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Clinical Laboratory Fees and Test Counts

 

Clinical Laboratory Fees and Test Counts

Calculating Fees

  • If you are accredited by an approved accreditation organization (A2LA, AABB, ASHI, CAP, COLA, or The Joint Commission), the biennial licensure fee is $100.
  • If you are an out-of-state Laboratory, please let your accrediting organization know that you are seeking licensure in Florida so that the $100 fee can apply. Also, if you are surveyed by New York or Washington, please provide that information to qualify as an out-of-state exempt Laboratory and for the $100 fee. If not accredited, please count only tests on specimens from Florida laboratories.
  • If you are performing non-waived tests including PPM testing and are not accredited by an approved accreditation organization, you will be assessed a biennial (two year) licensure fee based on the specialties and volumes of testing that you perform. The table below describes those fees.
Although CLIA CMS116 forms are a part of the Laboratory application packet submitted to the state, the CLIA program separately bills the Laboratory for payment. CLIA fees should never be sent to the State of Florida.
Annual Volume of Non-Waived Testing Number of Specialties Biennial Fee
Not more than 2,000 tests per year NA $400
More than 2,000, but not more than 10,000 Not more than 3 testing categories $965
Not more than 10,000
At Least 4 testing categories
$1,294
More than 10,000, but not more than 25,000 Not more than 3 testing categories $1,592
More than 10,000, but not more than 25,000 At least 4 testing categories $2,103
More than 25,000 but not more than 50,000 NA $2,364
More than 50,000, but not more than 75,000 NA $2,625
More than 75,000, but not more than 100,000 NA $2,886
More than 100,000, but not more than 500,000 NA $3,397
More than 500,000, but not more than 1,000,000 NA $3,658
More than 1,000,000 tests NA $3,919

Counting Tests

Do not count:

  • Waived tests
  • Proficiency test samples
  • Quality control samples
  • Calculated test results
  • Tests referred to another Laboratory
Procedure How to Count
All PPM tests Count each specimen as one test.
Urinalysis dipstick (Non-waived) Count as one test, regardless of the number of reagent pads on the test strip.
Urine Microscopic Count each specimen as one test.
Chemistry Tests and Profiles Count each test individually, even if performed as part of a profile. Do not count calculated results such as A/G & BUN/creatinine ratios, osmolality, etc.
Allergens Count each allergen as one test.
CBC Count each measured CBC parameter (WBC/RBC/platelet/hemoglobin/MCV) individually. Do not count calculated results such as automated hematocrit, indices, etc.
Manual or automated WBC differentials Count manual or automated WBC differentials as one test, regardless of the number of parameters reported.
Immunohematology tests Count each individual immunohematology test (ABO, Rh, antibody screen, antibody identification, crossmatch or other immunohematology test) as one test each.
Cultures Count each culture type as one, regardless of the extent of identification. (e.g., If a sputum specimen is provided for routine culture, gram stain, AFB smear and culture, and a mycology culture, it counts as five tests.
Antimicrobial susceptibility tests Count each test as one, regardless of the number of disks.
Direct parasite smear/concentration Count each specimen as one test.
Trichrome stains, etc. Count each specimen as one test.
Pathology and Cytology Count each specimen as one test.