User:Shawndouglas/sandbox/sublevel10

Sandbox begins below

-----Return to the beginning of this guide-----

5. Final thoughts and additional resources

5.1 Final thoughts

The physician office laboratory (POL) has come a long way since its humble origins in the 1800s, using urinalysis to diagnose patient afflictions. The modern POL has a wider range of testing options thanks to evolutions in technologies such as molecular diagnostics. Yet they are also more regulated today (at least in the U.S.) than their ancestors, with the likes of the Clinical Laboratory Improvement Amendments (CLIA) framing test complexity and the requirements that come with each level of complexity. Laboratory testing is not all that is regulated either, with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) dictating how data and other information generated from testing must be protected. Add to that concerns about ensuring financial reimbursement for testing, maintaining competent staff, implementing and reviewing standardized procedures, tracking specimens, and reporting results in a timely and accurate fashion; this can leave the enterprising physician office doubting whether a POL is worth the effort.

However, the promise of caring for a patient's needs at or near the point of care—and the benefits that come with that—remains strong. Yes, pharmacy laboratories have increasingly sprung up in the last 10 years, taking away some of the momentum of the POL, but the physician isn't found at the pharmacy. Patients will continue to visit their physician, and many will continue to get value from having some level of laboratory testing at the physician office. This is usually represented by a set of specific tests that lend themselves well to being conducted relatively easily and interpreted rapidly. Types of urinalysis, blood analysis, clinical chemistry, and immunological analysis—particularly those that are CLIA-waived—are most likely to be employed in the POL for a number of conditions, diseases, or analytes, including pregnancy, cholesterol, thyroid-stimulating hormone, and mononucleosis.

This testing requires thoughtful workflow preparation and management that takes into account not only the order of operations but also the flow of information. Data and information management practices are important to the POL, and if their workload justifies it, the POL may require software solutions like laboratory information systems (LIS) and electronic health records (EHRs). However, implementing such systems isn't necessarily straightforward, requiring additional considerations about budget and usefulness. Decisions on such software implementations, as well as the testing the lab conducts and how it's conducted, requires knowledgeable personnel who have been trained in information systems and testing protocols. How the laboratory is classified with CLIA will determine whether or not a laboratory manager is a hard requirement; however, in all cases someone should be taking the lead on POL operations. Are processes and procedures properly documented? Is there a quality management process in the POL? Does the lab participate in proficiency testing? These and other aspects of the POL must be addressed, regardless of the POL's CLIA classification.

In the end, a POL still serves an important role within the sphere of clinical laboratory testing. As molecular testing options continue to expand to the point of care, the POL will likely see additional opportunities to expand its test menu. This was seen with the emergence of the COVID-19 pandemic and the demand for rapid molecular testing that came with it, which made clear that a quick diagnosis at the physician's office, among other locations, is valuable to patient management and treatment. But the POL's continued utility and success will largely hinge upon effective setup and management, which in turn requires knowledgeable and motivated people to ensure the POL's long-term success.

5.2 Further reading

Clinical laboratories, including the POL

• American Academy of Family Physicians (2013). AAFP Physician's Office Laboratory Microscopy Atlas (4th ed.). American Academy of Family Physicians. pp. 125. ISBN 9781940373003. https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/pt-lab-testing/microscopy-atlas.html. 

• Centers for Disease Control and Prevention (July 2015). "To Test or Not to Test? Considerations for Waived Testing" (PDF). Centers for Disease Control and Prevention. https://www.cdc.gov/labquality/docs/waived-tests/15_255581-test-or-not-test-booklet.pdf. 

• Dasgupta, A.; Sepulveda, J.L. (2019). Accurate Results in the Clinical Laboratory: A Guide to Error Detection and Correction (2nd ed.). Elsevier. pp. 510. ISBN 9780128137772. https://books.google.com/books?id=HB2kDwAAQBAJ&printsec=frontcover. 

• Garrels, Marti; Oatis, Carol S. (2018). Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Health Care Professionals (4th ed.). Elsevier Health Sciences. pp. 368. ISBN 9780323532235. https://www.elsevier.com/books/laboratory-and-diagnostic-testing-in-ambulatory-care/major/978-0-323-53223-5. 

• Pagana, Kathleen Deska; Pagana, Timothy J.; Pagana, Theresa N. (2021). Mosby's Diagnostic and Laboratory Test Reference (15th ed.). Elsevier Health Sciences. pp. 1104. ISBN 9780323675192. https://evolve.elsevier.com/cs/product/9780323675192. 

• Turgeon, M. (2018). Linne & Ringsrud's Clinical Laboratory Science (8th ed.). Elsevier Health Sciences. pp. 704. ISBN 9780323549837. https://www.elsevier.com/books/linne-and-ringsruds-clinical-laboratory-science/turgeon/978-0-323-53082-8. 

• Wager, K.A.; Lee, F.W.; Glaser, J.P. (2021). Health Care Information Systems: A Practical Approach for Health Care Management. Wiley. pp. 416. ISBN 9781119853879. https://www.wiley.com/en-us/Health+Care+Information+Systems%3A+A+Practical+Approach+for+Health+Care+Management%2C+5th+Edition-p-9781119853879. 

Industry magazines

• "Lab Manager Magazine". LabX Media Group. 2022. https://www.labmanager.com/magazine. 

• "Medical Laboratory Observer Magazine". Endeavor Business Media, LLC. 2022. https://www.mlo-online.com/magazine. 

• "Physicians Office Resource Magazine". Medical Education Resources, LLC. 2022. https://www.physiciansofficeresource.com/articles/magazine/. 

5.3 CLIA-waived POL instrument and test kit vendors

The following is a list of vendors verified to sell CLIA-waived instruments and/or test kits. Vendors were pulled from the FDA's downloadable CLIA file from May 2022. The file was sorted to pull out the CLIA-waived devices, and then the vendors were researched to see if they still actively marketed the listed product(s). In some cases, the vendor listed on the FDA file was acquired by another company. If the associated products were still found to be marketed by the acquiring company, that company name was used. CLIA-waived device and test kit types are given as a general guide to what CLIA-waived items the vendor offers.

