1 - I

Section 1 : REGULATIONS


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

17. Influenza - check company

ALL WAIVED TEST MUST STATE WAIVED ON THE MANUFACTURER INFORMATION

Physician Performed Microscopy

1. Wet mounts including preparation of vaginal, cervical or skin specimens

2. All potassium hydroxide preparations (KOH)

3. Pinworm examinations

4. Fem 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)

* A complete list of approved waived tests is available by accessing the CLIA web site: http://www.cms.gov/medicaid/clia/waivebl.htm



CLIA PERSONNEL REQUIREMENTS

WAIVED TESTING

DIRECTOR:

1. Licensed physician

TESTING PERSONNEL:

1. Minimum: High school graduate with documented on the job training for tests performed.

PROVIDER PERFORMED MICROSCOPY DIRECTOR:

l. Licensed physician - MD or DO, Podiatrists, Dentists qualified in pathology.

TESTING PERSONNEL

1. Physician

2. Nurse midwives - documented training for tests performed

3. Physician Assistants (degree/certified) - documented training for tests performed

4. Nurse practitioners - documented training for tests performed