Clinical laboratory - Revision history

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	<!---Place all category tags here-->		<!---Place all category tags here-->
	~~[[Category:Healthcare setting]]~~
	[[Category:Laboratory types]]		[[Category:Laboratory types]]

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	* {{cite book \|title=Textbook of Medical Laboratory Technology \|chapter=Chapter 1: Laboratory \|author=Sood, Ramnik \|url=http://books.google.com/books?id=NJNYKeftqYQC \|pages=01–28 \|year=2006 \|publisher=Jaypee Brothers Publishers \|isbn=818061591X}}		* {{cite book \|title=Textbook of Medical Laboratory Technology \|chapter=Chapter 1: Laboratory \|author=Sood, Ramnik \|url=http://books.google.com/books?id=NJNYKeftqYQC \|pages=01–28 \|year=2006 \|publisher=Jaypee Brothers Publishers \|isbn=818061591X}}
	* {{cite journal \|url=http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906/ \|title=Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories \|author=Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP \|journal=Journal of Pharmaceutical and Biomedical Analysis \|volume=46 \|issue=1 \|pages=18–29 \|year=2008 \|doi=10.1016/j.jpba.2007.10.010}}		* {{cite journal \|url=http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906/ \|title=Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories \|author=Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP \|journal=Journal of Pharmaceutical and Biomedical Analysis \|volume=46 \|issue=1 \|pages=18–29 \|year=2008 \|doi=10.1016/j.jpba.2007.10.010}}

			==Notes==

			An element or two of this article is reused from [http://en.wikipedia.org/wiki/Clinical_laboratory the Wikipedia article].

	==References==		==References==

Shawndouglas: /* Laboratory information systems */ Internal link

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Laboratory information systems: Internal link

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	==Laboratory information systems==		==Laboratory information systems==

	A significant component of most clinical laboratories is their [[laboratory information system]] (LIS). These systems vary significantly in complexity, with systems for anatomical pathology laboratories often requiring significant customization, while smaller systems for supporting basic clinical chemistry laboratories acting as an "out of the box" solution.<ref name="MedLabInfoPaper">{{cite journal \|url=http://www.sciencedirect.com/science/article/pii/S0272271207000893 \|journal=Clinics in Laboratory Medicine \|year=December 2007 \|volume=27 \|issue=4 \|pages=823–43 \|title=Medical Laboratory Informatics \|author=Pantanowitz, Liron; Henricks, Walter H.; Beckwith, Bruce A. \|doi=10.1016/j.cll.2007.07.011 \|accessdate=11 September 2013}}</ref><ref name="MedLabInfoDesc">{{cite web \|url=http://clinfowiki.org/wiki/index.php/Medical_laboratory_informatics \|title=Medical laboratory informatics \|publisher=ClinfoWiki \|date=19 November 2011 \|accessdate=11 September 2013}}</ref><ref name="CPAPLISDiffs">{{cite web \|url=http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf \|format=PDF \|title=LIS Basics: CP and AP LIS Design and Operations \|work=Pathology Informatics 2012 \|author=Henricks, Walter H. \|publisher=Walter H. Henricks, MD \|date=09 October 2012 \|accessdate=11 September 2013}}</ref>		A significant component of most clinical laboratories is their [[laboratory information system]] (LIS). These systems vary significantly in complexity, with systems for anatomical pathology laboratories often requiring significant customization, while smaller systems for supporting basic [[clinical chemistry]] laboratories acting as an "out of the box" solution.<ref name="MedLabInfoPaper">{{cite journal \|url=http://www.sciencedirect.com/science/article/pii/S0272271207000893 \|journal=Clinics in Laboratory Medicine \|year=December 2007 \|volume=27 \|issue=4 \|pages=823–43 \|title=Medical Laboratory Informatics \|author=Pantanowitz, Liron; Henricks, Walter H.; Beckwith, Bruce A. \|doi=10.1016/j.cll.2007.07.011 \|accessdate=11 September 2013}}</ref><ref name="MedLabInfoDesc">{{cite web \|url=http://clinfowiki.org/wiki/index.php/Medical_laboratory_informatics \|title=Medical laboratory informatics \|publisher=ClinfoWiki \|date=19 November 2011 \|accessdate=11 September 2013}}</ref><ref name="CPAPLISDiffs">{{cite web \|url=http://www.pathinformatics.pitt.edu/sites/default/files/2012Powerpoints/01HenricksTues.pdf \|format=PDF \|title=LIS Basics: CP and AP LIS Design and Operations \|work=Pathology Informatics 2012 \|author=Henricks, Walter H. \|publisher=Walter H. Henricks, MD \|date=09 October 2012 \|accessdate=11 September 2013}}</ref>

