recommendations it had made prior (April 2019) in regards to updates to CLIA, grouped into CLIA personnel requirement changes, nontraditional test workflow (big data- and machine learning-driven) changes, and changes related to next-generation sequencing testing, workflows, and best practices.<ref name="CLIACSumm19">{{cite web \|url=https://www.cdc.gov/cliac/docs/summary/cliac0919_summary.pdf \|format=PDF \|title=CLIAC Summary Report November 6–7, 2019, Atlanta, Georgia \|author=Clinical Laboratory Improvement Advisory Committee \|publisher=Centers for Disease Control and Prevention \|date=07 November 2019 \|accessdate=15 April 2020}}</ref><ref name="CLIACClinical19">{{cite web \|url=https://www.cdc.gov/cliac/docs/CLIAC_RecommendationsTable_10012019.pdf \|format=PDF \|title=Clinical Laboratory Improvement Advisory Committee (CLIAC) Recommendations Table \|author=Clinical Laboratory Improvement Advisory Committee \|publisher=Centers for Disease Control and Prevention \|date=01 October 2019 \|accessdate=15 April 2020}}</ref>

	==CLIA program==		==CLIA program==
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	The [[Centers for Medicare and Medicaid Services]] (CMS) has the primary responsibility for the operation of the CLIA program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.		The [[Centers for Medicare and Medicaid Services]] (CMS) has the primary responsibility for the operation of the CLIA program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services.

	The CLIA Program is funded by user fees collected from over ~~265~~,000 laboratories<ref name="CLIADec13">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=CLIA Update – October ~~2019~~ - Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=October ~~2019~~ \|accessdate=~~15 April 2020~~}}</ref>, most located in the United States.<ref name="CLIABroch">{{cite web \|url=https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/CLIABrochure.pdf \|format=PDF \|title=CLIA Program and Medicare Laboratory Services \|publisher=Centers for Medicare and Medicaid Services \|date=October 2018 \|accessdate=15 April 2020}}</ref>		The CLIA Program is funded by user fees collected from over 317,000 laboratories<ref name="CLIADec13">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=CLIA Update – October 2021 - Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=October 2021 \|accessdate=07 January 2022}}</ref>, most located in the United States.<ref name="CLIABroch">{{cite web \|url=https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/CLIABrochure.pdf \|format=PDF \|title=CLIA Program and Medicare Laboratory Services \|publisher=Centers for Medicare and Medicaid Services \|date=October 2018 \|accessdate=15 April 2020}}</ref>

	==CLIA waived tests==		==CLIA waived tests==
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	===List of tests===		===List of tests===
	A list of tests categorized by the FDA as waived since 2000 can be found at the [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm FDA website]. As of ~~April 2020~~, the list includes slightly more than 2,~~000~~ unique approved CLIA-waived test devices.		A list of tests categorized by the FDA as waived since 2000 can be found at the [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm FDA website]. As of January 2022, the list includes slightly more than 4,600 unique approved CLIA-waived test devices.

	==See also==		==See also==
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	==Further reading==		==Further reading==
	* {{cite journal \|url=http://www.clinchem.org/content/33/2/328.full.pdf \|format=PDF \|journal=Clinical Chemistry \|volume=33 \|issue=2 \|year=February 1987 \|pages=328–336 \|title=Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field \|author=Kenney, Michael L. \|pmid=3542302}}		* {{cite journal \|url=http://www.clinchem.org/content/33/2/328.full.pdf \|archiveurl=https://web.archive.org/web/20140324170132/http://www.clinchem.org/content/33/2/328.full.pdf \|format=PDF \|journal=Clinical Chemistry \|volume=33 \|issue=2 \|year=February 1987 \|pages=328–336 \|title=Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field \|author=Kenney, Michael L. \|doi=10.1093/clinchem/33.2.328 \|pmid=3542302 \|archivedate=24 March 2014}}

