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[[File:Rapid point-of-care syphilis test-CDC.jpg|right|thumb|Point-of-care devices such as this rapid syphilis test are commonly used in the POL.]]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=09 March 2021 |accessdate=18 November 2021}}</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=18 November 2021}}</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 2021, the [[Centers for Medicare and Medicaid Services]] (CMS) reported 41% of all CLIA-approved laboratories in the United States (130,335) 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 2021 |accessdate=18 November 2021}}</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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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 2021, 68% 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 2021 |accessdate=18 November 2021}}</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=18 November 2021}}</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 [[Food and Drug Administration]] (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" />
==''Introduction to Quality and Quality Management Systems''==
{{ombox
| type      = content
| style    = width: 500px;
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
}}
The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.


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=18 November 2021}}</ref>:
;1. What is quality?
* urine analysis
:''Key terms''
* urine pregnancy
:[[Quality (business)|Quality]]
* blood occult
:[[Quality assurance]]
* glucose blood
:[[Quality control]]
* pathology consultation during surgery
:''The rest''
* crystal identification by microscope
:[[Data quality]]
* sperm identification and analyses
:[[Information quality]]
* bilirubin total
:[[Nonconformity (quality)|Nonconformity]]
* blood gasses
:[[Service quality]]
* complete blood count
;2. Processes and improvement
* bone marrow smear
:[[Business process]]
* blood bank services
:[[Process capability]]
* transfusion medicine
:[[Risk management]]
:[[Workflow]]
;3. Mechanisms for quality
:[[Acceptance testing]]
:[[Conformance testing]]
:[[Clinical quality management system]]
:[[Continual improvement process]]
:[[Corrective and preventive action]]
:[[Good manufacturing practice]]
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
:[[Quality management]]
:[[Quality management system]]
:[[Total quality management]]
;4. Quality standards
:[[ISO 9000]]
:[[ISO 13485]]
:[[ISO 14000|ISO 14001]]
:[[ISO 15189]]
:[[ISO/IEC 17025]]
:[[ISO/TS 16949]]
;5. Quality in software
:[[Software quality]]
:[[Software quality assurance]]
:[[Software quality management]]


==References==
<!--Place all category tags here-->
{{Reflist|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

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Introduction to Quality and Quality Management Systems

This book should not be considered complete until this message box has been removed. This is a work in progress.

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management


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