	==Further reading==		==Further reading==

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	<references/>		<references/>

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			[[Category:Healthcare setting]]
	[[Category:Laboratory types]]		[[Category:Laboratory types]]

Shawndouglas: Internal link

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Internal link

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	[[File:Medical Laboratory Scientist US NIH.jpg\|\|thumb\|400px\|right\|The clinical/medical laboratory plays a vital role in the diagnosis of disease in the human and animal population.]]		[[File:Medical Laboratory Scientist US NIH.jpg\|\|thumb\|400px\|right\|The clinical/medical laboratory plays a vital role in the diagnosis of disease in the human and animal population.]]
	A '''clinical laboratory''' (sometimes referred to as a '''medical laboratory''') is a [[laboratory]] where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.<ref name="MedLabTech">{{cite book \|title=Textbook of Medical Laboratory Technology \|chapter=Chapter 1: Laboratory \|author=Sood, Ramnik \|url=http://books.google.com/books?id=NJNYKeftqYQC \|pages=01–28 \|year=2006 \|publisher=Jaypee Brothers Publishers \|isbn=818061591X}}</ref> The Clinical Laboratory Improvement Amendments (CLIA) program defines a clinical (medical) laboratory as "a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings."<ref name="CLIACDCLab">{{cite web \|url=http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0210/Addendum%20F.pdf‎ \|format=PDF \|title=CLIA - How to Obtain a CLIA Certificate of Waiver \|publisher=Centers for Disease Control and Prevention \|date=March 2006 \|accessdate=10 September 2013}}</ref>		A '''clinical laboratory''' (sometimes referred to as a '''medical laboratory''') is a [[laboratory]] where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.<ref name="MedLabTech">{{cite book \|title=Textbook of Medical Laboratory Technology \|chapter=Chapter 1: Laboratory \|author=Sood, Ramnik \|url=http://books.google.com/books?id=NJNYKeftqYQC \|pages=01–28 \|year=2006 \|publisher=Jaypee Brothers Publishers \|isbn=818061591X}}</ref> The [[Clinical Laboratory Improvement Amendments]] (CLIA) program defines a clinical (medical) laboratory as "a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings."<ref name="CLIACDCLab">{{cite web \|url=http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0210/Addendum%20F.pdf‎ \|format=PDF \|title=CLIA - How to Obtain a CLIA Certificate of Waiver \|publisher=Centers for Disease Control and Prevention \|date=March 2006 \|accessdate=10 September 2013}}</ref>

	==Basics of operations==		==Basics of operations==

Shawndouglas: /* Government regulatory bodies */ Internal link.

2014-03-23T23:43:47Z

Government regulatory bodies: Internal link.

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	==Government regulatory bodies==		==Government regulatory bodies==