	==External links==		==External links==
	* [~~http~~://www.~~gpo~~.gov/~~fdsys~~/~~granule~~/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493~~/content-detail.html~~ 42 CFR 493 at the U.S. Government Printing Office]		* [https://www.govinfo.gov/app/details/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493 42 CFR 493 at the U.S. Government Printing Office]
	* [~~http~~://~~wwwn~~.cdc.gov/clia/~~Regulatory/default~~.~~aspx~~ CLIA Law & Regulations at CDC]		* [https://www.cdc.gov/clia/law-regulations.html CLIA Law & Regulations at CDC]
	* [~~http~~://~~wwwn~~.cdc.gov/~~CLIA~~/~~Regulatory/Chronology~~.~~aspx~~ Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations]		* [https://www.cdc.gov/clia/clia-documents.html Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations]

	==Notes==		==Notes==
	A couple elements of this article are reused from [~~http~~://en.wikipedia.org/wiki/Clinical_Laboratory_Improvement_Amendments the Wikipedia article].		A couple elements of this article are reused from [https://en.wikipedia.org/wiki/Clinical_Laboratory_Improvement_Amendments the Wikipedia article].

	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

			<!---Place all category tags here-->
	[[Category:Health standards]]		[[Category:Health standards]]
	[[Category:Regulatory information]]		[[Category:Regulatory information]]

Shawndouglas: /* History */ Added 2019 history

2020-04-15T19:49:06Z

History: Added 2019 history

← Older revision		Revision as of 19:49, 15 April 2020
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	On January 24, 2003, the [[Centers for Medicare and Medicaid Services]] submitted their final rule (68 FR 3639), effective April 24, 2003, affecting QC requirements for laboratories and qualification requirements for lab directors. The final rule also made revisions to 42 CFR 493, including the renaming, reorganizing, and consolidation of similar requirements into one section, the deletion of duplicate requirements, and the rewording of the requirements to better clarify their original intent. It also addressed requirements regarding the entire testing process, making those requirement better correlate with the workflow of a lab specimen in the laboratory, from acquisition to reporting of results, including the subdivision of testing into pre-analytic, analytic, and post-analytic phases.<ref name="68FR3639" /><ref name="NewMexH">{{cite web \|url=http://dhi.health.state.nm.us/CLIA/clia_history.php \|archiveurl=https://web.archive.org/web/20140309070758/http://dhi.health.state.nm.us/CLIA/clia_history.php \|title=Clinical Laboratory Improvement Act (CLIA) - Legislative History \|publisher=New Mexico Department of Health \|archivedate=09 March 2014 \|accessdate=15 April 2020}}</ref>		On January 24, 2003, the [[Centers for Medicare and Medicaid Services]] submitted their final rule (68 FR 3639), effective April 24, 2003, affecting QC requirements for laboratories and qualification requirements for lab directors. The final rule also made revisions to 42 CFR 493, including the renaming, reorganizing, and consolidation of similar requirements into one section, the deletion of duplicate requirements, and the rewording of the requirements to better clarify their original intent. It also addressed requirements regarding the entire testing process, making those requirement better correlate with the workflow of a lab specimen in the laboratory, from acquisition to reporting of results, including the subdivision of testing into pre-analytic, analytic, and post-analytic phases.<ref name="68FR3639" /><ref name="NewMexH">{{cite web \|url=http://dhi.health.state.nm.us/CLIA/clia_history.php \|archiveurl=https://web.archive.org/web/20140309070758/http://dhi.health.state.nm.us/CLIA/clia_history.php \|title=Clinical Laboratory Improvement Act (CLIA) - Legislative History \|publisher=New Mexico Department of Health \|archivedate=09 March 2014 \|accessdate=15 April 2020}}</ref>

