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| ==1.1 Medical diagnostics lab== | | == LIS User Requirements for the Physician Office Laboratory (POL) == |
| 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>
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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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| The medical laboratory at a basic level, whether chemistry or pathology, operates like many other analytical testing laboratories. However, there are a few nuances between the medical laboratory and 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 (e.g., the [[Health Insurance Portability and Accountability Act]] [HIPAA] in the U.S. and General Data Protection Regulation [GDPR] in Europe). This creates a significant challenge not generally experienced by other types of analytical laboratories.
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| In most parts of the world, the medical laboratory is either attached to a [[hospital]], performing tests on their patients, or acts as a private (or public) laboratory that receives analysis requests and samples from physicians, insurance companies, clinical research sites, and other health clinics for analysis. In cases where a particularly specialized analysis is required and standard medical laboratory is not equipped to handle it, a research laboratory with the appropriate equipment and expertise may be employed. In other cases, a laboratory may decide it's simply more cost effective to contract more specialized, less common analyses out to specialized medical labs rather than heavily invest in the equipment and training to perform such analyses. Examples include the molecular diagnostics and cytogenetics laboratory, which provide diagnoses and treatment options for genetic or cancer-related disorders.
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| Like other analytical laboratories, regulations, laws, and standards typically drive how vital aspects of the laboratory operate. In the United States, clinical laboratories are primarily regulated by the [[United States Department of Health and Human Services|Department of Health and Human Services]]. Inside that infrastructure are sub-entities like the [[Centers for Disease Control and Prevention]] (CDC) and the [[Centers for Medicare and Medicaid Services]] (CMS) to apply standards and regulations through their respective Laboratory Quality Assurance and Standardization Programs, and the Clinical Laboratory Improvement Amendments.<ref name="DHHS_HHS19">{{cite web |urlhttps://www.hhs.gov/about/agencies/orgchart/index.html |title=HHS Organizational Chart |publisher=U.S. Department of Health & Human Services |date=31 December 2019 |accessdate=03 January 2020}}</ref><ref name="CDCLaboratory17">{{cite web |url=https://www.cdc.gov/labstandards/ |title=Laboratory Quality Assurance and Standardization Programs |publisher=Centers for Disease Control and Prevention |date=25 July 2017 |accessdate=03 January 2020}}</ref><ref name="CMS_CLIA">{{cite web |url=https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index |title=Clinical Laboratory Improvement Amendments (CLIA) |publisher=Centers for Medicare and Medicaid Services |date=03 December 2019 |accessdate=03 January 2019}}</ref> Although generally not as strict as the regulations regarding pharmaceutical and diagnostic manufacturers, the regulations affecting the medical laboratory nonetheless act as a significant hurdle to managing the overall operations of the laboratory, from acquiring customers and samples, to testing, reporting results, and handling billing for the completed tests.
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| Internationally, regulatory bodies vary from country to country. However, organizations like the not-for-profit Clinical and Laboratory Standards Institute (CLSI)<ref name="CLSIAbout">{{cite web |url=https://clsi.org/about/about-clsi/ |title=About CLSI |publisher=Clinical and Laboratory Standards Institute |accessdate=03 January 2020}}</ref> and associations like the Research Quality Association (RQA)<ref name="RQAAbout">{{cite web |url=https://www.therqa.com/about/ |title=What is RQA? |publisher=Research Quality Association |accessdate=03 January 2020}}</ref> exist to promote a more global approach to regulations and guidance affecting medical diagnostic and research laboratories. Additionally, a set of Good Clinical Laboratory Practice standards—originally developed in 2002 and since adopted by the World Health Organisation (WHO), non-governmental organisations (NGOs), and research institutions worldwide—provide guidance on implementing laboratory practices that are critical for laboratory operations around the world.<ref name="RQAGCLP">{{cite web |url=https://www.therqa.com/resources/publications/booklets/good-clinical-laboratory-practice-booklet/ |title=Good Clinical Laboratory Practice (GCLP) |publisher=Research Quality Association |date=January 2012 |accessdate=03 January 2020}}</ref><ref name="GCLPEzzelle">{{cite journal |title=Guidelines on Good Clinical Laboratory Practice - Bridging Operations between Research and Clinical Research Laboratories |author=Ezzelle, J.; Rodriguez-Chavez, I.R.; Darden, J.M. et al. |journal=Journal of Pharmaceutical and Biomedical Analysis |volume=46 |issue=1 |pages=18–29 |year=2008 |doi=10.1016/j.jpba.2007.10.010 |pmid=18037599 |pmc=PMC2213906}}</ref>
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| ===1.1.1 Physician office lab===
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| 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>
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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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| Dr. Ralph Snyderman, Director of the Center for Personalized Health Care at Duke University, defines integrative medicine as a process that creates and encourages "a seamless engagement by patients and caregivers in the full range of physical, psychological, social, preventive, and therapeutic factors known to be effective and necessary for the achievement of optimal health over the course of one's life."<ref name="SnydermanInteg11">{{cite web |url=https://www.scripps.org/assets/documents/ralph_snyderman_md_03-30-11.pdf |format=PDF |title=Integrative Medicine: A Comprehensive Approach to Personalized Care |author=Snyderman, R. |work=Scripps Clinic Green Hospital Grand Rounds |date=30 March 2011 |accessdate=04 January 2020}}</ref> This type of personalized healthcare takes a more holistic approach to the causes of illnesses, including the biological, behavioral, psychosocial, and environmental contributors.<ref name="BravewellInteg15">{{cite web |url=http://www.bravewell.org/integrative_medicine/ |title=Integrative Medicine |publisher=The Bravewell Collaborative |date=2015 |accessdate=04 January 2020}}</ref> Some medical laboratories such as those found within Duke Integrative Medicine<ref name="BravewellDuke15">{{cite web |url=http://www.bravewell.org/current_projects/clinical_network/duke_center/ |title=Duke Integrative Medicine |publisher=The Bravewell Collaborative |date=2015 |accessdate=04 January 2020}}</ref>, as well as Harvard Medical School's Contemplative Neuroscience and Integrative Medicine Laboratory<ref name="HarvardCNIM20">{{cite web |url=https://davidvago.bwh.harvard.edu/contemplative-neuroscience-and-integrative-medicine-cnim-laboratory/ |title=Contemplative Neuroscience and Integrative Medicine (CNIM) Laboratory |work=David R. Vago - Brigham and Women's Hospital |publisher=Harvard Medical School |date=2020 |accessdate=04 January 2020}}</ref>, include an integrative medicine approach to their medical diagnostic and research activities. Laboratories associated with integrative medicine approaches are quite similar to standard medical laboratories, though, broadly speaking, they focus more on nutritional, metabolic, and toxicity test types.<ref name="BralleyBasic">{{cite book |url=https://books.google.com/books?id=CpXVAwgOv7sC&pg=PT11 |chapter=Chapter 1: Basic Concepts |title=Laboratory Evaluations for Integrative and Functional Medicine |author=Bralley, J.A.; Lord, R.S. |publisher=MetaMetrix Institute |edition=2nd |pages=1–16 |year=2008 |isbn=0967394945}}</ref>
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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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