Difference between revisions of "LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Final thoughts and additional resources"

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The following is a list of vendors verified to sell CLIA-waived instruments and/or test kits. Vendors were pulled from the FDA's [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm142437.htm 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.
The following is a list of vendors verified to sell CLIA-waived instruments and/or test kits. Vendors were pulled from the FDA's [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm142437.htm 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''': Keep in mind that 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. Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived.  
'''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.  


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Revision as of 22:30, 14 July 2015

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

This seventh chapter containing additional resources has eight sections.

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

7. Additional Resources

Further reading

Clinical laboratories, including the POL


Point-of-care testing


List of CLIA-waived POL instrument and test kit vendors

The following is a list of vendors verified to sell CLIA-waived instruments and/or test kits. Vendors were pulled from the FDA's downloadable CLIA file from May 2015. The file was sorted to pull out the CLIA-waived devices, and then the vendors were researched to see if they still actively marketed the listed product(s). In some cases, the vendor listed on the FDA file was acquired by another company. If the associated products were still found to be marketed by the acquiring company, that company name was used. CLIA-waived device and test kit types are given as a general guide to what CLIA-waived items the vendor offers.

Note: Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived. Some of these vendors may also sell analyzers and tests that are certified moderate or complex. Additionally, this listing does not name the specific CLIA-waived item(s). It is ultimately up to the potential buyer to verify with the vendor that a specific item is CLIA-waived before purchase.

Vendors of CLIA-waived Instruments and Devices
Original manufacturer Testing domains covered Device type(s)
Abaxis, Inc. clinical chemistry chemistry analyzers
Abbot Point of Care clinical chemistry blood analyzers, chemistry analyzers
Abbot Diabetes Care clinical chemistry blood glucose monitors
ACON Laboratories, Inc. clinical chemistry, hematology, urinalysis blood glucose monitors, hematology devices, urine analyzers

KEY

  • BA = blood analyzer
  • BGM = blood glucose monitor
  • CA = chemistry analyzer
  • DIA = digital immunoassay analyzer
  • FM = fertility monitor
  • HD = hematology device
  • UA = urine analyzer
Vendors of CLIA-waived Instruments and Devices
Original manufacturer Testing domains covered BA BGM CA DIA FM HD UA
Abaxis, Inc. clinical chemistry Y
Abbot Point of Care clinical chemistry Y Y
Abbot Diabetes Care clinical chemistry Y
ACON Laboratories, Inc. clinical chemistry, hematology, urinalysis Y Y Y
Vendors of CLIA-waived Test Kits and Supplies
Original manufacturer Testing domains covered Test kit type(s)
1 Step Detect Associates, LLC toxicology drug screen
AccuTech, LLC clinical chemistry HDL
ACON Laboratories, Inc. immunology, toxicology, urinalysis drug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips
Advin Biotech, Inc. toxicology drug screen

KEY

  • ACO = adenoviral conjunctivitis
  • BTA = bladder tumor associated antigen
  • DRU = drug screen
  • FOB = fecal occult blood
  • FSH = follicle-stimulating hormone
  • GAS = gastrick pH
  • GOB = gastric occult blood
  • HCG = pregnancy test
  • HCV = Hepatitis C virus antibody
  • HDL = HDL cholestrol
  • HIV = HIV-1 and/or HIV-2
  • HPY = H. pylori
  • IAB = influenza A and/or B
  • MMP = MMP-9 protein (for dry eye disease)
  • MON = mononucleosis
  • OVU = ovulation test
  • RSV = respiratory syncytial virus
  • SEM = semen (fertility)
  • STR = Strep A
  • SYP = syphilis
  • TRI = trichomonas
  • TSH = thyroid-stimulating hormone
  • URS = urine reagent strips
  • VAG = vaginal pH
Vendors of CLIA-waived Instruments and Devices
Original manufacturer Testing domains covered ACO BTA DRU FOB FSH GAS GOB HCG HCV HDL HIV HPY IAB MMP MON OVU RSV SEM STR SYP TRI TSH URS VAG
1 Step Detect Associates, LLC clinical chemistry Y
AccuTech, LLC clinical chemistry Y
ACON Laboratories, Inc. clinical chemistry Y Y Y Y Y Y Y
Advin Biotech, Inc. clinical chemistry, hematology, urinalysis Y

List of other POL vendors, not covered elsewhere

List of distributors

List of consultants in the POL market

List of consumables and supplies used in POL

List of suppliers

Laboratory billing

References


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