LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Final thoughts and additional resources

Setting up and running a physician office laboratory (POL) requires resources and know-how. The more you know the better, they say. This chapter offers a variety of additional resources for those who want to know more about setting up and operating a POL, including vendors, distributors, consultants, and other recommended reading.

This seventh chapter containing additional resources has eight sections.

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6. Additional Resources

Addendum

The following LIMSwiki pages are addendum to the rest of the material presented here.

• Laboratory information system (LIS) questionnaire: This contains a thorough collection of requirements for evaluating and requesting information about a LIS.

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://nf.aafp.org/Shop/proficiency-testing/microscopy-atlas-4th-edition. 

• Cox, Phyllis; Wilken, Danielle (2010). Palko's Medical Laboratory Procedures (3rd ed.). McGraw-Hill Education. pp. 480. ISBN 9780073401959. https://books.google.com/books?id=6uWWPQAACAAJ. 

• Douglas, Shawn; Fein, Rebecca A., Smith, Jason (2013). "Introduction to Clinical Laboratory Informatics - LII 006". LIMSforum.com. Laboratory Informatics Institute, Inc. http://www.limsforum.com/courses/introduction-to-clinical-laboratory-informatics-lii-006/. 

• Garrels, Marti; Oatis, Carol S. (2014). Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Healthcare Professionals (3rd ed.). Elsevier Health Sciences. pp. 368. ISBN 9780323292368. https://books.google.com/books?id=LM9sBQAAQBAJ. 

• Lieseke, Constance L.; Zeibig, Elizabeth A. (2012). Essentials Of Medical Laboratory Practice. F. A. Davis. pp. 539. ISBN 9780803630352. http://books.google.com/books?id=IX_2AAAAQBAJ&pg=PA29. 

• Pagana, Kathleen Deska; Pagana, Timothy J.; Pagana, Theresa N. (2014). Mosby's Diagnostic and Laboratory Test Reference (12th ed.). Elsevier Health Sciences. pp. 1104. ISBN 9780323225922. https://books.google.com/books?id=J7eXBAAAQBAJ. 

• Weaver, Charlotte; Kiel, Joan; Ball, Marion; Douglas, Judith V.; O'Desky, Robert I.; Albright, James W. (2013). Healthcare Information Management Systems: A Practical Guide. Springer Science & Business Media. pp. 367. ISBN 9781475740431. https://books.google.com/books?id=SyoBCAAAQBAJ. 

Point-of-care testing

• "Point-of-Care Diagnostic Testing". Research Portfolio Online Reporting Tools. National Institutes of Health. 29 March 2013. http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=112. 

Other

• "ADVANCE for Laboratory Administrators Magazine". Merion Matters. 2015. http://laboratory-manager.advanceweb.com/Editorial/Content/editorial.aspx?CTIID=1094. 

• "Medical Laboratory Observer Magazine". The Biotech Communications Group. 2015. http://www.biotechmedia.com/y2001-ed-me-mlo.html. 

• "Physicians Office Resource Magazine". Medical Education Resources, LLC. 2015. http://articles.physiciansofficeresource.com/magazine/. 

