View source for The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Primary laboratory testing domains in the POL/Toxicology and pain management

===2.5 Toxicology and pain management===
Toxicology is the study of the effects of chemicals, elements, and other molecules on living organisms. In the CLIA-waived POL, this testing is essentially limited to drugs of abuse and the heavy metal lead (a CLIA-waived system for lithium testing called InstaRead<ref name="RLHomeArch">{{cite web |url=https://www.relialab.com/ |archiveurl=https://web.archive.org/web/20061205044853/https://www.relialab.com/ |title=ReliaLab |publisher=ReliaLab, Inc |archivedate=05 December 2006 |accessdate=17 May 2022}}</ref> seems to no longer be manufactured). Drug screenings in particular became more common in the first two decades of the twenty-first century, mandated not only by employers but also in some cases by the federal government. While this sort of testing holds importance inside and outside the POL, it also has been abused historically.<ref name="CollenDrug" /><ref name="WSJWeaverMatthews">{{cite web |url=https://www.wsj.com/articles/doctors-cash-in-on-drug-tests-for-seniors-and-medicare-pays-the-bill-1415676782 |title=Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill |author=Weaver, Christopher; Matthews, Anna-Wilde |work=The Wall Street Journal |publisher=Dow Jones & Company, Inc |date=10 November 2014 |accessdate=17 May 2022}}</ref> For example, the number of POL-based drug screenings paid for by Medicare skyrocketed between 2000 and 2009 as physician offices realized they could make good money on easy testing. As such, CMS amended their rules in 2010 to prevent this type of unintended billing behavior, decreasing the financial viability of such tests for the POL.<ref name="CollenDrug">{{cite journal |url=https://www.academia.edu/7840929/Profit-driven_drug_testing |title=Proﬁt-Driven Drug Testing |author=Collen, Mark |journal=Journal of Pain & Palliative Care Pharmacotherapy |year=2012 |issue=26 |pages=13–17 |doi=10.3109/15360288.2011.650358 |accessdate=21 April 2022}}</ref>

Tangentially related is the practice of pain management, the study of how best to improve the quality of life of those living with pain. Chronic opioid therapy is one such related treatment method, though it too hasn't come without risk of abuse. Physician-owned pain management clinics or private practices offering pain management services are increasingly regulated<ref name="CDCMenu12">{{cite web |url=https://www.cdc.gov/phlp/docs/menu-pmcr.pdf |format=PDF |title=Menu of Pain Management Clinic Regulation |publisher=Centers for Disease Control and Prevention |date=28 September 2012 |accessdate=13 May 2022}}</ref>, though those regulations neither explicitly state that urine drug tests or some other form of adherence monitoring are required, nor do they currently prohibit opioid and other drug-based therapies on patients abusing controlled substances.<ref name="JannettoInt14">{{cite web |url=http://www.mayomedicallaboratories.com/media/articles/hot-topic/2014/2014-02-15-urine-opiate-tests-pain-management-fulltext.pdf |archiveurl=https://web.archive.org/web/20170329160914/http://www.mayomedicallaboratories.com/media/articles/hot-topic/2014/2014-02-15-urine-opiate-tests-pain-management-fulltext.pdf |format=PDF |title=Interpretation of Qualitative and Quantitative Urine Opiate Tests for Pain Management Patients |author=Jannetto, Paul J. |publisher=Mayo Foundation for Medical Education and Research |page=6 |date=15 February 2014 |archivedate=29 March 2017 |accessdate=13 May 2022}}</ref> Despite this, "compliance monitoring has been shown to be crucial in delivering proper opioid therapy and preserving this therapy for the future,"<ref name="ChristoUrine11">{{cite journal |title=Urine Drug Testing In Chronic Pain |journal=Pain Physician |author=Christo, Paul J.; Manchikanti, Laxmaiah; Ruan, Xiulu; Bottros, Michael; Hansen, Hans; Solanki, Daneshvari R.; Jordan, Arthur E.; Colson, James |volume=14 |issue=2 |pages=123-143 |year=2011 |pmid=21412368 |url=https://www.painphysicianjournal.com/current/past?journal=60 |accessdate=13 May 2022}}</ref> and urine drug testing is one of the major tools used in this monitoring.<ref>{{Cite journal |last=Koyyalagunta |first=Dhanalakshmi |last2=Bruera |first2=Eduardo |last3=Engle |first3=Mitchell P |last4=Driver |first4=Larry |last5=Dong |first5=Wenli |last6=Demaree |first6=Chris |last7=Novy |first7=Diane M |date=2018-07-01 |title=Compliance with Opioid Therapy: Distinguishing Clinical Characteristics and Demographics Among Patients with Cancer Pain |url=https://academic.oup.com/painmedicine/article/19/7/1469/4056219 |journal=Pain Medicine |language=en |volume=19 |issue=7 |pages=1469–1477 |doi=10.1093/pm/pnx178 |issn=1526-2375 |pmc=PMC6279272 |pmid=29016951}}</ref>