Note: Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived. Some of these vendors may also sell analyzers and tests that are certified moderate or complex. Additionally, this listing does not name the specific CLIA-waived item(s). It is ultimately up to the potential buyer to verify with the vendor that a specific item is CLIA-waived before purchase.

Vendors of CLIA-waived Instruments and Devices Original manufacturer Testing domain(s) covered Device type(s) Abaxis, Inc. clinical chemistry chemistry analyzers Abbot Diabetes Care clinical chemistry blood glucose monitors Abbot Point of Care clinical chemistry, hematology blood analyzers, chemistry analyzers, hematology devices, molecular immunoassay analyzer ACON Laboratories, Inc. clinical chemistry, hematology, urinalysis blood glucose monitors, hematology devices, urine analyzers Advocate Meters, Inc. clinical chemistry blood glucose monitors AgaMatrix, Inc. clinical chemistry blood glucose monitors All Medicus Co., Ltd. clinical chemistry blood glucose monitors Alliance International Co., Ltd. clinical chemistry blood glucose monitors AmVenturex, Inc. clinical chemistry blood ketone monitors American Screening Corp. clinical chemistry blood glucose monitors Andon Health Co., Ltd. clinical chemistry blood glucose monitors Apex Biotechnology Corp. clinical chemistry blood glucose monitors, blood ketone monitors Applied Biomedical, LLC clinical chemistry blood glucose monitors Arkray USA, Inc. clinical chemistry blood glucose monitors, chemistry analyzers Ascensia Diabetes Care Holdings AG clinical chemistry blood glucose monitors Athelas, Inc. hematology hematology devices Becton Dickson and Company immunology digital immunoassay analyzer Bigfoot Biomedical, Inc. clinical chemistry blood glucose monitors binx health, Inc. immunology molecular immunoassay analyzer BioLand Technology Ltd. clinical chemistry blood glucose monitors Bionime Corporation clinical chemistry blood glucose monitors BioSys Laboratories, Inc. urinalysis urine analyzers BioTelemetry, Inc. clinical chemistry blood glucose monitors Biotron Diagnostics, Inc. clinical chemistry blood glucose monitors Bonraybio Co., Ltd. miscellaneous fertility monitor (male) Bruno Pharma Innovations, LLC clinical chemistry blood glucose monitors, blood ketone monitors BTNX, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers Cambridge Sensors Ltd. clinical chemistry blood glucose monitors Cardinal Health, Inc. urinalysis urine analyzers CGETC, Inc. clinical chemistry blood glucose monitors Clarity Diagnostics, LLC clinical chemistry, hematology, urinalysis blood glucose monitors, hematology devices, urine analyzers CoaguSense, Inc. hematology hematology devices DELBio, Inc. clinical chemistry blood glucose monitors Diathrive, Inc. clinical chemistry blood glucose monitors EKF Diagnostics Holding Plc clinical chemistry, hematology blood glucose monitors, blood ketone monitors, hematology devices Empecs Medical Co., Ltd. clinical chemistry blood glucose monitors EPS Bio Technology Corp. clinical chemistry blood glucose monitors Fifty 50 Medical, Inc. clinical chemistry blood glucose monitors FirstVitals Health and Wellness, Inc. clinical chemistry blood glucose monitors ForaCare, Inc. clinical chemistry blood glucose monitors General Life Biotechnology Co., Ltd. clinical chemistry blood glucose monitors Germaine Laboratories, Inc. clinical chemistry, urinalysis blood cholesterol monitors, blood glucose monitors, urine analyzers GL Diabetes, LLC clinical chemistry blood glucose monitors Gluco Perfect, Inc. clinical chemistry blood glucose monitors Greater Goods, LLC clinical chemistry blood glucose monitors GreenCross Medis Corp. clinical chemistry blood glucose monitors HemoCue AB clinical chemistry, hematology blood glucose monitors, hematology devices Henry Schein, Inc. urinalysis urine analyzers HMD Biomedical, Inc. clinical chemistry blood glucose monitors Home Aide Diagnostics, Inc. clinical chemistry blood glucose monitors Hummingbird Medical, Inc. dba Nurse Rosie Products clinical chemistry blood glucose monitors i-SENS. Inc. clinical chemistry blood glucose monitors, blood ketone monitors iHealth Labs, Inc. clinical chemistry blood glucose monitors ijDream Corporation clinical chemistry blood glucose monitors iLine Microsystems SL hematology hematology devices Infopia Co., Ltd. clinical chemistry blood glucose monitors Intuity Medical, Inc. clinical chemistry blood glucose monitors Jant Pharmacal Corp. hematology hematology devices Joicom Corporation clinical chemistry blood glucose monitors Joinsoon Medical Technology Co., Ltd. hematology hematology devices Keto-Check, Inc. clinical chemistry blood glucose monitors, blood ketone monitors KPI Healthcare, Inc. clinical chemistry blood cholesterol monitors LabStyle Innovations Ltd. clinical chemistry blood glucose monitors LifeScan, Inc. clinical chemistry blood glucose monitors Livongo Health, Inc. clinical chemistry blood glucose monitors Magellan Diagnostics, Inc. clinical chemistry blood analyzers Major Biosystem Co., Ltd. clinical chemistry blood glucose monitors McKesson Medical-Surgical McKesson Medical-Surgical, PSS site clinical chemistry, urinalysis blood glucose monitors, urine analyzers MediVena, LLC clinical chemistry blood glucose monitors Medline Industries, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers Meridian Bioscience, Inc. clinical chemistry blood lead analyzer Mesa Biotech, Inc. immunology digital immunoassay analyzer Metene Limited clinical chemistry blood glucose monitors MHC Medical Products, LLC clinical chemistry blood glucose monitors MiCoBioMed Co., Ltd. clinical chemistry blood glucose monitors MicroTech Medical (Hangzhou) Co., Ltd. clinical chemistry blood glucose monitors Midwest Trading Group, Inc. clinical chemistry blood glucose monitors Nova Biomedical Corp. clinical chemistry blood glucose monitors O2 Lifecare, LLC clinical chemistry blood glucose monitors, blood cholesterol monitors Ok Biotech Co., Ltd. clinical chemistry blood glucose monitors Omnis Health, LLC clinical chemistry blood glucose monitors OptumRx, Inc. clinical chemistry blood glucose monitors Philosys Co., Ltd. clinical chemistry blood glucose monitors Pip Diabetes Care clinical chemistry blood glucose monitors Polymer Technology Systems, Inc. clinical chemistry blood glucose monitors, blood cholesterol monitors POPS! Diabetes Care, Inc. clinical chemistry blood glucose monitors Prodigy Diabetes Care, LLC clinical chemistry blood glucose monitors PTS Diagnostics clinical chemistry, hematology blood glucose monitors, hematology devices Roche Diagnostics clinical chemistry, hematology, urinalysis blood glucose monitors, hematology devices, urine analyzers SD BioSensor, Inc. clinical chemistry blood glucose monitors Separation Technology, Inc. hematology hematology devices Siemens Healthcare GmbH hematology, urinalysis hematology devices, urine analyzers Simple Diagnostics, Inc. clinical chemistry blood glucose monitors Sinocare, Inc. clinical chemistry blood glucose monitors Smart Meter, LLC clinical chemistry blood glucose monitors SMC Direct, LLC clinical chemistry, urinalysis blood glucose monitors, urine analyzers Stanbio Laboratory L.P. hematology, urinalysis hematology devices, urine analyzers Swiss Precision Diagnostics GmbH urinalysis fertility monitor (female) TearLab Corporation clinical chemistry chemistry analyzers Teco Diagnostics, Inc. urinalysis urine analyzers Tenovi Ltd. clinical chemistry blood glucose monitors Trividia Health, Inc. clinical chemistry blood glucose monitors Tyson Bioresearch, Inc. clinical chemistry blood glucose monitors US Diagnostics, Inc. clinical chemistry blood glucose monitors Vidan Diagnostics, LLC clinical chemistry blood glucose monitors, blood ketone monitors Visgeneer, Inc. clinical chemistry blood glucose monitors VivaChek Laboratories, Inc. clinical chemistry blood glucose monitors, blood ketone monitors YD Diagnostics Corp. urinalysis urine analyzers Zenith Diagnostics clinical chemistry blood glucose monitors

