POL series: Part 2

Edition: November 2008 - Vol 16 Number 11
Article#: 3060
Author: Repertoire

Editor's Note: In the second part of this series, Repertoire has provided a list of CLIA-Waived tests and descriptions.


Adenovirus Rapid Test Kit 87809QW

Albumin, Urine or Other Source, Quantitative 82042QW

Albumin, Urine, Semi-Quantitative 82044QW

Alkaline Phosphatase 84075QW

ALT (SGPT) 84460QW

Amylase 82150QW

AST (SGOT) 84450QW

Alcohol Saliva Test 82055QW

Amines and pH 82120QW

Amines and pH 83986QW

Aspirin Resistance Test 85576QW

Bilirubin 82247QW

Bladder Cancer Antigen 83518QW

BNP 83880QW

BUN 84520QW

Chemistry Tests: Basic Metabolic Panel 80048QW

Chemistry Tests: Comprehensive Metabolic Panel 80053QW

Cholesterol 82465QW

Cholesterol, HDL 83718QW

Cholesterol, LDL 83721QW

Drugs of Abuse Tests 80101QW

FOB, Diagnostic 82272

FOB, Screening 82270

FOB, Single Test for Colorectal Neoplasm G0394

FOB, Immunoassay 82274QW or G0328

FSH 83001QW

Gastric Occult Blood 82273QW

GGT 82977QW

Glucose Meters 82962

Glucose Tolerance Test, 3 Specimens 82951QW

Glucose 82947QW

Hemoglobin A1c 83036QW

Hematocrit 85014QW

Hemoglobin 85018QW

H. Pylori Rapid Test Kits 86318QW

HIV (Saliva and Whole Blood) Test 86703QW

HIV, Whole Blood (only) Test 86701QW

Influenza Rapid Test Kits 87804QW

Lead Test 83655QW

Lipid Panel 80061QW

Lyme Disease Rapid Test Kit 86618QW

Microalbumin Immunoassay 83518QW

Microalbumin, Urine Quantitative 82043QW

Mononucleosis Test Kits 86308QW

Nicotine Test 80101QW

Ovulation Test Kits 84830

Pregnancy Test Kits Urine, Qualitative 81025

Pregnancy Test Urine Instrument 84703QW

Protein, Total 84157QW

Prothrombin Time 85610QW

RSV Rapid Test Kit 87807QW

Sedimentation Rate, Non-Automated 85651

Strep Rapid Test Kits 87880QW

Trichomonas Rapid Test Kit 87808QW

Triglycerides 84478QW

TSH, Qualitative 84443QW

Urinalysis, Automated 81003QW

Urinalysis, Visual, Dipstrip 81002

Urine Creatinine 82570QW

Urinary Tract Infections 81007QW

CLIA Test Classification

The CLIA requirements are based on the complexity of tests (waived, moderate and high) and not the type of entity where testing is performed. CLIA classifies all tests into the following categories:


Moderate Complexity

High Complexity

Provider Performed Microscopy Procedures (PPMP), technically a subspecialty of the moderate complexity category.

CLIA requirements for personnel and quality measures range from onerous for very complicated tests (termed highly complex) to virtually nonexistent for the simplest tests (CLIA-waived).

PPMP Tests

Microscopic tests performed by a physician, physician's assistant, nurse practitioner, nurse midwife, or dentist:

Wet Mounts

KOH Preps

Pinworm Preps

Fern Tests

Post-Coital Qualitative Exam

Urine Sediment Exam

Nasal Smears for Granulocytes

Fecal WBC Examinations

Semen Analysis, Qualitative

Moderately Complex Tests

Hematology Instruments:

- CBCs

- Manual Differential/Limited ID

Chemistry Tests: Large Analyzers

Microbiology Tests

- DNA Analyzer for Trichomonas vaginalis, Gardnerella vaginalis, Candida albicans

- Urine Culture/Colony Count Only

- Gram Stain/Urethral,Cervical for GC

- Throat Culture Screen Using Hemolysis, Bacitracin Disk, Selective Strep Agar

- GC Culture Screen Using Gram Stain and Oxidase Test

- Some Rapid Kits: Chlamydia, RF, etc.

Highly Complex Tests

All remaining tests are classified as highly complex.