LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Additional Resources

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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.

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6. Additional Resources

Addendum

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

Further reading

Clinical laboratories, including the POL

Point-of-care testing

Other

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 January 2020. 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
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
Applied Biomedical, LLC 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
Bigfoot Biomedical, Inc. clinical chemistry blood glucose monitors
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
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
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
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
FirstVitals Health and Wellness, Inc. clinical chemistry blood glucose monitors
ForaCare, Inc. clinical chemistry blood glucose monitors
General Electric Company 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 Labs, Inc. clinical chemistry blood glucose monitors
i-SENS. Inc. clinical chemistry blood glucose monitors
ijDream Corporation clinical chemistry blood glucose monitors
Infopia Co., Ltd. clinical chemistry blood glucose monitors
Intuity Medical, Inc. clinical chemistry blood glucose monitors
Jant Pharmacal Corp. hematology hematology devices
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
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
MediVena, LLC clinical chemistry blood glucose monitors
Medline Industries, Inc. clinical chemistry, urinalysis blood glucose monitors, urine analyzers
Mesa Biotech, Inc. immunology digital immunoassay analyzer
MHC Medical Products, LLC clinical chemistry blood glucose monitors
MiCoBioMed Co., Ltd. clinical chemistry blood glucose monitors
Midwest Trading Group, 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
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
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
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
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
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
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
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
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 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
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 Strep A
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
EZ Testing Solutions, Inc. toxicology drug screen
First Check Diagnostics, LLC toxicology drug screen
Germaine Laboratories, Inc. immunology, urinalysis fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips
Get Stix, LLC immunology pregnancy test
Guangzhou Wondfo Co., Ltd. toxicology drug screen
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
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
Innovus Pharmaceuticals, Inc. urinalysis urine reagent strips
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
Kaasac Laboratories toxicology drug screen
Labsystems Diagnostics Oy immunology pregnancy test
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 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 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
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 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
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
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
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
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
Ramco Laboratories, Inc. immunology pregnancy test
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
Savyon Diagnostics Ltd. urinalysis urine reagent strips
Scanwell Health, Inc. urinalysis urine reagent strips
Safecare Biotech (Hangzhou) Co. Ltd. toxicology drug screen
Scanadu, Inc. urinalysis urine reagent strips
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
Shenzhen Aukeyhi Technology 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
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
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
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

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.

AB Sciex Pte. Ltd.
Abbot
Accelerate Diagnostics, Inc.
Access Bio, Inc.
Acro Biotech, LLC
Advanced Tear Diagnostics, LLC
Advin Biotech, Inc.
AESKU.GROUP GmbH & Co. KG
Affymetrix, Inc.
Aggredyne, Inc.
Agilent Technologies, Inc.
AiDe Diagnostic Co., Ltd.
Akers Biosciences, Inc.
Akonni Biosystems, Inc.
Alba Bioscience Ltd.
Alfa Wassermann, Inc.
Alifax S.r.l.
Alpha Laboratories Ltd.
American Laboratory Products Company Ltd.
AMS Srl
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.
Awareness Technology, Inc.
Azure Biotech, Inc.
BacterioScan, Inc.
Beckman Coulter, Inc.
Becton, Dickinson and Company
Baebies, Inc.
The Binding Site Group Ltd.
binx health, Inc.
Bio-Rad Laboratories, Inc.
Biocartis NV
Biofire Diagnostics, LLC
BioGenix Laboratories, Inc.
Biofortuna Ltd.
Biokit SA
bioLytical Laboratories, Inc.
Biophor Diagnostics, Inc.
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
Chrono-Log Corporation
Clever Culture Systems AG
Clinical Diagnostics Solutions, Inc.
Clinical Innovations, LLC
Coramed Technologies, LLC
Curetis NV
Cytocell Ltd.
Denka Seiken Co. Ltd.
DiAgam SA
DIAGAST SAS
Diagnostic Grifols SA
Diagnostica Stago, Inc.
Diamedix, 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.
DxNA, LLC
EDAN Instruments, Inc.
Eiken Chemical Co., Ltd.
ELITech Group SAS
Erba Diagonstics Mannheim GmbH
Erba Lachema s.r.o.
Euro Diagnostica AB
EUROIMMUN Medizinische Labordiagnostika AG
Eurospital SpA