Vendors of CLIA-waived Test Kits and Supplies Original manufacturer Testing domain(s) covered Test kit type(s) 1 Step Detect Associates, LLC toxicology drug screen Abbott (formerly Alere/Inverness/Innovacon) immunology, toxicology drug screen, fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A ACON Laboratories, Inc. immunology, toxicology, urinalysis drug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips Acro Biotech, Inc. immunology pregnancy test Advin Biotech, Inc. toxicology drug screen Aerscher Diagnostics, LLC immunology fecal occult, gastric occult Ai De Diagnostic Co. immunology pregnancy test Alfa Scientific Designs, Inc. immunology, toxicology, urinalysis drug screen, fecal occult, H. pylori, ovulation test, pregnancy test ALYK, Inc. immunology pregnancy test American Bio Medica Corp. toxicology drug screen American Screening Corp. toxicology drug screen Ameritek USA, Inc. immunology fecal occult, ovulation test, pregnancy test, trichomonas Analyticon Biotechnologies AG urinalysis urine reagent strips Arlington Scientific, Inc. immunology pregnancy test Artron Laboratories, Inc. immunology pregnancy test Assure Tech. (Hangzhou) Co., Ltd. toxicology drug screen Atlas Medical Ltd. immunology pregnancy test Axium BioResearch, Inc. toxicology drug screen Azure Biotech, Inc. immunology pregnancy test Beckman Coulter, Inc. immunology fecal occult, gastric occult, H. pylori, mono, pregnancy test, Strep A Becton Dickson and Company immunology H. pylori, ovulation test, pregnancy test, Strep A Best Value Medical toxicology drug screen Bhat Bio-tech India Private Limited urinalysis urine reagent strips Big Room Testing, LLC toxicology drug screen bioLytical Laboratories, Inc. immunology HIV-1 Biomerica, Inc. immunology fecal occult, ovulation test, pregnancy test bioMérieux SA immunology pregnancy test Biorex Labs, LLC urinalysis urine reagent strips Biotech Screening, LLC toxicology drug screen Biotron Diagnostics, Inc. urinalysis urine reagent strips BTNX, Inc. immunology, toxicology drug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH Cambridge Diagnostic Products, Inc. immunology fecal occult Cardinal Health, Inc. immunology, urinalysis H. pylori, mono, pregnancy test, Strep A, urine reagent strips Cen-Med Enterprises, Inc. immunology fecal occult, pregnancy test Cenogenics Corp. immunology, urinalysis fecal occult, pregnancy test, urine reagent strips Cepheid immunology influenza, Strep A Chain Drug Marketing Association, Inc. urinalysis urine reagent strips Chematics, Inc. toxicology drug screen Chembio Diagnostic Systems, Inc. immunology HIV-1, HIV-2 Chemtron Biotech, Inc. immunology, toxicology drug screen, pregnancy test Church & Dwight Co., Inc. immunology pregnancy test Clarity Diagnostics, LLC immunology, toxicology drug screen, fecal occult, H. pylori, mono, pregnancy test CLIAwaived, Inc. immunology, toxicology, urinalysis drug screen, fecal occult, H. pylori, pregnancy test, Strep A, TSH, urine reagent strips Clinical Genomics Technologies Pty. Ltd. immunology fecal occult Clinical Reference Laboratory, Inc. toxicology drug screen Coastline Medical Management, LLC toxicology drug screen Co-innovation Biotech Co., Ltd. immunology, toxicology drug screen, pregnancy test Common Sense Ltd. immunology vaginal pH Confirm Biosciences toxicology drug screen Coretests, Inc. immunology, toxicology drug screen, pregnancy test Dealmed Medical Supplies, LLC immunology pregnancy test, Strep A Devon Medical Products, Inc. toxicology drug screen DFI Co., Ltd. urinalysis urine reagent strips Diagnostics Direct, LLC immunology syphilis Deus Vult, LLC toxicology drug screen Drug Test City, Inc. toxicology drug screen EASY at Home Medical, LLC immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips EKLA Corporation immunology, toxicology drug screen, pregnancy test Express Diagnostics International, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips EZ Testing Solutions, Inc. toxicology drug screen First Check Diagnostics, LLC toxicology drug screen Fisher Healthcare immunology influenza, RSV Germaine Laboratories, Inc. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips Get Stix, LLC immunology pregnancy test, urine reagent strips Guangzhou Wondfo Co., Ltd. immunology, toxicology drug screen, pregnancy test Halyard Worldwide, Inc. immunology H. pylori Hangzhou AllTest Biotech Co., Ltd. toxicology drug screen Hangzhou Biotest Biotech Co., Ltd. toxicology drug screen Hangzhou Clongene Biotech Co. Ltd. immunology pregnancy test Hangzhou Sejoy Electronics & Instruments Co. Ltd. immunology pregnancy test Hatty, Inc. urinalysis urine reagent strips Healgen Scientific, LLC immunology, toxicology, urinalysis drug screen, fecal occult, pregnancy test, urine reagent strips Healthy.io Ltd. urinalysis urine reagent strips Helena Laboratories Corp. immunology fecal occult Henry Schein, Inc. immunology, urinalysis fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A, urine reagent strips Heritage House '76 Inc. immunology pregnancy test Home Health UK, Ltd. immunology pregnancy test Hospital Connect, Inc. toxicology drug screen i-Health, Inc. urinalysis urine reagent strips IMCO, Inc. immunology mono, pregnancy test, Strep A, trichomonas Immunostics, Inc. immunology, urinalysis pregnancy test, Strep A, urine reagent strips Innovative Laboratory Solutions, LLC toxicology drug screen Innovita (Tangshan) Biological Technology Co. Ltd. immunology pregnancy test Independent Medical Co-Op, Inc. immunology, toxicology drug screen, pregnancy test Intrinsic Interventions, Inc. toxicology drug screen Jant Pharmacal Corp. immunology, toxicology drug screen, fecal occult, H. pylori, mono, pregnancy test, Strep A, TSH, urine reagent strips Labsystems Diagnostics Oy immunology pregnancy test Lendas, UAB toxicology drug screen LIA Diagnostics, Inc. immunology pregnancy test LifeSign, LLC immunology fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A LumiQuick Diagnostics, Inc. toxicology drug screen MACHEREY-NAGEL GmbH & Co. KG urinalysis urine reagent strips Mandarin Enterprises, LLC immunology pregnancy test Magenta Technology Partners, LLC toxicology drug screen Masena Invest BV immunology pregnancy test McKesson