Physician office laboratory - Revision history

Shawndouglas: Updated CMS stats

2022-05-17T19:45:35Z

Updated CMS stats

← Older revision		Revision as of 19:45, 17 May 2022
Line 102:		Line 102:

	===Present and future state of U.S. POLs===		===Present and future state of U.S. POLs===
	Since reaching a peak of around 50.7% of all CLIA-certified labs in the U.S. in June 2011<ref name="CMSJune11Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|archiveurl=https://web.archive.org/web/20120410205217/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, the prevalence of POLs compared to other lab types has noticeably dipped. In ~~March~~ 2022, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 40.2% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-~~certified~~ laboratories in the United States (~~132~~,~~124~~) were physician office laboratories, down more than 10% since June 2011.<ref name="CMSMar22Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=~~March~~ 2022 \|accessdate=17 ~~April~~ 2022}}</ref> Since June 2011, lab types like pharmacy, assisted living facility, and school/student health service labs have picked up much of the ground the POL has lost.<ref name="CMSJune11Count" /><ref name="CMSMar22Count" /> While the overall number of POLs continues to grow, the decrease in POLs as a percentage of all CLIA-certified laboratory types may be attributed to a number of factors, including the urine drug screen investigations of the 2010s<ref name="KirkwoodTheDoc18">{{cite web \|url=https://www.aacc.org/cln/articles/2018/janfeb/the-doctor-will-test-you-now \|title=The Doctor Will Test You Now \|author=Kirkwood, J. \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=01 January 2018 \|accessdate=17 April 2022}}</ref><ref name="CLNStatTheRise18">{{cite web \|url=https://www.aacc.org/cln/cln-stat/2018/february/15/the-rise-of-physician-office-labs \|title=The Rise and Fall of Physician Office Labs \|author=CLN Stat \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=14 February 2018 \|accessdate=17 April 2022}}</ref>, a series of reimbursement reductions<ref name=MyersSmart17">{{cite web \|url=https://www.mlo-online.com/management/reimbursement/article/13009042/smart-steps-for-labs-and-hospital-outreach-as-cms-prepares-to-cut-medicare-fees \|title=Smart steps for labs and hospital outreach as CMS prepares to cut Medicare fees \|author=Myers, J.H. \|work=Medical Laboratory Observer \|date=21 March 2017 \|accessdate=17 April 2022}}</ref><ref name="DalyDecl20">{{cite web \|url=https://blog.cola.org/insider/declining-reimbursement-in-the-clinical-laboratory \|title=Declining Reimbursement in the Clinical Laboratory \|author=Daly, J. \|work=Insider Blog \|publisher=COLA \|date=30 January 2020 \|accessdate=17 April 2022}}</ref>, and even the [[COVID-19]] [[pandemic]].<ref name="BonislawskiLab20">{{cite web \|url=https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|archiveurl=https://web.archive.org/web/20200412112320/https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|title=Lab test volumes plummet as patients put off care \|author=Bonislawski, A. \|work=Modern Healthcare \|date=06 April 2020 \|archivedate=12 April 2020 \|accessdate=17 April 2022}}</ref> Some like COLA director of accreditation Susan Densford and Marwood Group Advisory's Mark Slomlany suggest that reimbursement issues have been less impactful to the POL, but rather a consolidation pattern of physician offices—and thus POLs—is and will continue to be a major factor.<ref name="ThillSelling20">{{cite web \|url=https://repertoiremag.com/selling-moderate-complexity.html \|title=Selling Moderate Complexity \|author=Thill, M. \|work=Repertoire \|date=October 2020 \|accessdate=17 April 2022}}</ref><ref name="SlomlanyTheDiag21">{{cite web \|url=https://www.marwoodgroup.com/wp-content/uploads/2021/10/The-Diagnostic-Laboratory-Space-An-Ecosystem-in-Transformation.pdf \|format=PDF \|title=The Diagnostic Laboratory Space: An Ecosystem in Transformation \|author=Slomlany, M. \|publisher=Marwood Group Advisory, LLC \|date=25 October 2021 \|accessdate=17 April 2022}}</ref> Writing for Marwoord, Slomlany notes:		Since reaching a peak of around 50.7% of all CLIA-certified labs in the U.S. in June 2011<ref name="CMSJune11Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|archiveurl=https://web.archive.org/web/20120410205217/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, the prevalence of POLs compared to other lab types has noticeably dipped. In May 2022, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 40% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-enrolled laboratories in the United States (133,062) were physician office laboratories, down more than 10% since June 2011.<ref name="CMSMar22Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=May 2022 \|accessdate=17 May 2022}}</ref> Since June 2011, lab types like pharmacy, assisted living facility, and school/student health service labs have picked up much of the ground the POL has lost.<ref name="CMSJune11Count" /><ref name="CMSMar22Count" /> While the overall number of POLs continues to grow, the decrease in POLs as a percentage of all CLIA-certified laboratory types may be attributed to a number of factors, including the urine drug screen investigations of the 2010s<ref name="KirkwoodTheDoc18">{{cite web \|url=https://www.aacc.org/cln/articles/2018/janfeb/the-doctor-will-test-you-now \|title=The Doctor Will Test You Now \|author=Kirkwood, J. \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=01 January 2018 \|accessdate=17 April 2022}}</ref><ref name="CLNStatTheRise18">{{cite web \|url=https://www.aacc.org/cln/cln-stat/2018/february/15/the-rise-of-physician-office-labs \|title=The Rise and Fall of Physician Office Labs \|author=CLN Stat \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=14 February 2018 \|accessdate=17 April 2022}}</ref>, a series of reimbursement reductions<ref name=MyersSmart17">{{cite web \|url=https://www.mlo-online.com/management/reimbursement/article/13009042/smart-steps-for-labs-and-hospital-outreach-as-cms-prepares-to-cut-medicare-fees \|title=Smart steps for labs and hospital outreach as CMS prepares to cut Medicare fees \|author=Myers, J.H. \|work=Medical Laboratory Observer \|date=21 March 2017 \|accessdate=17 April 2022}}</ref><ref name="DalyDecl20">{{cite web \|url=https://blog.cola.org/insider/declining-reimbursement-in-the-clinical-laboratory \|title=Declining Reimbursement in the Clinical Laboratory \|author=Daly, J. \|work=Insider Blog \|publisher=COLA \|date=30 January 2020 \|accessdate=17 April 2022}}</ref>, and even the [[COVID-19]] [[pandemic]].<ref name="BonislawskiLab20">{{cite web \|url=https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|archiveurl=https://web.archive.org/web/20200412112320/https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|title=Lab test volumes plummet as patients put off care \|author=Bonislawski, A. \|work=Modern Healthcare \|date=06 April 2020 \|archivedate=12 April 2020 \|accessdate=17 April 2022}}</ref> Some like COLA director of accreditation Susan Densford and Marwood Group Advisory's Mark Slomlany suggest that reimbursement issues have been less impactful to the POL, but rather a consolidation pattern of physician offices—and thus POLs—is and will continue to be a major factor.<ref name="ThillSelling20">{{cite web \|url=https://repertoiremag.com/selling-moderate-complexity.html \|title=Selling Moderate Complexity \|author=Thill, M. \|work=Repertoire \|date=October 2020 \|accessdate=17 April 2022}}</ref><ref name="SlomlanyTheDiag21">{{cite web \|url=https://www.marwoodgroup.com/wp-content/uploads/2021/10/The-Diagnostic-Laboratory-Space-An-Ecosystem-in-Transformation.pdf \|format=PDF \|title=The Diagnostic Laboratory Space: An Ecosystem in Transformation \|author=Slomlany, M. \|publisher=Marwood Group Advisory, LLC \|date=25 October 2021 \|accessdate=17 April 2022}}</ref> Writing for Marwoord, Slomlany notes:

	<blockquote>Marwood believes that consolidation among physician office labs as well as joint ventures with independent labs are expected to increase over the next 3-5 years. It is unlikely that this is currently being driven by reimbursement pressure, which has not been as severe as that faced by large independent laboratories, but rather by larger macro trends shaping the industry. Namely, as growing health systems acquire physician practices as part of their geographic footprint, the expectation is that they funnel work back into outreach labs.</blockquote>		<blockquote>Marwood believes that consolidation among physician office labs as well as joint ventures with independent labs are expected to increase over the next 3-5 years. It is unlikely that this is currently being driven by reimbursement pressure, which has not been as severe as that faced by large independent laboratories, but rather by larger macro trends shaping the industry. Namely, as growing health systems acquire physician practices as part of their geographic footprint, the expectation is that they funnel work back into outreach labs.</blockquote>

	As of ~~March~~ 2022, 68.9% of the POLs in the United States today are running [[Clinical Laboratory Improvement Amendments]] (CLIA) waived tests, and 17.3% hold provider performed microscopy (PPM) certificates.<ref name="CMS22Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=~~March~~ 2022 \|accessdate=17 ~~April~~ 2022}}</ref> Compared to June 2011, when 56.1% of POLs were running CLIA-waived tests and 26.5% were running PPM testing<ref name="CMS11Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|archiveurl=https://web.archive.org/web/20120410205216/http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, it's clear that POLs have moved even further into predominantly performing CLIA waived testing. A July 2021 article by COLA's Irwin Z. Rothenberg suggested that the increase in waived testing in the POL has been influenced by a number of factors, including<ref name="RothenbergTheIncrease21">{{cite web \|url=https://www.physiciansofficeresource.com/articles/finance/waived-testing/ \|title=The Increase in Waived Testing in the Physician Office \|author=Rothenberg, I.Z. \|work=Physicians Office Resource \|date=01 July 2021 \|accessdate=17 April 2022}}</ref>:		As of May 2022, 70.6% of the non-exempt POLs in the United States today are running [[Clinical Laboratory Improvement Amendments]] (CLIA) waived tests, and 17.5% of non-exempt POLs hold provider performed microscopy (PPM) certificates.<ref name="CMS22Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=May 2022 \|accessdate=17 May 2022}}</ref> Compared to June 2011, when 56.1% of POLs were running CLIA-waived tests and 26.5% were running PPM testing<ref name="CMS11Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|archiveurl=https://web.archive.org/web/20120410205216/http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, it's clear that POLs have moved even further into predominantly performing CLIA waived testing. A July 2021 article by COLA's Irwin Z. Rothenberg suggested that the increase in waived testing in the POL has been influenced by a number of factors, including<ref name="RothenbergTheIncrease21">{{cite web \|url=https://www.physiciansofficeresource.com/articles/finance/waived-testing/ \|title=The Increase in Waived Testing in the Physician Office \|author=Rothenberg, I.Z. \|work=Physicians Office Resource \|date=01 July 2021 \|accessdate=17 April 2022}}</ref>:

	* technical advances in point-of-care systems, that bring improved rapid, high-quality testing closer to the patient;		* technical advances in point-of-care systems, that bring improved rapid, high-quality testing closer to the patient;

Shawndouglas: /* Present and future state of U.S. POLs */ Typo

2022-05-16T23:38:28Z

Present and future state of U.S. POLs: Typo

← Older revision		Revision as of 23:38, 16 May 2022
Line 102:		Line 102:

