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==1.1 Medical diagnostics lab==
==1.1 Medical diagnostics lab==
Often referred to as simply a medical or clinical laboratory, the medical diagnostics lab performs tests on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.<ref name="MedLabTech">{{cite book |title=Textbook of Medical Laboratory Technology |chapter=Chapter 1: Laboratory |author=Sood, R. |url=https://books.google.com/books?id=hpNhAQAACAAJ |pages=01–28 |year=2006 |publisher=Jaypee Brothers Publishers |isbn=818061591X}}</ref> An additional definition is provided by the [[Clinical Laboratory Improvement Amendments]] (CLIA) program, as "a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings."<ref name="CLIACDCLab">{{cite web |url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCertificateofWaiver.pdf |format=PDF |title=CLIA - How to Obtain a CLIA Certificate of Waiver |publisher=Centers for Disease Control and Prevention |date=March 2019 |accessdate=03 January 2020}}</ref>
The medical laboratory at a basic level, whether chemistry or pathology, operates like many other analytical testing laboratories. However, there are a number of operational differences between the medical laboratory and the many other analytical laboratories. One of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination and to establish assurance that sample cross contamination is minimized.<ref name="ChenGood09">{{cite journal |url=https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5806a1.htm |title=Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions |author=Chen, B.; Gagnon, M.; Shahangian, S. et al. |journal=Morbidity and Mortality Weekly Report |volume=58 |issue=RR06 |pages=1–29 |date=12 June 2009 |accessdate=03 January 2020}}</ref><ref name="VianaGood11">{{cite book |title=Wide Spectra of Quality Control |chapter=Chapter 3: Good Clinical Laboratory Practice (GCLP) for Molecular Based Tests Used in Diagnostic Laboratories |author=Viana, R.V.; Wallis, C.L. |editor=Isin, A. |url=http://www.intechopen.com/download/pdf/23728 |format=PDF |pages=29–52 |year=2011 |publisher=InTech |isbn=9789533076836}}</ref> Another major difference concerns the regulations governing the management of patient data. This creates a significant challenge not generally experienced by other types of analytical laboratories.
===1.1.1 Physician office lab===
===1.1.1 Physician office lab===
The physician office lab, or POL, is a physician-, partnership-, or group-maintained [[laboratory]] that performs medical 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 POL 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> In October 2019, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 46% of all CLIA-approved ([[Clinical Laboratory Improvement Amendments]]) 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> However, as of 2014, POLs were estimated to be processing only about nine percent of all clinical laboratory tests.<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=03 January 2020}}</ref>
The physician office lab, or POL, is a physician-, partnership-, or group-maintained [[laboratory]] that performs medical 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 POL 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> In October 2019, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 46% of all CLIA-approved 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> However, as of 2014, POLs were estimated to be processing only about nine percent of all clinical laboratory tests.<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=03 January 2020}}</ref>


Testing and reporting at a POL, at least in the U.S., is largely concentrated on the realm of waived CLIA testing. As of October 2019, 67% of the POLs in the United States were primarily running CLIA waived tests.<ref name="CMS13Enroll">{{cite web |url=https://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> CLIA test complexity has three levels: high, moderate, and waived.<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> 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" /> 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" />  
Testing and reporting at a POL, at least in the U.S., is largely concentrated on the realm of waived CLIA testing. As of October 2019, 67% of the POLs in the United States were primarily running CLIA waived tests.<ref name="CMS13Enroll">{{cite web |url=https://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> CLIA test complexity has three levels: high, moderate, and waived.<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> 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" /> 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" />  
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===1.1.2 Integrative medicine lab===
===1.1.2 Integrative medicine lab===
==1.3 Public health lab==
==1.3 Public health lab==
==1.4 Pathology lab==
==1.4 Pathology lab==

Revision as of 22:39, 3 January 2020

Introductory chapter text goes here

1.1 Medical diagnostics lab

Often referred to as simply a medical or clinical laboratory, the medical diagnostics lab performs tests on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.[1] An additional definition is provided by the Clinical Laboratory Improvement Amendments (CLIA) program, as "a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings."[2]

The medical laboratory at a basic level, whether chemistry or pathology, operates like many other analytical testing laboratories. However, there are a number of operational differences between the medical laboratory and the many other analytical laboratories. One of these differences is the need to have a specific unidirectional workflow. This is intended to both minimize the risk of biohazard contamination and to establish assurance that sample cross contamination is minimized.[3][4] Another major difference concerns the regulations governing the management of patient data. This creates a significant challenge not generally experienced by other types of analytical laboratories.