	In the United States, clinical laboratories are primarily regulated by the Department of Health and Human Services. Inside that infrastructure are sub-entities like the [[Centers for Disease Control and Prevention]] (CDC) and the [[Centers for Medicare and Medicaid Services]] (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs and [[Clinical Laboratory Improvement Amendments]] (CLIA).<ref name="DHHS">{{cite web \|url=http://www.hhs.gov/about/orgchart/ \|title=HHS Organizational Chart \|publisher=U.S. Department of Health & Human Services \|accessdate=11 September 2013}}</ref><ref name="CDCProgs">{{cite web \|url=http://www.cdc.gov/labstandards/ \|title=Laboratory Quality Assurance and Standardization Programs \|publisher=Centers for Disease Control and Prevention \|accessdate=11 September 2013}}</ref><ref name="CLIA">{{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=11 September 2013}}</ref> Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, they nonetheless establish a significant hurdle to managing the overall operations of the laboratory, from acquiring customers to acquiring samples, to testing, reporting results, and handling billing for the completed tests.		In the United States, clinical laboratories are primarily regulated by the [[United States Department of Health and Human Services\|Department of Health and Human Services]]. Inside that infrastructure are sub-entities like the [[Centers for Disease Control and Prevention]] (CDC) and the [[Centers for Medicare and Medicaid Services]] (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs and [[Clinical Laboratory Improvement Amendments]] (CLIA).<ref name="DHHS">{{cite web \|url=http://www.hhs.gov/about/orgchart/ \|title=HHS Organizational Chart \|publisher=U.S. Department of Health & Human Services \|accessdate=11 September 2013}}</ref><ref name="CDCProgs">{{cite web \|url=http://www.cdc.gov/labstandards/ \|title=Laboratory Quality Assurance and Standardization Programs \|publisher=Centers for Disease Control and Prevention \|accessdate=11 September 2013}}</ref><ref name="CLIA">{{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=11 September 2013}}</ref> Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, they nonetheless establish a significant hurdle to managing the overall operations of the laboratory, from acquiring customers to acquiring samples, to testing, reporting results, and handling billing for the completed tests.

	Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)<ref name="CLSIAbout">{{cite web \|url=http://www.clsi.org/about-clsi/ \|title=About CLSI \|publisher=Clinical and Laboratory Standards Institute \|accessdate=11 September 2013}}</ref> and associations like the Research Quality Association (RQA)<ref name="RQAAbout">{{cite web \|url=http://www.therqa.com/about-us/ \|title=What is RQA? \|publisher=Research Quality Association \|accessdate=11 September 2013}}</ref> exist to promote a more global approach to regulations and guidance affecting clinical laboratories. Additionally, a set of Good Clinical Laboratory Practice standards — originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide — provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.<ref name="RQAGCLP">{{cite web \|url=http://www.therqa.com/publications/booklets/gclp/ \|title=Good Clinical Laboratory Practice (GCLP) Version 2 \|publisher=Research Quality Association \|accessdate=11 September 2013}}</ref><ref name="GCLPEzzelle">{{cite journal \|url=http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906/ \|title=Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories \|author=Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP \|journal=Journal of Pharmaceutical and Biomedical Analysis \|volume=46 \|issue=1 \|pages=18–29 \|year=2008 \|accessdate=11 September 2013 \|doi=10.1016/j.jpba.2007.10.010}}</ref>		Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)<ref name="CLSIAbout">{{cite web \|url=http://www.clsi.org/about-clsi/ \|title=About CLSI \|publisher=Clinical and Laboratory Standards Institute \|accessdate=11 September 2013}}</ref> and associations like the Research Quality Association (RQA)<ref name="RQAAbout">{{cite web \|url=http://www.therqa.com/about-us/ \|title=What is RQA? \|publisher=Research Quality Association \|accessdate=11 September 2013}}</ref> exist to promote a more global approach to regulations and guidance affecting clinical laboratories. Additionally, a set of Good Clinical Laboratory Practice standards — originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide — provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.<ref name="RQAGCLP">{{cite web \|url=http://www.therqa.com/publications/booklets/gclp/ \|title=Good Clinical Laboratory Practice (GCLP) Version 2 \|publisher=Research Quality Association \|accessdate=11 September 2013}}</ref><ref name="GCLPEzzelle">{{cite journal \|url=http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906/ \|title=Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories \|author=Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP \|journal=Journal of Pharmaceutical and Biomedical Analysis \|volume=46 \|issue=1 \|pages=18–29 \|year=2008 \|accessdate=11 September 2013 \|doi=10.1016/j.jpba.2007.10.010}}</ref>

Shawndouglas: Internal links

2014-03-23T17:37:19Z

Internal links

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	==Government regulatory bodies==		==Government regulatory bodies==