	===Present and future state of U.S. POLs===		===Present and future state of U.S. POLs===
	Since reaching a peak of around 50.7% of all CLIA-certified labs in the U.S. in June 2011<ref name="CMSJune11Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|archiveurl=https://web.archive.org/web/20120410205217/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, the prevalence of POLs compared to other lab types has noticeably dipped. In March 2022, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 40.2% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-certified laboratories in the United States (132,124) were physician office laboratories, down more than 10% since June 2011.<ref name="CMSMar22Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> Since June 2011, lab types like pharmacy, assisted living facility, and school/student health service labs have picked up much of the ground the POL has lost.<ref name="CMSJune11Count" /><ref name="CMSMar22Count" /> While the overall number of POLs continues to grow, the decrease in POLs as a percentage of all CLIA-certified laboratory types may be attributed to a number of factors, including the urine drug screen investigations of the 2010s<ref name="KirkwoodTheDoc18">{{cite web \|url=https://www.aacc.org/cln/articles/2018/janfeb/the-doctor-will-test-you-now \|title=The Doctor Will Test You Now \|author=Kirkwood, J. \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=01 January 2018 \|accessdate=17 April 2022}}</ref><ref name="CLNStatTheRise18">{{cite web \|url=https://www.aacc.org/cln/cln-stat/2018/february/15/the-rise-of-physician-office-labs \|title=The Rise and Fall of Physician Office Labs \|author=CLN Stat \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=14 February 2018 \|accessdate=17 April 2022}}</ref>, a series of reimbursement reductions<ref name=MyersSmart17">{{cite web \|url=https://www.mlo-online.com/management/reimbursement/article/13009042/smart-steps-for-labs-and-hospital-outreach-as-cms-prepares-to-cut-medicare-fees \|title=Smart steps for labs and hospital outreach as CMS prepares to cut Medicare fees \|author=Myers, J.H. \|work=Medical Laboratory Observer \|date=21 March 2017 \|accessdate=17 April 2022}}</ref><ref name="DalyDecl20">{{cite web \|url=https://blog.cola.org/insider/declining-reimbursement-in-the-clinical-laboratory \|title=Declining Reimbursement in the Clinical Laboratory \|author=Daly, J. \|work=Insider Blog \|publisher=COLA \|date=30 January 2020 \|accessdate=17 April 2022}}</ref>, and even the [[COVID-19]] [[pandemic]].<ref name="BonislawskiLab20">{{cite web \|url=https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|archiveurl=https://web.archive.org/web/20200412112320/https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|title=Lab test volumes plummet as patients put off care \|author=Bonislawski, A. \|work=Modern Healthcare \|date=06 April 2020 \|archivedate=12 April 2020 \|accessdate=17 April 2022}}</ref> Some like COLA director of accreditation Susan Densford and Marwood Group Advisory's Mark Slomlany suggest that reimbursement issues have been less impactful to the POL, but rather a consolidation pattern of physician offices—and ~~this~~ POLs—is and will continue to be a major factor.<ref name="ThillSelling20">{{cite web \|url=https://repertoiremag.com/selling-moderate-complexity.html \|title=Selling Moderate Complexity \|author=Thill, M. \|work=Repertoire \|date=October 2020 \|accessdate=17 April 2022}}</ref><ref name="SlomlanyTheDiag21">{{cite web \|url=https://www.marwoodgroup.com/wp-content/uploads/2021/10/The-Diagnostic-Laboratory-Space-An-Ecosystem-in-Transformation.pdf \|format=PDF \|title=The Diagnostic Laboratory Space: An Ecosystem in Transformation \|author=Slomlany, M. \|publisher=Marwood Group Advisory, LLC \|date=25 October 2021 \|accessdate=17 April 2022}}</ref> Writing for Marwoord, Slomlany notes:		Since reaching a peak of around 50.7% of all CLIA-certified labs in the U.S. in June 2011<ref name="CMSJune11Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|archiveurl=https://web.archive.org/web/20120410205217/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, the prevalence of POLs compared to other lab types has noticeably dipped. In March 2022, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 40.2% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-certified laboratories in the United States (132,124) were physician office laboratories, down more than 10% since June 2011.<ref name="CMSMar22Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> Since June 2011, lab types like pharmacy, assisted living facility, and school/student health service labs have picked up much of the ground the POL has lost.<ref name="CMSJune11Count" /><ref name="CMSMar22Count" /> While the overall number of POLs continues to grow, the decrease in POLs as a percentage of all CLIA-certified laboratory types may be attributed to a number of factors, including the urine drug screen investigations of the 2010s<ref name="KirkwoodTheDoc18">{{cite web \|url=https://www.aacc.org/cln/articles/2018/janfeb/the-doctor-will-test-you-now \|title=The Doctor Will Test You Now \|author=Kirkwood, J. \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=01 January 2018 \|accessdate=17 April 2022}}</ref><ref name="CLNStatTheRise18">{{cite web \|url=https://www.aacc.org/cln/cln-stat/2018/february/15/the-rise-of-physician-office-labs \|title=The Rise and Fall of Physician Office Labs \|author=CLN Stat \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=14 February 2018 \|accessdate=17 April 2022}}</ref>, a series of reimbursement reductions<ref name=MyersSmart17">{{cite web \|url=https://www.mlo-online.com/management/reimbursement/article/13009042/smart-steps-for-labs-and-hospital-outreach-as-cms-prepares-to-cut-medicare-fees \|title=Smart steps for labs and hospital outreach as CMS prepares to cut Medicare fees \|author=Myers, J.H. \|work=Medical Laboratory Observer \|date=21 March 2017 \|accessdate=17 April 2022}}</ref><ref name="DalyDecl20">{{cite web \|url=https://blog.cola.org/insider/declining-reimbursement-in-the-clinical-laboratory \|title=Declining Reimbursement in the Clinical Laboratory \|author=Daly, J. \|work=Insider Blog \|publisher=COLA \|date=30 January 2020 \|accessdate=17 April 2022}}</ref>, and even the [[COVID-19]] [[pandemic]].<ref name="BonislawskiLab20">{{cite web \|url=https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|archiveurl=https://web.archive.org/web/20200412112320/https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|title=Lab test volumes plummet as patients put off care \|author=Bonislawski, A. \|work=Modern Healthcare \|date=06 April 2020 \|archivedate=12 April 2020 \|accessdate=17 April 2022}}</ref> Some like COLA director of accreditation Susan Densford and Marwood Group Advisory's Mark Slomlany suggest that reimbursement issues have been less impactful to the POL, but rather a consolidation pattern of physician offices—and thus POLs—is and will continue to be a major factor.<ref name="ThillSelling20">{{cite web \|url=https://repertoiremag.com/selling-moderate-complexity.html \|title=Selling Moderate Complexity \|author=Thill, M. \|work=Repertoire \|date=October 2020 \|accessdate=17 April 2022}}</ref><ref name="SlomlanyTheDiag21">{{cite web \|url=https://www.marwoodgroup.com/wp-content/uploads/2021/10/The-Diagnostic-Laboratory-Space-An-Ecosystem-in-Transformation.pdf \|format=PDF \|title=The Diagnostic Laboratory Space: An Ecosystem in Transformation \|author=Slomlany, M. \|publisher=Marwood Group Advisory, LLC \|date=25 October 2021 \|accessdate=17 April 2022}}</ref> Writing for Marwoord, Slomlany notes:

	<blockquote>Marwood believes that consolidation among physician office labs as well as joint ventures with independent labs are expected to increase over the next 3-5 years. It is unlikely that this is currently being driven by reimbursement pressure, which has not been as severe as that faced by large independent laboratories, but rather by larger macro trends shaping the industry. Namely, as growing health systems acquire physician practices as part of their geographic footprint, the expectation is that they funnel work back into outreach labs.</blockquote>		<blockquote>Marwood believes that consolidation among physician office labs as well as joint ventures with independent labs are expected to increase over the next 3-5 years. It is unlikely that this is currently being driven by reimbursement pressure, which has not been as severe as that faced by large independent laboratories, but rather by larger macro trends shaping the industry. Namely, as growing health systems acquire physician practices as part of their geographic footprint, the expectation is that they funnel work back into outreach labs.</blockquote>

Shawndouglas: /* Testing and reporting */ Added information

2022-04-18T19:50:20Z

Testing and reporting: Added information

← Older revision		Revision as of 19:50, 18 April 2022
Line 123:		Line 123:
	High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.<ref name="CDCTestCom" /> It is important to understand the complexity level of the testing provided in order to ensure full compliance with CLIA.		High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.<ref name="CDCTestCom" /> It is important to understand the complexity level of the testing provided in order to ensure full compliance with CLIA.

	Commonly performed tests include<ref name="UHOxInOffice">{{cite web \|url=https://www.oxhp.com/secure/policy/in_office_laboratory_testing_and_procedures_list.pdf \|format=PDF \|title=UnitedHealthcare Oxford's in-office laboratory testing and procedures list \|author=UnitedHealthcare Oxford \|date=01 January 2018 \|accessdate=03 January 2020}}</ref>:		Commonly performed tests include<ref name="UHOxInOffice">{{cite web \|url=https://www.oxhp.com/secure/policy/in_office_laboratory_testing_and_procedures_list.pdf \|format=PDF \|title=UnitedHealthcare Oxford's in-office laboratory testing and procedures list \|author=UnitedHealthcare Oxford \|date=01 January 2018 \|accessdate=03 January 2020}}</ref><ref name="FDAClin21">{{cite web \|url=https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data \|title=Clinical Laboratory Improvement Amendments - Download Data \|publisher=U.S. FDA \|date=23 November 2021 \|accessdate=18 April 2022}}</ref>:
	* urine analysis		* urine analysis
	* urine pregnancy		* urine pregnancy
	* blood occult		* blood occult
	* glucose blood		* glucose blood
			* bacterial and viral infection
			* sexually transmitted infection
	* pathology consultation during surgery		* pathology consultation during surgery
	* crystal identification by microscope		* crystal identification by microscope
	* sperm identification and analyses		* sperm identification and analyses
			* ovulation testing
			* THS and FHS testing
	* bilirubin total		* bilirubin total
	* blood gasses		* blood gasses

Shawndouglas: More updates.

2022-04-17T19:29:31Z

More updates.

← Older revision		Revision as of 19:29, 17 April 2022
Line 79:		Line 79:

	In early 2011, researchers estimated the worldwide market for ''in vitro'' diagnostic (IVD) company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.<ref name="ReutHealthcareCosts">{{cite web \|url=http://www.reuters.com/article/2011/02/10/idUS249575+10-Feb-2011+MW20110210 \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|publisher=Thomson Reuters \|date=10 February 2011 \|accessdate=3 April 2014}}</ref><ref name="KaloramaHealth11">{{cite web \|url=https://www.pressreleasepoint.com/healthcare-cost-worries-boost-physician-office-lab-market \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|author=Kalorama Information \|work=PressReleasePoint \|date=10 February 2011 \|accessdate=17 April 2022}}</ref>		In early 2011, researchers estimated the worldwide market for ''in vitro'' diagnostic (IVD) company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.<ref name="ReutHealthcareCosts">{{cite web \|url=http://www.reuters.com/article/2011/02/10/idUS249575+10-Feb-2011+MW20110210 \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|publisher=Thomson Reuters \|date=10 February 2011 \|accessdate=3 April 2014}}</ref><ref name="KaloramaHealth11">{{cite web \|url=https://www.pressreleasepoint.com/healthcare-cost-worries-boost-physician-office-lab-market \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|author=Kalorama Information \|work=PressReleasePoint \|date=10 February 2011 \|accessdate=17 April 2022}}</ref>

	~~====Present state of POLs====~~
	Since reaching a peak of around 50.7% of all CLIA-certified labs in the U.S. in June 2011<ref name="CMSJune11Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|archiveurl=https://web.archive.org/web/20120410205217/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, the prevalence of POLs compared to other lab types has noticeably dipped. In March 2022, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 40.2% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-certified laboratories in the United States (132,124) were physician office laboratories, down more than 10% since June 2011.<ref name="CMSMar22Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> Since June 2011, lab types like pharmacy, assisted living facility, and school/student health service labs have picked up much of the ground the POL has lost.<ref name="CMSJune11Count" /><ref name="CMSMar22Count" /> While the overall number of POLs continues to grow, the decrease in POLs as a percentage of all CLIA-certified laboratory types may be attributed to a number of factors, including the urine drug screen investigations of the 2010s<ref name="KirkwoodTheDoc18">{{cite web \|url=https://www.aacc.org/cln/articles/2018/janfeb/the-doctor-will-test-you-now \|title=The Doctor Will Test You Now \|author=Kirkwood, J. \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=01 January 2018 \|accessdate=17 April 2022}}</ref><ref name="CLNStatTheRise18">{{cite web \|url=https://www.aacc.org/cln/cln-stat/2018/february/15/the-rise-of-physician-office-labs \|title=The Rise and Fall of Physician Office Labs \|author=CLN Stat \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=14 February 2018 \|accessdate=17 April 2022}}</ref>, a series of reimbursement reductions<ref name=MyersSmart17">{{cite web \|url=https://www.mlo-online.com/management/reimbursement/article/13009042/smart-steps-for-labs-and-hospital-outreach-as-cms-prepares-to-cut-medicare-fees \|title=Smart steps for labs and hospital outreach as CMS prepares to cut Medicare fees \|author=Myers, J.H. \|work=Medical Laboratory Observer \|date=21 March 2017 \|accessdate=17 April 2022}}</ref><ref name="DalyDecl20">{{cite web \|url=https://blog.cola.org/insider/declining-reimbursement-in-the-clinical-laboratory \|title=Declining Reimbursement in the Clinical Laboratory \|author=Daly, J. \|work=Insider Blog \|publisher=COLA \|date=30 January 2020 \|accessdate=17 April 2022}}</ref>, and even the [[COVID-19]] [[pandemic]].<ref name="BonislawskiLab20">{{cite web \|url=https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|archiveurl=https://web.archive.org/web/20200412112320/https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|title=Lab test volumes plummet as patients put off care \|author=Bonislawski, A. \|work=Modern Healthcare \|date=06 April 2020 \|archivedate=12 April 2020 \|accessdate=17 April 2022}}</ref> In 2021, consulting firm Marwood Group Advisory suggested that reimbursement issues have been less impactful to the POL, but rather a consolidation pattern of physician offices—and this POLs—is and will continue to be major factor<ref name="SlomlanyTheDiag21">{{cite web \|url=https://www.marwoodgroup.com/wp-content/uploads/2021/10/The-Diagnostic-Laboratory-Space-An-Ecosystem-in-Transformation.pdf \|format=PDF \|title=The Diagnostic Laboratory Space: An Ecosystem in Transformation \|author=Slomlany, M. \|publisher=Marwood Group Advisory, LLC \|date=25 October 2021 \|accessdate=17 April 2022}}</ref>:

	<blockquote>Marwood believes that consolidation among physician office labs as well as joint ventures with independent labs are expected to increase over the next 3-5 years. It is unlikely that this is currently being driven by reimbursement pressure, which has not been as severe as that faced by large independent laboratories, but rather by larger macro trends shaping the industry. Namely, as growing health systems acquire physician practices as part of their geographic footprint, the expectation is that they funnel work back into outreach labs.</blockquote>

	As of March 2022, 68.9% of the POLs in the United States today are running [[Clinical Laboratory Improvement Amendments]] (CLIA) waived tests, and 17.3% hold provider performed microscopy (PPM) certificates.<ref name="CMS22Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> Compared to June 2011, when 56.1% of POLs were running CLIA waived tests and 26.5% were running PPM testing<ref name="CMS11Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|archiveurl=https://web.archive.org/web/20120410205216/http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, it's clear that POLs have moved even further into predominantly performing CLIA waived testing. A July 2021 article by COLA's Irwin Z. Rothenberg suggested that the increase in waived testing in the POL has been influenced by a number of factors, including<ref name="RothenbergTheIncrease21">{{cite web \|url=https://www.physiciansofficeresource.com/articles/finance/waived-testing/ \|title=The Increase in Waived Testing in the Physician Office \|author=Rothenberg, I.Z. \|work=Physicians Office Resource \|date=01 July 2021 \|accessdate=17 April 2022}}</ref>:

	* technical advances in point-of-care systems, that bring improved rapid, high-quality testing closer to the patient;
	* a greater abundance and variety of CLIA-waived tests for clinical testing;
	* a greater decentralization of laboratory services away from core laboratories; and
	* more CLIA-waived testing moving into drug abuse or pain management clinics.

