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. Note: The appearance of an entity on these lists does not constitute as an endorsement for that entity.

This seventh chapter containing additional resources has eight sections.

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

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 Ascensia Diabetes Care Holdings AG 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 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, Inc. 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 iHealth Lab, Inc. 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 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 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 SMC Direct, LLC clinical chemistry, urinalysis blood glucose monitors, urine analyzers Specialty Medical Group, LLC clinical chemistry blood glucose monitors Stanbio Laboratory L.P. 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 Trividia Health, 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 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 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 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 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 Screening, LLC toxicology drug screen Biotron Diagnostics, Inc. urinalysis urine reagent strips 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 Clinical Genomics Technologies Pty. Ltd. immunology fecal occult 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 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 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 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 L.P. 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 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 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.

Access Bio, Inc. Acro Biotech, LLC Advanced Tear Diagnostics, LLC Aggredyne, Inc. AiDe Diagnostic Co., Ltd. Akers Biosciences, Inc. Alfa Wassermann, Inc. Alifax S.r.l. Alpha Laboratories Ltd. AMS Srl Astute Medical, Inc. ATAGO U.S.A., Inc. Becton, Dickinson and Company Biofire Diagnostics, LLC Biokit SA Biophor Diagnostics, Inc. Bio-Rad Laboratories, Inc. Bioview Ltd. Boditech Med, Inc. Carolina Liquid Chemistries Corp. Cepheid Chrono-Log Corporation Clinical Diagnostics Solutions, Inc. Clinical Innovations, LLC Coramed Technologies, LLC Diagnostica Stago, Inc. Diamedix, Inc. Diamond Diagnostics, Inc. DiaSorin S.p.A. Diatron Medical Instruments Ltd. Diazyme Laboratories DIRUI Industrial Co., Ltd. Drew Scientific, Inc. ELITech Group SAS

Erba Diagonstics Mannheim GmbH Erba Lachema s.r.o. Euro Diagnostica AB Focus Diagnostics, Inc. GenBio GenPrime, Inc. Genzyme Corporation Gold Standard Diagnostics Great Basin Corporation Haemonetics Corporation Healgen Scientific, LLC HemaTechnologies Hitachi Chemical Diagnostics, Inc. Hologic, Inc. HORIBA, Ltd. Hycor Biomedical, Inc. HYPHEN Biomed SAS IDS PLC Immucor, Inc. Immunalysis Corporation Immuno-Mycologics, Inc. InBios International, Inc. Instrumentation Laboratory LifeSign, LLC Luminex Corporation LumiQuick Diagnostics, Inc. M Dialysis AB MACHEREY-NAGEL GmbH & Co. KG MagnaBioSciences, LLC Medica Corporation Medical Electronic Systems, LLC Medical Wire & Equipment Medimpex United, Inc. Medtronic PLC

MELET SCHLOESING Laboratoires SA Micro Distributing II, Ltd. Mindray Medical International Ltd. Mitsubishi Chemical Medience Corp. Nano-Ditech Corporation NanoEnTek, Inc. Native Diagnostics International NOVX Systems, Inc. NOWDiagnostics, Inc. OPTI Medical Systems Ortho-Clinical Diagnostics, Inc. Otsuka Pharmaceutical Co., Ltd. Oy Medix Biochemica Ab Pall Corporation PointCare Technologies, Inc. Premier Biotech, Inc. Quidel Corporation r2 Diagnostics Radiometer Medical ApS Randox Laboratories Ltd. Rapid Detect, Inc. Response Biomedical Corporation Sakae, Inc. Spectral Medical, Inc. Sysmex America, Inc. T2 Biosystems, Inc. TECHLAB, Inc. TEM Innovations GmbH Tokyo Boeki Machinery Ltd. Tosoh Corporation URIT Medical Electronic Group Co., Ltd. Vital Diagnostics, Inc. Wako Diagnostics

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 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 Concordance Healthcare Solutions, LLC Y Y 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 Lab Supply Specialists 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 Medicus Health N N Y Medline Industries, Inc. N Y Y Mercedes Scientific 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 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

List of consultants in the POL market

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

Vendor	Headquarters	Key services	Services page
AMS Medical Laboratories	St. Louis, MO, U.S.	Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, profitability analysis, procedure development, etc.	Services page
Ancillary Medical Solutions	San Diego, CA, U.S.	Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, staffing, procedure development, etc.	Services page
BP Laboratory Consulting, LLC	Arvada, CO, U.S.	Laboratory start-up, workflow improvement, procedure development, training, regulatory compliance, etc.	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
Carlos M. Madan & Associates	Dallas, TX, U.S.	Laboratory start-up, workflow improvement, quality management, procedure development, training, profitability analysis, etc.	Services page
Catalyst Consulting	Austin, TX, U.S.	Laboratory start-up, regulatory compliance, workflow improvement, profitability analysis	Services page
Clinical Lab Consulting, LLC	Carmel, IN, 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
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
ELITech Group SAS	Puteaux, France	Laboratory operations, billing and reimbursement, regulatory assistance, profitability analysis	Services page
Gnosis International, LLC	Garden Grove, CA, U.S.	Laboratory start-up, laboratory operations, regulatory assistance	Services page
Harrison Consultant	Cleveland, TX, U.S.	Pre-inspection evaluation, quality management, regulatory compliance, procedure development, technical writing, etc.	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
LisWalter Consulting	New York, NY, U.S.	Laboratory informatics, compliance management, quality management, procedure development, training, etc.	Services page
Medical Lab Consulting	Oklahoma City, OK, U.S.	Application processing, staffing, training, workflow management, inspection preparation	Services page
Narayan Laboratory Consulting Services, Inc.	Philadelphia, PA, U.S.	Laboratory start-up, regulatory requirements, training, process development, pre- and post-inspection guidance, quality management, inspection readiness	Services page
NueMedical Consulting	Lawrenceville, GA, U.S.	Moderate to complex toxicology laboratory setup and organization	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
POC Consultants, LLC	FL and NJ, U.S.	Regulatory compliance, review, and inspection services; training	Services page

List of consumables and supplies used in POL

Diagnostic analyzers and devices (CLIA-waived)

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

Diagnostic test kits and supplies (CLIA-waived)

• blood glucose test strips
• adenoviral conjunctivitis
• 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

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

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

Laboratory billing and revenue enhancement

The following businesses offer laboratory/medical billing and reimbursement assistance:

• Adept Clinical Consulting Team, LLC
• APS Medical Billing
• ClinLab Consultants
• Colaborate
• Hunter Consulting
• Kellison & Company
• LabMetrics, LLC
• Laboratory Billing Solutions
• LabPath Consulting
• MedCross Billing & Consulting Services
• Nichols Management Group Ltd.
• NueMedical Consulting
• OutCode, LLC
• Overbrook Advisory Services

Citation information for this chapter

Chapter: 6. 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 2015