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| Introductory chapter text goes here
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| ==1.1 Medical diagnostics lab== | | == LIS User Requirements for the Physician Office Laboratory (POL) == |
| ===1.1.1 Physician office lab=== | | {{ombox |
| 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 206 |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>
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| | ;Chapter 1 Introduction |
| | :[[Clinical laboratory]] |
| | :[[Health informatics]] |
| | ;Chapter 2 The Physician Office Laboratory (POL) |
| | :[[Physician office laboratory]] |
| | :[[LII:The Practical Guide to the U.S. Physician Office Laboratory]] |
| | ;Chapter 3 Defining LIS Requirements with the LIMSpec |
| | :[[LIS feature]] |
| | :[[Clinical Laboratory Improvement Amendments]] |
| | :[[Health Insurance Portability and Accountability Act]] |
| | ;Chapter 4 Example LIMSpec for the Physician Office Lab |
| | :[[POL Registration/accession|Registration/Accession]] |
| | :[[POL Assays|Assays]] |
| | :[[POL Data entry|Data Entry]] |
| | :[[POL Reporting|Reporting]] |
| | :[[POL Compliance|Compliance]] |
| | :[[POL Interfacing|Interfacing]] |
| | :[[POL System|System]] |
| | :[[POL General|General]] |
| | :[[POL Functions - General]] |
| | ;Chapter 5 LIS Products for the Physician Office Lab |
| | :[[Vendor:Apex HealthWare, LLC|Apex HealthWare, LLC]] |
| | :[[Vendor:CompuGroup Medical AG|CompuGroup Medical AG]] |
| | :[[Vendor:J&S Medical Associates, Inc.|J&S Medical Associates, Inc.]] |
| | :[[Vendor:Orchard Software Corporation|Orchard Software Corporation]] |
| | :[[Schuyler House]] |
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| 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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| 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>:
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| * urine analysis
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| * urine pregnancy
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| * blood occult
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| * glucose blood
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| * pathology consultation during surgery
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| * crystal identification by microscope
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| * sperm identification and analyses
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| * bilirubin total
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| * blood gasses
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| * complete blood count
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| * bone marrow smear
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| * blood bank services
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| * transfusion medicine
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| ===1.1.2 Integrative medicine lab===
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| ==1.3 Public health lab==
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| ==1.4 Pathology lab==
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| ===1.4.1 Anatomical pathology===
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| ===1.4.2 Clinical pathology===
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| ===1.4.3 Forensic pathology (medical examiner)===
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| ==1.5 Toxicology lab==
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| ==1.6 Blood bank and transfusion lab==
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| ==1.7 Central and contract research lab (CT/CRO)==
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| ==1.8 Cytogenetics lab==
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| ==1.9 Genetic diagnostics lab (NGS)==
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| ==References==
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| {{Reflist|colwidth=30em}}
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