Difference between revisions of "User:Shawndouglas/sandbox/sublevel2"
Shawndouglas (talk | contribs) |
Shawndouglas (talk | contribs) |
||
| Line 1: | Line 1: | ||
<div class="nonumtoc">__TOC__</div> | <div class="nonumtoc">__TOC__</div> | ||
Introductory chapter text goes here | |||
==1.1 Medical diagnostics lab== | ==1.1 Medical diagnostics lab== | ||
===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 206 |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 [[Clinical Laboratory Improvement Amendments]] (CLIA) testing. 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" /> | |||
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 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=== | ===1.1.2 Integrative medicine lab=== | ||
==1.3 Public health lab== | ==1.3 Public health lab== | ||
Revision as of 21:50, 3 January 2020
Introductory chapter text goes here
1.1 Medical diagnostics 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.[1][2] 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.[2][3]
Testing and reporting at a POL, at least in the U.S., is largely concentrated on the realm of waived Clinical Laboratory Improvement Amendments (CLIA) testing. CLIA test complexity has three levels: high, moderate, and waived.[4] 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.[4] 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.[4]
Commonly performed tests include[5]:
- 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
- ↑ "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.
- ↑ 2.0 2.1 "Physician Office Laboratory Evaluation Program (POLEP)". Wadsworth Center New York State Department of Health. https://www.wadsworth.org/regulatory/polep. Retrieved 03 January 2020.
- ↑ "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 206. https://web.archive.org/web/20161229143212/http://www.cdph.ca.gov/programs/lfs/Documents/POL-FAQ.pdf. Retrieved 03 January 2020.
- ↑ 4.0 4.1 4.2 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.
- ↑ 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.
