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4 Things You Need to Know About Outfitting Your Primary Care Lab


To provide improved patient satisfaction, fast turnaround and increased revenue, many physicians have their own primary care laboratories which may vary in scope depending on the needs of the practice.

The most popular primary care laboratories are those that perform waived tests, where the risk of adverse outcome is low. More advanced laboratory testing requires Clinical Laboratory Improvement Amendment (CLIA) accreditation which can be cost-effective for larger practices. Below are four things you must know about setting up and outfitting primary care laboratories.

Laboratory Status

Primary care laboratories fall under the Centers for Medicare and Medicaid Services (CMS). Lab regulations include:

  • Certificate of waiver: Only certain simple tests are performed with a low error probability. Laboratories must be registered but are exempt from other CLIA requirements.
  • Certificate of provider-performed microscopy: Moderate complexity tests are performed by a physician or mid-level practitioner.
  • Compliance certificate for moderate to highly complex testing: Lab staff must meet minimum educational and experience requirements, survey and accreditation biannually.

Why You Should Consider a Primary Care Laboratory

If your practice requests large numbers of common laboratory tests, your own laboratory may be your best option. Most tests that fall under the waiver program are fast and automated. All you need to do is enroll with CLIA. Provided the cost of running tests is lower than an outside lab, you will reduce the practice expenditure. It also allows you to get results and diagnose quicker.

Staffing Requirements

Apart from personnel needed to perform tests, there are no other staffing requirements for waived tests. However, microscopy tests must be performed by yourself, another physician or a mid-level practitioner.

If you seek a higher level of accreditation, you must fill specific positions such as lab director, testing staff, technical consultant and clinical consultant.

Although each position has certain requirements, one person can serve more than one role, provided they have the required training, qualifications and experience.

Key Equipment

To set up a waived laboratory, you must buy the automated equipment necessary to perform the waived tests. The list of waived tests is broad and includes hemoglobin, strep, mono, flu and drug abuse tests.

If you are going to perform more advanced lab work, you'll need additional equipment including:

  • Centrifuges
  • Microscopes
  • Incubators
  • Lab refrigerators
  • Pipets, beakers, slides and flasks
  • Lab timers
  • Temperature monitors
  • Specimen transfer bags
  • Mixers

Outfitting your Primary Care Laboratory

The best place to start is with a waived laboratory that performs the common tests for your practice. Once you know the volume of tests, you can acquire the equipment and knowledge of consumable costs and determine whether or not you will require additional staff. Depending on the volume, you may find your existing staff may be sufficient.

Concordance Healthcare Solutions is pleased to provide highly-trained laboratory professionals to aid you in outfitting your primary care laboratory. They will guide you through the process of ordering the medical equipment and supplies you need to get your primary care laboratory up and running. Contact us here for more information.

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