LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Additional Resources
Setting up and running a physician office laboratory (POL) requires resources and know-how. The more you know the better, they say. This chapter offers a variety of additional resources for those who want to know more about setting up and operating a POL, including vendors, distributors, consultants, and other recommended reading. Note: The appearance of an entity on these lists does not constitute as an endorsement for that entity.
This seventh chapter containing additional resources has eight sections.
- 1 6. Additional Resources
- 1.1 Addendum
- 1.2 Further reading
- 1.3 List of CLIA-waived POL instrument and test kit vendors
- 1.4 List of other diagnostic instrument and test kit vendors
- 1.5 List of distributors
- 1.6 List of consultants in the POL market
- 1.7 List of consumables and supplies used in POL
- 1.8 Laboratory billing and revenue enhancement
- 2 References
- 3 Citation information for this chapter
6. Additional Resources
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.
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 Diagnostic Testing". Research Portfolio Online Reporting Tools. National Institutes of Health. 29 March 2013. http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=112.
- "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 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.
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.
|Ancillary Medical Solutions||San Diego, CA, U.S.|| Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,
staffing, procedure development, etc.
|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.
|Carlos M. Madan & Associates||Dallas, TX, U.S.|| Laboratory start-up, workflow improvement, quality management, procedure development, training,
profitability analysis, etc.
|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."
|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."
|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.
|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.
|K&K Consultant Group, Inc.||Torrence, CA, U.S.|| Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement,
training, procedure development, etc.
|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
|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."
|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)
- ovulation test
- respiratory syncytial virus (RSV)
- semen (fertility)
- Strep A
- thyroid-stimulating hormone (TSH)
- urine reagent strips
- vaginal pH
Laboratory furniture and equipment
- blood pressure meters
- cabinets and stands
- chairs: doctor and patient
- EKG machines
- eyewash stations
- fume hoods
- glove boxes
- hot plates
- mats and trays
- microscopes and accessories
- refrigerators and freezers
- sharps containers
- sterilization equipment
- tube rockers
- waste containers
- bandages and dressings
- buffers, reagents, and solvents
- cleaning supplies
- eyeware and safety goggles
- face and splash shields
- gloves: chloroprene, latex, synthetic, vinyl
- labels and tapes
- needles, lancets, and other sharps
- swabs and applicators
- surgical instruments
- table paper
- tube racks
- urine and stool containers
- vacutainer tubes
- 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.
- Advanced Data Systems Corporation
- Affinity Billing, Inc.
- AMC Billing Services, LLC
- APS Medical Billing, Inc.
- Bikham Information Technology Corporation
- Change Healthcare, Inc.
- ClaimCare, Inc.
- CollaborateMD, Inc.
- Healthteq Services, LLC
- Infallibill Corp.
- Kellison & Co.
- Laboratory Billing Solutions, Inc.
- Laboratory Experts, LLC
- Medcare MSO, LLC
- MedConverge, LLC
- MPM, Inc.
- The Negotiators, LLC
- Phoenix Healthcare Services, Inc.
- Physicians Group Management, LLC
- Physicians' Service Center, Inc.
- PractiSource, LLC
- Quadax, Inc.
- Quest National Services, LLC
- RPM Billing, LLC
- Softactics, Inc.
- TELCOR, Inc.
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