	===Regulatory considerations===		===Regulatory considerations===
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	Prior to 2014, most laboratories were exempt from the HIPAA requirement to provide patients with lab results or other protected health information.<ref name="HHS14" /> However, in February 2014, the [[United States Department of Health and Human Services\|Department of Health and Human Services]] wanted to provide patients the opportunity to become better members of their own care team by giving them more information about their health. This resulted in the amendment of CLIA 1988 to require a laboratory to give a patient, or their designated representative, lab results within 30 days of said individual sending a written request.<ref name="HHS14" /> Laboratories are still required to ensure those accessing this data have authorization to do so, as the original requirements to keep data secure and private remain the same.		Prior to 2014, most laboratories were exempt from the HIPAA requirement to provide patients with lab results or other protected health information.<ref name="HHS14" /> However, in February 2014, the [[United States Department of Health and Human Services\|Department of Health and Human Services]] wanted to provide patients the opportunity to become better members of their own care team by giving them more information about their health. This resulted in the amendment of CLIA 1988 to require a laboratory to give a patient, or their designated representative, lab results within 30 days of said individual sending a written request.<ref name="HHS14" /> Laboratories are still required to ensure those accessing this data have authorization to do so, as the original requirements to keep data secure and private remain the same.

	~~{{As of\|July 2014}}, it remains unclear as to how this impacts the POL.~~ Since the POL is located at the physician office, access to results is most likely determined by the provider’s regular procedures for acquiring personal health information (PHI). The POL could provide forms to patients for release of PHI, just as any other lab can, but it is unclear as to how this rule change will impact the POL in the long term.		Since the POL is located at the physician office, access to results is most likely determined by the provider’s regular procedures for acquiring personal health information (PHI). The POL could provide forms to patients for release of PHI, just as any other lab can, but it is unclear as to how this rule change will impact the POL in the long term.

	====PPACA====		====PPACA====
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	The laboratory space in general may face challenges from the accountable care organization (ACO) model under the PPACA, due to a decrease in laboratory testing volume.<ref name="HughesCamm">{{cite web \|url=https://www.law360.com/articles/500623/clinical-labs-under-aca-challenge-and-opportunity \|title=Clinical labs under ACA: Challenge and opportunity \|author=Hughes, D.; Cammarata, B. \|publisher=Law360 \|date=16 January 2014 \|accessdate=17 April 2022}}</ref> Under the ACO model, unnecessary or redundant testing would be discouraged.<ref name="HughesCamm" />		The laboratory space in general may face challenges from the accountable care organization (ACO) model under the PPACA, due to a decrease in laboratory testing volume.<ref name="HughesCamm">{{cite web \|url=https://www.law360.com/articles/500623/clinical-labs-under-aca-challenge-and-opportunity \|title=Clinical labs under ACA: Challenge and opportunity \|author=Hughes, D.; Cammarata, B. \|publisher=Law360 \|date=16 January 2014 \|accessdate=17 April 2022}}</ref> Under the ACO model, unnecessary or redundant testing would be discouraged.<ref name="HughesCamm" />

			===Present and future state of U.S. POLs===
			Since reaching a peak of around 50.7% of all CLIA-certified labs in the U.S. in June 2011<ref name="CMSJune11Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|archiveurl=https://web.archive.org/web/20120410205217/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, the prevalence of POLs compared to other lab types has noticeably dipped. In March 2022, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 40.2% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-certified laboratories in the United States (132,124) were physician office laboratories, down more than 10% since June 2011.<ref name="CMSMar22Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> Since June 2011, lab types like pharmacy, assisted living facility, and school/student health service labs have picked up much of the ground the POL has lost.<ref name="CMSJune11Count" /><ref name="CMSMar22Count" /> While the overall number of POLs continues to grow, the decrease in POLs as a percentage of all CLIA-certified laboratory types may be attributed to a number of factors, including the urine drug screen investigations of the 2010s<ref name="KirkwoodTheDoc18">{{cite web \|url=https://www.aacc.org/cln/articles/2018/janfeb/the-doctor-will-test-you-now \|title=The Doctor Will Test You Now \|author=Kirkwood, J. \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=01 January 2018 \|accessdate=17 April 2022}}</ref><ref name="CLNStatTheRise18">{{cite web \|url=https://www.aacc.org/cln/cln-stat/2018/february/15/the-rise-of-physician-office-labs \|title=The Rise and Fall of Physician Office Labs \|author=CLN Stat \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=14 February 2018 \|accessdate=17 April 2022}}</ref>, a series of reimbursement reductions<ref name=MyersSmart17">{{cite web \|url=https://www.mlo-online.com/management/reimbursement/article/13009042/smart-steps-for-labs-and-hospital-outreach-as-cms-prepares-to-cut-medicare-fees \|title=Smart steps for labs and hospital outreach as CMS prepares to cut Medicare fees \|author=Myers, J.H. \|work=Medical Laboratory Observer \|date=21 March 2017 \|accessdate=17 April 2022}}</ref><ref name="DalyDecl20">{{cite web \|url=https://blog.cola.org/insider/declining-reimbursement-in-the-clinical-laboratory \|title=Declining Reimbursement in the Clinical Laboratory \|author=Daly, J. \|work=Insider Blog \|publisher=COLA \|date=30 January 2020 \|accessdate=17 April 2022}}</ref>, and even the [[COVID-19]] [[pandemic]].<ref name="BonislawskiLab20">{{cite web \|url=https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|archiveurl=https://web.archive.org/web/20200412112320/https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|title=Lab test volumes plummet as patients put off care \|author=Bonislawski, A. \|work=Modern Healthcare \|date=06 April 2020 \|archivedate=12 April 2020 \|accessdate=17 April 2022}}</ref> Some like COLA director of accreditation Susan Densford and Marwood Group Advisory's Mark Slomlany suggest that reimbursement issues have been less impactful to the POL, but rather a consolidation pattern of physician offices—and this POLs—is and will continue to be a major factor.<ref name="ThillSelling20">{{cite web \|url=https://repertoiremag.com/selling-moderate-complexity.html \|title=Selling Moderate Complexity \|author=Thill, M. \|work=Repertoire \|date=October 2020 \|accessdate=17 April 2022}}</ref><ref name="SlomlanyTheDiag21">{{cite web \|url=https://www.marwoodgroup.com/wp-content/uploads/2021/10/The-Diagnostic-Laboratory-Space-An-Ecosystem-in-Transformation.pdf \|format=PDF \|title=The Diagnostic Laboratory Space: An Ecosystem in Transformation \|author=Slomlany, M. \|publisher=Marwood Group Advisory, LLC \|date=25 October 2021 \|accessdate=17 April 2022}}</ref> Writing for Marwoord, Slomlany notes:

			<blockquote>Marwood believes that consolidation among physician office labs as well as joint ventures with independent labs are expected to increase over the next 3-5 years. It is unlikely that this is currently being driven by reimbursement pressure, which has not been as severe as that faced by large independent laboratories, but rather by larger macro trends shaping the industry. Namely, as growing health systems acquire physician practices as part of their geographic footprint, the expectation is that they funnel work back into outreach labs.</blockquote>

			As of March 2022, 68.9% of the POLs in the United States today are running [[Clinical Laboratory Improvement Amendments]] (CLIA) waived tests, and 17.3% hold provider performed microscopy (PPM) certificates.<ref name="CMS22Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> Compared to June 2011, when 56.1% of POLs were running CLIA-waived tests and 26.5% were running PPM testing<ref name="CMS11Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|archiveurl=https://web.archive.org/web/20120410205216/http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, it's clear that POLs have moved even further into predominantly performing CLIA waived testing. A July 2021 article by COLA's Irwin Z. Rothenberg suggested that the increase in waived testing in the POL has been influenced by a number of factors, including<ref name="RothenbergTheIncrease21">{{cite web \|url=https://www.physiciansofficeresource.com/articles/finance/waived-testing/ \|title=The Increase in Waived Testing in the Physician Office \|author=Rothenberg, I.Z. \|work=Physicians Office Resource \|date=01 July 2021 \|accessdate=17 April 2022}}</ref>:

			* technical advances in point-of-care systems, that bring improved rapid, high-quality testing closer to the patient;
			* a greater abundance and variety of CLIA-waived tests for clinical testing;
			* a greater decentralization of laboratory services away from core laboratories; and
			* more CLIA-waived testing moving into drug abuse or pain management clinics.

			While the percentage of labs performing PPM and other forms of moderate testing has gone down since 2011, some like ''Repertoire'' magazine's Mark Thill envision those numbers slowly increasing again in the future. Thill and others note the rapid technological developments in [[molecular diagnostics]] testing, shifting some CLIA moderate molecular tests to waived, and other high-complexity molecular test to moderate. POLs wanting to perform more COVID-19 testing for their patients may also be a motivating factor to move up to CLIA moderate testing. This move to moderate may also be compelling to larger physician practices of five or more physicians wanting to conduct a higher throughput of both waived and moderate testing.<ref name="ThillSelling20" />

	===Testing and reporting===		===Testing and reporting===

Shawndouglas: Added more history

2022-04-17T19:07:22Z

Added more history

← Older revision		Revision as of 19:07, 17 April 2022
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	The 1976–1977 report is also notable for its focus on the "independent clinical laboratory" (the commercial clinical laboratory) as defined by Medicare, indicating an increase from 2,355 such labs in 1967 to 3,024 on January 1976.<ref name="HRS76-77" />		The 1976–1977 report is also notable for its focus on the "independent clinical laboratory" (the commercial clinical laboratory) as defined by Medicare, indicating an increase from 2,355 such labs in 1967 to 3,024 on January 1976.<ref name="HRS76-77" />