			In the fall of 2019, the [[Centers for Disease Control and Prevention]]'s Director of Laboratory Systems Reynolds Salerno requested comments from its Clinical Laboratory Improvement Advisory Committee (CLIAC), as well as from the public, in regards to how CLIA regulations should be revised. “It’s a dramatic step for the government to ask the laboratory community how to revise the CLIA regulations,” Salerno told Dark Daily.<ref name="BurnsFederal19">{{cite web \|url=https://www.darkdaily.com/federal-advisory-committee-seeks-public-comments-on-revising-clia-regulations-says-keynote-speaker-at-13th-annual-lab-quality-confab-in-atlanta/ \|title=Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta \|author=Burns, J. \|work=Dark Daily \|date=16 October 2019 \|accessdate=15 April 2020}}</ref> During the November CLIAC meeting, attendees reviewed CLIAC's 23 recommendations it had made prior (April 2019) in regards to updates to CLIA, grouped into CLIA personnel requirement changes, nontraditional test workflow (big data- and machine learning-driven) changes, and changes related to next-generation sequencing testing, workflows, and best practices.<ref name="CLIACSumm19">{{cite web \|url=https://www.cdc.gov/cliac/docs/summary/cliac0919_summary.pdf \|format=PDF \|title=CLIAC Summary Report November 6–7, 2019, Atlanta, Georgia \|author=Clinical Laboratory Improvement Advisory Committee \|publisher=Centers for Disease Control and Prevention \|date=07 November 2019 \|accessdate=15 April 2020}}</ref><ref name="CLIACClinical19">{{cite web \|url=https://www.cdc.gov/cliac/docs/CLIAC_RecommendationsTable_10012019.pdf \|format=PDF \|title=Clinical Laboratory Improvement Advisory Committee (CLIAC) Recommendations Table \|author=Clinical Laboratory Improvement Advisory Committee \|publisher=Centers for Disease Control and Prevention \|date=01 October 2019 \|accessdate=15 April 2020}}</ref>

	==CLIA program==		==CLIA program==

Shawndouglas: Updated citations for 2020.

2020-04-15T18:04:11Z

Updated citations for 2020.

Show changes

Shawndouglas: /* History */ Fixed quote

2015-05-19T17:29:37Z

History: Fixed quote

← Older revision		Revision as of 17:29, 19 May 2015
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	and Evaluation (ASPE) of the U.S. Department of Health and Human Services commissioned a study to assess the effectiveness of federal regulations affecting clinical laboratories and their goal of protecting the public health. On April 8, 1986, the ''Final Report on Assessment of Clinical Laboratory Regulations'' by Michael L. Kenney and Don P. Greenberg was submitted to the ASPE.<ref name="KenneyQACLIA">{{cite journal \|url=http://www.clinchem.org/content/33/2/328.full.pdf \|format=PDF \|journal=Clinical Chemistry \|volume=33 \|issue=2 \|year=February 1987 \|pages=328–336 \|title=Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field \|author=Kenney, Michael L. \|pmid=3542302}}</ref>		and Evaluation (ASPE) of the U.S. Department of Health and Human Services commissioned a study to assess the effectiveness of federal regulations affecting clinical laboratories and their goal of protecting the public health. On April 8, 1986, the ''Final Report on Assessment of Clinical Laboratory Regulations'' by Michael L. Kenney and Don P. Greenberg was submitted to the ASPE.<ref name="KenneyQACLIA">{{cite journal \|url=http://www.clinchem.org/content/33/2/328.full.pdf \|format=PDF \|journal=Clinical Chemistry \|volume=33 \|issue=2 \|year=February 1987 \|pages=328–336 \|title=Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field \|author=Kenney, Michael L. \|pmid=3542302}}</ref>

	<blockquote>The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and (c clinical laboratory regulations should be based upon objective data to the maximum extent possible.<ref name="KenneyQACLIA" /></blockquote>		<blockquote>The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and (d) clinical laboratory regulations should be based upon objective data to the maximum extent possible.<ref name="KenneyQACLIA" /></blockquote>

	On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as ''Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs''. The proposal aspired "to remove outdated, obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal credentialing requirements and detailed personnel standards in existing regulations."<ref name="SingerGLQA">{{cite book \|url=http://books.google.ca/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273 \|chapter=Appendix F: Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 - Department of Health and Human Services: Health Care Financing Administration \|title=Guidelines for Laboratory Quality Auditing \|author=Singer, Donald C.; Upton, Ronald P. \|publisher=CRC Press \|year=1993 \|pages=273–402 \|isbn=9780824787844}}</ref> This ultimately led to the proposal becoming law on October 31, 1988 under Public Law 100-578 as the ''Clinical Laboratory Improvement Amendments of 1988''.<ref name="CLIA88Doc">{{cite web \|url=http://www.gpo.gov/fdsys/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf \|format=PDF \|title=Public Law 100-578 \|work=United States Statutes at Large, Volume 102 \|date=1988 \|accessdate=24 March 2014}}</ref>		On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as ''Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs''. The proposal aspired "to remove outdated, obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal credentialing requirements and detailed personnel standards in existing regulations."<ref name="SingerGLQA">{{cite book \|url=http://books.google.ca/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273 \|chapter=Appendix F: Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 - Department of Health and Human Services: Health Care Financing Administration \|title=Guidelines for Laboratory Quality Auditing \|author=Singer, Donald C.; Upton, Ronald P. \|publisher=CRC Press \|year=1993 \|pages=273–402 \|isbn=9780824787844}}</ref> This ultimately led to the proposal becoming law on October 31, 1988 under Public Law 100-578 as the ''Clinical Laboratory Improvement Amendments of 1988''.<ref name="CLIA88Doc">{{cite web \|url=http://www.gpo.gov/fdsys/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf \|format=PDF \|title=Public Law 100-578 \|work=United States Statutes at Large, Volume 102 \|date=1988 \|accessdate=24 March 2014}}</ref>

