Difference between revisions of "LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Final thoughts and additional resources"
Shawndouglas (talk | contribs) (→List of CLIA-waived POL instrument and test kit vendors: URL updates) |
Shawndouglas (talk | contribs) (→List of CLIA-waived POL instrument and test kit vendors: URL updates) |
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! style="color:brown; background-color:#ffffee;"| Test kit type(s) | ! style="color:brown; background-color:#ffffee;"| Test kit type(s) | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.1stepdtx.com/ 1 Step Detect Associates, LLC] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |||
| style="font-weight: bold; padding-left:10px;"|[https://www.alere.com/en/home.html Abbott (formerly Alere/Inverness/Innovacon)] | |||
| style="background-color:white; padding-left:10px;"|immunology, toxicology | |||
| style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A | |||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.aconlabs.com/ ACON Laboratories, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|drug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, H. pylori, mono, ovulation test, pregnancy test, Strep A, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.advinbio.com/ Advin Biotech, Inc.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://hemaprompt.com/ Aerscher Diagnostics, LLC] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|fecal occult, gastric occult | | style="background-color:white; padding-left:10px;"|fecal occult, gastric occult | ||
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| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.alfascientific.com/ Alfa Scientific Designs, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, ovulation test, pregnancy test | | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, ovulation test, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://abmc.com/ American Bio Medica Corp.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.americanscreeningcorp.com/ American Screening Corp.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://ameritek.org/ Ameritek USA, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|fecal occult, ovulation test, pregnancy test, trichomonas | | style="background-color:white; padding-left:10px;"|fecal occult, ovulation test, pregnancy test, trichomonas | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.analyticon-diagnostics.com/en/ Analyticon Biotechnologies AG] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
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|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http://atlas-medical.com/ Atlas Medical Ltd.] | | style="font-weight: bold; padding-left:10px;"|[http://atlas-medical.com/ Atlas Medical Ltd.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
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| style="background-color:white; padding-left:10px;"|fecal occult, gastric occult, H. pylori, mono, pregnancy test, Strep A | | style="background-color:white; padding-left:10px;"|fecal occult, gastric occult, H. pylori, mono, pregnancy test, Strep A | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.bd.com/en-us Becton Dickson and Company] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|H. pylori, ovulation test, pregnancy test, Strep A | | style="background-color:white; padding-left:10px;"|H. pylori, ovulation test, pregnancy test, Strep A | ||
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| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://biolytical.com/ bioLytical Laboratories, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|HIV-1 | | style="background-color:white; padding-left:10px;"|HIV-1 | ||
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| style="background-color:white; padding-left:10px;"|fecal occult, ovulation test, pregnancy test | | style="background-color:white; padding-left:10px;"|fecal occult, ovulation test, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.biomerieux-diagnostics.com/ bioMérieux SA] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
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| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http://www.biotrondiagnostics.com | | style="font-weight: bold; padding-left:10px;"|[http://www.biotrondiagnostics.com/ Biotron Diagnostics, Inc.] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.brananmedical.com/ Branan Medical Corporation] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.btnx.com/ BTNX, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology | | style="background-color:white; padding-left:10px;"|immunology, toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH | | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, FSH, H. pylori, pregnancy test, RSV, Strep A, TSH | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://ecamco.com/ Cambridge Diagnostic Products, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|fecal occult | | style="background-color:white; padding-left:10px;"|fecal occult | ||
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| style="background-color:white; padding-left:10px;"|fecal occult | | style="background-color:white; padding-left:10px;"|fecal occult | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.cenmedonline.com/ Cen-Med Enterprises, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
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| style="background-color:white; padding-left:10px;"|fecal occult, pregnancy test, urine reagent strips | | style="background-color:white; padding-left:10px;"|fecal occult, pregnancy test, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://chematics.com/ Chematics, Inc.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
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| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://churchdwight.com/ Church & Dwight Co., Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://claritydiagnostics.com/ Clarity Diagnostics, LLC] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology | | style="background-color:white; padding-left:10px;"|immunology, toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, mono | | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, mono | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.cliawaived.com/ CLIAwaived, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, pregnancy test, Strep A, TSH, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, pregnancy test, Strep A, TSH, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.clinicalgenomics.com/ Clinical Genomics Technologies Pty. Ltd.] | ||
| style="background-color:white; padding-left:10px;"|immunology | |||
| style="background-color:white; padding-left:10px;"|fecal occult | |||
|- | |||
| style="font-weight: bold; padding-left:10px;"|[https://www.coastlinems.com/ Coastline Medical Management, LLC] | |||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
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| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http://cs-commonsense.com/ Common Sense Ltd.] | | style="font-weight: bold; padding-left:10px;"|[http://www.cs-commonsense.com/ Common Sense Ltd.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|vaginal pH | | style="background-color:white; padding-left:10px;"|vaginal pH | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.confirmbiosciences.com/ Confirm Biosciences] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