List of 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 2015. 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 blood analyzers, chemistry analyzers 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 Alere, Inc. clinical chemistry, hematology chemistry analyzers, hematology devices, molecular immunoassay analyzer All Medicus Co., Ltd. clinical chemistry blood glucose monitors Alliance International Co., Ltd. clinical chemistry blood glucose 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 Arkray USA, Inc. clinical chemistry blood glucose monitors Aventir Biotech, LLC clinical chemistry blood glucose monitors Bayer Healthcare, LLC clinical chemistry blood glucose monitors Becton Dickson and Company immunology digital immunoassay analyzer BioLand Technology Ltd. clinical chemistry blood glucose monitors Bionime Corporation clinical chemistry blood glucose monitors BioSense Medical Devices clinical chemistry blood glucose monitors BioSys Laboratories, Inc. urinalysis urine analyzers Biotest Medical Corporation clinical chemistry blood glucose monitors Biotron Diagnostics, Inc. clinical chemistry blood glucose monitors BTNX, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers Cambridge Sensors Ltd. 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 EKF Diagnostics Holding Plc hematology hematology devices Empecs Medical Co., Ltd. clinical chemistry blood glucose monitors Entra Health Systems, Ltd. clinical chemistry blood glucose monitors EPS Bio Technology Corp. clinical chemistry blood glucose monitors Fifty 50 Medical, Inc. clinical chemistry blood glucose monitors Fora Care, Inc. clinical chemistry blood glucose monitors General Life Biotechnology Co., Ltd. clinical chemistry blood glucose monitors Germaine Laboratories, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers GL Diabetes, LLC clinical chemistry blood glucose monitors Gluco Perfect, LLC clinical chemistry blood glucose monitors Green Cross Medis 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 iHealth Lab, Inc. clinical chemistry blood glucose monitors Infopia USA, LLC clinical chemistry blood glucose monitors i-SENS. Inc. clinical chemistry blood glucose monitors Jant Pharmacal Corp. hematology hematology devices LifeScan, 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 MEC Dynamics Corp. hematology hematology devices Medline Industries, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers MHC Medical Products, LLC clinical chemistry blood glucose monitors MiCoBioMed Co., Ltd. clinical chemistry blood glucose monitors Nipro Diagnostics, Inc. clinical chemistry blood glucose monitors Nova Biomedical Corp. clinical chemistry blood glucose 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 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 sanofi-aventis U.S., LLC clinical chemistry blood glucose monitors SD BioSensor, Inc. clinical chemistry blood glucose monitors Sein Electronics Co., Ltd. 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 SMC Direct, LLC clinical chemistry, urinalysis blood glucose monitors, urine analyzers Specialty Medical Group, LLC clinical chemistry blood glucose monitors Stanbio Laboratory hematology, urinalysis hematology devices, urine analyzers Swiss Precision Diagnostics GmbH urinalysis fertility monitor TearLab Corporation clinical chemistry chemistry analyzers Telcare, Inc. clinical chemistry blood glucose monitors Tyson Bioresearch, Inc. clinical chemistry blood glucose monitors US Diagnostics, Inc. clinical chemistry blood glucose monitors Visgeneer, Inc. clinical chemistry blood glucose monitors 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 AccuTech, LLC clinical chemistry HDL ACON Laboratories, Inc. immunology, toxicology, urinalysis drug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips Advin Biotech, Inc. toxicology drug screen Aerscher Diagnostics, LLC immunology fecal occult, gastric occult Ai De Diagnostic Co. immunology pregnancy test Alere, Inc. immunology, toxicology drug screen, fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A Alfa Scientific Designs, Inc. immunology, toxicology, urinalysis drug screen, fecal occult, H. pylori, ovulation test, pregnancy test Amedica Biotech, Inc. toxicology drug screen 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 Atlas Medical Ltd. immunology pregnancy test Aventir Biotech, LLC immunology, toxicology, urinalysis drug screen, TSH, urine reagent strips AZOG, 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 Bhat Bio-tech India Private Limited urinalysis urine reagent strips bioLytical Laboratories, Inc. immunology HIV-1 Biomerica, Inc. immunology fecal occult, ovulation test, pregnancy test bioMérieux SA immunology pregnancy test BioTech Atlantic, Inc. immunology pregnancy test Biotech Screening, LLC toxicology drug screen Biotron Diagnostics, Inc. urinalysis urine reagent strips Blue Cross Biomedical Company immunology pregnancy test Branan Medical Corporation toxicology drug screen BTNX, Inc. immunology, toxicology drug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH Cambridge Diagnostic Products, Inc. immunology fecal occult CARE Products, Inc. immunology fecal occult Cen-Med Enterprises, Inc. immunology pregnancy test Cenogenics Corp. immunology, urinalysis fecal occult, pregnancy test, 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 CLIAwaived, Inc. immunology, toxicology, urinalysis drug screen, fecal occult, H. pylori, pregnancy test, Strep A, TSH, urine reagent strips 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 Devon Medical Products, Inc. toxicology drug screen DFI Co., Ltd. urinalysis urine reagent strips Diagnostics Direct, LLC immunology syphilis EASY at Home Medical, LLC immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips EKLA Corporation immunology, toxicology drug screen, pregnancy test Enterix, Inc. immunology fecal occult Express Diagnostics International, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips First Check Diagnostics, LLC toxicology drug screen Germaine Laboratories, Inc. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips Halyard Worldwide, Inc. immunology H. pylori Healgen Scientific, LLC immunology, toxicology, urinalysis drug screen, pregnancy test, 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 i-Health, Inc. urinalysis urine reagent strips Immunostics, Inc. immunology, urinalysis fecal occult, pregnancy test, Strep A, urine reagent strips Independent Medical Co-Op, Inc. immunology, toxicology drug screen, pregnancy test Innovacon, Inc. immunology, toxicology drug screen, fecal occult, pregnancy test Jant Pharmacal Corp. immunology, toxicology drug screen, fecal occult, H. pylori, mono, pregnancy test, Strep A, TSH, urine reagent strips Kaasac Laboratories toxicology drug screen Labsystems Diagnostics Oy immunology pregnancy test LifeSign, LLC immunology fecal occult, H. pylori, mono, pregnancy test, Strep A MACHEREY-NAGEL GmbH & Co. KG urinalysis urine reagent strips McKesson Medical-Surgical immunology, urinalysis H. pylori, mono, pregnancy test, Strep A, urine reagent strips Medimpex United, Inc. immunology, toxicology drug screen, pregnancy test Medline Industries, Inc. immunology, urinalysis fecal occult, influenza, mono, pregnancy test, urine reagent strips Meridian Bioscience, Inc. immunology pregnancy test Micro Distributing II, Ltd. toxicology drug screen Moore Medical, LLC immunology, urinalysis pregnancy test, Strep A, urine reagent strips Mossman Associates, Inc. toxicology drug screen MP Biomedicals, LLC toxicology drug screen Nantong EGENS Bio Technology Company immunology pregnancy test National Diagnostic Products Pty. Ltd. clinical chemistry blood glucose test strips 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 NewScen Coast Bio-Pharmaceutical Co., Ltd. immunology pregnancy test NexScreen, LLC toxicology drug screen Noble Medical, Inc. toxicology drug screen On-Site Testing Specialists, Inc. toxicology drug screen OraSure Technologies, Inc. immunology, toxicology drug screen, HCV, HIV-1 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 Integrity Solutions, 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 Propper Manufacturing Co., Inc. immunology fecal occult Qualigen, Inc. immunology TSH Quidel Corporation immunology, urinalysis H. pylori, influenza, mono, pregnancy test, RSV, Strep A, urine reagent strips, vaginal pH Ramco Laboratories, Inc. immunology pregnancy test Rapid Pathogen Screening, Inc. adenovirus, MMP-9 pregnancy test Redwood Toxicology Laboratory, 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 SCI International, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, urine reagent strips Screening Devices Canada, Inc. clinical chemistry TSH Sekisui Diagnostics, LLC immunology mono, pregnancy test, Strep A, trichomonas Serim Research Corporation immunology H. pylori Shanghai Chemtron Biotech Co., Ltd. immunology pregnancy test Siemens Healthcare GmbH urinalysis urine reagent strips SMC Direct, LLC immunology, urinalysis pregnancy test, Strep A, urine reagent strips SpermCheck immunology semen Stanbio Laboratory immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips Swiss Precision Diagnostics GmbH immunology ovulation test, pregnancy test Syntron Bioresearch, Inc. immunology, toxicology, urinalysis drug screen, pregnancy test, 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 Total Diagnostic Solutions, LLC toxicology drug screen Transmetron, Inc. toxicology drug screen Trinity Biotech Plc immunology H. pylori, HIV-1 Turklab AS immunology pregnancy test UCP Biosciences, Inc. toxicology drug screen Ultimate Analysis Cup, Inc. toxicology drug screen US Diagnostics, Inc. toxicology drug screen uVera Diagnostics, Inc. toxicology drug screen VicTorch Meditek, Inc. immunology pregnancy test W.H.P.M., Inc. immunology, toxicology drug screen, 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 YD Diagnostics urinalysis urine reagent strips Zer Hitech Ltd. immunology pregnancy test Zhejiang Orient Gene Biotech Co., Ltd. immunology fecal occult, pregnancy test

