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

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