	In the United States, clinical laboratories are primarily regulated by the Department of Health and Human Services. Inside that infrastructure are sub-entities like the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs and [[Clinical Laboratory Improvement Amendments]] (CLIA).<ref name="DHHS">{{cite web \|url=http://www.hhs.gov/about/orgchart/ \|title=HHS Organizational Chart \|publisher=U.S. Department of Health & Human Services \|accessdate=11 September 2013}}</ref><ref name="CDCProgs">{{cite web \|url=http://www.cdc.gov/labstandards/ \|title=Laboratory Quality Assurance and Standardization Programs \|publisher=Centers for Disease Control and Prevention \|accessdate=11 September 2013}}</ref><ref name="CLIA">{{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=11 September 2013}}</ref> Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, they nonetheless establish a significant hurdle to managing the overall operations of the laboratory, from acquiring customers to acquiring samples, to testing, reporting results, and handling billing for the completed tests.		In the United States, clinical laboratories are primarily regulated by the Department of Health and Human Services. Inside that infrastructure are sub-entities like the [[Centers for Disease Control and Prevention]] (CDC) and the [[Centers for Medicare and Medicaid Services]] (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs and [[Clinical Laboratory Improvement Amendments]] (CLIA).<ref name="DHHS">{{cite web \|url=http://www.hhs.gov/about/orgchart/ \|title=HHS Organizational Chart \|publisher=U.S. Department of Health & Human Services \|accessdate=11 September 2013}}</ref><ref name="CDCProgs">{{cite web \|url=http://www.cdc.gov/labstandards/ \|title=Laboratory Quality Assurance and Standardization Programs \|publisher=Centers for Disease Control and Prevention \|accessdate=11 September 2013}}</ref><ref name="CLIA">{{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=11 September 2013}}</ref> Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, they nonetheless establish a significant hurdle to managing the overall operations of the laboratory, from acquiring customers to acquiring samples, to testing, reporting results, and handling billing for the completed tests.

	Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)<ref name="CLSIAbout">{{cite web \|url=http://www.clsi.org/about-clsi/ \|title=About CLSI \|publisher=Clinical and Laboratory Standards Institute \|accessdate=11 September 2013}}</ref> and associations like the Research Quality Association (RQA)<ref name="RQAAbout">{{cite web \|url=http://www.therqa.com/about-us/ \|title=What is RQA? \|publisher=Research Quality Association \|accessdate=11 September 2013}}</ref> exist to promote a more global approach to regulations and guidance affecting clinical laboratories. Additionally, a set of Good Clinical Laboratory Practice standards — originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide — provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.<ref name="RQAGCLP">{{cite web \|url=http://www.therqa.com/publications/booklets/gclp/ \|title=Good Clinical Laboratory Practice (GCLP) Version 2 \|publisher=Research Quality Association \|accessdate=11 September 2013}}</ref><ref name="GCLPEzzelle">{{cite journal \|url=http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906/ \|title=Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories \|author=Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP \|journal=Journal of Pharmaceutical and Biomedical Analysis \|volume=46 \|issue=1 \|pages=18–29 \|year=2008 \|accessdate=11 September 2013 \|doi=10.1016/j.jpba.2007.10.010}}</ref>		Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)<ref name="CLSIAbout">{{cite web \|url=http://www.clsi.org/about-clsi/ \|title=About CLSI \|publisher=Clinical and Laboratory Standards Institute \|accessdate=11 September 2013}}</ref> and associations like the Research Quality Association (RQA)<ref name="RQAAbout">{{cite web \|url=http://www.therqa.com/about-us/ \|title=What is RQA? \|publisher=Research Quality Association \|accessdate=11 September 2013}}</ref> exist to promote a more global approach to regulations and guidance affecting clinical laboratories. Additionally, a set of Good Clinical Laboratory Practice standards — originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide — provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.<ref name="RQAGCLP">{{cite web \|url=http://www.therqa.com/publications/booklets/gclp/ \|title=Good Clinical Laboratory Practice (GCLP) Version 2 \|publisher=Research Quality Association \|accessdate=11 September 2013}}</ref><ref name="GCLPEzzelle">{{cite journal \|url=http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2213906/ \|title=Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories \|author=Ezzelle, J; Rodriguez-Chavez, IR; Darden, JM; Stirewalt, M; Kunwar, N; Hitchcock, R; Walter, T; D'Souza, MP \|journal=Journal of Pharmaceutical and Biomedical Analysis \|volume=46 \|issue=1 \|pages=18–29 \|year=2008 \|accessdate=11 September 2013 \|doi=10.1016/j.jpba.2007.10.010}}</ref>

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	==References==		==References==
	<references/>		<references/>

			[[Category:Laboratory types]]