	====1980 to ~~present~~====		====1980 to 2021====
	Between 1983 and 1984 physician office testing increased by an estimated 11 percent, while the volume of physician-referred diagnostic tests to third-party labs declined 2 percent<ref name="GallivanPhys">{{cite journal \|journal=Hospitals \|title=Physician offices invade clinical laboratory market \|author=Gallivan, Mary \|volume=59 \|issue=20 \|year=1985 \|pages=84, 89, 92–4 \|pmid=3899902}}</ref>, likely buoyed by relatively inexpensive in-office laboratory equipment and more efficient drug monitoring capabilities.<ref name="CuminsInOff">{{cite journal \|journal=Computers in Healthcare \|title=The In-Office Laboratory: Benefits for You and Your Patients \|author=Cumins, L. \|volume=5 \|issue=9 \|year=1984 \|pages=60–2 \|pmid=10267706}}</ref> The Deficit Reduction Act of 1984 further helped to increase the number of physician office laboratories by eliminating physicians' ability to mark up tests sent out to referral labs. Additional changes to Medicare reimbursement meant the laboratory that performed the tests got paid, while physicians were suddenly limited to a $3 payment per patient visit for collecting and distributing specimens. As physician laboratories were at that point still not regulated, physicians and equipment vendors alike saw an opportunity to expand physician office laboratory functions.<ref name="GallivanPhys" /> By the end of 1985, 10 percent of group practices with one to five physicians and 40 percent of those with six to 25 physicians were operating POLs.<ref name="WilkinsonAre">{{cite journal \|journal=Hospitals \|title=Are physician labs a competitive threat? \|author=Wilkinson, Richard \|volume=61 \|issue=8 \|year=1987 \|pages=96, 98 \|pmid=3557409}}</ref> In 1989, an estimated 98,400 POLs were operating in the United States, conducting roughly 25 percent of all laboratory testing in the country. Estimates from the time vary from 20,000 to 200,000 due to the lack of a standard definition for a POL and the need for physicians to self-report the status of their lab.<ref name="HHS89">{{cite journal \|url=https://oig.hhs.gov/oei/reports/oai-05-88-00330.pdf \|title=Quality assurance in physician office labs \|author=Kusserow, R. P. \|publisher=U.S. Department of Health and Human Services, Office of Analysis and Inspections \|version=OAI-0588-00330 \|date=March 1989 \|accessdate=14 May 2014}}</ref> Some of these issues continue to persist today, as states often have different definitions for a POL.		Between 1983 and 1984 physician office testing increased by an estimated 11 percent, while the volume of physician-referred diagnostic tests to third-party labs declined 2 percent<ref name="GallivanPhys">{{cite journal \|journal=Hospitals \|title=Physician offices invade clinical laboratory market \|author=Gallivan, Mary \|volume=59 \|issue=20 \|year=1985 \|pages=84, 89, 92–4 \|pmid=3899902}}</ref>, likely buoyed by relatively inexpensive in-office laboratory equipment and more efficient drug monitoring capabilities.<ref name="CuminsInOff">{{cite journal \|journal=Computers in Healthcare \|title=The In-Office Laboratory: Benefits for You and Your Patients \|author=Cumins, L. \|volume=5 \|issue=9 \|year=1984 \|pages=60–2 \|pmid=10267706}}</ref> The Deficit Reduction Act of 1984 further helped to increase the number of physician office laboratories by eliminating physicians' ability to mark up tests sent out to referral labs. Additional changes to Medicare reimbursement meant the laboratory that performed the tests got paid, while physicians were suddenly limited to a $3 payment per patient visit for collecting and distributing specimens. As physician laboratories were at that point still not regulated, physicians and equipment vendors alike saw an opportunity to expand physician office laboratory functions.<ref name="GallivanPhys" /> By the end of 1985, 10 percent of group practices with one to five physicians and 40 percent of those with six to 25 physicians were operating POLs.<ref name="WilkinsonAre">{{cite journal \|journal=Hospitals \|title=Are physician labs a competitive threat? \|author=Wilkinson, Richard \|volume=61 \|issue=8 \|year=1987 \|pages=96, 98 \|pmid=3557409}}</ref> In 1989, an estimated 98,400 POLs were operating in the United States, conducting roughly 25 percent of all laboratory testing in the country. Estimates from the time vary from 20,000 to 200,000 due to the lack of a standard definition for a POL and the need for physicians to self-report the status of their lab.<ref name="HHS89">{{cite journal \|url=https://oig.hhs.gov/oei/reports/oai-05-88-00330.pdf \|title=Quality assurance in physician office labs \|author=Kusserow, R. P. \|publisher=U.S. Department of Health and Human Services, Office of Analysis and Inspections \|version=OAI-0588-00330 \|date=March 1989 \|accessdate=14 May 2014}}</ref> Some of these issues continue to persist today, as states often have different definitions for a POL.

Line 75:		Line 75:

	Surveys conducted by Mathematica Policy Research in 1991 and again in 1995 provided data that suggested "that CLIA '88 was primarily responsible for the reduction of in-office laboratory testing between 1991 and 1995. While more than 70% of practices surveyed have reduced or eliminated testing during this period, we found that a vast majority of those surveyed (64%) cited CLIA '88 as the force driving this change."<ref name="BornInfluence">{{cite journal \|journal=Journal of Family Practice \|title=The influence of CLIA '88 on physician office laboratories \|author=Born, Patricia H.; Thran, Sara L. \|volume=46 \|issue=4 \|year=1998 \|pages=319–327 \|pmid=9564374}}</ref> Yet by 2000, some physicians were still espousing the benefits of the POL despite the implementation of CLIA, stating that CLIA fees, proficiency testing fees, inspection fees, and staff time account for only roughly about three to four percent of overall lab costs.<ref name="WalpertHow" /> However, a 2003 report from the College of American Pathologists found "a small, slow drop-off in the POL market as some laboratories close or move to waived testing.<ref name="CAP03POL">{{cite web \|url=http://www.cap.org/apps/portlets/contentViewer/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html \|archiveurl=https://web.archive.org/web/20090106224221/http://www.cap.org/apps/portlets/contentViewer/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html \|title=What lies in wait for office labs? \|author=Dolan, Thomas \|work=CAP Today \|publisher=College of American Pathologists \|date=June 2003 \|archivedate=06 January 2009 \|accessdate=17 April 2022}}</ref>"		Surveys conducted by Mathematica Policy Research in 1991 and again in 1995 provided data that suggested "that CLIA '88 was primarily responsible for the reduction of in-office laboratory testing between 1991 and 1995. While more than 70% of practices surveyed have reduced or eliminated testing during this period, we found that a vast majority of those surveyed (64%) cited CLIA '88 as the force driving this change."<ref name="BornInfluence">{{cite journal \|journal=Journal of Family Practice \|title=The influence of CLIA '88 on physician office laboratories \|author=Born, Patricia H.; Thran, Sara L. \|volume=46 \|issue=4 \|year=1998 \|pages=319–327 \|pmid=9564374}}</ref> Yet by 2000, some physicians were still espousing the benefits of the POL despite the implementation of CLIA, stating that CLIA fees, proficiency testing fees, inspection fees, and staff time account for only roughly about three to four percent of overall lab costs.<ref name="WalpertHow" /> However, a 2003 report from the College of American Pathologists found "a small, slow drop-off in the POL market as some laboratories close or move to waived testing.<ref name="CAP03POL">{{cite web \|url=http://www.cap.org/apps/portlets/contentViewer/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html \|archiveurl=https://web.archive.org/web/20090106224221/http://www.cap.org/apps/portlets/contentViewer/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html \|title=What lies in wait for office labs? \|author=Dolan, Thomas \|work=CAP Today \|publisher=College of American Pathologists \|date=June 2003 \|archivedate=06 January 2009 \|accessdate=17 April 2022}}</ref>"

			In late 2010, POLs were estimated to be processing only about eight percent of all clinical laboratory tests.<ref name="CarlsonPhys">{{cite web \|url=https://www.genengnews.com/magazine/145/physician-office-lab-diagnostic-market/ \|title=Physician Office Lab Diagnostic Market \|work=GEN \|author=Carlson, Bruce \|publisher=Genetic Engineering & Biotechnology News \|date=1 December 2010 \|accessdate=17 April 2022}}</ref> That number went up to nine percent in late 2014.<ref name="KalHow14Arch">{{cite web \|url=http://www.kaloramainformation.com/article/2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2 \|archiveurl=https://web.archive.org/web/20150417204832/http://www.kaloramainformation.com/article/2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2 \|title=How and Where IVD Will Find Growth in the Global POL Market – Part 2 \|publisher=Kalorama Information \|date=November 2014 \|archivedate=17 April 2015 \|accessdate=02 December 2015}}</ref>

	In early 2011, researchers estimated the worldwide market for ''in vitro'' diagnostic (IVD) company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.<ref name="ReutHealthcareCosts">{{cite web \|url=http://www.reuters.com/article/2011/02/10/idUS249575+10-Feb-2011+MW20110210 \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|publisher=Thomson Reuters \|date=10 February 2011 \|accessdate=3 April 2014}}</ref><ref name="KaloramaHealth11">{{cite web \|url=https://www.pressreleasepoint.com/healthcare-cost-worries-boost-physician-office-lab-market \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|author=Kalorama Information \|work=PressReleasePoint \|date=10 February 2011 \|accessdate=17 April 2022}}</ref>		In early 2011, researchers estimated the worldwide market for ''in vitro'' diagnostic (IVD) company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.<ref name="ReutHealthcareCosts">{{cite web \|url=http://www.reuters.com/article/2011/02/10/idUS249575+10-Feb-2011+MW20110210 \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|publisher=Thomson Reuters \|date=10 February 2011 \|accessdate=3 April 2014}}</ref><ref name="KaloramaHealth11">{{cite web \|url=https://www.pressreleasepoint.com/healthcare-cost-worries-boost-physician-office-lab-market \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|author=Kalorama Information \|work=PressReleasePoint \|date=10 February 2011 \|accessdate=17 April 2022}}</ref>

	In March 2022, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 40.2% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-certified laboratories in the United States (132,124) were physician office laboratories.<ref name="~~CMSDec13Count~~">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> ~~Additionally~~, 68.9% of the POLs in the United States today are running [[Clinical Laboratory Improvement Amendments]] (CLIA) waived tests, and 17.3% hold provider performed microscopy (PPM) certificates.<ref name="~~CMS13Enroll~~">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> ~~However, in late 2010~~, POLs were ~~estimated to be processing only about eight percent of all clinical laboratory~~ tests.<ref name="~~CarlsonPhys~~">{{cite web \|url=https://~~www~~.~~genengnews~~.~~com~~/~~magazine~~/~~145~~/~~physician~~-~~office~~-~~lab-diagnostic-market~~/ \|~~title~~=~~Physician Office Lab Diagnostic Market~~ \|~~work~~=~~GEN~~ \|author=~~Carlson~~, ~~Bruce~~ \|~~publisher~~=~~Genetic Engineering & Biotechnology News~~ \|~~date~~=~~1 December 2010~~ \|accessdate=17 April 2022}}</ref> ~~That~~ number ~~went up to nine percent in late 2014.~~<ref name="~~KalHow14Arch~~">{{cite web \|url=~~http~~://www.~~kaloramainformation~~.com/~~article~~/~~2014-11~~/~~How-and-Where-IVD-Will~~-~~Find-Growth-Global-POL-Market-%E2%80%93-Part-2 \|archiveurl=https://web.archive.org/web/20150417204832/http://www.kaloramainformation.com/article~~/~~2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2~~ \|title=~~How and Where IVD Will Find Growth~~ in the ~~Global POL Market – Part 2~~ \|~~publisher~~=~~Kalorama Information~~ \|date=~~November 2014~~ \|~~archivedate~~=17 April ~~2015 \|accessdate=02 December 2015~~}}</ref>		====Present state of POLs====
			Since reaching a peak of around 50.7% of all CLIA-certified labs in the U.S. in June 2011<ref name="CMSJune11Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|archiveurl=https://web.archive.org/web/20120410205217/https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, the prevalence of POLs compared to other lab types has noticeably dipped. In March 2022, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 40.2% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-certified laboratories in the United States (132,124) were physician office laboratories, down more than 10% since June 2011.<ref name="CMSMar22Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> Since June 2011, lab types like pharmacy, assisted living facility, and school/student health service labs have picked up much of the ground the POL has lost.<ref name="CMSJune11Count" /><ref name="CMSMar22Count" /> While the overall number of POLs continues to grow, the decrease in POLs as a percentage of all CLIA-certified laboratory types may be attributed to a number of factors, including the urine drug screen investigations of the 2010s<ref name="KirkwoodTheDoc18">{{cite web \|url=https://www.aacc.org/cln/articles/2018/janfeb/the-doctor-will-test-you-now \|title=The Doctor Will Test You Now \|author=Kirkwood, J. \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=01 January 2018 \|accessdate=17 April 2022}}</ref><ref name="CLNStatTheRise18">{{cite web \|url=https://www.aacc.org/cln/cln-stat/2018/february/15/the-rise-of-physician-office-labs \|title=The Rise and Fall of Physician Office Labs \|author=CLN Stat \|work=Clinical Laboratory News \|publisher=American Association for Clinical Chemistry \|date=14 February 2018 \|accessdate=17 April 2022}}</ref>, a series of reimbursement reductions<ref name=MyersSmart17">{{cite web \|url=https://www.mlo-online.com/management/reimbursement/article/13009042/smart-steps-for-labs-and-hospital-outreach-as-cms-prepares-to-cut-medicare-fees \|title=Smart steps for labs and hospital outreach as CMS prepares to cut Medicare fees \|author=Myers, J.H. \|work=Medical Laboratory Observer \|date=21 March 2017 \|accessdate=17 April 2022}}</ref><ref name="DalyDecl20">{{cite web \|url=https://blog.cola.org/insider/declining-reimbursement-in-the-clinical-laboratory \|title=Declining Reimbursement in the Clinical Laboratory \|author=Daly, J. \|work=Insider Blog \|publisher=COLA \|date=30 January 2020 \|accessdate=17 April 2022}}</ref>, and even the [[COVID-19]] [[pandemic]].<ref name="BonislawskiLab20">{{cite web \|url=https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|archiveurl=https://web.archive.org/web/20200412112320/https://www.modernhealthcare.com/clinical/lab-test-volumes-plummet-patients-put-care \|title=Lab test volumes plummet as patients put off care \|author=Bonislawski, A. \|work=Modern Healthcare \|date=06 April 2020 \|archivedate=12 April 2020 \|accessdate=17 April 2022}}</ref> In 2021, consulting firm Marwood Group Advisory suggested that reimbursement issues have been less impactful to the POL, but rather a consolidation pattern of physician offices—and this POLs—is and will continue to be major factor<ref name="SlomlanyTheDiag21">{{cite web \|url=https://www.marwoodgroup.com/wp-content/uploads/2021/10/The-Diagnostic-Laboratory-Space-An-Ecosystem-in-Transformation.pdf \|format=PDF \|title=The Diagnostic Laboratory Space: An Ecosystem in Transformation \|author=Slomlany, M. \|publisher=Marwood Group Advisory, LLC \|date=25 October 2021 \|accessdate=17 April 2022}}</ref>:

			<blockquote>Marwood believes that consolidation among physician office labs as well as joint ventures with independent labs are expected to increase over the next 3-5 years. It is unlikely that this is currently being driven by reimbursement pressure, which has not been as severe as that faced by large independent laboratories, but rather by larger macro trends shaping the industry. Namely, as growing health systems acquire physician practices as part of their geographic footprint, the expectation is that they funnel work back into outreach labs.</blockquote>

			As of March 2022, 68.9% of the POLs in the United States today are running [[Clinical Laboratory Improvement Amendments]] (CLIA) waived tests, and 17.3% hold provider performed microscopy (PPM) certificates.<ref name="CMS22Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=March 2022 \|accessdate=17 April 2022}}</ref> Compared to June 2011, when 56.1% of POLs were running CLIA waived tests and 26.5% were running PPM testing<ref name="CMS11Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|archiveurl=https://web.archive.org/web/20120410205216/http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=June 2011 \|archivedate=10 April 2012 \|accessdate=17 April 2022}}</ref>, it's clear that POLs have moved even further into predominantly performing CLIA waived testing. A July 2021 article by COLA's Irwin Z. Rothenberg suggested that the increase in waived testing in the POL has been influenced by a number of factors, including<ref name="RothenbergTheIncrease21">{{cite web \|url=https://www.physiciansofficeresource.com/articles/finance/waived-testing/ \|title=The Increase in Waived Testing in the Physician Office \|author=Rothenberg, I.Z. \|work=Physicians Office Resource \|date=01 July 2021 \|accessdate=17 April 2022}}</ref>:

			* technical advances in point-of-care systems, that bring improved rapid, high-quality testing closer to the patient;
			* a greater abundance and variety of CLIA-waived tests for clinical testing;
			* a greater decentralization of laboratory services away from core laboratories; and
			* more CLIA-waived testing moving into drug abuse or pain management clinics.

	===Regulatory considerations===		===Regulatory considerations===

Shawndouglas: Updated outdated URLs and citations

2022-04-17T17:43:54Z

Updated outdated URLs and citations

Show changes

Shawndouglas: Fixed citation issue

2021-09-19T20:37:00Z

Fixed citation issue

← Older revision		Revision as of 20:37, 19 September 2021
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	====1900 to 1979====		====1900 to 1979====
	The promotion and success of the physician office laboratory continued on into the first decade of the twentieth century, with most urban physicians able to perform analysis of urine, blood, sputum, and feces.<ref name="POLHarrower">{{cite journal \|url=http://books.google.com/books?id=CxIxAQAAMAAJ&pg=PA7 \|journal=Practical Therapeutics \|title=The Physician's Office Laboratory \|author=Harrower, Henry R. \|volume=23 \|issue=1 \|date=July 1909 \|pages=7–10 \|accessdate=14 April 2014}}</ref><ref name="IC1901">{{cite book \|url=https://books.google.com/books?id=TigSAAAAYAAJ&pg=PA289 \|title=International Clinics: A Quarterly of Clinical Lectures \|chapter=The Clinical Laboratory in Private Practice and in the Physician's Office \|author=Camac, C. N. B.; Cattell, Henry W. (ed.) \|publisher=J.B. Lippincott Company \|volume=3 \|issue=11 \|pages=289–299 \|year=1901 \|accessdate=23 June 2017}}</ref> Yet the first two decades of the 1900s also saw the slow rise of the "commercial laboratory," a privately- or group-held clinical pathology, chemical, or radiological lab that processed laboratory tests or chemical compounds ordered by a referring physician.<ref name="~~TNHJan1921~~">{{cite journal \|url=http://books.google.com/books?id=dzMKAQAAMAAJ&pg=PA1498 \|journal=Journal of the American Medical Association \|title=Clinical Laboratory Service for Physicians \|author=American Medical Association \|volume=77 \|issue=19 \|date=5 November 1921 \|pages=1498–1499 \|accessdate=5 April 2014}}</ref><ref name="PSMar1908">{{cite journal \|url=http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442 \|journal=The Physician and Surgeon \|title=What We Owe to the Manufacturing Pharmacist and the Commercial Scientific Laboratory \|author=Saint Paul Medical Journal \|volume=30 \|issue=3 \|date=March 1908 \|pages=130–131 \|accessdate=5 April 2014}}</ref> (Though the same idea, the term "[[Reference laboratory\|referral lab]]" didn't begin to appear in medical literature regularly until the early 1950s and "independent laboratory" until the mid-1960s.<ref name="TXTSep1952">{{cite journal \|url=http://books.google.com/books?id=pMwvAQAAMAAJ \|journal=The X-Ray Technician / Radiologic Technology \|title=Unknown \|author=The American Society of X-Ray Technicians \|volume=24 \|issue=3 \|date=September 1952 \|page=251 \|accessdate=5 April 2014}}</ref><ref name="NYDH1953">{{cite web \|url=http://books.google.com/books?id=-5E4AAAAIAAJ \|title=Annual Report of the Dept. of Health of the City of New York \|author=New York Dept. of Health \|date=1953 \|page=72 \|accessdate=5 April 2014}}</ref><ref name="CodeLawsUS">{{cite web \|url=http://books.google.com/books?id=W-I5AAAAIAAJ&pg=PA533 \|title=US Code of Federal Regulations, Title 20, Part 405, Subpart M, Sections 1301–1316 \|publisher=Office of the Federal Register \|date=01 January 1972 \|accessdate=14 April 2014}}</ref> ) While some physicians — especially those in thriving urban areas — had a large enough clientele to invest in laboratory equipment and supplies for their own office, others in rural areas were less likely to be able to afford such luxuries. In the latter case, physicians were not able to as effectively provide a clinical diagnosis to their patients. These physicians had to either hope for connections at community regional hospitals to utilize the hospital laboratory (if they were even in reasonable distance or had the testing tools) or find some other means of sample testing.<ref name="MHSept1921">{{cite journal \|url=http://books.google.com/books?id=tcsyAQAAMAAJ&pg=PA196 \|journal=The Modern Hospital \|title=The Diagnostic Hospital of a Small Community \|author=Pettit, Roswell T. \|volume=17 \|issue=3 \|date=September 1921 \|pages=195–199 \|accessdate=5 April 2014}}</ref> Practitioners and businesspeople alike saw an opportunity for the commercial laboratory to fill those gaps.		The promotion and success of the physician office laboratory continued on into the first decade of the twentieth century, with most urban physicians able to perform analysis of urine, blood, sputum, and feces.<ref name="POLHarrower">{{cite journal \|url=http://books.google.com/books?id=CxIxAQAAMAAJ&pg=PA7 \|journal=Practical Therapeutics \|title=The Physician's Office Laboratory \|author=Harrower, Henry R. \|volume=23 \|issue=1 \|date=July 1909 \|pages=7–10 \|accessdate=14 April 2014}}</ref><ref name="IC1901">{{cite book \|url=https://books.google.com/books?id=TigSAAAAYAAJ&pg=PA289 \|title=International Clinics: A Quarterly of Clinical Lectures \|chapter=The Clinical Laboratory in Private Practice and in the Physician's Office \|author=Camac, C. N. B.; Cattell, Henry W. (ed.) \|publisher=J.B. Lippincott Company \|volume=3 \|issue=11 \|pages=289–299 \|year=1901 \|accessdate=23 June 2017}}</ref> Yet the first two decades of the 1900s also saw the slow rise of the "commercial laboratory," a privately- or group-held clinical pathology, chemical, or radiological lab that processed laboratory tests or chemical compounds ordered by a referring physician.<ref name="AMAClinical21">{{cite journal \|url=http://books.google.com/books?id=dzMKAQAAMAAJ&pg=PA1498 \|journal=Journal of the American Medical Association \|title=Clinical Laboratory Service for Physicians \|author=American Medical Association \|volume=77 \|issue=19 \|date=5 November 1921 \|pages=1498–1499 \|accessdate=5 April 2014}}</ref><ref name="PSMar1908">{{cite journal \|url=http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442 \|journal=The Physician and Surgeon \|title=What We Owe to the Manufacturing Pharmacist and the Commercial Scientific Laboratory \|author=Saint Paul Medical Journal \|volume=30 \|issue=3 \|date=March 1908 \|pages=130–131 \|accessdate=5 April 2014}}</ref> (Though the same idea, the term "[[Reference laboratory\|referral lab]]" didn't begin to appear in medical literature regularly until the early 1950s and "independent laboratory" until the mid-1960s.<ref name="TXTSep1952">{{cite journal \|url=http://books.google.com/books?id=pMwvAQAAMAAJ \|journal=The X-Ray Technician / Radiologic Technology \|title=Unknown \|author=The American Society of X-Ray Technicians \|volume=24 \|issue=3 \|date=September 1952 \|page=251 \|accessdate=5 April 2014}}</ref><ref name="NYDH1953">{{cite web \|url=http://books.google.com/books?id=-5E4AAAAIAAJ \|title=Annual Report of the Dept. of Health of the City of New York \|author=New York Dept. of Health \|date=1953 \|page=72 \|accessdate=5 April 2014}}</ref><ref name="CodeLawsUS">{{cite web \|url=http://books.google.com/books?id=W-I5AAAAIAAJ&pg=PA533 \|title=US Code of Federal Regulations, Title 20, Part 405, Subpart M, Sections 1301–1316 \|publisher=Office of the Federal Register \|date=01 January 1972 \|accessdate=14 April 2014}}</ref> ) While some physicians — especially those in thriving urban areas — had a large enough clientele to invest in laboratory equipment and supplies for their own office, others in rural areas were less likely to be able to afford such luxuries. In the latter case, physicians were not able to as effectively provide a clinical diagnosis to their patients. These physicians had to either hope for connections at community regional hospitals to utilize the hospital laboratory (if they were even in reasonable distance or had the testing tools) or find some other means of sample testing.<ref name="MHSept1921">{{cite journal \|url=http://books.google.com/books?id=tcsyAQAAMAAJ&pg=PA196 \|journal=The Modern Hospital \|title=The Diagnostic Hospital of a Small Community \|author=Pettit, Roswell T. \|volume=17 \|issue=3 \|date=September 1921 \|pages=195–199 \|accessdate=5 April 2014}}</ref> Practitioners and businesspeople alike saw an opportunity for the commercial laboratory to fill those gaps.