List of distributors

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 Block Scientific, Inc. Y Y Y Cardinal Health, Inc. Y Y Y Clarkson Laboratory and Supply, Inc. Y Y Y ClearChem Diagnostics Y N Y Cole-Parmer Instrument Company, LLC N N Y Daigger Scientific, Inc. N N Y DRE Medical, Inc. N N Y Dynamic Diagnostics, Inc. N N Y ExpotechUSA, Inc. N Y Y FDI Medical, Inc. Y Y Y Fisher Healthcare Y Y Y Fox Scientific, Inc. U U Y GENEQ, Inc. N N Y Hamilton Bell Company, Inc. N N Y Henry Schein, Inc. Y Y Y High Technology, Inc. Y Y Y Hoskin Scientific, Ltd. N N Y Inter Medico Y N Y Kreisers, Inc. Y Y Y Lab Supply Specialists Y Y Y Laboratory Supply Company, Inc. (LABSCO) Y Y 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 MED/TECH Y N N Medicus Health N N Y Medline Industries, Inc. N Y Y Mercedes Medical Y Y Y Midwest Medical Supply Company, Inc. (MMS) U U U Moore Medical, LLC Y Y Y Physician Sales and Service Y Y Y Preiser Scientific N N Y R. Weinstein Pharmaceuticals & Medical Products Y Y Y Scientific Supply & Equipment, Inc. Y Y Y Siemens Healthcare GmbH Y Y N SSI Healthcare Solutions Y N Y TechNeal, Inc. Y Y Y Thomas Scientific N N Y Tri-Medical Sales Y Y 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