Shawndouglas: /* History */ Mispelling

2015-05-19T17:28:51Z

History: Mispelling

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	and Evaluation (ASPE) of the U.S. Department of Health and Human Services commissioned a study to assess the effectiveness of federal regulations affecting clinical laboratories and their goal of protecting the public health. On April 8, 1986, the ''Final Report on Assessment of Clinical Laboratory Regulations'' by Michael L. Kenney and Don P. Greenberg was submitted to the ASPE.<ref name="KenneyQACLIA">{{cite journal \|url=http://www.clinchem.org/content/33/2/328.full.pdf \|format=PDF \|journal=Clinical Chemistry \|volume=33 \|issue=2 \|year=February 1987 \|pages=328–336 \|title=Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field \|author=Kenney, Michael L. \|pmid=3542302}}</ref>		and Evaluation (ASPE) of the U.S. Department of Health and Human Services commissioned a study to assess the effectiveness of federal regulations affecting clinical laboratories and their goal of protecting the public health. On April 8, 1986, the ''Final Report on Assessment of Clinical Laboratory Regulations'' by Michael L. Kenney and Don P. Greenberg was submitted to the ASPE.<ref name="KenneyQACLIA">{{cite journal \|url=http://www.clinchem.org/content/33/2/328.full.pdf \|format=PDF \|journal=Clinical Chemistry \|volume=33 \|issue=2 \|year=February 1987 \|pages=328–336 \|title=Quality Assurance in Changing Times: Proposals for Reform and Research in the Clinical Laboratory Field \|author=Kenney, Michael L. \|pmid=3542302}}</ref>

	<blockquote>The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform set of federal regulations should be developed that covers all civilian laboratories ~~receMng~~ federal reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and (c clinical laboratory regulations should be based upon objective data to the maximum extent possible.<ref name="KenneyQACLIA" /></blockquote>		<blockquote>The analysis found that many federal regulations are technically obsolescent and many may be operationally unnecessary as a result of changing laboratory technology and changed federal reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the regulatory classification system based upon physical location of laboratories is no longer appropriate and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform set of federal regulations should be developed that covers all civilian laboratories receiving federal reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should emphasize measures of performance such as personnel and inspection requirements; and (c clinical laboratory regulations should be based upon objective data to the maximum extent possible.<ref name="KenneyQACLIA" /></blockquote>

	On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as ''Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs''. The proposal aspired "to remove outdated, obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal credentialing requirements and detailed personnel standards in existing regulations."<ref name="SingerGLQA">{{cite book \|url=http://books.google.ca/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273 \|chapter=Appendix F: Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 - Department of Health and Human Services: Health Care Financing Administration \|title=Guidelines for Laboratory Quality Auditing \|author=Singer, Donald C.; Upton, Ronald P. \|publisher=CRC Press \|year=1993 \|pages=273–402 \|isbn=9780824787844}}</ref> This ultimately led to the proposal becoming law on October 31, 1988 under Public Law 100-578 as the ''Clinical Laboratory Improvement Amendments of 1988''.<ref name="CLIA88Doc">{{cite web \|url=http://www.gpo.gov/fdsys/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf \|format=PDF \|title=Public Law 100-578 \|work=United States Statutes at Large, Volume 102 \|date=1988 \|accessdate=24 March 2014}}</ref>		On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as ''Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs''. The proposal aspired "to remove outdated, obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal credentialing requirements and detailed personnel standards in existing regulations."<ref name="SingerGLQA">{{cite book \|url=http://books.google.ca/books?id=tTm3hfom96sC&pg=PA273&lpg=PA273 \|chapter=Appendix F: Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 - Department of Health and Human Services: Health Care Financing Administration \|title=Guidelines for Laboratory Quality Auditing \|author=Singer, Donald C.; Upton, Ronald P. \|publisher=CRC Press \|year=1993 \|pages=273–402 \|isbn=9780824787844}}</ref> This ultimately led to the proposal becoming law on October 31, 1988 under Public Law 100-578 as the ''Clinical Laboratory Improvement Amendments of 1988''.<ref name="CLIA88Doc">{{cite web \|url=http://www.gpo.gov/fdsys/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf \|format=PDF \|title=Public Law 100-578 \|work=United States Statutes at Large, Volume 102 \|date=1988 \|accessdate=24 March 2014}}</ref>