Medical-Surgical immunology, urinalysis drug screen, H. pylori, mono, pregnancy test, Strep A, urine reagent strips Medical Disposables Corporation immunology, toxicology drug screen, fecal occult Medical Distribution Group, Inc. toxicology drug screen Medical Electronic Systems, LLC immunology semen Medimpex United, Inc. immunology, toxicology drug screen, pregnancy test Medline Industries, Inc. immunology, urinalysis drug screen, fecal occult, influenza, mono, pregnancy test, urine reagent strips Mercedes Scientific, Inc. toxicology drug screen Meridian Bioscience, Inc. immunology pregnancy test Mergers Marketing, Inc. immunology, toxicology drug screen, pregnancy test Mesa Biotech, Inc. immunology Strep A MFB Fertility, Inc. immunology fertility test Micro Distributing II, Ltd. toxicology drug screen Mosie, LLC immunology pregnancy test Mossman Associates, Inc. toxicology drug screen MotilityCount ApS immunology semen MP Biomedicals, LLC toxicology drug screen MyDrugTestCups.com, LLC toxicology drug screen Nantong EGENS Bio Technology Company immunology pregnancy test National Diagnostic Products Pty. Ltd. clinical chemistry blood glucose National Distribution & Contracting, Inc. immunology fecal occult, H. pylori, mono, pregnancy test, Strep A National Test Systems, LLC toxicology drug screen Native Diagnostics, Inc. toxicology drug screen Natural Cycles Nordic AB immunology pregnancy test NewScen Coast Bio-Pharmaceutical Co., Ltd. immunology pregnancy test NexScreen, LLC toxicology drug screen Noble Medical, Inc. toxicology drug screen Omega Laboratories, Inc. toxicology drug screen On-Site Testing Specialists, Inc. toxicology drug screen OraSure Technologies, Inc. immunology, toxicology drug screen, HCV, HIV-1 Origin, Inc. toxicology drug screen Owens & Minor, Inc. immunology pregnancy test Phamatech, Inc. toxicology drug screen Pharmaceutical Marketing Systems, Inc. immunology TSH Pinnacle BioLabs, LLC urinalysis urine reagent strips Polymed Therapeutics, Inc. immunology, toxicology drug screen, pregnancy test Polymedco, Inc. immunology BTA, fecal occult, H. pylori, mono, pregnancy test, Strep A Premier Biotech, Inc. toxicology drug screen Prestige Brands Holdings, Inc. immunology pregnancy test Princeton BioMeditech Corporation immunology, toxicology drug screen, fecal occult, H. pylori, ovulation test, pregnancy test, Strep A Proctor and Gamble immunology pregnancy test Professional Medical, Inc. urinalysis urine reagent strips Propper Manufacturing Co., Inc. immunology fecal occult Qingdao Hightop Biotech Co. Ltd. immunology pregnancy test Qualigen, Inc. immunology TSH Quidel Corporation immunology, urinalysis H. pylori, influenza, mono, pregnancy test, RSV, Strep A, urine reagent strips, vaginal pH Rapid Pathogen Screening, Inc. adenovirus, MMP-9 pregnancy test Rapid Self Test, Inc. toxicology drug screen Redwood Toxicology Laboratory, Inc. toxicology drug screen Rhema Scientific, Inc. toxicology drug screen RightBio Metrics, Inc. immunology gastric pH Runbio Biotech Co., Ltd. immunology ovulation test, pregnancy test SA Scientific, Ltd. immunology influenza, pregnancy test, RSV, Strep A Sandstone Diagnostics, Inc. immunology semen Sasmar, Inc. immunology pregnancy test Savyon Diagnostics Ltd. urinalysis urine reagent strips Scanwell Health, Inc. urinalysis urine reagent strips Safecare Biotech (Hangzhou) Co. Ltd. immunology, toxicology drug screen, pregnancy test Scanadu, Inc. urinalysis urine reagent strips SCI Medic, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips Screening Devices Canada, Inc. clinical chemistry TSH Sekisui Diagnostics, LLC immunology influenza, mono, pregnancy test, Strep A, trichomonas Serim Research Corporation immunology H. pylori Shanghai Chemtron Biotech Co., Ltd. immunology pregnancy test Shenzhen Bioeasy Biotechnology Co., Ltd. toxicology drug screen Siemens Healthcare GmbH urinalysis urine reagent strips SMC Direct, LLC immunology, urinalysis pregnancy test, Strep A, urine reagent strips SolCraft, Inc. immunology pregnancy test SpermCheck immunology semen Speedy Solutions, LLC toxicology drug screen Stanbio Laboratory L.P. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips Sugentech, Inc. immunology pregnancy test Swiss Precision Diagnostics GmbH immunology ovulation test, pregnancy test Syntron Bioresearch, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips SZIO+, Inc. urinalysis urine reagent strips Tanner Scientific, Inc. urinalysis urine reagent strips Teco Diagnostics, Inc. immunology, toxicology, urinalysis drug screen, fecal occult, ovulation test, pregnancy test, urine reagent strips Thermo Fisher Scientific, Inc. immunology, urinalysis fecal occult, H. pylori, influenza, pregnancy test, RSV, Strep A, urine reagent strips Tianjin New Bay Bioresearch Co. Ltd. immunology pregnancy test TransMed Co., LLC toxicology drug screen Transmetron, Inc. toxicology drug screen Trinity Biotech Plc immunology H. pylori, HIV-1 True Diagnostics, Inc. immunology pregnancy test Turklab AS immunology pregnancy test UA Cups, Inc. toxicology drug screen UCP Biosciences, Inc. toxicology drug screen Ultimate Analysis Cup, Inc. toxicology drug screen Universal Meditech, Inc. immunology, urinalysis fecal occult, pregnancy test, urine reagent strips Uqora, Inc. urinalysis urine reagent strips US Diagnostics, Inc. toxicology drug screen UTest toxicology drug screen uVera Diagnostics, Inc. toxicology drug screen Verify Diagnostics, Inc. immunology, toxicology drug screen, pregnancy test VicTorch Meditek, Inc. immunology pregnancy test Visby Medical, Inc. immunology STI test W.H.P.M., Inc. immunology, toxicology drug screen, pregnancy test Weihai Kangzhou Biotechnology Engineering Co., Ltd. immunology pregnancy test Wholepower Biotech Co., Ltd. immunology pregnancy test Wiener Laboratorios SAIC urinalysis urine reagent strips WOLFE, Inc. toxicology drug screen Wondfo Biotech Co. Ltd. immunology, toxicology drug screen, ovulation test, pregnancy test Xiamen Useful Import and Export Co., Ltd. toxicology drug screen YD Diagnostics urinalysis urine reagent strips Zer Hitech Ltd. immunology pregnancy test Zhejiang Orient Gene Biotech Co., Ltd. immunology fecal occult, pregnancy test