	However, around the early 1920s, the push for or against the increasingly popular commercial laboratory became more noticeably vocal. Some physicians, specialists, and dentists complained heavily of the lack of quality standards, regulations, and ethics inherent in for-profit clinical, chemical, and radiological laboratories.<ref name="TSJMOct1920">{{cite journal \|url=http://books.google.com/books?id=LbEDAAAAYAAJ&pg=PA229 \|journal=Texas State Journal of Medicine \|title=Advertising Medical Laboratories (Encore) \|author=Taylor, Holman (ed.) \|volume=16 \|issue=6 \|date=October 1920 \|pages=229–230 \|accessdate=5 April 2014}}</ref><ref name="NYSJMOct1921">{{cite journal \|url=http://books.google.com/books?id=j7hYAAAAYAAJ&pg=PA390 \|journal=New York State Journal of Medicine \|title=Commercial Laboratories \|author=Sondern, Frederic E. (ed.) \|volume=21 \|issue=10 \|date=October 1921 \|page=390 \|accessdate=5 April 2014}}</ref><ref name="KMJAug1922">{{cite journal \|url=http://books.google.com/books?id=OTMTAAAAYAAJ&pg=PA755 \|journal=Kentucky Medical Journal \|title=The Role of the Nonmedical Graduate in the Medical Laboratory \|author=White, Courtland Y. \|volume=25 \|issue=11 \|date=August 1922 \|pages=755–760 \|accessdate=5 April 2014}}</ref><ref name="BMSJMar1922">{{cite journal \|url=http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442 \|journal=The Boston Medical and Surgical Journal \|title=The Business Side of X-ray Diagnosis and Treatment \|author=Sundelof, E. M. \|volume=186 \|issue=13 \|date=30 March 1922 \|pages=442–444 \|accessdate=5 April 2014}}</ref> An alternative was at times proposed in the form of a state or local diagnostic lab or a referral-only "clinic" that could be well-equipped with professional tools, staff, and procedures, critical for rural areas and usable for more than just public health care diagnoses.<ref name="TNHJan1921">{{cite journal \|url=http://books.google.com/books?id=TI7lAAAAMAAJ&pg=PA35 \|journal=The Nation's Health \|title=Group Consultation Clinic \|author=Boddy, Edmund C. \|volume=3 \|issue=1 \|date=January 1921 \|pages=35–36 \|accessdate=5 April 2014}}</ref><ref name="KMJDec1922">{{cite journal \|url=http://books.google.com/books?id=WOcvAQAAMAAJ&pg=PA839 \|journal=Kentucky Medical Journal \|title=The County and Community Diagnostic Laboratory \|author=Jones, Vernon R. \|volume=20 \|issue=12 \|date=December 1922 \|pages=836–841 \|accessdate=5 April 2014}}</ref> However, other medical professionals, while recognizing the need for more professional laboratory environments and more ethical advertising, dismissed those declaring the commercial laboratory as "evil,"<ref name="JNDAVol81921">{{cite journal \|url=http://books.google.com/books?id=vcoyAQAAMAAJ&pg=PA68 \|journal=The Journal of the National Dental Association \|title=Need and Means of Educating Laboratory Assistants \|author=Sears, Victor H. \|volume=8 \|issue=1 \|date=January 1921 \|pages=65–68 \|accessdate=5 April 2014}}</ref> content to state those types of labs were needed and then fully entrenched in the health care environment.<ref name="TNHJan1921" /><ref name="KMJAug1922" />		However, around the early 1920s, the push for or against the increasingly popular commercial laboratory became more noticeably vocal. Some physicians, specialists, and dentists complained heavily of the lack of quality standards, regulations, and ethics inherent in for-profit clinical, chemical, and radiological laboratories.<ref name="TSJMOct1920">{{cite journal \|url=http://books.google.com/books?id=LbEDAAAAYAAJ&pg=PA229 \|journal=Texas State Journal of Medicine \|title=Advertising Medical Laboratories (Encore) \|author=Taylor, Holman (ed.) \|volume=16 \|issue=6 \|date=October 1920 \|pages=229–230 \|accessdate=5 April 2014}}</ref><ref name="NYSJMOct1921">{{cite journal \|url=http://books.google.com/books?id=j7hYAAAAYAAJ&pg=PA390 \|journal=New York State Journal of Medicine \|title=Commercial Laboratories \|author=Sondern, Frederic E. (ed.) \|volume=21 \|issue=10 \|date=October 1921 \|page=390 \|accessdate=5 April 2014}}</ref><ref name="KMJAug1922">{{cite journal \|url=http://books.google.com/books?id=OTMTAAAAYAAJ&pg=PA755 \|journal=Kentucky Medical Journal \|title=The Role of the Nonmedical Graduate in the Medical Laboratory \|author=White, Courtland Y. \|volume=25 \|issue=11 \|date=August 1922 \|pages=755–760 \|accessdate=5 April 2014}}</ref><ref name="BMSJMar1922">{{cite journal \|url=http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442 \|journal=The Boston Medical and Surgical Journal \|title=The Business Side of X-ray Diagnosis and Treatment \|author=Sundelof, E. M. \|volume=186 \|issue=13 \|date=30 March 1922 \|pages=442–444 \|accessdate=5 April 2014}}</ref> An alternative was at times proposed in the form of a state or local diagnostic lab or a referral-only "clinic" that could be well-equipped with professional tools, staff, and procedures, critical for rural areas and usable for more than just public health care diagnoses.<ref name="TNHJan1921">{{cite journal \|url=http://books.google.com/books?id=TI7lAAAAMAAJ&pg=PA35 \|journal=The Nation's Health \|title=Group Consultation Clinic \|author=Boddy, Edmund C. \|volume=3 \|issue=1 \|date=January 1921 \|pages=35–36 \|accessdate=5 April 2014}}</ref><ref name="KMJDec1922">{{cite journal \|url=http://books.google.com/books?id=WOcvAQAAMAAJ&pg=PA839 \|journal=Kentucky Medical Journal \|title=The County and Community Diagnostic Laboratory \|author=Jones, Vernon R. \|volume=20 \|issue=12 \|date=December 1922 \|pages=836–841 \|accessdate=5 April 2014}}</ref> However, other medical professionals, while recognizing the need for more professional laboratory environments and more ethical advertising, dismissed those declaring the commercial laboratory as "evil,"<ref name="JNDAVol81921">{{cite journal \|url=http://books.google.com/books?id=vcoyAQAAMAAJ&pg=PA68 \|journal=The Journal of the National Dental Association \|title=Need and Means of Educating Laboratory Assistants \|author=Sears, Victor H. \|volume=8 \|issue=1 \|date=January 1921 \|pages=65–68 \|accessdate=5 April 2014}}</ref> content to state those types of labs were needed and then fully entrenched in the health care environment.<ref name="TNHJan1921" /><ref name="KMJAug1922" />

Shawndouglas: Updates for a few citations.

2020-01-03T22:14:30Z

Updates for a few citations.

← Older revision		Revision as of 22:14, 3 January 2020
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	[[File:Johannes Cordua Arzt in seinem Studierzimmer.jpg\|\|thumb\|280px\|right\|The early physician's laboratory was certainly more modest than the 21st-century POL.]]		[[File:Johannes Cordua Arzt in seinem Studierzimmer.jpg\|\|thumb\|280px\|right\|The early physician's laboratory was certainly more modest than the 21st-century POL.]]
	A '''physician office laboratory''' ('''POL''') is a physician-, partnership-, or group-maintained [[laboratory]] that performs diagnostic tests or examines specimens in order to diagnose, prevent, and/or treat a disease or impairment in a patient as part of the physician practice.<ref name="CMSPOLDef">{{cite web \|url=~~http~~://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf \|format=PDF \|title=Chapter 16 - Laboratory Services \|work=Medicare Claims Processing Manual \|publisher=Centers for Medicare and Medicaid Services \|date=~~20 June 2013~~ \|accessdate=~~3 April 2014~~}}</ref><ref name="WasPOLEP">{{cite web \|url=~~http~~://www.wadsworth.org/~~labcert~~/polep/ \|title=Physician Office Laboratory Evaluation Program (POLEP) \|publisher=Wadsworth Center New York State Department of Health \|accessdate=~~3 April 2014~~}}</ref> The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the physician office laboratory is considered a [[clinical laboratory]] and is thus regulated by federal, state, and/or local laws affecting such laboratories.<ref name="WasPOLEP" /><ref name="CDPHLabs">{{cite web \|url=http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf \|format=PDF \|title=Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration \|publisher=California Department of Public Health \|date=May 2008 \|accessdate=~~3 April 2014~~}}</ref>		A '''physician office laboratory''' ('''POL''') is a physician-, partnership-, or group-maintained [[laboratory]] that performs diagnostic tests or examines specimens in order to diagnose, prevent, and/or treat a disease or impairment in a patient as part of the physician practice.<ref name="CMSPOLDef">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf \|format=PDF \|title=Chapter 16 - Laboratory Services \|work=Medicare Claims Processing Manual \|publisher=Centers for Medicare and Medicaid Services \|date=03 May 2019 \|accessdate=03 January 2020}}</ref><ref name="WasPOLEP">{{cite web \|url=https://www.wadsworth.org/regulatory/polep \|title=Physician Office Laboratory Evaluation Program (POLEP) \|publisher=Wadsworth Center New York State Department of Health \|accessdate=03 January 2020}}</ref> The POL shows up in primary care physician offices as well as the offices of specialists like urologists, hematologists, gynecologists, and endocrinologists. In many countries like the United States, the physician office laboratory is considered a [[clinical laboratory]] and is thus regulated by federal, state, and/or local laws affecting such laboratories.<ref name="WasPOLEP" /><ref name="CDPHLabs">{{cite web \|url=http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf \|archiveurl=https://web.archive.org/web/20161229143212/http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf \|format=PDF \|title=Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration \|publisher=California Department of Public Health \|date=May 2008 \|archivedate=29 December 2016 \|accessdate=03 January 2020}}</ref>

	==POL workflow==		==POL workflow==
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	* In 1962, around 2,000 independent/commercial labs employed roughly 10,000 personnel.		* In 1962, around 2,000 independent/commercial labs employed roughly 10,000 personnel.

	The publication didn't mention the number of POLs in 1962. One could arguably assume hospital labs still outnumbered POLs that year. In the last year of its publication of ''Health Resources Statistics'' (1976–1977), the NCHS reported "[t]he largest number of clinical laboratories are in the offices of private physicians, and the next largest number are in hospitals,<ref name="HRS76-77">{{cite book \|url=http://babel.hathitrust.org/cgi/pt?id=mdp.39015068164634;view=1up;seq=44 \|title=Health Resources Statistics \|author=National Center for Health Statistics \|publisher=U.S. Dept. of Health, Education, and Welfare; Public Health Service \|year=1976–77 \|page=49; 359–361 \|accessdate=14 April 2014}}</ref>" indicating a potential flip-flop in lab numbers over a period of nearly 15 years. The increase in POLs during the 1970s has been largely attributed to the technological development of small, affordable analyzers; more affordable office laboratory equipment; and the convenience associated with in-office testing.<ref name="StJohnImprove">{{cite journal \|url=http://www.archivesofpathology.org/doi/full/10.1043/0003-9985%282000%29124%3C1066:IIPSOL%3E2.0.CO;2 \|journal=Archives of Pathology & Laboratory Medicine \|title=Improvement in Physician's Office Laboratory Practices, 1989–1994 \|author=St. John, Tina M.; Lipman, Harvey B.; Krolak, John M.; Hearn, Thomas L. \|volume=124 \|issue=7 \|date=2000 \|pages=1066–1073 \|pmid= 10888785 \|accessdate=17 April 2014}}</ref>		The publication didn't mention the number of POLs in 1962. One could arguably assume hospital labs still outnumbered POLs that year. In the last year of its publication of ''Health Resources Statistics'' (1976–1977), the NCHS reported "[t]he largest number of clinical laboratories are in the offices of private physicians, and the next largest number are in hospitals,<ref name="HRS76-77">{{cite book \|url=http://babel.hathitrust.org/cgi/pt?id=mdp.39015068164634;view=1up;seq=44 \|title=Health Resources Statistics \|author=National Center for Health Statistics \|publisher=U.S. Dept. of Health, Education, and Welfare; Public Health Service \|year=1976–77 \|page=49; 359–361 \|accessdate=14 April 2014}}</ref>" indicating a potential flip-flop in lab numbers over a period of nearly 15 years. The increase in POLs during the 1970s has been largely attributed to the technological development of small, affordable analyzers; more affordable office laboratory equipment; and the convenience associated with in-office testing.<ref name="StJohnImprove">{{cite journal \|url=http://www.archivesofpathology.org/doi/full/10.1043/0003-9985%282000%29124%3C1066:IIPSOL%3E2.0.CO;2 \|journal=Archives of Pathology & Laboratory Medicine \|title=Improvement in Physician's Office Laboratory Practices, 1989–1994 \|author=St. John, Tina M.; Lipman, Harvey B.; Krolak, John M.; Hearn, Thomas L. \|volume=124 \|issue=7 \|date=2000 \|pages=1066–1073 \|pmid=10888785 \|accessdate=17 April 2014}}</ref>

	The 1976–1977 report is also notable for its focus on the "independent clinical laboratory" (the commercial clinical laboratory) as defined by Medicare, indicating an increase from 2,355 such labs in 1967 to 3,024 on January 1976.<ref name="HRS76-77" />		The 1976–1977 report is also notable for its focus on the "independent clinical laboratory" (the commercial clinical laboratory) as defined by Medicare, indicating an increase from 2,355 such labs in 1967 to 3,024 on January 1976.<ref name="HRS76-77" />
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	In early 2011, researchers estimated the worldwide market for ''in vitro'' diagnostic (IVD) company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.<ref name="ReutHealthcareCosts">{{cite web \|url=http://www.reuters.com/article/2011/02/10/idUS249575+10-Feb-2011+MW20110210 \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|publisher=Thomson Reuters \|date=10 February 2011 \|accessdate=3 April 2014}}</ref>		In early 2011, researchers estimated the worldwide market for ''in vitro'' diagnostic (IVD) company sales from over 100 companies to POLs was valued at around $2.3 billion U.S.<ref name="ReutHealthcareCosts">{{cite web \|url=http://www.reuters.com/article/2011/02/10/idUS249575+10-Feb-2011+MW20110210 \|title=Healthcare Cost Worries Boost Physician Office Lab Market \|publisher=Thomson Reuters \|date=10 February 2011 \|accessdate=3 April 2014}}</ref>

