What tests are CLIA waived tests?

What tests are CLIA waived tests?

What is waived testing? By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.

Is blood gas testing high complexity?

Currently, blood gas instrumentation used for POCT as well as that used in the central laboratory is classified as moderately complex.

What is CLIA high complexity testing?

High complexity tests include those that require clinical laboratory expertise beyond normal automation to perform. If the output of the data requires some expertise, these would also be highly complex.

How often should blood gas analyzers be tested?

The analysis of QC materials is mandatory for blood gas testing and two levels per day are recommended.

What Istat tests are CLIA waived?

At this time, only the i-STAT CHEM8+ cartridge is waived. All other i-STAT cartridges are non-waived. It is the responsibility of the facility performing the laboratory tests to meet the CLIA requirements.

What should blood gas levels be?

In general, normal values at sea level include: pH: 7.35-7.45. Partial pressure of oxygen (PaO2): 75 to 100 millimeters of mercury (mmHg). Partial pressure of carbon dioxide (PaCO2): 35 to 45 mmHg.

How does CLIA rank test?

How does CLIA rank tests? A nursing assistant needs to collect a urine sample from her patient. When she hands the specimen container to the patient, the patient touches the inside of the container.

Is i-STAT Chem 8 CLIA waived?

The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status.

What tests can be done on i-STAT?

i-STAT test cartridges are available for a broad range of diagnostic and treatment indicators including blood gases, electrolytes, metabolites and coagulation markers. Blood samples do not need to be processed before testing and results are available in around 2 minutes.

How do you read a blood gas test?

The first value a nurse should look at is the pH to determine if the patient is in the normal range, above, or below. If a patient’s pH > 7.45, the patient is in alkalosis. If the pH < 7.35, then the patient is acidosis. Remember, the lower the pH number, the higher the acid level in the body.

What are 3 examples of CLIA-waived tests?

As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring. CMS maintains a complete list of waived tests.