LII:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/Final thoughts and additional resources
5. Final thoughts and additional resources
5.1 Final thoughts
The physician office laboratory (POL) has come a long way since its humble origins in the 1800s, using urinalysis to diagnose patient afflictions. The modern POL has a wider range of testing options thanks to evolutions in technologies such as molecular diagnostics. Yet they are also more regulated today (at least in the U.S.) than their ancestors, with the likes of the Clinical Laboratory Improvement Amendments (CLIA) framing test complexity and the requirements that come with each level of complexity. Laboratory testing is not all that is regulated either, with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) dictating how data and other information generated from testing must be protected. Add to that concerns about ensuring financial reimbursement for testing, maintaining competent staff, implementing and reviewing standardized procedures, tracking specimens, and reporting results in a timely and accurate fashion; this can leave the enterprising physician office doubting whether a POL is worth the effort.
However, the promise of caring for a patient's needs at or near the point of care—and the benefits that come with that—remains strong. Yes, pharmacy laboratories have increasingly sprung up in the last 10 years, taking away some of the momentum of the POL, but the physician isn't found at the pharmacy. Patients will continue to visit their physician, and many will continue to get value from having some level of laboratory testing at the physician office. This is usually represented by a set of specific tests that lend themselves well to being conducted relatively easily and interpreted rapidly. Types of urinalysis, blood analysis, clinical chemistry, and immunological analysis—particularly those that are CLIA-waived—are most likely to be employed in the POL for a number of conditions, diseases, or analytes, including pregnancy, cholesterol, thyroid-stimulating hormone, and mononucleosis.
This testing requires thoughtful workflow preparation and management that takes into account not only the order of operations but also the flow of information. Data and information management practices are important to the POL, and if their workload justifies it, the POL may require software solutions like laboratory information systems (LIS) and electronic health records (EHRs). However, implementing such systems isn't necessarily straightforward, requiring additional considerations about budget and usefulness. Decisions on such software implementations, as well as the testing the lab conducts and how it's conducted, requires knowledgeable personnel who have been trained in information systems and testing protocols. How the laboratory is classified with CLIA will determine whether or not a laboratory manager is a hard requirement; however, in all cases someone should be taking the lead on POL operations. Are processes and procedures properly documented? Is there a quality management process in the POL? Does the lab participate in proficiency testing? These and other aspects of the POL must be addressed, regardless of the POL's CLIA classification.
In the end, a POL still serves an important role within the sphere of clinical laboratory testing. As molecular testing options continue to expand to the point of care, the POL will likely see additional opportunities to expand its test menu. This was seen with the emergence of the COVID-19 pandemic and the demand for rapid molecular testing that came with it, which made clear that a quick diagnosis at the physician's office, among other locations, is valuable to patient management and treatment. But the POL's continued utility and success will largely hinge upon effective setup and management, which in turn requires knowledgeable and motivated people to ensure the POL's long-term success.
5.2 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://www.aafp.org/family-physician/practice-and-career/managing-your-practice/pt-lab-testing/microscopy-atlas.html.
- Centers for Disease Control and Prevention (July 2015). "To Test or Not to Test? Considerations for Waived Testing" (PDF). Centers for Disease Control and Prevention. https://www.cdc.gov/labquality/docs/waived-tests/15_255581-test-or-not-test-booklet.pdf.
- Dasgupta, A.; Sepulveda, J.L. (2019). Accurate Results in the Clinical Laboratory: A Guide to Error Detection and Correction (2nd ed.). Elsevier. pp. 510. ISBN 9780128137772. https://books.google.com/books?id=HB2kDwAAQBAJ&printsec=frontcover.
- Garrels, Marti; Oatis, Carol S. (2018). Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Health Care Professionals (4th ed.). Elsevier Health Sciences. pp. 368. ISBN 9780323532235. https://www.elsevier.com/books/laboratory-and-diagnostic-testing-in-ambulatory-care/major/978-0-323-53223-5.