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| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http:// | | style="font-weight: bold; padding-left:10px;"|[http://www.dficare.com/en/index.php/ DFI Co., Ltd.] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.diagnosticsdirect2u.com/ Diagnostics Direct, LLC] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|syphilis | | style="background-color:white; padding-left:10px;"|syphilis | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://healthcare-manager.com/ EASY at Home Medical, LLC] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | ||
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| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.drugcheck.com/ Express Diagnostics International, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.firstcheckfamily.com/ First Check Diagnostics, LLC] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
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| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.helena.com/ Helena Laboratories Corp.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|fecal occult | | style="background-color:white; padding-left:10px;"|fecal occult | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[https://www.henryschein.com/us-en/ | | style="font-weight: bold; padding-left:10px;"|[https://www.henryschein.com/us-en/medical/ Henry Schein, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A, urine reagent strips | | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, influenza, mono, pregnancy test, Strep A, urine reagent strips | ||
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| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://homehealth-uk.com/ Home Health UK, Ltd.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.azoproducts.com/ i-Health, Inc.] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.immunostics.com/ Immunostics, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|fecal occult, pregnancy test, Strep A, urine reagent strips | | style="background-color:white; padding-left:10px;"|fecal occult, pregnancy test, Strep A, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.imcoinc.com/ Independent Medical Co-Op, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology | | style="background-color:white; padding-left:10px;"|immunology, toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.jantdx.com/ Jant Pharmacal Corp.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology | | style="background-color:white; padding-left:10px;"|immunology, toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, mono, pregnancy test, Strep A, TSH, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, mono, pregnancy test, Strep A, TSH, urine reagent strips | ||
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| style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A | | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.mn-net.com/ MACHEREY-NAGEL GmbH & Co. KG] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
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| style="background-color:white; padding-left:10px;"|H. pylori, mono, pregnancy test, Strep A, urine reagent strips | | style="background-color:white; padding-left:10px;"|H. pylori, mono, pregnancy test, Strep A, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.meditests.com/ Medimpex United, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology | | style="background-color:white; padding-left:10px;"|immunology, toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | ||
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| style="background-color:white; padding-left:10px;"|fecal occult, influenza, mono, pregnancy test, urine reagent strips | | style="background-color:white; padding-left:10px;"|fecal occult, influenza, mono, pregnancy test, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.meridianbioscience.com/ Meridian Bioscience, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.micro-distributing.com/ Micro Distributing II, Ltd.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http://www.mossmanassociates.com/ Mossman Associates, Inc.] | | style="font-weight: bold; padding-left:10px;"|[http://www.mossmanassociates.com/ Mossman Associates, Inc.] | ||
Line 662: | Line 630: | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.mpbio.com/ MP Biomedicals, LLC] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http://www. | | style="font-weight: bold; padding-left:10px;"|[http://www.egens-bio.com/ Nantong EGENS Bio Technology Company] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[https:// | | style="font-weight: bold; padding-left:10px;"|[https://betachek-europe.com/ National Diagnostic Products Pty. Ltd.] | ||
| style="background-color:white; padding-left:10px;"|clinical chemistry | | style="background-color:white; padding-left:10px;"|clinical chemistry | ||
| style="background-color:white; padding-left:10px;"|blood glucose test strips | | style="background-color:white; padding-left:10px;"|blood glucose test strips | ||
Line 678: | Line 646: | ||
| style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A | | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.ntsbiz.com/ National Test Systems, LLC] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
Line 690: | Line 658: | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.nexscreen.com/ NexScreen, LLC] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.noblemedical.com/ Noble Medical, Inc.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.ostsus.com/ On-Site Testing Specialists, Inc.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
Line 706: | Line 674: | ||
| style="background-color:white; padding-left:10px;"|drug screen, HCV, HIV-1 | | style="background-color:white; padding-left:10px;"|drug screen, HCV, HIV-1 | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.owens-minor.com/ Owens & Minor, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.phamatech.com/ Phamatech, Inc.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
Line 718: | Line 686: | ||
| style="background-color:white; padding-left:10px;"|TSH | | style="background-color:white; padding-left:10px;"|TSH | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.pblabs.com/ Pinnacle BioLabs, LLC] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
Line 726: | Line 694: | ||
| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.polymedco.com/ Polymedco, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|BTA, fecal occult, H. pylori, mono, pregnancy test, Strep A | | style="background-color:white; padding-left:10px;"|BTA, fecal occult, H. pylori, mono, pregnancy test, Strep A | ||
Line 734: | Line 702: | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.eptfamily.com/ Prestige Brands Holdings, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
Line 742: | Line 710: | ||
| style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, ovulation test, pregnancy test, Strep A | | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, H. pylori, ovulation test, pregnancy test, Strep A | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://us.pg.com/ Proctor and Gamble] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