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			[[File:Medical Laboratory Scientist US NIH.jpg\|\|thumb\|400px\|right\|The clinical/medical laboratory plays a vital role in the diagnosis of disease in the human and animal population.]]
	A '''clinical laboratory''' (sometimes referred to as a '''medical laboratory''') is a [[laboratory]] where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.<ref name="MedLabTech">{{cite book \|title=Textbook of Medical Laboratory Technology \|chapter=Chapter 1: Laboratory \|author=Sood, Ramnik \|url=http://books.google.com/books?id=NJNYKeftqYQC \|pages=01–28 \|year=2006 \|publisher=Jaypee Brothers Publishers \|isbn=818061591X}}</ref> The Clinical Laboratory Improvement Amendments (CLIA) program defines a clinical (medical) laboratory as "a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings."<ref name="CLIACDCLab">{{cite web \|url=http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0210/Addendum%20F.pdf‎ \|format=PDF \|title=CLIA - How to Obtain a CLIA Certificate of Waiver \|publisher=Centers for Disease Control and Prevention \|date=March 2006 \|accessdate=10 September 2013}}</ref>		A '''clinical laboratory''' (sometimes referred to as a '''medical laboratory''') is a [[laboratory]] where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.<ref name="MedLabTech">{{cite book \|title=Textbook of Medical Laboratory Technology \|chapter=Chapter 1: Laboratory \|author=Sood, Ramnik \|url=http://books.google.com/books?id=NJNYKeftqYQC \|pages=01–28 \|year=2006 \|publisher=Jaypee Brothers Publishers \|isbn=818061591X}}</ref> The Clinical Laboratory Improvement Amendments (CLIA) program defines a clinical (medical) laboratory as "a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings."<ref name="CLIACDCLab">{{cite web \|url=http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0210/Addendum%20F.pdf‎ \|format=PDF \|title=CLIA - How to Obtain a CLIA Certificate of Waiver \|publisher=Centers for Disease Control and Prevention \|date=March 2006 \|accessdate=10 September 2013}}</ref>

Shawndouglas: /* Medicare regulations (CLIA) */ Added reference.

2013-09-14T01:32:37Z

Medicare regulations (CLIA): Added reference.

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	In 1988, in response to fatalities due to improper reading of PAP smears, Congress passed the Clinical Laboratory Improvement Amendments, which established quality standards for clinical laboratories. Although the faulty PAP smears were performed by Federal laboratories, the new law applied to all clinical laboratories, though interestingly enough, one major part of Federal laboratories, the Veteran's Administration, received an exemption from the new CLIA regulations.<ref name="CLIAHist">{{cite web \|url=http://www.aapsonline.org/msas/clia.php \|title=Clinical Laboratory Improvement Act (CLIA) \|publisher=Association of American Physicians and Surgeons, Inc \|accessdate=11 September 2013}}</ref>		In 1988, in response to fatalities due to improper reading of PAP smears, Congress passed the Clinical Laboratory Improvement Amendments, which established quality standards for clinical laboratories. Although the faulty PAP smears were performed by Federal laboratories, the new law applied to all clinical laboratories, though interestingly enough, one major part of Federal laboratories, the Veteran's Administration, received an exemption from the new CLIA regulations.<ref name="CLIAHist">{{cite web \|url=http://www.aapsonline.org/msas/clia.php \|title=Clinical Laboratory Improvement Act (CLIA) \|publisher=Association of American Physicians and Surgeons, Inc \|accessdate=11 September 2013}}</ref>

	The CLIA regulations are not particularly complex, largely focusing on proficiency verification requirements for individuals performing tests, and the classification of tests according to complexity. It is this classification which, in turn, affects the licensing requirements of laboratories and individuals performing those tests.<ref name="CLIA" />		The CLIA regulations are not particularly complex, largely focusing on proficiency verification requirements for individuals performing tests, and the classification of tests according to complexity. It is this classification which, in turn, affects the licensing requirements of laboratories and individuals performing those tests.<ref name="CLIA" /><ref name="CLIAIVD">{{cite web \|url=http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124208.htm \|title=VD Regulatory Assistance - CLIA Categorization Criteria \|publisher=Food and Drug Administration \|accessdate=13 September 2013}}</ref>

	==Laboratory information systems==		==Laboratory information systems==