- Pagana, Kathleen Deska; Pagana, Timothy J.; Pagana, Theresa N. (2021). Mosby's Diagnostic and Laboratory Test Reference (15th ed.). Elsevier Health Sciences. pp. 1104. ISBN 9780323675192. https://evolve.elsevier.com/cs/product/9780323675192.
- Turgeon, M. (2018). Linne & Ringsrud's Clinical Laboratory Science (8th ed.). Elsevier Health Sciences. pp. 704. ISBN 9780323549837. https://www.elsevier.com/books/linne-and-ringsruds-clinical-laboratory-science/turgeon/978-0-323-53082-8.
- Wager, K.A.; Lee, F.W.; Glaser, J.P. (2021). Health Care Information Systems: A Practical Approach for Health Care Management. Wiley. pp. 416. ISBN 9781119853879. https://www.wiley.com/en-us/Health+Care+Information+Systems%3A+A+Practical+Approach+for+Health+Care+Management%2C+5th+Edition-p-9781119853879.
- "Lab Manager Magazine". LabX Media Group. 2022. https://www.labmanager.com/magazine.
- "Medical Laboratory Observer Magazine". Endeavor Business Media, LLC. 2022. https://www.mlo-online.com/magazine.
- "Physicians Office Resource Magazine". Medical Education Resources, LLC. 2022. https://www.physiciansofficeresource.com/articles/magazine/.
5.3 CLIA-waived 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 2022. 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.
5.4 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.
5.5 Instrument and equipment distributors
The following is a representative listing of distributors offering clinical analyzers, point-of-care equipment, and other medical laboratory supplies the POL may require.
5.6 Consultants serving the POL market
The following consultancies state they assist the POL market on their website:
|Vendor||Headquarters||Key services||Services page|
|A&J Laboratory Consultants||Dallas, TX, U.S.||Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, quality management, procedure development, etc.||Services page|
|Ancillary Medical Solutions||Beachwood, OH, U.S.||"Our comprehensive portfolio of medical ancillary programs are designed to help medical clinics improve practice efficiency, increase revenue, and deliver the highest level of care to patients."||Services page|
|Beyond Lab Consulting||New York, NY, U.S.||"Our scope ranges from small physician office labs (POL) to large reference laboratories. BLC consultants are well versed in CLIA regulations, hiring and training of clinical staff, maximizing income while keeping laboratory costs down."||Services page|
|Bruce North Country Consulting Services, LLC||Daytona Beach, FL, U.S.||"BNCCS is an experienced provider for physician office laboratories and small to moderate size hospital laboratories ... BNCCS provides expertise in designing, planning, implementing, seeking accreditation, and providing short and long term management."||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|
|Catalyst Consulting||Austin, TX, U.S.||Laboratory start-up, regulatory compliance, workflow improvement, profitability analysis||Services page|
|Clinical Lab Consultants, LLC||Sanford, FL, U.S.||Laboratory start-up, regulatory compliance, plans of correction||Services page|
|Clinical Lab Consulting, LLC||Dublin, OH, 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|
|Colaborate||Tampa, FL, U.S.||"We provide a full range of financial, technical and advisory consultation to fulfill the needs of pathology laboratories, medical laboratories, and clinical laboratories."||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|
|Eastern Connecticut Pathology Consultants||Manchester, CT, U.S.||Physician office laboratory management||Services page|
|K&K Consultant Group, Inc.||Torrence, CA, U.S.||Laboratory start-up, pre-inspection evaluation, post-inspection correction, workflow improvement, training, procedure development, etc.||Services page|
|Lab Advisory Bureau||Abilene, TX, U.S.||Data management, quality managementm, regulatory guidance, training, accreditation prep||Services page|
|Lab IQ, LLC||Calabasas, CA, U.S.||Compliance management, workflow improvement, training, procedure development, feasibility studies, etc.||Services page|