Line 750: | Line 718: | ||
| style="background-color:white; padding-left:10px;"|fecal occult | | style="background-color:white; padding-left:10px;"|fecal occult | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.qualigeninc.com/ Qualigen, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|TSH | | style="background-color:white; padding-left:10px;"|TSH | ||
Line 762: | Line 730: | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.rpsdetectors.com/ Rapid Pathogen Screening, Inc.] | ||
| style="background-color:white; padding-left:10px;"|adenovirus, MMP-9 | | style="background-color:white; padding-left:10px;"|adenovirus, MMP-9 | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
Line 770: | Line 738: | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://rightbiometrics.com/ RightBio Metrics, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|gastric pH | | style="background-color:white; padding-left:10px;"|gastric pH | ||
Line 782: | Line 750: | ||
| style="background-color:white; padding-left:10px;"|influenza, pregnancy test, RSV, Strep A | | style="background-color:white; padding-left:10px;"|influenza, pregnancy test, RSV, Strep A | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http:// | | style="font-weight: bold; padding-left:10px;"|[http://sciinternational.com/ SCI International, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http:// | | style="font-weight: bold; padding-left:10px;"|[http://thyrochek.com/ Screening Devices Canada, Inc.] | ||
| style="background-color:white; padding-left:10px;"|clinical chemistry | | style="background-color:white; padding-left:10px;"|clinical chemistry | ||
| style="background-color:white; padding-left:10px;"|TSH | | style="background-color:white; padding-left:10px;"|TSH | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.sekisuidiagnostics.com/ Sekisui Diagnostics, LLC] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|mono, pregnancy test, Strep A, trichomonas | | style="background-color:white; padding-left:10px;"|mono, pregnancy test, Strep A, trichomonas | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.serim.com/ Serim Research Corporation] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|H. pylori | | style="background-color:white; padding-left:10px;"|H. pylori | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http://www.chemtronbio.com | | style="font-weight: bold; padding-left:10px;"|[http://www.chemtronbio.com/ Shanghai Chemtron Biotech Co., Ltd.] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.siemens-healthineers.com/ Siemens Healthcare GmbH] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[https:// | | style="font-weight: bold; padding-left:10px;"|[https://smcdirectonline.com/ SMC Direct, LLC] | ||
| style="background-color:white; padding-left:10px;"|immunology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|pregnancy test, Strep A, urine reagent strips | | style="background-color:white; padding-left:10px;"|pregnancy test, Strep A, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://spermcheck.com/ SpermCheck] | ||
| style="background-color:white; padding-left:10px;"|immunology | | style="background-color:white; padding-left:10px;"|immunology | ||
| style="background-color:white; padding-left:10px;"|semen | | style="background-color:white; padding-left:10px;"|semen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.ekfusa.com/ Stanbio Laboratory L.P.] | ||
| style="background-color:white; padding-left:10px;"|immunology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips | | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, mono, pregnancy test, Strep A, urine reagent strips | ||
Line 822: | Line 790: | ||
| style="background-color:white; padding-left:10px;"|ovulation test, pregnancy test | | style="background-color:white; padding-left:10px;"|ovulation test, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.syntron.net/ Syntron Bioresearch, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://tannerscientific.com/ Tanner Scientific, Inc.] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.tecodiagnostics.com/ Teco Diagnostics, Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, toxicology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|drug screen, fecal occult, ovulation test, pregnancy test, urine reagent strips | | style="background-color:white; padding-left:10px;"|drug screen, fecal occult, ovulation test, pregnancy test, urine reagent strips | ||
Line 837: | Line 805: | ||
| style="background-color:white; padding-left:10px;"|immunology, urinalysis | | style="background-color:white; padding-left:10px;"|immunology, urinalysis | ||
| style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, influenza, pregnancy test, RSV, Strep A, urine reagent strips | | style="background-color:white; padding-left:10px;"|fecal occult, H. pylori, influenza, pregnancy test, RSV, Strep A, urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[http://www.transmetrondrugtest.com/ Transmetron, Inc.] | | style="font-weight: bold; padding-left:10px;"|[http://www.transmetrondrugtest.com/ Transmetron, Inc.] | ||
Line 854: | Line 818: | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://ucpbiosciences.com/ UCP Biosciences, Inc.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
Line 866: | Line 830: | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://uveradiagnostics.com/ uVera Diagnostics, Inc.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen | ||
Line 874: | Line 838: | ||
| style="background-color:white; padding-left:10px;"|pregnancy test | | style="background-color:white; padding-left:10px;"|pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.whpm.com/ W.H.P.M., Inc.] | ||
| style="background-color:white; padding-left:10px;"|immunology, toxicology | | style="background-color:white; padding-left:10px;"|immunology, toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | | style="background-color:white; padding-left:10px;"|drug screen, pregnancy test | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://www.wiener-lab.com.ar/EN/ Wiener Laboratorios SAIC] | ||
| style="background-color:white; padding-left:10px;"|urinalysis | | style="background-color:white; padding-left:10px;"|urinalysis | ||
| style="background-color:white; padding-left:10px;"|urine reagent strips | | style="background-color:white; padding-left:10px;"|urine reagent strips | ||
|- | |- | ||
| style="font-weight: bold; padding-left:10px;"|[ | | style="font-weight: bold; padding-left:10px;"|[https://wolfeinc.com/ WOLFE, Inc.] | ||
| style="background-color:white; padding-left:10px;"|toxicology | | style="background-color:white; padding-left:10px;"|toxicology | ||
| style="background-color:white; padding-left:10px;"|drug screen | | style="background-color:white; padding-left:10px;"|drug screen |
Revision as of 03:26, 15 January 2020
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.
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.
|
|
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.
List of distributors
|
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
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