5.4 Other diagnostic instrument and test kit vendors

The following is a list of additional vendors verified to offer CLIA-certified moderate or complex diagnostic instruments and/or test kits.

Note: Most of these vendors sell analyzers and tests that are CLIA-certified moderate or complex. However, is ultimately up to the potential buyer to verify with the vendor an item's CLIA certification status before purchase.

AB Sciex Pte. Ltd. Abbot Accelerate Diagnostics, Inc. Access Bio, Inc. Acro Biotech, LLC Advin Biotech, Inc. AESKU.GROUP GmbH & Co. KG Aggredyne, Inc. Agilent Technologies, Inc. AiDe Diagnostic Co., Ltd. Akonni Biosystems, Inc. Alba Bioscience Ltd. ALCOR Scientific, Inc. Alfa Wassermann, Inc. Alifax S.r.l. Alpha Laboratories Ltd. American Laboratory Products Company Ltd. Ansh Labs, LLC Applied Biocode, Inc. Applied Spectral Imaging, Inc. Arlington Scientific, Inc. ARK Diagnostics, Inc. Associates of Cape Cod, Inc. Astute Medical, Inc. ATAGO U.S.A., Inc. Athelas, Inc. Atlas Medical Ltd. Avioq, Inc. Awareness Technology, Inc. AXIM Biotechnologies, Inc. Azure Biotech, Inc. BacterioScan, Inc. Beckman Coulter, Inc. Becton, Dickinson and Company - Biosciences Becton, Dickinson and Company - Molecular Baebies, Inc. The Binding Site Group Ltd. binx health, Inc. Bio-Rad Laboratories, Inc. Biocare Medical, LLC Biocartis NV Biofire Diagnostics, LLC BioGenix Laboratories, Inc. Biofortuna Ltd. bioLytical Laboratories, Inc. bioMérieux SA Biorex Labs, LLC BioSystems SA BioTek Instruments, Inc. Bioview Ltd. Boditech Med, Inc. Bonraybio Co., Ltd. BÜHLMANN Laboratories AG BRAHMS GmbH Bruker Corporation Cardinal Health, Inc. Carolina Liquid Chemistries Corp. CellaVision AB CD Diagnostics, Inc. Cepheid Check-Points Health BV Chembio Diagnostic Systems, Inc. Chrono-Log Corporation Clever Culture Systems AG Clinical Diagnostics Solutions, Inc. Curetis NV Denka Company Limited DiAgam SA DIAGAST SAS Diagnostic Grifols SA Diagnostica Stago, Inc. Diamond Diagnostics, Inc. DiaSorin S.p.A. Diatron Medical Instruments Ltd. Diazyme Laboratories, Inc. DIESSE Diagnostica Senese SpA DIRUI Industrial Co. Ltd. Drew Scientific, Inc. Drawbridge Health, Inc. EDAN Instruments, Inc. Eiken Chemical Co., Ltd. ELITech Group SAS Erba Diagnostics Mannheim GmbH Erba Lachema s.r.o. EUROIMMUN Medizinische Labordiagnostika AG Eurospital SpA

