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CLINICAL LABORATORY LICENSURE FEE ASSESSMENTS

(These fees are in addition to federal CLIA fees.)
 
Section 483.172, F.S., provides for the following clinical laboratory licensure fees:
  • If you are performing waived testing only, the biennial (two-year) licensure fee is $100.
  • If you are accredited by an approved accreditation organization (CAP, COLA, the Joint Commission, AABB, ASHI), the biennial licensure fee is $100.
  • 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.
Annual Volume of Non-Waived TestingNumber of SpecialtiesBiennial Fee
Not more than 2,000 tests per yearNA$400
More than 2,000, but not more than 10,000Not 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 testsNA$3,919


HOW TO COUNT TESTS
Do not count:
  • Waived tests
  • Proficiency test samples
  • Quality control samples
  • Calculated test results
  • Tests referred to another laboratory

ProcedureHow 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 MicroscopicCount each specimen as one test.
Chemistry Tests and ProfilesCount 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.
AllergensCount each allergen as one test.
CBCCount 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 differentialsCount manual or automated WBC differentials as one test, regardless of the number of parameters reported.
Immunohematology testsCount each individual immunohematology test (ABO, Rh, antibody screen, antibody identification, crossmatch or other immunohematology test) as one test each.
CulturesCount 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 testsCount each test as one, regardless of the number of disks.
Direct parasite smear/concentrationCount each specimen as one test.
Trichrome stains, etc.Count each specimen as one test.
Pathology and CytologyCount each specimen as one test.