CLIA 88 TEST LEVEL LIST
Certificate of Waiver
1. Dipstick or Tablet Reagent Urinalysis (nonautomated) for the following: Bilirubin, Glucose, Hemoglobin, Ketone, Leukocyte, Nitrite, pH, Protein, Specific gravity and Urobilinogen, micro-albumin.
2. Fecal occult blood
3. Ovulation test - visual color comparison tests
4. Urine pregnancy test - visual color comparison tests
5. Erythrocyte sedimentation rate, nonautomated
6. Hemoglobin - Hemocue, Cholesteck LDX or copper sulfate
7. Spun Hematocrit
8. Blood Glucose (FDA - Cleared Home Use Devices, HemoCue, Cholesteck)
9. Cholesterol - using the "AccuMeter", "Advance Care" or Cholesteck LDX
10. Triglycerides, HDL - Cholesteck LDX
11. Rapid Strep - check company
12. H. Pylori - Pyloritek Test Kit, Quidel H. Pylori, CLOtest, Abbott Flex
13. Prothrombin Time - check company
14. A2 Hemoglobin - check company
15. Automated urinalysis - check company
16. Alcohol level - check company
New tests keep getting added to this list - check manufacturer or: http://www.fda.gov/cdrh/clia/testswaived.html
Physician Performed Microscopy
1. Wet mounts including preparation of vaginal, cervical or skin specimens
2. All potassium hydroxide preparations (KOH)
3. Pinworm examinations
4. Fern tests
5. Postcoital direct tests
6. Qualitative examination of vaginal or cervical mucous
7. Urine sediment examination
8. Fecal leukocyte examination
9. Wet mount exams of prostatic secretions
10. Qualitative semen analysis (absence or presence)
Moderate Complexity (non-waived)
1. Clinical Cytogenetics2. Histopathology
3. Histocompatibility
4. Cytology - no procedures
5. Bacteriology (complexity level will depend on method used)
(i) Primary culture inoculation
(ii) Urine culture/colony count only
(iii) Microscopic evaluation of direct wet mount preparations
(iv) Isolation and presumptive identification of aerobic bacteria from throat or urine or cervical/urethral specimens
(v) Isolation and confirmatory identification of aerobic bacteria from throat or urine or cervical/urethral specimens
(vi) Gram stain
(vii) Dark̵field examination for Treponema pallidum
(viii) Manual procedures with limited steps and with limited sample or reagent preparation.
(ix) Manual screening devices for bacteriuria with limited steps and with limited sample or reagent preparation
(x) Automated procedures that do not require operator intervention during the analytic process.
6. Mycobacteriology
(i) Direct acid-fast smear
7. Mycology
(i) Primary culture inoculation
(ii) Isolation and identification of yeast limited to Candida Albicans
(iii) Identification procedures for Candida albicans (excluding semi-automated and semi-quantitative procedures)
(iv) Microscopic evaluation of direct wet mount preparations
(v) Tests using selective media for the presence or absence of dermatophytes
(vi) Microscopic evaluations of KOH preparations (if not performed by physician)
(vii) Manual procedures with limited steps and with limited sample or reagent preparation
(viii) Automated procedures that do not require operator intervention during the analytic process.
8. Parasitology
(i) Microscopic evaluation of pinworm preparations
(ii) Microscopic evaluation of direct wet mount preparation for the presence or absence of parasites
(iii) Manual screening with limited steps and with limited sample or reagent preparation
(iv) Culture devices indicating the presence or absence of Trichomonas vaginalis
9. Virology
(i) Manual procedures with limited steps and with limited sample or reagent preparation(ii) Automated procedures that do not require operator intervention during the analytic process.
10. Immunology
(i) Manual procedures with limited steps and with limited sample or reagent preparation(ii) Automated procedures that do not require operator intervention during the analytic process.
(iii) Dark̵field examinations for Treponema pallidum
11. Chemistry (Routine/Endocrinology/Toxicology)
(i) Automated procedures that do not require operator intervention during the analytic process.(ii) Automated blood gas analyses not requiring extensive operator intervention(such as instruments that have an automated process for calibration, sample intake, and flushing of sample lines).
(iii) Whole blood measurements using test stripmeters, (excluding glucose monitoring devices cleared by the FDA specifically for home use)
(iv) Osmolality measurements
(v) Manual procedures limited steps and with limited sample or reagent preparation
12. Urinalysis
(i) Microscopic analysis of urinary sediment (if not performed by physician)
(ii) Automated procedures that do not require operator intervention during the analytic process.
13. Hematology
(i) Automated hematology procedures without differentials that do not require operator intervention during the analytic process
(ii) Automated hematology procedures with differentials that do not require operator intervention during the analytic process and that do not require an analyst to interpret a histogram or scattergram.
(iii) Manual white blood cell differential counts when the analyst is not required to interpret any atypical cells.
(iv) Manual hematological procedures with limited steps or with limited sample or reagent preparation
(v) Automated procedures that do not require operator intervention during the analytic process.
(vi) Manual coagulation procedures with limited steps and with limited sample or reagent preparation
14. Immunohematology
(i) Manual or semiautomated procedures with limited steps and with limited sample or reagent preparation
(ii) Automated procedures that do not require operator intervention during the analytic process.
15. Other
(i) Semen analysis (qualitative) (if not performed by physician)
(ii) Occult blood on body fluid
(iii) Crystal analysis on joint fluid
(iv) Viscosity
Tests of High Complexity
All other tests