	In ~~July 2015~~, the [[Centers for Medicare and Medicaid Services]] (CMS) reported ~~nearly half~~ of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-certified laboratories in the United States (~~122~~,~~189~~) were physician office laboratories.<ref name="CMSDec13Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=~~July 2015~~ \|accessdate=~~02 December 2015~~}}</ref> Additionally, ~~61.3~~% of the POLs in the United States today are running [[Clinical Laboratory Improvement Amendments]] (CLIA) waived tests, and ~~22.7~~% hold provider performed microscopy (PPM) certificates.<ref name="CMS13Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=~~July 2015~~ \|accessdate=~~02 December 2015~~}}</ref> However, in late 2010 POLs were estimated to be processing only about eight percent of all clinical laboratory tests.<ref name="CarlsonPhys">{{cite web \|url=http://www.genengnews.com/gen-articles/physician-office-lab-diagnostic-market/3493/ \|title=Physician Office Lab Diagnostic Market \|work=GEN \|author=Carlson, Bruce \|publisher=Genetic Engineering & Biotechnology News \|date=1 December 2010 \|accessdate=3 April 2014}}</ref> That number went up to nine percent in late 2014.<ref name="KalHow14Arch">{{cite web \|url=http://www.kaloramainformation.com/article/2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2 \|archiveurl=https://web.archive.org/web/20150417204832/http://www.kaloramainformation.com/article/2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2 \|title=How and Where IVD Will Find Growth in the Global POL Market – Part 2 \|publisher=Kalorama Information \|date=November 2014 \|archivedate=17 April 2015 \|accessdate=02 December 2015}}</ref>		In October 2019, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 46% of all [[Clinical Laboratory Improvement Amendments\|CLIA]]-certified laboratories in the United States (121,265) were physician office laboratories.<ref name="CMSDec13Count">{{cite web \|url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf \|format=PDF \|title=Laboratories by Type of Facility \|publisher=Centers for Medicare and Medicaid Services \|date=October 2019 \|accessdate=03 January 2020}}</ref> Additionally, 67% of the POLs in the United States today are running [[Clinical Laboratory Improvement Amendments]] (CLIA) waived tests, and 20% hold provider performed microscopy (PPM) certificates.<ref name="CMS13Enroll">{{cite web \|url=http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf \|format=PDF \|title=Enrollment, CLIA exempt states, and certification of accreditation by organization \|author=Centers for Medicare and Medicaid Services, Division of Laboratory Services \|date=October 2019 \|accessdate=03 January 2020}}</ref> However, in late 2010 POLs were estimated to be processing only about eight percent of all clinical laboratory tests.<ref name="CarlsonPhys">{{cite web \|url=http://www.genengnews.com/gen-articles/physician-office-lab-diagnostic-market/3493/ \|title=Physician Office Lab Diagnostic Market \|work=GEN \|author=Carlson, Bruce \|publisher=Genetic Engineering & Biotechnology News \|date=1 December 2010 \|accessdate=3 April 2014}}</ref> That number went up to nine percent in late 2014.<ref name="KalHow14Arch">{{cite web \|url=http://www.kaloramainformation.com/article/2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2 \|archiveurl=https://web.archive.org/web/20150417204832/http://www.kaloramainformation.com/article/2014-11/How-and-Where-IVD-Will-Find-Growth-Global-POL-Market-%E2%80%93-Part-2 \|title=How and Where IVD Will Find Growth in the Global POL Market – Part 2 \|publisher=Kalorama Information \|date=November 2014 \|archivedate=17 April 2015 \|accessdate=02 December 2015}}</ref>

	===Regulatory considerations===		===Regulatory considerations===
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	====CLIA====		====CLIA====
	The [[Clinical Laboratory Improvement Amendments]] (CLIA) arguably have the largest effect on the physician office laboratory. The U.S. federal statute was implemented in 1988 to remove obsolete laboratory requirements and include new requirements to improve the quality of a modern clinical laboratory. Most POLs operate as CLIA waiver labs. Waived tests have a low risk of an incorrect result; this includes the tests the Food and Drug Administration (FDA) has approved for consumers to use in their homes.<ref name="CDCTestCom"~~>{{cite web \|url=http:~~//wwwn.cdc.gov/clia/Resources/TestComplexities.aspx \|title=Clinical Laboratory Improvement Amendments (CLIA): Test complexities \|author=Centers for Disease Control and Prevention \|date=31 May 2013 \|accessdate=14 May 2014}}</ref> Tests performed under this provision are done at laboratories that have registered as required by CLIA and obtained a certificate of waiver. These labs are not inspected on a routine basis like labs certified to perform moderate- and high-complexity testing. Laboratories that wish to change their status from waived to one of the other statuses must comply with the CLIA requirements for registration, inspection, and proficiency testing as outlined in the law. Waived laboratory staff, as previously mentioned, does not require proficiency testing, and anyone can be qualified to be the laboratory director.<ref name="CDCTestCom" />		The [[Clinical Laboratory Improvement Amendments]] (CLIA) arguably have the largest effect on the physician office laboratory. The U.S. federal statute was implemented in 1988 to remove obsolete laboratory requirements and include new requirements to improve the quality of a modern clinical laboratory. Most POLs operate as CLIA waiver labs. Waived tests have a low risk of an incorrect result; this includes the tests the Food and Drug Administration (FDA) has approved for consumers to use in their homes.<ref name="CDCTestCom" /> Tests performed under this provision are done at laboratories that have registered as required by CLIA and obtained a certificate of waiver. These labs are not inspected on a routine basis like labs certified to perform moderate- and high-complexity testing. Laboratories that wish to change their status from waived to one of the other statuses must comply with the CLIA requirements for registration, inspection, and proficiency testing as outlined in the law. Waived laboratory staff, as previously mentioned, does not require proficiency testing, and anyone can be qualified to be the laboratory director.<ref name="CDCTestCom" />

	====HIPAA====		====HIPAA====
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	===Testing and reporting===		===Testing and reporting===
	[[File:CBC report.JPG\|thumb\|280px\|right\|The complete blood count, typically done with an automated analyzer, is a common test performed in the POL today.]]		[[File:CBC report.JPG\|thumb\|280px\|right\|The complete blood count, typically done with an automated analyzer, is a common test performed in the POL today.]]
	In the United States, CLIA lays out seven criteria for determining the complexity of a test, including the origin of the test.<ref name="CDCTestCom">{{cite web \|url=~~http~~://~~wwwn~~.cdc.gov/clia/~~Resources/TestComplexities~~.~~aspx~~ \|title=Clinical Laboratory Improvement Amendments (CLIA): Test complexities \|author=Centers for Disease Control and Prevention \|date=~~31 May 2013~~ \|accessdate=~~14 May 2014~~}}</ref> For example, if a new test is developed or an existing test is modified, and then it's used at that laboratory, the test is automatically rated a high-complexity test. The complexity of the test determines the requirements the laboratory needs to comply with in order to maintain regulatory compliance. The more complex the test is, the stricter the requirements are.<ref name="CDCTestCom" />		In the United States, CLIA lays out seven criteria for determining the complexity of a test, including the origin of the test.<ref name="CDCTestCom">{{cite web \|url=https://www.cdc.gov/clia/test-complexities.html \|title=Clinical Laboratory Improvement Amendments (CLIA): Test complexities \|author=Centers for Disease Control and Prevention \|date=06 August 2018 \|accessdate=03 January 2020}}</ref> For example, if a new test is developed or an existing test is modified, and then it's used at that laboratory, the test is automatically rated a high-complexity test. The complexity of the test determines the requirements the laboratory needs to comply with in order to maintain regulatory compliance. The more complex the test is, the stricter the requirements are.<ref name="CDCTestCom" />

	Test complexity has three levels: high, moderate, and waived.<ref name="CDCTestCom" /> Waived tests are simple to perform and have a relatively low risk of an incorrect test result. Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit. Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.<ref name="CDCTestCom" />		Test complexity has three levels: high, moderate, and waived.<ref name="CDCTestCom" /> Waived tests are simple to perform and have a relatively low risk of an incorrect test result. Moderately complex tests include tests like provider performed microscopy (PPM), which requires the use of a microscope during the office visit. Providers that want to perform PPM tests must be qualified to do so under CLIA regulations.<ref name="CDCTestCom" />
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	High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.<ref name="CDCTestCom" /> It is important to understand the complexity level of the testing provided in order to ensure full compliance with CLIA.		High-complexity tests require the most regulation. These tests are the most complicated and run the highest risk of an inaccurate result, as determined during the FDA pre-market approval process. Tests may come from the manufacturer with their complexity level on them, or one can search the FDA database to determine the complexity of the test.<ref name="CDCTestCom" /> It is important to understand the complexity level of the testing provided in order to ensure full compliance with CLIA.

	Commonly performed tests include<ref name="UHOxInOffice">{{cite web \|url=https://www.oxhp.com/secure/policy/~~oxfords_in_office_laboratory_testing_and_procedures_list~~.pdf \|format=PDF \|title=Oxford's in-office laboratory testing and procedures list \|author=UnitedHealthcare Oxford \|date=01 ~~July 2012~~ \|accessdate=~~14 May 2014~~}}</ref>:		Commonly performed tests include<ref name="UHOxInOffice">{{cite web \|url=https://www.oxhp.com/secure/policy/in_office_laboratory_testing_and_procedures_list.pdf \|format=PDF \|title=UnitedHealthcare Oxford's in-office laboratory testing and procedures list \|author=UnitedHealthcare Oxford \|date=01 January 2018 \|accessdate=03 January 2020}}</ref>:
	* urine analysis		* urine analysis
	* urine pregnancy		* urine pregnancy

Shawndouglas: Fixed citation

2017-06-23T16:46:48Z

Fixed citation

← Older revision		Revision as of 16:46, 23 June 2017
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	====1900 to 1979====		====1900 to 1979====
	The promotion and success of the physician office laboratory continued on into the first decade of the twentieth century, with most urban physicians able to perform analysis of urine, blood, sputum, and feces.<ref name="POLHarrower">{{cite journal \|url=http://books.google.com/books?id=CxIxAQAAMAAJ&pg=PA7 \|journal=Practical Therapeutics \|title=The Physician's Office Laboratory \|author=Harrower, Henry R. \|volume=23 \|issue=1 \|date=July 1909 \|pages=7–10 \|accessdate=14 April 2014}}</ref><ref name="IC1901">{{cite book \|url=~~http~~://~~www~~.~~forgottenbooks~~.~~org~~/~~readbook/International_Clinics_v3_1000133973#329~~ \|title=International Clinics: A Quarterly of Clinical Lectures \|chapter=The Clinical Laboratory in Private Practice and in the Physician's Office \|author=Camac, C. N. B.; Cattell, Henry W. (ed.) \|publisher=J.B. Lippincott Company \|volume=3 \|pages=289–299 \|year=1901 \|accessdate=~~14 April 2014~~}}</ref> Yet the first two decades of the 1900s also saw the slow rise of the "commercial laboratory," a privately- or group-held clinical pathology, chemical, or radiological lab that processed laboratory tests or chemical compounds ordered by a referring physician.<ref name="TNHJan1921">{{cite journal \|url=http://books.google.com/books?id=dzMKAQAAMAAJ&pg=PA1498 \|journal=Journal of the American Medical Association \|title=Clinical Laboratory Service for Physicians \|author=American Medical Association \|volume=77 \|issue=19 \|date=5 November 1921 \|pages=1498–1499 \|accessdate=5 April 2014}}</ref><ref name="PSMar1908">{{cite journal \|url=http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442 \|journal=The Physician and Surgeon \|title=What We Owe to the Manufacturing Pharmacist and the Commercial Scientific Laboratory \|author=Saint Paul Medical Journal \|volume=30 \|issue=3 \|date=March 1908 \|pages=130–131 \|accessdate=5 April 2014}}</ref> (Though the same idea, the term "[[Reference laboratory\|referral lab]]" didn't begin to appear in medical literature regularly until the early 1950s and "independent laboratory" until the mid-1960s.<ref name="TXTSep1952">{{cite journal \|url=http://books.google.com/books?id=pMwvAQAAMAAJ \|journal=The X-Ray Technician / Radiologic Technology \|title=Unknown \|author=The American Society of X-Ray Technicians \|volume=24 \|issue=3 \|date=September 1952 \|page=251 \|accessdate=5 April 2014}}</ref><ref name="NYDH1953">{{cite web \|url=http://books.google.com/books?id=-5E4AAAAIAAJ \|title=Annual Report of the Dept. of Health of the City of New York \|author=New York Dept. of Health \|date=1953 \|page=72 \|accessdate=5 April 2014}}</ref><ref name="CodeLawsUS">{{cite web \|url=http://books.google.com/books?id=W-I5AAAAIAAJ&pg=PA533 \|title=US Code of Federal Regulations, Title 20, Part 405, Subpart M, Sections 1301–1316 \|publisher=Office of the Federal Register \|date=01 January 1972 \|accessdate=14 April 2014}}</ref> ) While some physicians — especially those in thriving urban areas — had a large enough clientele to invest in laboratory equipment and supplies for their own office, others in rural areas were less likely to be able to afford such luxuries. In the latter case, physicians were not able to as effectively provide a clinical diagnosis to their patients. These physicians had to either hope for connections at community regional hospitals to utilize the hospital laboratory (if they were even in reasonable distance or had the testing tools) or find some other means of sample testing.<ref name="MHSept1921">{{cite journal \|url=http://books.google.com/books?id=tcsyAQAAMAAJ&pg=PA196 \|journal=The Modern Hospital \|title=The Diagnostic Hospital of a Small Community \|author=Pettit, Roswell T. \|volume=17 \|issue=3 \|date=September 1921 \|pages=195–199 \|accessdate=5 April 2014}}</ref> Practitioners and businesspeople alike saw an opportunity for the commercial laboratory to fill those gaps.		The promotion and success of the physician office laboratory continued on into the first decade of the twentieth century, with most urban physicians able to perform analysis of urine, blood, sputum, and feces.<ref name="POLHarrower">{{cite journal \|url=http://books.google.com/books?id=CxIxAQAAMAAJ&pg=PA7 \|journal=Practical Therapeutics \|title=The Physician's Office Laboratory \|author=Harrower, Henry R. \|volume=23 \|issue=1 \|date=July 1909 \|pages=7–10 \|accessdate=14 April 2014}}</ref><ref name="IC1901">{{cite book \|url=https://books.google.com/books?id=TigSAAAAYAAJ&pg=PA289 \|title=International Clinics: A Quarterly of Clinical Lectures \|chapter=The Clinical Laboratory in Private Practice and in the Physician's Office \|author=Camac, C. N. B.; Cattell, Henry W. (ed.) \|publisher=J.B. Lippincott Company \|volume=3 \|issue=11 \|pages=289–299 \|year=1901 \|accessdate=23 June 2017}}</ref> Yet the first two decades of the 1900s also saw the slow rise of the "commercial laboratory," a privately- or group-held clinical pathology, chemical, or radiological lab that processed laboratory tests or chemical compounds ordered by a referring physician.<ref name="TNHJan1921">{{cite journal \|url=http://books.google.com/books?id=dzMKAQAAMAAJ&pg=PA1498 \|journal=Journal of the American Medical Association \|title=Clinical Laboratory Service for Physicians \|author=American Medical Association \|volume=77 \|issue=19 \|date=5 November 1921 \|pages=1498–1499 \|accessdate=5 April 2014}}</ref><ref name="PSMar1908">{{cite journal \|url=http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442 \|journal=The Physician and Surgeon \|title=What We Owe to the Manufacturing Pharmacist and the Commercial Scientific Laboratory \|author=Saint Paul Medical Journal \|volume=30 \|issue=3 \|date=March 1908 \|pages=130–131 \|accessdate=5 April 2014}}</ref> (Though the same idea, the term "[[Reference laboratory\|referral lab]]" didn't begin to appear in medical literature regularly until the early 1950s and "independent laboratory" until the mid-1960s.<ref name="TXTSep1952">{{cite journal \|url=http://books.google.com/books?id=pMwvAQAAMAAJ \|journal=The X-Ray Technician / Radiologic Technology \|title=Unknown \|author=The American Society of X-Ray Technicians \|volume=24 \|issue=3 \|date=September 1952 \|page=251 \|accessdate=5 April 2014}}</ref><ref name="NYDH1953">{{cite web \|url=http://books.google.com/books?id=-5E4AAAAIAAJ \|title=Annual Report of the Dept. of Health of the City of New York \|author=New York Dept. of Health \|date=1953 \|page=72 \|accessdate=5 April 2014}}</ref><ref name="CodeLawsUS">{{cite web \|url=http://books.google.com/books?id=W-I5AAAAIAAJ&pg=PA533 \|title=US Code of Federal Regulations, Title 20, Part 405, Subpart M, Sections 1301–1316 \|publisher=Office of the Federal Register \|date=01 January 1972 \|accessdate=14 April 2014}}</ref> ) While some physicians — especially those in thriving urban areas — had a large enough clientele to invest in laboratory equipment and supplies for their own office, others in rural areas were less likely to be able to afford such luxuries. In the latter case, physicians were not able to as effectively provide a clinical diagnosis to their patients. These physicians had to either hope for connections at community regional hospitals to utilize the hospital laboratory (if they were even in reasonable distance or had the testing tools) or find some other means of sample testing.<ref name="MHSept1921">{{cite journal \|url=http://books.google.com/books?id=tcsyAQAAMAAJ&pg=PA196 \|journal=The Modern Hospital \|title=The Diagnostic Hospital of a Small Community \|author=Pettit, Roswell T. \|volume=17 \|issue=3 \|date=September 1921 \|pages=195–199 \|accessdate=5 April 2014}}</ref> Practitioners and businesspeople alike saw an opportunity for the commercial laboratory to fill those gaps.