Avaughan at 19:39, 30 April 2015

2015-04-30T19:39:31Z

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	The '''Clinical Laboratory Improvement Amendments''' ('''CLIA''') of 1988 is a United States federal statute and regulatory standards program that applies to all [[clinical laboratory]] testing performed on humans in the United States, except clinical trials and basic research.<ref name="CMSAboutCLIA">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html \|title=Clinical Laboratory Improvement Amendments (CLIA) \|publisher=Centers for Medicare and Medicaid Services \|accessdate=23 March 2014}}</ref> ~~[[file:CLIA_Logo.gif\|right]]~~		[[File:CLIA_Logo.gif\|\|thumb\|400px\|right]]
			The '''Clinical Laboratory Improvement Amendments''' ('''CLIA''') of 1988 is a United States federal statute and regulatory standards program that applies to all [[clinical laboratory]] testing performed on humans in the United States, except clinical trials and basic research.<ref name="CMSAboutCLIA">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html \|title=Clinical Laboratory Improvement Amendments (CLIA) \|publisher=Centers for Medicare and Medicaid Services \|accessdate=23 March 2014}}</ref>

Avaughan at 19:38, 30 April 2015

2015-04-30T19:38:06Z

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	The '''Clinical Laboratory Improvement Amendments''' ('''CLIA''') of 1988 is a United States federal statute and regulatory standards program that applies to all [[clinical laboratory]] testing performed on humans in the United States, except clinical trials and basic research.<ref name="CMSAboutCLIA">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html \|title=Clinical Laboratory Improvement Amendments (CLIA) \|publisher=Centers for Medicare and Medicaid Services \|accessdate=23 March 2014}}</ref>		The '''Clinical Laboratory Improvement Amendments''' ('''CLIA''') of 1988 is a United States federal statute and regulatory standards program that applies to all [[clinical laboratory]] testing performed on humans in the United States, except clinical trials and basic research.<ref name="CMSAboutCLIA">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html \|title=Clinical Laboratory Improvement Amendments (CLIA) \|publisher=Centers for Medicare and Medicaid Services \|accessdate=23 March 2014}}</ref> [[file:CLIA_Logo.gif\|right]]



	==History==		==History==

Shawndouglas: /* CLIA waived tests */ Agency names

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CLIA waived tests: Agency names

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	==CLIA waived tests==		==CLIA waived tests==
	Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.<ref name="CDCWaived">{{cite web \|url=http://wwwn.cdc.gov/clia/Resources/WaivedTests/default.aspx \|title=Clinical Laboratory Improvement Amendments (CLIA) - CLIA Waived Tests \|publisher=Centers for Disease Control and Prevention \|date=14 March 2014 \|accessdate=23 March 2014}}</ref><ref name="CLIABroch" /> In its 2014 document ''Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff'', the FDA advises its staff that a medical testing device originally rated moderately complex could receive a waiver "if the device is simple to use and the sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant risk of erroneous results."<ref name="APCC">{{cite web \|url=http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070762.htm \|title=Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff \|publisher=U.S. Food and Drug Administration \|date=12 March 2014 \|accessdate=17 February 2015}}</ref>		Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.<ref name="CDCWaived">{{cite web \|url=http://wwwn.cdc.gov/clia/Resources/WaivedTests/default.aspx \|title=Clinical Laboratory Improvement Amendments (CLIA) - CLIA Waived Tests \|publisher=Centers for Disease Control and Prevention \|date=14 March 2014 \|accessdate=23 March 2014}}</ref><ref name="CLIABroch" /> In its 2014 document ''Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff'', the U.S. Food and Drug Administration (FDA) advises its staff that a medical testing device originally rated moderately complex could receive a waiver "if the device is simple to use and the sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant risk of erroneous results."<ref name="APCC">{{cite web \|url=http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070762.htm \|title=Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff \|publisher=U.S. Food and Drug Administration \|date=12 March 2014 \|accessdate=17 February 2015}}</ref>