First Light Diagnostics, Inc. Focus Diagnostics, Inc. Foundation Medicine, Inc. FUJIFILM Healthcare Americas Corporation Fujirebio Europe NV Genalyte, Inc. GenBio GenMark Diagnostics, Inc. GenPrime, Inc. Genzyme Corporation GlycoMark, Inc. Gold Standard Diagnostics Great Basin Corporation Guangzhou Wondfo Co., Ltd. Guardant Health, Inc. Haemonetics Corporation Hardy Diagnostics, Inc. Healgen Scientific, LLC Healthy.io Ltd. Helena Laboratories Corporation Helix OpCo, LLC HemaTechnologies Hemosonics, LLC Henry Schein, Inc. Hologic, Inc. HORIBA, Ltd. - Main Site HORIBA, Ltd. - MedTestDx) Hycor Biomedical, Inc. HYPHEN Biomed SAS iCubate, Inc. IDS PLC iLine Microsystems SL Illumina, Inc. Immucor, Inc. Immunalysis Corporation Immuno Concepts N.A. Ltd. Immuno-Mycologics, Inc. Immunodiagnostic Systems Holdings PLC Immunotech sro InBios International, Inc. Independent Medical Co-Op, Inc. InDevR, Inc. Infrared Laboratory Systems, LLC Invivoscribe, Inc IVD Research, Inc. iXensor Co., Ltd. Jana Care, Inc. Kamiya Biomedical Company, LLC KPS Analytics KRONUS, Inc. Laborie Medical Technologies Corp. Leica Biosystems Nussloch GmbH LifeSign, LLC Lin-Zhi International, Inc. Liofilchem srl Lite-On Technology Corporation Luminex Corporation LumiQuick Diagnostics, Inc. M Dialysis AB MACHEREY-NAGEL GmbH & Co. KG MagnaBioSciences, LLC Medica Corporation Medical Electronic Systems, LLC Medical Wire & Equipment Medicon Hellas SA Medimpex United, Inc. Medtronic PLC MELET SCHLOESING Laboratoires SA MeMed Diagnostics, Ltd. Meridian Bioscience, Inc. Meso Scale Diagnostics, LLC MetaSystems Indigo GmbH Micro Distributing II, Ltd. Minaris Medical America, Inc. Mindray Medical International Ltd. Mitsubishi Chemical Medience Corp. Monobind, Inc. Myriad Genetics, Inc. Nano-Ditech Corporation NanoEnTek, Inc. NantHealth, Inc. Native Diagnostics International NeuMoDx Molecular, Inc. NexScreen, LLC NG Biotech SAS Nova Biomedical Corporation

NOVX Systems, Inc. NOWDiagnostics, Inc. One Lambda, Inc. OPKO Health, Inc. OPTI Medical Systems OraSure Technologies, Inc. Orion Diagnostica Oy Ortho-Clinical Diagnostics, Inc. Otsuka Pharmaceutical Co., Ltd. Oxford Gene Technology IP Limited Oy Medix Biochemica Ab Pall Corporation Panion & BF Biotech Inc. Parsagen Diagnostics, Inc. PerkinElmer, Inc. Phamatech, Inc. Pixcell Medical Technologies, Ltd. Pointe Scientific, Inc. Polymedco CDP, LLC Polymer Technology Systems, Inc. Precision BioLogic, Inc. Premier Biotech, Inc. Progenika Biopharma SA Psychemedics Corporation QIAGEN GmbH Quidel Corporation Quotient Ltd. R-Biopharm AG r2 Diagnostics Radiometer Medical ApS Randox Laboratories Ltd. Rapid Detect, Inc. Reichert, Inc. Response Biomedical Corporation Roche Diagnostics Sakae, Inc. Sanguina, LLC Scopio Labs Ltd. Sebia SA Sekisui Diagnostics PEI, Inc. Sentinel CH SpA Serosep Ltd. Shenzhen Bioeasy Biotechnology Co. Ltd. Shenzhen New Industries Biomedical Engineering Co. Ltd. Siemens Healthcare Diagnostics Sight Diagnostics Ltd. Skyla Corporation Spectral Medical, Inc. SSI Diagnostica A/S Stanbio Laboratory L.P. Stratec Biomedical AG Streck, Inc. Svar Life Science AB Sysmex America, Inc. T2 Biosystems, Inc. TaiDoc Technology Corporation Tecan Trading AG TECHLAB, Inc. Teco Diagnostics, Inc. TEM Innovations GmbH Texas BioGene, Inc. Thermo Fisher Scientific Tokyo Boeki Holdings Corp. Tosoh Corporation Trinity Biotech Plc Universal Meditech, Inc. URIT Medical Electronic Group Co., Ltd. Vela Diagnostics Pte. Ltd. Viramed Biotech AG Werfen Wiener Laboratorios SAIC Wuxi BioHermes Biomedical Technology Co. Ltd. YD Diagnostics Corp.