====2.5.1 Testing====
As drugs are metabolized, they produce metabolites which show up in urine and saliva. As such, both urine- and saliva-based tests have been manufactured to make qualitative and quantitative determinations of a metabolite's presence relatively easy and accurate. Ethanol is a common legal drug in the U.S. and constitutes one of the drugs tested for in CLIA-waived tests. Note, however, that ethanol testing is not typically part of a qualitative immunoassay-based urine test; the associated metabolites ethyl glucuronide (EtG) and ethyl sulfate (EtS) may appear in urine for reasons other than direct alcohol consumption, including the ingestion of partially fermented juices and absorption through the skin of alcohol-based lotions.<ref name="KFDrugPolicy">{{cite web |url=http://www.keystonefirstpa.com/pdf/provider/resources/clinical/policies/quantitative-vs-qualitative-drug-screen.pdf |archiveurl=https://web.archive.org/web/20220513204029/https://studyres.com/doc/8035430/quantitative-and-qualitative-drug-screens-for-illicit-use-of |format=PDF |title=Clinical Policy Title: Drug Screens — Quantitative and Qualitative Drug Screens for Illicit Use of Pharmaceuticals |publisher=Keystone First |date=18 June 2014 |archivedate=13 May 2022 |accessdate=13 May 2022}}</ref><ref name="QuestUrineDrug">{{cite web |url=https://testdirectory.questdiagnostics.com/test/test-detail/90418/drug-toxicology-monitoring-alcohol-metabolites-with-confirmation-urine?p=r&q=Alcohol%20Metabolites%20with%20Confirmation,%20Urine&cc=MASTER |title=Drug Toxicology Monitoring Alcohol Metabolites, with Confirmation, Urine |publisher=Quest Diagnostics |accessdate=13 May 2022}}</ref><ref name="VeriWhatUrine">{{cite journal |url=http://www.verificationsinc.com/newsletter/10152006/urinealcoholtesting.html |archiveurl=https://web.archive.org/web/20151128094608/http://www.verificationsinc.com/newsletter/10152006/urinealcoholtesting.html |title=What You Should Know About Testing for Alcohol in Urine |journal=Verifications, Inc. Client Newsletter |publisher=Verifications, Inc. |volume=1 |issue=1 |year=Fall 2006 |archivedate=28 November 2015 |accessdate=13 May 2022}}</ref> Since ethanol equilibrates rapidly between saliva and blood<ref name="DegutisThe04">{{cite journal |title=The saliva strip test is an accurate method to determine blood alcohol concentration in trauma patients |journal=Academic Emergency Medicine |author=Degutis, L.C1.; Rabinovici, R.; Sabbaj, A.; Mascia, R.; D'Onofrio, G. |volume=11 |issue=8 |pages=885-7 |doi=10.1197/j.aem.2004.02.529 |pmid=15289199}}</ref><ref name="KarchDrug06">{{cite book |url=https://books.google.com/books?id=F0mUte90ATUC&pg=PA404 |title=Drug Abuse Handbook |author=Karch, Steven B. |publisher=CRC Press |edition=2nd |isbn=9781420003468 |year=2006 |page=404 |accessdate=13 May 2022}}</ref>, and a saliva test is rapid and easy to administer, most CLIA-waived tests for ethanol—usually quantitative—will be saliva-based.<ref name="CMSCLIATests">{{cite web |url=https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data |title=Clinical Laboratory Improvement Amendments - Download Data |publisher=U.S. Food & Drug Administration |date=23 November 2021 |accessdate=13 May 2022}}</ref> Qualitative testing for amphetamines, cannabinoids, morphine, and many other constituents of drugs classified as drugs of abuse is typically done with relatively simple CLIA-waived urine test cups and cards.<ref name="CMSCLIATests" /> However, proper care in specimen labeling, storage, technique (including timing recommendations), and interpretation are still vital to ensure the most accurate results.<ref name="LiesekeZeibig">{{cite book |url=https://books.google.com/books?id=IX_2AAAAQBAJ&pg=PA1 |title=Essentials Of Medical Laboratory Practice |author=Lieseke, Constance L.; Zeibig, Elizabeth A. |publisher=F. A. Davis |year=2012 |pages=539 |isbn=9780803630352 |accessdate=13 May 2022}}</ref>

In the particular case of pain management, a simple qualitative immunoassay-based urine drug screen isn't always appropriate or accurate. Differences in metabolites and problems with accuracy come with those simplified tests.<ref name="ChristoUrine11" /><ref name="JonesPain12">{{cite web |url=http://articles.physiciansofficeresource.com/2012/december/4/pain-practice-laboratory-made-simple/ |archiveurl=https://web.archive.org/web/20180213034200/http://articles.physiciansofficeresource.com/2012/december/4/pain-practice-laboratory-made-simple/ |title=Pain Practice Laboratory Made Simple |author=Jones, Elizabeth |work=Physicians Office Resource |publisher=Medical Education Resources, LLC |date=04 December 2012 |archivedate=13 February 2018 |accessdate=13 May 2022}}</ref> More accurate measurements may be necessary in the pain management laboratory, necessitating chromatographic tools and techniques that fall under CLIA moderate to advanced status. Given the previously mentioned fact that only 11.9 percent of all registered non-exempt POLs would be CLIA certified for such testing<ref name="CMS14Enroll">{{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=May 2022 |accessdate=13 May 2022}}</ref>, this sort of advanced testing would be limited to pain management POLs willing to go through the financial and regulatory hoops involved.<ref name="JonesPain12" />

For testing levels of lead in blood, the LeadCare II lead testing system remains the only CLIA-waived option.<ref name="LCIIAbout">{{cite web |url=https://www.magellandx.com/leadcare-products/leadcare-ii/ |title=LeadCare II |publisher=Magellan Diagnostics, Inc |accessdate=13 May 2022}}</ref>