	While a waived test is deemed to have an acceptably low level of risk, the CDC reminds administrators and recipients of such tests that no test is 100 percent safe<ref name="CDCWaived" />:		While a waived test is deemed to have an acceptably low level of risk, the [[Centers for Disease Control and Prevention]] (CDC) reminds administrators and recipients of such tests that no test is 100 percent safe<ref name="CDCWaived" />:

	<blockquote>Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system. Some waived tests have potential for serious health impacts if performed incorrectly... To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. </blockquote>		<blockquote>Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system. Some waived tests have potential for serious health impacts if performed incorrectly... To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. </blockquote>

Shawndouglas: /* CLIA waived tests */ Added content.

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	==CLIA waived tests==		==CLIA waived tests==
	Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.<ref name="CDCWaived">{{cite web \|url=http://wwwn.cdc.gov/clia/Resources/WaivedTests/default.aspx \|title=Clinical Laboratory Improvement Amendments (CLIA) - CLIA Waived Tests \|publisher=Centers for Disease Control and Prevention \|date=14 March 2014 \|accessdate=23 March 2014}}</ref><ref name="CLIABroch" /> In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver<ref name="FDAWaivers">{{cite web \|url=http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm124202.htm \|title=IVD Regulatory Assistance - CLIA Waivers \|publisher=U.S. Food and Drug Administration \|date=19 June 2009 \|accessdate=23 March 2014}}</ref>		Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate of waiver.<ref name="CDCWaived">{{cite web \|url=http://wwwn.cdc.gov/clia/Resources/WaivedTests/default.aspx \|title=Clinical Laboratory Improvement Amendments (CLIA) - CLIA Waived Tests \|publisher=Centers for Disease Control and Prevention \|date=14 March 2014 \|accessdate=23 March 2014}}</ref><ref name="CLIABroch" /> In its 2014 document ''Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff'', the FDA advises its staff that a medical testing device originally rated moderately complex could receive a waiver "if the device is simple to use and the sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant risk of erroneous results."<ref name="APCC">{{cite web \|url=http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070762.htm \|title=Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff \|publisher=U.S. Food and Drug Administration \|date=12 March 2014 \|accessdate=17 February 2015}}</ref>

			While a waived test is deemed to have an acceptably low level of risk, the CDC reminds administrators and recipients of such tests that no test is 100 percent safe<ref name="CDCWaived" />:

			<blockquote>Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system. Some waived tests have potential for serious health impacts if performed incorrectly... To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. </blockquote>

			In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver.<ref name="FDAWaivers">{{cite web \|url=http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm124202.htm \|title=IVD Regulatory Assistance - CLIA Waivers \|publisher=U.S. Food and Drug Administration \|date=19 June 2009 \|accessdate=23 March 2014}}</ref>

			===List of tests===

			A list of tests categorized by the FDA as waived since 2000 can be found at the [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm FDA website]. As of February 17, 2015, the list included 6,669 separate test devices.

	==See also==		==See also==

Shawndouglas: Added attribution.

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Added attribution.

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	* [http://wwwn.cdc.gov/clia/Regulatory/default.aspx CLIA Law & Regulations at CDC]		* [http://wwwn.cdc.gov/clia/Regulatory/default.aspx CLIA Law & Regulations at CDC]
	* [http://wwwn.cdc.gov/CLIA/Regulatory/Chronology.aspx Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations]		* [http://wwwn.cdc.gov/CLIA/Regulatory/Chronology.aspx Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations]

			==Notes==

			A couple elements of this article are reused from [http://en.wikipedia.org/wiki/Clinical_Laboratory_Improvement_Amendments the Wikipedia article].

	==References==		==References==