5.5 Instrument and equipment distributors

The following is a representative listing of distributors offering clinical analyzers, point-of-care equipment, and other medical laboratory supplies the POL may require.

Distributors of clinical analyzers, point-of-care equipment, and other medical/laboratory supplies and equipment Distributor Clinical analyzers? Point-of-care? Medical/laboratory supplies and equipment? Adelsys, Inc. Y N Y AKW Medical, Inc. N N Y Alaska Scientific, Inc. Y Y Y Andwin Scientific Y Y Y Atlantic Medical Solutions Y Y Y Beach Medical Y N N BioGX, Inc. N N Y Block Scientific, Inc. Y Y Y Cardinal Health, Inc. Y Y Y Cen-Med Enterprises N Y Y Clarkson Laboratory and Supply, Inc. Y Y Y ClearChem Diagnostics Y N Y Cole-Parmer Instrument Company, LLC N N Y Custom Pack, Inc. N N Y Daigger Scientific, Inc. N N Y DRE Medical, Inc. N N Y Dynamic Diagnostics, Inc. N N Y ELITech Group Y Y Y ExpotechUSA, Inc. N Y Y Federal Industries Corporation N N Y Fisher Healthcare Y Y Y Fox Scientific, Inc. U U Y Foxx Life Sciences, LLC N N Y GENEQ, Inc. N N Y Henry Schein, Inc. Y Y Y High Technology, Inc. Y Y Y Hoskin Scientific, Ltd. N N Y Impact Diagnostic International N Y Y Inter Medico Y N Y Lab Supply Specialists Y Y Y McCoy Health Science Supply N N Y McGuff Company, Inc. N Y Y McKesson Medical-Surgical Y Y Y McMaster-Carr Supply N N Y Med Lab Supply N Y Y Medical Distribution Group, Inc. N N Y Medicus Health N N Y Medline Industries, Inc. N Y Y Mercedes Scientific, Inc. Y Y Y OMNILAB-LABORZENTRUM GmbH & Co. KG Y N Y Preiser Scientific N N Y R. Weinstein Pharmaceuticals & Medical Products Y Y Y Siemens Healthcare GmbH Y Y N Stat Technologies Y Y Y TechNeal, Inc. Y Y Y Thomas Scientific N N Y Troy Biologicals, Inc. N Y Y Universal Medical N N Y US Specialty Labs Y N N USABluebook N N Y Vessel Medical Y Y N VWR International Y Y Y W.W. Grainger, Inc. N N Y

5.6 Consultants serving the POL market

The following consultancies state they assist the POL market on their website:

Vendor	Headquarters	Key services	Services page
A&J Laboratory Consultants	Dallas, TX, U.S.	Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, quality management, procedure development, etc.	Services page
Ancillary Medical Solutions	Beachwood, OH, U.S.	"Our comprehensive portfolio of medical ancillary programs are designed to help medical clinics improve practice efficiency, increase revenue, and deliver the highest level of care to patients."	Services page
Beyond Lab Consulting	New York, NY, U.S.	"Our scope ranges from small physician office labs (POL) to large reference laboratories. BLC consultants are well versed in CLIA regulations, hiring and training of clinical staff, maximizing income while keeping laboratory costs down."	Services page
Bruce North Country Consulting Services, LLC	Daytona Beach, FL, U.S.	"BNCCS is an experienced provider for physician office laboratories and small to moderate size hospital laboratories ... BNCCS provides expertise in designing, planning, implementing, seeking accreditation, and providing short and long term management."	Services page
C&C Clinical Laboratory Consulting, LLC	Dallas, TX, U.S.	Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, quality management, procedure development, etc.	Services page
Catalyst Consulting	Austin, TX, U.S.	Laboratory start-up, regulatory compliance, workflow improvement, profitability analysis	Services page
Clinical Lab Consultants, LLC	Sanford, FL, U.S.	Laboratory start-up, regulatory compliance, plans of correction	Services page
Clinical Lab Consulting, LLC	Dublin, OH, U.S.	Provides a wide range of services "to all types of clinical laboratories including governmental, academia, hospital, reference and physician office laboratories."	Services page
Clinical Laboratory Consultants dba Medical Source	Marietta, GA, U.S.	"Medical Source offers experience, guidance, and unmatched expertise in the physician office and independent reference laboratory."	Services page
Colaborate	Tampa, FL, U.S.	"We provide a full range of financial, technical and advisory consultation to fulfill the needs of pathology laboratories, medical laboratories, and clinical laboratories."	Services page
CT POL Consultants	South Windsor, CT, U.S.	Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, LIS, EHR, lab billing, procedure development, etc.	Services page
DoctorsManagement	Knoxville, TN, U.S.	Laboratory and physician practice accounting, compliance, development, and operation improvement	Services page
Eastern Connecticut Pathology Consultants	Manchester, CT, U.S.	Physician office laboratory management	Services page
K&K Consultant Group, Inc.	Torrence, CA, U.S.	Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, training, procedure development, etc.	Services page
Lab Advisory Bureau	Abilene, TX, U.S.	Data management, quality managementm, regulatory guidance, training, accreditation prep	Services page
Lab IQ, LLC	Calabasas, CA, U.S.	Compliance management, workflow improvement, training, procedure development, feasibility studies, etc.	Services page
LabMetrics, LLC	Ishpeming, MI, U.S.	Laboratory start-up, compliance management, workflow improvement, procedure development, revenue management, etc.	Services page
Lighthouse Lab Services	Charlotte, NC, U.S.	Laboratory start-up, compliance management, workflow improvement, procedure development, revenue management, growth strategy, etc.	Services page
Nichols Management Group Ltd.	York Harbor, ME, U.S.	"The Nichols Management Group, LTD., (NMG) provides laboratory consulting services for healthcare organizations. NMG specializes in operations optimization, strategic planning, mergers and acquisitions (M&A), sales and marketing development and go-to-market strategies."	Services page
OnTarget Consulting Services, LLC	Atlanta, GA, U.S.	Accreditation prep, operational and risk assessment, training, process management	Services page
Physicians Office Consulting, LLC	Jackson, TN, U.S.	Laboratory CLIA compliance, regulatory review, and inspection services; laboratory start-up and development	Services page
Physicians Office Laboratory Specialists, Inc.	Puyallup, WA, U.S.	Urine drug testing, opioid addiction treatment	Services page
Point of Care Consults	FL and NJ, U.S.	Regulatory compliance, review, and inspection services; training	Services page
ProSource Lab Consulting, LLC	Jersey City, NJ, U.S.	Laboratory start-up, procedure development, regulatory compliance, revenue management, etc.	Services page
Sound Lab Consultants	Phoenix, AZ, U.S.	Laboratory feasibility, laboratory start-up, procedure development, revenue management, technical consultation, etc.	Services page
South Shore Laboratory Consultants, Inc.	Braintree, MA, U.S.	"We have the expertise to facilitate all needs, from initial laboratory start-up through complete licensure, while ensuring continuous maintenance of your regulatory and quality systems."	Services page

