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Blood Gas Analysis under CLIA

CLIA regulations governing blood gas analysis in both moderate and high complexity labs are very specific as to the qualifications of those performing the tests and signing-off on competencies. CMS revised surveyor guidelines at the beginning of 2015 to require mandatory citations in four areas regardless of the presence or absence of any negative outcome or potential harm. One of the four citations involves issues related to personnel qualifications. While the CLIA regulations regarding personnel qualifications and responsibilities for testing and supervision have not changed, the requirement to issue mandatory citations has caused concerns among respiratory therapists involved in blood gas analyses. At issue are the education requirements one must meet in order to conduct blood gas testing, requirements for sign-off authority on competencies, and whether a Bachelor’s Degree in a title other than Respiratory Therapy meets the criteria. Answers to these issues are provided in a chart and a list of FAQs to assist RTs in clarifying the qualification standards. However, it is important to keep in mind that accrediting bodies such as the Joint Committee and the College of American Pathologists (CAP) may have more stringent standards than current regulations.