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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7. Additional Resources

Further reading

Clinical laboratories, including the POL

• 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 - LC 006". LIMSuniversity.com. Laboratory Informatics Institute, Inc. http://www.limsuniversity.com/course/view.php?id=45. 

• 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. 

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. 

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 domains 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 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 domains 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