1.1.1 Physician office lab

The physician office lab, or POL, is a physician-, partnership-, or group-maintained laboratory that performs medical 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.[5][6] 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 POL is considered a clinical laboratory and is thus regulated by federal, state, and/or local laws affecting such laboratories.[6][7] In October 2019, the Centers for Medicare and Medicaid Services (CMS) reported 46% of all CLIA-approved laboratories in the United States (121,265) were physician office laboratories.[8] However, as of 2014, POLs were estimated to be processing only about nine percent of all clinical laboratory tests.[9]

Testing and reporting at a POL, at least in the U.S., is largely concentrated on the realm of waived CLIA testing. As of October 2019, 67% of the POLs in the United States were primarily running CLIA waived tests.[10] CLIA test complexity has three levels: high, moderate, and waived.[11] 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.[11] 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.[11]

Commonly performed tests include[12]:

  • urine analysis
  • urine pregnancy
  • blood occult
  • glucose blood
  • pathology consultation during surgery
  • crystal identification by microscope
  • sperm identification and analyses
  • bilirubin total
  • blood gasses
  • complete blood count
  • bone marrow smear
  • blood bank services
  • transfusion medicine

1.1.2 Integrative medicine lab

1.3 Public health lab

1.4 Pathology lab

1.4.1 Anatomical pathology

1.4.2 Clinical pathology

1.4.3 Forensic pathology (medical examiner)

1.5 Toxicology lab

1.6 Blood bank and transfusion lab

1.7 Central and contract research lab (CT/CRO)

1.8 Cytogenetics lab

1.9 Genetic diagnostics lab (NGS)

References

  1. ↑ Sood, R. (2006). "Chapter 1: Laboratory". Textbook of Medical Laboratory Technology. Jaypee Brothers Publishers. pp. 01–28. ISBN 818061591X. https://books.google.com/books?id=hpNhAQAACAAJ. 
  2. ↑ "CLIA - How to Obtain a CLIA Certificate of Waiver" (PDF). Centers for Disease Control and Prevention. March 2019. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCertificateofWaiver.pdf. Retrieved 03 January 2020. 
  3. ↑ Chen, B.; Gagnon, M.; Shahangian, S. et al. (12 June 2009). "Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions". Morbidity and Mortality Weekly Report 58 (RR06): 1–29. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5806a1.htm. Retrieved 03 January 2020. 
  4. ↑ Viana, R.V.; Wallis, C.L. (2011). "Chapter 3: Good Clinical Laboratory Practice (GCLP) for Molecular Based Tests Used in Diagnostic Laboratories". In Isin, A. (PDF). Wide Spectra of Quality Control. InTech. pp. 29–52. ISBN 9789533076836. http://www.intechopen.com/download/pdf/23728. 
  5. ↑ "Chapter 16 - Laboratory Services" (PDF). Medicare Claims Processing Manual. Centers for Medicare and Medicaid Services. 3 May 2019. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf. Retrieved 03 January 2020. 
  6. ↑ 6.0 6.1 "Physician Office Laboratory Evaluation Program (POLEP)". Wadsworth Center New York State Department of Health. https://www.wadsworth.org/regulatory/polep. Retrieved 03 January 2020. 
  7. ↑ "Physician Office Laboratories or Clinics - Frequently Asked Questions about Clinical Laboratory Licensing and Registration" (PDF). California Department of Public Health. May 2008. Archived from the original on 29 December 2016. https://web.archive.org/web/20161229143212/http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf. Retrieved 03 January 2020. 
  8. ↑ "Laboratories by Type of Facility" (PDF). Centers for Medicare and Medicaid Services. October 2019. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/factype.pdf. Retrieved 03 January 2020. 
  9. ↑ "How and Where IVD Will Find Growth in the Global POL Market – Part 2". Kalorama Information. November 2014. Archived from the original on 17 April 2015. 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. Retrieved 03 January 2020. 
  10. ↑ Centers for Medicare and Medicaid Services, Division of Laboratory Services (October 2019). "Enrollment, CLIA exempt states, and certification of accreditation by organization" (PDF). https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statupda.pdf. Retrieved 03 January 2020. 
  11. ↑ 11.0 11.1 11.2 Centers for Disease Control and Prevention (6 August 2018). "Clinical Laboratory Improvement Amendments (CLIA): Test complexities". https://www.cdc.gov/clia/test-complexities.html. Retrieved 03 January 2020. 
  12. ↑ UnitedHealthcare Oxford (1 January 2018). "UnitedHealthcare Oxford's in-office laboratory testing and procedures list" (PDF). https://www.oxhp.com/secure/policy/in_office_laboratory_testing_and_procedures_list.pdf. Retrieved 03 January 2020. 
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