	However, around the early 1920s, the push for or against the increasingly popular commercial laboratory became more noticeably vocal. Some physicians, specialists, and dentists complained heavily of the lack of quality standards, regulations, and ethics inherent in for-profit clinical, chemical, and radiological laboratories.<ref name="TSJMOct1920">{{cite journal \|url=http://books.google.com/books?id=LbEDAAAAYAAJ&pg=PA229 \|journal=Texas State Journal of Medicine \|title=Advertising Medical Laboratories (Encore) \|author=Taylor, Holman (ed.) \|volume=16 \|issue=6 \|date=October 1920 \|pages=229–230 \|accessdate=5 April 2014}}</ref><ref name="NYSJMOct1921">{{cite journal \|url=http://books.google.com/books?id=j7hYAAAAYAAJ&pg=PA390 \|journal=New York State Journal of Medicine \|title=Commercial Laboratories \|author=Sondern, Frederic E. (ed.) \|volume=21 \|issue=10 \|date=October 1921 \|page=390 \|accessdate=5 April 2014}}</ref><ref name="KMJAug1922">{{cite journal \|url=http://books.google.com/books?id=OTMTAAAAYAAJ&pg=PA755 \|journal=Kentucky Medical Journal \|title=The Role of the Nonmedical Graduate in the Medical Laboratory \|author=White, Courtland Y. \|volume=25 \|issue=11 \|date=August 1922 \|pages=755–760 \|accessdate=5 April 2014}}</ref><ref name="BMSJMar1922">{{cite journal \|url=http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442 \|journal=The Boston Medical and Surgical Journal \|title=The Business Side of X-ray Diagnosis and Treatment \|author=Sundelof, E. M. \|volume=186 \|issue=13 \|date=30 March 1922 \|pages=442–444 \|accessdate=5 April 2014}}</ref> An alternative was at times proposed in the form of a state or local diagnostic lab or a referral-only "clinic" that could be well-equipped with professional tools, staff, and procedures, critical for rural areas and usable for more than just public health care diagnoses.<ref name="TNHJan1921">{{cite journal \|url=http://books.google.com/books?id=TI7lAAAAMAAJ&pg=PA35 \|journal=The Nation's Health \|title=Group Consultation Clinic \|author=Boddy, Edmund C. \|volume=3 \|issue=1 \|date=January 1921 \|pages=35–36 \|accessdate=5 April 2014}}</ref><ref name="KMJDec1922">{{cite journal \|url=http://books.google.com/books?id=WOcvAQAAMAAJ&pg=PA839 \|journal=Kentucky Medical Journal \|title=The County and Community Diagnostic Laboratory \|author=Jones, Vernon R. \|volume=20 \|issue=12 \|date=December 1922 \|pages=836–841 \|accessdate=5 April 2014}}</ref> However, other medical professionals, while recognizing the need for more professional laboratory environments and more ethical advertising, dismissed those declaring the commercial laboratory as "evil,"<ref name="JNDAVol81921">{{cite journal \|url=http://books.google.com/books?id=vcoyAQAAMAAJ&pg=PA68 \|journal=The Journal of the National Dental Association \|title=Need and Means of Educating Laboratory Assistants \|author=Sears, Victor H. \|volume=8 \|issue=1 \|date=January 1921 \|pages=65–68 \|accessdate=5 April 2014}}</ref> content to state those types of labs were needed and then fully entrenched in the health care environment.<ref name="TNHJan1921" /><ref name="KMJAug1922" />		However, around the early 1920s, the push for or against the increasingly popular commercial laboratory became more noticeably vocal. Some physicians, specialists, and dentists complained heavily of the lack of quality standards, regulations, and ethics inherent in for-profit clinical, chemical, and radiological laboratories.<ref name="TSJMOct1920">{{cite journal \|url=http://books.google.com/books?id=LbEDAAAAYAAJ&pg=PA229 \|journal=Texas State Journal of Medicine \|title=Advertising Medical Laboratories (Encore) \|author=Taylor, Holman (ed.) \|volume=16 \|issue=6 \|date=October 1920 \|pages=229–230 \|accessdate=5 April 2014}}</ref><ref name="NYSJMOct1921">{{cite journal \|url=http://books.google.com/books?id=j7hYAAAAYAAJ&pg=PA390 \|journal=New York State Journal of Medicine \|title=Commercial Laboratories \|author=Sondern, Frederic E. (ed.) \|volume=21 \|issue=10 \|date=October 1921 \|page=390 \|accessdate=5 April 2014}}</ref><ref name="KMJAug1922">{{cite journal \|url=http://books.google.com/books?id=OTMTAAAAYAAJ&pg=PA755 \|journal=Kentucky Medical Journal \|title=The Role of the Nonmedical Graduate in the Medical Laboratory \|author=White, Courtland Y. \|volume=25 \|issue=11 \|date=August 1922 \|pages=755–760 \|accessdate=5 April 2014}}</ref><ref name="BMSJMar1922">{{cite journal \|url=http://books.google.com/books?id=E741AQAAMAAJ&pg=PA442 \|journal=The Boston Medical and Surgical Journal \|title=The Business Side of X-ray Diagnosis and Treatment \|author=Sundelof, E. M. \|volume=186 \|issue=13 \|date=30 March 1922 \|pages=442–444 \|accessdate=5 April 2014}}</ref> An alternative was at times proposed in the form of a state or local diagnostic lab or a referral-only "clinic" that could be well-equipped with professional tools, staff, and procedures, critical for rural areas and usable for more than just public health care diagnoses.<ref name="TNHJan1921">{{cite journal \|url=http://books.google.com/books?id=TI7lAAAAMAAJ&pg=PA35 \|journal=The Nation's Health \|title=Group Consultation Clinic \|author=Boddy, Edmund C. \|volume=3 \|issue=1 \|date=January 1921 \|pages=35–36 \|accessdate=5 April 2014}}</ref><ref name="KMJDec1922">{{cite journal \|url=http://books.google.com/books?id=WOcvAQAAMAAJ&pg=PA839 \|journal=Kentucky Medical Journal \|title=The County and Community Diagnostic Laboratory \|author=Jones, Vernon R. \|volume=20 \|issue=12 \|date=December 1922 \|pages=836–841 \|accessdate=5 April 2014}}</ref> However, other medical professionals, while recognizing the need for more professional laboratory environments and more ethical advertising, dismissed those declaring the commercial laboratory as "evil,"<ref name="JNDAVol81921">{{cite journal \|url=http://books.google.com/books?id=vcoyAQAAMAAJ&pg=PA68 \|journal=The Journal of the National Dental Association \|title=Need and Means of Educating Laboratory Assistants \|author=Sears, Victor H. \|volume=8 \|issue=1 \|date=January 1921 \|pages=65–68 \|accessdate=5 April 2014}}</ref> content to state those types of labs were needed and then fully entrenched in the health care environment.<ref name="TNHJan1921" /><ref name="KMJAug1922" />

Shawndouglas: /* Further reading */ Corrected first citation

2017-06-23T16:45:51Z

Further reading: Corrected first citation

← Older revision		Revision as of 16:45, 23 June 2017
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	==Further reading==		==Further reading==

	* {{cite book \|url=~~http~~://~~www~~.~~forgottenbooks~~.~~org~~/~~readbook/International_Clinics_v3_1000133973#329~~ \|title=International Clinics: A Quarterly of Clinical Lectures \|chapter=The Clinical Laboratory in Private Practice and in the Physician's Office \|author=Camac, C. N. B.; Cattell, Henry W. (ed.) \|publisher=J.B. Lippincott Company \|volume=3 \|pages=289–299 \|year=1901}}		* {{cite book \|url=https://books.google.com/books?id=TigSAAAAYAAJ&pg=PA289 \|title=International Clinics: A Quarterly of Clinical Lectures \|chapter=The Clinical Laboratory in Private Practice and in the Physician's Office \|author=Camac, C. N. B.; Cattell, Henry W. (ed.) \|publisher=J.B. Lippincott Company \|volume=3 \|issue=11 \|pages=289–299 \|year=1901}}
	* {{cite web \|url=http://www.cap.org/apps/portlets/contentViewer/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html \|title=What lies in wait for office labs? \|author=Dolan, Thomas \|work=CAP Today \|publisher=College of American Pathologists \|date=June 2003}}		* {{cite web \|url=http://www.cap.org/apps/portlets/contentViewer/show.do?printFriendly=true&contentReference=cap_today%2Ffeature_stories%2Foffice_labs.html \|title=What lies in wait for office labs? \|author=Dolan, Thomas \|work=CAP Today \|publisher=College of American Pathologists \|date=June 2003}}
	* {{cite journal \|url=http://www.ncbi.nlm.nih.gov/pubmed/10177215 \|journal=Clinical Laboratory Science \|title=Tracing our roots: origins of clinical laboratory science \|author=Kotlarz, V. R. \|volume=11 \|issue=1 \|date=January–February 1998 \|pages=5–7 \|pmid=10177215}}		* {{cite journal \|url=http://www.ncbi.nlm.nih.gov/pubmed/10177215 \|journal=Clinical Laboratory Science \|title=Tracing our roots: origins of clinical laboratory science \|author=Kotlarz, V. R. \|volume=11 \|issue=1 \|date=January–February 1998 \|pages=5–7 \|pmid=10177215}}