|LabMetrics, LLC||Ishpeming, MI, U.S.||Laboratory start-up, compliance management, workflow improvement, procedure development, revenue management, etc.||Services page|
|Lighthouse Lab Services||Charlotte, NC, U.S.||Laboratory start-up, compliance management, workflow improvement, procedure development, revenue management, growth strategy, etc.||Services page|
|Nichols Management Group Ltd.||York Harbor, ME, U.S.||"The Nichols Management Group, LTD., (NMG) provides laboratory consulting services for healthcare organizations. NMG specializes in operations optimization, strategic planning, mergers and acquisitions (M&A), sales and marketing development and go-to-market strategies."||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|
|Point of Care Consults||FL and NJ, U.S.||Regulatory compliance, review, and inspection services; training||Services page|
|ProSource Lab Consulting, LLC||Jersey City, NJ, U.S.||Laboratory start-up, procedure development, regulatory compliance, revenue management, etc.||Services page|
|Sound Lab Consultants||Phoenix, AZ, U.S.||Laboratory feasibility, laboratory start-up, procedure development, revenue management, technical consultation, etc.||Services page|
|South Shore Laboratory Consultants, Inc.||Braintree, MA, U.S.||"We have the expertise to facilitate all needs, from initial laboratory start-up through complete licensure, while ensuring continuous maintenance of your regulatory and quality systems."||Services page|
5.7 Consumables and supplies used in the POL
5.7.1 Diagnostic analyzers and devices (CLIA-waived)
- blood analyzers
- blood glucose monitors
- blood ketone monitors
- blood lead analyzers
- chemistry analyzers
- digital immunoassay analyzer
- fertility monitor
- hematology devices
- molecular immunoassay analyzer
- urine analyzers
5.7.2 Diagnostic test kits and supplies (CLIA-waived)
- blood glucose test strips
- adenoviral conjunctivitis
- B-type natriuretic peptide (BNP)
- 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
5.7.3 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
5.7.4 Medical supplies
- 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
5.8 Staffing agencies
The following are staffing agencies that focus at least some of their energy towards finding and placing laboratory personnel and management, including medical technologists, medical laboratory technicians, medical laboratory scientists, cytotechnologists, histotechnologists, phlebotomists, and laboratory directors.
5.8.1 National (U.S.) and global
- ACARA Solutions
- Accountable Healthcare Staffing
- All Medical Personnel
- All's Well
- Allied Search Partners
- AMN Healthcare
- Anders Group
- Aureus Medical Group
- Blue Signal
- Club Staffing
- Fusion Medical Staffing
- HealthCare Connections, Inc.
- Joule Scientific Staffing Solutions
- Kelly Services, Inc.
- LabMinds Staffing & Recruiting
- Labtopia Staffing
- Lighthouse Lab Services
- Maxim Staffing Solutions
- Med Travellers
- Medical Staffing Services
- Millenia Medical Staffing
- Uniforce Staffing Solutions
5.8.2 Regional (U.S.)
- Access Staffing (New York)
- Florida Medical Staffing (Florida)
- Halo Staffing Agency, LLC (Pennsylvania)
- Innovative Lab Solutions (New York)
- Laboratory Staffing, Inc. (Minnesota)
- MSG Staffing (Northeast)
5.9 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.
- Coronis Health
- Healthteq Services, LLC
- Laboratory Billings
- Laboratory Experts, LLC
- Medcare MSO, LLC
- MedConverge, LLC
- Medsphere Systems Corporation
- MPM, Inc.
- The Negotiators, LLC
- Phoenix Healthcare Services, Inc.
- Physicians Group Management, LLC
- Physicians' Service Center, Inc.
- Quadax, Inc.
- Quest National Services, LLC
- RPM Billing, LLC
Citation information for this chapter
Chapter: 5. Final thoughts and additional resources
Title: The Comprehensive Guide to Physician Office Laboratory Setup and Operation
Edition: Second edition
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: June 2022