Is a CLIA license required for g-tube aspirate pH testing?

[OldRN1979]

One of the things I love about nursing is that I can always learn new things! I wanted to write a new policy for our facility to have nurses test g-tube aspirate for pH to determine placement instead of using an air bolus. But...my DON tells me that doing that would require us to have a CLIA license. Is this true? I can't find anything on the web either way.

[classicdame, MSN, EdD]

your lab director will know

[NRSKarenRN, BSN, RN]

CLIA Waivers

The Regulations (42 CFR part 493)

On February 28, 1992, regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.

The specified tests that are listed in the regulation are:

1. Dipstick or Tablet reagent urinalysis (non automated) for the following:
   
   
   • Bilirubin
     
   • Glucose
     
   • Hemoglobin
     
   • Ketone
     
   • Leukocytes
     
   • Nitrite
     
   • pH
     
   • Protein
     
   • Specific gravity
     
   • Urobilinogen
     

[*]Fecal occult blood

[*]Ovulation tests - visual color comparison tests for luteinizing hormone

[*]Urine pregnancy tests - visual color comparison tests

[*]Erythrocyte sedimentation rate-non-automated

[*]Hemoglobin-copper sulfate - non-automated

[*]Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use

[*]Spun microhematocrit

[*](added 1/19/93) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout

In November 1997, the CLIA waiver provisions were revised by Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver. Professional use versions of home use tests are not automatically waived. However, such professional versions do qualify for expedited waiver review since only the differences between the home use and professional use versions need to be examined to determine whether the professional version qualifies for waiver.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124202.htm

[wooh, BSN, RN]

We were going to start that but our GI group was against it. People on tube feeds tend to be meds that alter the pH. Not to mention, if they're on continuous feeds, you'll be getting the pH of the tube feed rather than the pH of stomach contents.