5.7 Consumables and supplies used in the POL

5.7.1 Diagnostic analyzers and devices (CLIA-waived)

• blood analyzers
• blood glucose monitors
• blood ketone monitors
• blood lead analyzers
• chemistry analyzers
• digital immunoassay analyzer
• fertility monitor
• hematology devices
• molecular immunoassay analyzer
• urine analyzers

5.7.2 Diagnostic test kits and supplies (CLIA-waived)

• blood glucose test strips
• adenoviral conjunctivitis
• B-type natriuretic peptide (BNP)
• bladder tumor associated antigen (BTA)
• drug screen
• fecal occult blood
• follicle-stimulating hormone (FSH)
• gastrick pH
• gastric occult blood
• hCG pregnancy test
• Hepatitis C virus antibody (HCV)
• HDL cholestrol
• HIV-1 and/or HIV-2
• H. pylori
• influenza A and/or B
• MMP-9 protein (for dry eye disease)
• mononucleosis
• ovulation test
• respiratory syncytial virus (RSV)
• semen (fertility)
• Strep A
• syphilis
• trichomonas
• thyroid-stimulating hormone (TSH)
• urine reagent strips
• vaginal pH

5.7.3 Laboratory furniture and equipment

• balances
• blood pressure meters
• cabinets and stands
• carts
• centrifuges
• chairs: doctor and patient
• EKG machines
• eyewash stations
• fume hoods
• glove boxes
• hot plates
• incubators
• lighting
• mats and trays
• microscopes and accessories
• mills
• mixers
• otoscopes
• refrigerators and freezers
• scales
• sharps containers
• stethoscopes
• sterilization equipment
• tables
• thermometers
• tube rockers
• waste containers

5.7.4 Medical supplies

• bandages and dressings
• buffers, reagents, and solvents
• catheters
• cleaning supplies
• eyeware and safety goggles
• face and splash shields
• gloves: chloroprene, latex, synthetic, vinyl
• gowns
• labels and tapes
• masks
• needles, lancets, and other sharps
• ointments
• pipettes
• swabs and applicators
• surgical instruments
• table paper
• timers
• tourniquets
• tube racks
• urine and stool containers
• vacutainer tubes
• wipes
• wound cleaners

5.8 Staffing agencies

The following are staffing agencies that focus at least some of their energy towards finding and placing laboratory personnel and management, including medical technologists, medical laboratory technicians, medical laboratory scientists, cytotechnologists, histotechnologists, phlebotomists, and laboratory directors.

5.8.1 National (U.S.) and global

• ACARA Solutions
• Accountable Healthcare Staffing
• All Medical Personnel
• All's Well
• Allied Search Partners
• AMN Healthcare
• Anders Group
• Aureus Medical Group
• Blue Signal
• Club Staffing
• CompHealth
• Fusion Medical Staffing
• HealthCare Connections, Inc.
• Joule Scientific Staffing Solutions
• Kelly Services, Inc.
• LabMinds Staffing & Recruiting
• Labtopia Staffing
• Lighthouse Lab Services
• Maxim Staffing Solutions
• Med Travellers
• Medical Staffing Services
• Millenia Medical Staffing
• Soliant
• Uniforce Staffing Solutions

5.8.2 Regional (U.S.)

• Access Staffing (New York)
• Florida Medical Staffing (Florida)
• Halo Staffing Agency, LLC (Pennsylvania)
• Innovative Lab Solutions (New York)
• Laboratory Staffing, Inc. (Minnesota)
• MSG Staffing (Northeast)

5.9 Laboratory billing and revenue enhancement

These businesses are known to provide revenue management and improvement services to laboratories. Additionally, a handful of these businesses may also offer their own laboratory billing software solutions in addition providing billing services.

• Advanced Data Systems Corporation
• Affinity Billing, Inc.
• AMC Billing Services, LLC
• APS Medical Billing, Inc.
• Bikham Information Technology Corporation
• Change Healthcare, Inc.
• ClaimCare, Inc.
• CollaborateMD, Inc.
• Coronis Health
• Healthteq Services, LLC
• Laboratory Billings
• Laboratory Experts, LLC
• Medcare MSO, LLC
• MedConverge, LLC
• Medsphere Systems Corporation
• MPM, Inc.
• The Negotiators, LLC
• Phoenix Healthcare Services, Inc.
• Physicians Group Management, LLC
• Physicians' Service Center, Inc.
• Quadax, Inc.
• Quest National Services, LLC
• RPM Billing, LLC

Citation information for this chapter

Chapter: 5. Final thoughts and additional resources

Title: The Comprehensive Guide to Physician Office Laboratory Setup and Operation

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: June 2022