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Transitioning from CLIA waived tests to moderately complex lab testing at your physician office

Making the transition from offering waived testing to moderately complex laboratory testing involves a shift in mindset from simply offering a service to running a business within your primary business. That's because the value that you can generate in operational efficiencies with moderately complex testing often makes the trade-off justifiable for high-volume practices.

The move toward this decision may start with the realization that testing volumes have increased enough to justify running tests in batches, using more sophisticated and expensive equipment.

One downside of moving to moderately complex testing, on the other hand, is that turnaround time for results shifts from real time or within hours to within days. You may be able to minimize wait times by using a combination of waived and moderately complex testing based on the specific needs of your practice.

Your patient volumes and testing menu will help you determine which analyzers, test systems and test kits you'll need. Analyzer selection will also be influenced by your level of laboratory license, the technical capabilities of your laboratory staff and the available space and specifications of your laboratory.

For example, when selecting laboratory test systems, consider analyzers and test systems that:1

  • Capture the test menu based on your send-out log
  • Offer the best cost per test and turnaround times (TAT)
  • Fit within your available physical space
  • Allow you to comply with the manufacturer's specifications regarding electrical, plumbing, ventilation and internet capability
  • Provide an easy-to-use instrument interface
  • Require little time for start up and maintenance
  • Offer service warranty options
  • Require few additional consumables and supplies
  • Can be connected to instruments and/or EMR at little additional cost

Once you select your analyzer, you'll sign a contract that includes:

  • Terms and conditions
  • Reagent pricing agreements
  • Service contracts
  • Leasing agreements
  • Warranties

Once you have completed the contract, your vendor will schedule training for your team members who will run the equipment. Once training is complete, your practice will be responsible for the analyzer's validation and the integration of a laboratory information system (LIS). Your team members must also review all policy, procedure and quality assessment plans. This will help ensure the quality of your testing and the completeness of your documentation review and retention.  

Personnel for moderately complex physician office lab testing

The major consideration in transitioning from CLIA waived laboratory procedures to moderately complex testing generally involves your staffing commitment. CLIA has personnel requirements that depend on the complexity of testing. Here are the staff positions you may need to fill to conduct moderately complex testing.  

Lab director

Many physicians and practice owners choose to fill this role by becoming qualified to oversee a moderately complex lab. You can find a variety of online lab director courses that meet the requirements to qualify someone as a lab director. Such courses are generally worth 20 or more CME credits. Once you have your certificate of completion, you'll need to submit it to CLIA and your state agency.

Lab supervisor

Though it's not a requirement for a moderately complex lab, you may decide that you want a lab supervisor on your staff. You'll want to choose a team member with good analytical skills to fill this role, with at least a high school diploma. The lab supervisor works with oversight by the lab director.

Technical consultant

You may need a technical consultant for a new lab setup if the lab director has not been listed on a past CLIA certificate or does not have prior experience overseeing a moderately complex lab for at least a year. The role of the technical consultant is to provide guidance and oversight with federal and state regulatory requirements.

The consultant you hire should have a Bachelor of Science degree with proof of Chemistry, Biology and/or Physics course studies or education from an accredited Medical Technology program. They should be licensed and have expertise in CLIA compliance, state regulatory concerns, licensure requirements and the integration of laboratory equipment. It's highly recommended that the technical consultant be available to review monthly records and, similar with the lab director, have some visitations during the year if they are contracted.

Many physicians turn to technical consultants such as MedSol laboratory consulting at McKesson Medical-Surgical for information on specific state regulations. You can also find consultants through the national accreditation organization COLA, Inc., local accreditation organizations or CLIA surveyors.

For more tips and guidance, continue reading McKesson's six-part series, The primary care physician's guide to expanding your practice with point-of-care testing

1: Shudfelt, John, M.D., J.D., M.B.A., FACEP, The Textbook of Urgent Care Management 

Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.

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