Focus Diagnostics, Inc.
Foundation Medicine, Inc.
Fujirebio Europe NV
Genalyte, Inc.
GenBio
GenePOC, Inc.
GenMark Diagnostics, Inc.
GenPrime, Inc.
Genzyme Corporation
GlycoMark, Inc.
Gold Standard Diagnostics
Great Basin Corporation
Guangzhou Wondfo Co., Ltd.
Haemonetics Corporation
Hardy Diagnostics, Inc.
Healgen Scientific, LLC
Healthy.io Ltd.
Helena Laboratories Corporation
HemaTechnologies
Hemosonics, LLC
Hitachi Chemical Diagnostics, Inc.
Hologic, Inc.
HORIBA, Ltd.
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.
InDevR, Inc.
Infrared Laboratory Systems, LLC
Inova Diagnostics, Inc.
Instrumentation Laboratory
Invivoscribe, Inc
IVD Research, Inc.
iXensor Co., Ltd.
Kamiya Biomedical Company, LLC
KRONUS, Inc.
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.
Medion Diagnostics International Corporation
MedTest DX, Inc.
Medtronic PLC
MELET SCHLOESING Laboratoires SA
Meridian Bioscience, Inc.
Meso Scale Diagnostics, LLC
MetaSystems Indigo GmbH
Micro Distributing II, Ltd.
Mindray Medical International Ltd.
Mitsubishi Chemical Medience Corp.
Monobind, Inc.
Myriad Genetics, Inc.
Nano-Ditech Corporation
NanoEnTek, Inc.
NantHealth, Inc.
National Genetics Institute
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
OptiScan Biomedical Corporation
OraSure Technologies, Inc.
Orion Diagnostica Oy
Ortho-Clinical Diagnostics, Inc.
Otsuka Pharmaceutical Co., Ltd.
Oy Medix Biochemica Ab
Pall Corporation
Panion & BF Biotech Inc.
Parsagen Diagnostics, Inc.
PerkinElmer, Inc.
Phamatech, Inc.
Pixcell Medical Technologies, Ltd.
PointCare Technologies, Inc.
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.
Response Biomedical Corporation
Roche Diagnostics
Sakae, Inc.
Sanguina, LLC
Sebia SA
Sekisui Diagnostics PEI, Inc.
Sentinel CH SpA
Serosep Ltd.
Shenzhen Bioeasy Biotechnology Co. Ltd.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Shenzhen New Industries Biomedical Engineering Co. Ltd.
Siemens Healthcare Diagnostics
Sight Diagnostics Ltd.
Skyla Corporation
Spectral Medical, Inc.
Stanbio Laboratory L.P.
Stratec Biomedical AG
Streck, Inc.
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
Vital Diagnostics, Inc.
Wako Diagnostics
Wiener Laboratorios SAIC
Wuxi BioHermes Biomedical Technology Co. Ltd.

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
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
Concordance Healthcare Solutions, LLC Y Y Y
Custom Pack, Inc. N N Y
Dakota Medical Solutions N 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
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
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
Impact Diagnostic International N Y 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
Medical Distribution Group, Inc. N N Y
Medicus Health N N Y
Medline Industries, Inc. N Y Y
Mercedes Scientific, Inc. 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
LabMetrics, LLC Ishpeming, MI, U.S. Laboratory start-up, compliance management, workflow improvement, procedure development, revenue management, 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
Nichols Management Group Ltd. York Harbor, ME, U.S. "NMG is the laboratory business! We provide advisory, financial, operational and technical assistance to the
full spectrum of the healthcare industry."
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

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.

References


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